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Li S, Pandat T, Chi B, Moon D, Mas M. Management Approaches to Spastic Gait Disorders. Muscle Nerve 2025. [PMID: 40196899 DOI: 10.1002/mus.28402] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2024] [Revised: 03/16/2025] [Accepted: 03/18/2025] [Indexed: 04/09/2025]
Abstract
Spastic gait presents clinically as the net mechanical consequence of neurological impairments of spasticity, weakness, and abnormal synergies and their interactions with the ground reaction force in patients with upper motor neuron syndromes and with some neuromuscular diseases. It is critical to differentiate whether the primary problem is weakness or spasticity, thus better understanding different phenotypes of spastic gait disorders. Pelvic girdle abnormality plays a pivotal role in determining the clinical presentation of gait disorders, since it determines the body vector and compensatory kinetic chain reactions in the knee and ankle joints. Knee joint abnormality can be a mechanical compensation for hip and/or ankle and foot abnormality. Diagnostic nerve blocks and instrumented gait analysis may be needed for diagnosing the underlying problems and developing an individualized plan of care. A wide spectrum of treatment options has been used to manage spastic gait disorders. Some are in early and investigational stages, such as neuromodulation modalities, while others are well-developed, such as therapeutic exercise, ankle-foot orthoses, botulinum toxin treatment, and surgical interventions. Physicians and other healthcare providers who manage spastic gait disorders should be familiar with these treatment options and should employ appropriate interventions concurrently rather than serially. The most effective treatments can be selected based on careful evaluation, inputs from patients, family, and therapists, along with appropriate goal setting. Treatment plans need to be re-evaluated for effectiveness, relevance, and in concordance with disease progress. This is particularly important for patients with progressive neuromuscular diseases such as amyotrophic lateral sclerosis.
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Affiliation(s)
- Sheng Li
- Department of Physical Medicine and Rehabilitation, McGovern Medical School, University of Texas Health Science Center - Houston, Houston, Texas, USA
- TIRR Memorial Hermann, Houston, Texas, USA
| | - Tulsi Pandat
- Department of Physical Medicine and Rehabilitation, McGovern Medical School, University of Texas Health Science Center - Houston, Houston, Texas, USA
- TIRR Memorial Hermann, Houston, Texas, USA
| | - Bradley Chi
- Department of Physical Medicine and Rehabilitation, McGovern Medical School, University of Texas Health Science Center - Houston, Houston, Texas, USA
- TIRR Memorial Hermann, Houston, Texas, USA
| | - Daniel Moon
- Jefferson Moss Magee Rehab, Elkins Park, Pennsylvania, USA
| | - Manuel Mas
- Department of Physical Medicine and Rehabilitation, School of Medicine, University of Puerto Rico - San Juan, San Juan, Puerto Rico
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Hefter H, Rosenthal D, Samadzadeh S. Effects of Combined Vibration Ergometry and Botulinum Toxin on Gait Improvement in Asymmetric Lower Limb Spasticity: A Pilot Study. J Funct Morphol Kinesiol 2025; 10:41. [PMID: 39982280 PMCID: PMC11843869 DOI: 10.3390/jfmk10010041] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/27/2024] [Revised: 11/27/2024] [Accepted: 01/14/2025] [Indexed: 02/22/2025] Open
Abstract
Objective: Botulinum neurotoxin type A (BoNT/A) injections and the new vibration ergometry training (VET) are studied for their combined effect on improving functional mobility in patients with asymmetric lower limb spasticity. Method: Gait was analyzed using the Infotronic® system, which measures ground reaction forces and foot contact patterns by means of special force-sensitive shoes strapped over feet or street shoes. Gait was measured several times, depending on the protocol patients underwent. Seven patients with asymmetric lower limb spasticity were analyzed according to the control protocol (CG-group): after a baseline walk of 20 m (NV-W1) patients received their routine BoNT/A injection and had to walk the same distance a second time (NV-W2). Approximately 3-5 weeks later, they had to walk a third time (NV-W3). A further seven patients (VG-group) were analyzed according to the vibration protocol: after a baseline walk (V-W1), patients underwent a first vibration training (VET1), walked a second time (V-W2), received their routine BoNT/A injection, and walked a third time (V-W3). About four weeks later, they had to walk again (V-W4), received another vibration training (VET3), and walked a fifth time (V-W5). At least six months after the analysis according to the vibration protocol, these patients were also analyzed according to the control protocol. Eleven gait parameters were compared between the CG- and VG-group, and within the VG-group. Result: Patients in the VG-group experienced a significant improvement in gait four weeks after BoNT/A injection, unlike the patients in the CG-group. VG-patients also showed improved gait after two VET sessions. However, there was no further functional improvement of gait when BoNT/A injections and VET sessions were combined. Conclusions: BoNT/A injections enhance functional mobility in patients with mild asymmetric leg spasticity. VET also induces an immediate gait improvement and offers a further treatment approach for leg spasticity. Whether combining BoNT treatment and vibration training offers superior outcomes compared to either treatment alone requires further investigation.
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Affiliation(s)
- Harald Hefter
- Department of Neurology, University of Düsseldorf, Moorenstrasse 5, 40225 Düsseldorf, Germany; (D.R.); (S.S.)
| | - Dietmar Rosenthal
- Department of Neurology, University of Düsseldorf, Moorenstrasse 5, 40225 Düsseldorf, Germany; (D.R.); (S.S.)
| | - Sara Samadzadeh
- Department of Neurology, University of Düsseldorf, Moorenstrasse 5, 40225 Düsseldorf, Germany; (D.R.); (S.S.)
- Charité–Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Unverstät zu Berlin, Experimental and Clinical Research Center, 13125 Berlin, Germany
- Department of Regional Health Research and Molecular Medicine, University of Southern Denmark, 5230 Odense, Denmark
- Department of Neurology, Slagelse Hospital, 4200 Slagelse, Denmark
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Esquenazi A, Zorowitz RD, Ashford S, Beneteau M, Maisonobe P, Hannes C, Jacinto J. Longitudinal Goal Attainment With Repeat Injections of AbobotulinumtoxinA in Adults With Lower Limb Spasticity: Results From a Prospective Observational Study. Arch Phys Med Rehabil 2024:S0003-9993(24)01348-0. [PMID: 39571744 DOI: 10.1016/j.apmr.2024.10.017] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/29/2024] [Revised: 10/17/2024] [Accepted: 10/28/2024] [Indexed: 12/07/2024]
Abstract
OBJECTIVE To assess longitudinal goal attainment with repeat abobotulinumtoxinA (AboBoNT-A) injections for lower limb spasticity (LLS) over 16 months. DESIGN Prospective, longitudinal, international, multicenter, observational study (NCT04050527). SETTING Specialist neurorehabilitation centers. PARTICIPANTS Ambulatory adults with unilateral LLS able to take ≥5 steps with/without assistance (effectiveness population, N=384). INTERVENTIONS Participants received ≥1 AboBoNT-A treatment cycle administered in accordance with local prescribing guidelines to achieve individualized treatment goals. MAIN OUTCOME MEASURES The primary endpoint was goal attainment as assessed using the cumulated Goal Attainment Scaling-Leg (GAS-leg) T score, across all treatment cycles for each patient. RESULTS Overall, participants underwent a median of 5 lower limb injection cycles (median dose 600U, range 100-1475U) with a mean±SD injection interval of 18.3±6.1 weeks. Participants generally achieved their goals as expected over repeated cycles; the mean (95% CI) GAS-leg T score at cycle 1 baseline was 38.0 (37.7, 38.3) and the mean cumulated GAS-leg T score at 16 months was 48.2 (47.4, 48.9) (mean change from a baseline of 9.9 [9.1, 10.7]). Participants injected with a guidance technique at baseline were more likely to attain their cycle 1 primary treatment goals (odds ratio: 1.9 [95% CI 1.1, 3.1], P=.02). Overall, 56 (13.5%) participants reported ≥1 adverse event, of which 6 participants (1.4%) had a treatment-related adverse event. CONCLUSIONS Findings from this large, international study provide evidence for the benefit of repeated cycles of AboBoNT-A for LLS. Multivariate analyses indicated that goal attainment during the first cycle was better with those injected using injection guidance than those injected without guidance.
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Affiliation(s)
| | - Richard D Zorowitz
- Department of PM&R, MedStar Health, Washington and Georgetown University School of Medicine, Washington, DC
| | - Stephen Ashford
- Department of PM&R, London North West University Healthcare NHS Trust, Regional Hyper-acute Rehabilitation Unit, Northwick Park Hospital, London, UK
| | | | | | | | - Jorge Jacinto
- Department of PM&R, Centro de Medicina de Reabilitaçãode Alcoitão, Serviço de Reabilitação de adultos 3, Estoril, Portugal
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Hara T, Takekawa T, Abo M. Gait Reconstruction Strategy Using Botulinum Toxin Therapy Combined with Rehabilitation. Toxins (Basel) 2024; 16:323. [PMID: 39057963 PMCID: PMC11281298 DOI: 10.3390/toxins16070323] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/01/2024] [Revised: 07/11/2024] [Accepted: 07/16/2024] [Indexed: 07/28/2024] Open
Abstract
Numerous studies have established a robust body of evidence for botulinum toxin A (BoNT-A) therapy as a treatment for upper motor neuron syndrome. These studies demonstrated improvements in spasticity, range of joint motion, and pain reduction. However, there are few studies that have focused on improvement of paralysis or functional enhancement as the primary outcome. This paper discusses the multifaceted aspects of spasticity assessment, administration, and rehabilitation with the goal of optimising the effects of BoNT-A on lower-limb spasticity and achieving functional improvement and gait reconstruction. This paper extracts studies on BoNT-A and rehabilitation for the lower limbs and provides new knowledge obtained from them. From these discussion,, key points in a walking reconstruction strategy through the combined use of BoNT-A and rehabilitation include: (1) injection techniques based on the identification of appropriate muscles through proper evaluation; (2) combined with rehabilitation; (3) effective spasticity control; (4) improvement in ankle joint range of motion; (5) promotion of a forward gait pattern; (6) adjustment of orthotics; and (7) maintenance of the effects through frequent BoNT-A administration. Based on these key points, the degree of muscle fibrosis and preintervention walking speed may serve as indicators for treatment strategies. With the accumulation of recent studies, a study focusing on walking functions is needed. As a result, it is suggested that BoNT-A treatment for lower limb spasticity should be established not just as a treatment for spasticity but also as a therapeutic strategy in the field of neurorehabilitation aimed at improving walking function.
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Affiliation(s)
- Takatoshi Hara
- Department of Physical Rehabilitation, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo 187-8551, Japan
| | - Toru Takekawa
- Department of Rehabilitation Medicine, The Jikei University School of Medicine, Tokyo 105-8461, Japan; (T.T.); (M.A.)
| | - Masahiro Abo
- Department of Rehabilitation Medicine, The Jikei University School of Medicine, Tokyo 105-8461, Japan; (T.T.); (M.A.)
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Raciti L, Raciti G, Ammendolia A, de Sire A, Onesta MP, Calabrò RS. Improving Spasticity by Using Botulin Toxin: An Overview Focusing on Combined Approaches. Brain Sci 2024; 14:631. [PMID: 39061372 PMCID: PMC11274891 DOI: 10.3390/brainsci14070631] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/10/2024] [Revised: 06/11/2024] [Accepted: 06/20/2024] [Indexed: 07/28/2024] Open
Abstract
Spasticity is a very common sign in the neurological field. It can be defined as "a motor disorder marked by a velocity-dependent increase in muscle tone or tonic stretch reflexes" associated with hypertonia. It leads to a high risk of limb deformities and pain that prejudices residual motor function, impairing quality of life". The treatment of spasticity depends on its severity and its location and, in general, it is based on rehabilitation, oral therapies (the gamma-aminobutyric acid b agonist baclofen) and injectable medications (i.e., botulin toxins, acting on polysynaptic reflex mechanisms). The botulin toxin type A (BoNT-A) injection has been effectively used to improve different types of spasticity. However, when BoNT-A is not sufficient, a combination of nonpharmacological approaches could be attempted. Therefore, additional intervention, such as conventional physical therapy by itself or further combined with robotic gait training, may be needed. Indeed, it has been shown that combination of BoNT-A and robotics has a positive effect on activity level and upper limb function in patients with stroke, including those in the chronic phase. The aim of this review is to evaluate the efficacy of pharmacological or nonpharmacological treatment in combination with BoNT-A injections on spasticity. The combined therapy of BoNT with conventional or adjunct activities or robot-assisted training, especially with end-effectors, is a valid tool to improve patients' performance and outcomes. The combined strategies might rise the toxin's effect, lowering its dosages of botulinum and reducing side effects and costs.
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Affiliation(s)
- Loredana Raciti
- Unità Spinale Unipolare, AO Cannizzaro, 98102 Catania, Italy; (L.R.); (M.P.O.)
| | - Gianfranco Raciti
- Department of Medical and Surgical Sciences, Magna Græcia University, 88100 Catanzaro, Italy; (G.R.); (A.A.); (A.d.S.)
| | - Antonio Ammendolia
- Department of Medical and Surgical Sciences, Magna Græcia University, 88100 Catanzaro, Italy; (G.R.); (A.A.); (A.d.S.)
| | - Alessandro de Sire
- Department of Medical and Surgical Sciences, Magna Græcia University, 88100 Catanzaro, Italy; (G.R.); (A.A.); (A.d.S.)
| | - Maria Pia Onesta
- Unità Spinale Unipolare, AO Cannizzaro, 98102 Catania, Italy; (L.R.); (M.P.O.)
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Shen KH, Borrelli J, Gray VL, Rogers MW, Hsiao HY. Lower limb vertical stiffness and frontal plane angular impulse during perturbation-induced single limb stance and their associations with gait in individuals post-stroke. J Biomech 2024; 163:111917. [PMID: 38184906 PMCID: PMC10932872 DOI: 10.1016/j.jbiomech.2023.111917] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/14/2023] [Revised: 11/30/2023] [Accepted: 12/31/2023] [Indexed: 01/09/2024]
Abstract
After stroke, deficits in paretic single limb stance (SLS) are commonly observed and affect walking performance. During SLS, the hip abductor musculature is critical in providing vertical support and regulating balance. Although disrupted paretic hip abduction torque production has been identified in individuals post-stroke, interpretation of previous results is limited due to the discrepancies in weight-bearing conditions. Using a novel perturbation-based assessment that could induce SLS by removing the support surface underneath one limb, we aim to investigate whether deficits in hip abduction torque production, vertical body support, and balance regulation remain detectable during SLS when controlling for weight-bearing, and whether these measures are associated with gait performance. Our results showed that during the perturbation-induced SLS, individuals post-stroke had lower hip abduction torque, less vertical stiffness, and increased frontal plane angular impulse at the paretic limb compared to the non-paretic limb, while no differences were found between the paretic limb and healthy controls. In addition, vertical stiffness during perturbation-induced SLS was positively correlated with single support duration during gait at the paretic limb and predicted self-selected and fast walking speeds in individuals post-stroke. The findings indicate that reduced paretic hip abduction torque during SLS likely affects vertical support and balance control. Enhancing SLS hip abduction torque production could be an important rehabilitation target to improve walking function for individuals post-stroke.
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Affiliation(s)
- Keng-Hung Shen
- Department of Kinesiology and Health Education, The University of Texas at Austin, TX, USA
| | - James Borrelli
- Department of Biomedical Engineering, Stevenson University, MD, USA; Department of Physical Therapy and Rehabilitation Science, University of Maryland Baltimore, MD, USA
| | - Vicki L Gray
- Department of Physical Therapy and Rehabilitation Science, University of Maryland Baltimore, MD, USA
| | - Mark W Rogers
- Department of Physical Therapy and Rehabilitation Science, University of Maryland Baltimore, MD, USA
| | - Hao-Yuan Hsiao
- Department of Kinesiology and Health Education, The University of Texas at Austin, TX, USA; Department of Physical Therapy and Rehabilitation Science, University of Maryland Baltimore, MD, USA.
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Shen KH, Borrelli J, Gray VL, Rogers MW, Hsiao HY. Lower Limb Vertical Stiffness and Frontal Plane Angular Impulse during Perturbation-Induced Single Limb Stance and Their Associations with Gait in Individuals Post-Stroke. BIORXIV : THE PREPRINT SERVER FOR BIOLOGY 2023:2023.04.10.536288. [PMID: 37090545 PMCID: PMC10120673 DOI: 10.1101/2023.04.10.536288] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 04/25/2023]
Abstract
Background After stroke, deficits in paretic single limb stance (SLS) are commonly observed and affect walking performance. During SLS, the hip abductor musculature is critical in providing vertical support and regulating balance. Although disrupted paretic hip abduction torque production has been identified in individuals post-stroke, interpretation of previous results is limited due to the discrepancies in weight-bearing conditions. Objective To investigate whether deficits in hip abduction torque production, vertical body support, and balance regulation remain during SLS when controlling for weight-bearing using a perturbation-based assessment, and whether these measures are associated with gait performance. Methods We compared hip abduction torque, vertical stiffness, and frontal plane angular impulse between individuals post-stroke and healthy controls when SLS was induced by removing the support surface underneath one limb. We also tested for correlations between vertical stiffness and angular impulse during perturbation-induced SLS and gait parameters during overground walking. Results During the perturbation-induced SLS, lower hip abduction torque, less vertical stiffness, and increased frontal plane angular impulse were observed at the paretic limb compared to the non-paretic limb, while no differences were found between the paretic limb and healthy controls. Vertical stiffness during perturbation-induced SLS was positively correlated with single support duration during gait at the paretic limb and predicted self-selected and fast walking speeds in individuals post-stroke. Conclusions Reduced paretic hip abduction torque during SLS likely affects vertical support and balance control. Enhancing SLS hip abduction torque production could be an important rehabilitation target to improve walking function for individuals post-stroke.
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Affiliation(s)
- Keng-Hung Shen
- Department of Kinesiology and Health Education, The University of Texas at Austin, TX, USA
| | - James Borrelli
- Department of Biomedical Engineering, Stevenson University, MD, USA
- Department of Physical Therapy and Rehabilitation Science, University of Maryland Baltimore, MD, USA
| | - Vicki L. Gray
- Department of Physical Therapy and Rehabilitation Science, University of Maryland Baltimore, MD, USA
| | - Mark W. Rogers
- Department of Physical Therapy and Rehabilitation Science, University of Maryland Baltimore, MD, USA
| | - Hao-Yuan Hsiao
- Department of Kinesiology and Health Education, The University of Texas at Austin, TX, USA
- Department of Physical Therapy and Rehabilitation Science, University of Maryland Baltimore, MD, USA
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Shear Wave Velocity to Evaluate the Effect of Botulinum Toxin on Post-Stroke Spasticity of the Lower Limb. Toxins (Basel) 2022; 15:toxins15010014. [PMID: 36668834 PMCID: PMC9865964 DOI: 10.3390/toxins15010014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2022] [Revised: 12/11/2022] [Accepted: 12/21/2022] [Indexed: 12/28/2022] Open
Abstract
(1) Background: The evaluation of muscles with spasticity using ultrasound elastography has attracted attention recently, and the shear wave velocity (SWV) technique can measure the mechanical properties of tissues objectively and quantitatively. The purpose of this study was to evaluate the effect of using SWV to assess the effect of Botulinum toxin type A (BoNT-A) treatment in adult patients with post-stroke lower limb spasticity. (2) Methods: We assessed the modified Ashworth Scale, the modified Tardieu Scale, and SWV at rest and after stretching before and at 1 month after BoNT-A treatment in 10 adult participants with post-stroke lower limb spasticity. (3) Results: Significant changes in SWV of the ankle joint in maximum dorsiflexion to the extent possible (SWV stretched) were observed after BoNT-A treatment. SWV stretched was positively correlated with joint range of motion. Participants whose joint range of motion did not improve (i.e., gastrocnemius medialis muscle (GCM) extension distance did not change) had significantly more reductions in SWV stretched after BoNT-A treatment. (4) Conclusions: Our results suggest that the SWV measurements may serve as a quantitative assessment to determine the effect of the BoNT-A treatment in adult stroke patients. SWV measurements to assess GCM spasticity should consider the effects of tension, material properties and activation level of muscles. The challenge is to measure SWV with matching limb positions in patients without contractures.
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Schnitzler A, Dince C, Freitag A, Iheanacho I, Fahrbach K, Lavoie L, Loze JY, Forestier A, Gasq D. AbobotulinumtoxinA Doses in Upper and Lower Limb Spasticity: A Systematic Literature Review. Toxins (Basel) 2022; 14:toxins14110734. [PMID: 36355984 PMCID: PMC9698883 DOI: 10.3390/toxins14110734] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/16/2022] [Revised: 10/12/2022] [Accepted: 10/20/2022] [Indexed: 01/26/2023] Open
Abstract
Disabling limb spasticity can result from stroke, traumatic brain injury or other disorders causing upper motor neuron lesions such as multiple sclerosis. Clinical studies have shown that abobotulinumtoxinA (AboBoNT-A) therapy reduces upper and lower limb spasticity in adults. However, physicians may administer potentially inadequate doses, given the lack of consensus on adjusting dose according to muscle volume, the wide dose ranges in the summary of product characteristics or cited in the published literature, and/or the high quantity of toxin available for injection. Against this background, a systematic literature review based on searches of MEDLINE and Embase (via Ovid SP) and three relevant conferences (2018 to 2020) was conducted in November 2020 to examine AboBoNT-A doses given to adults for upper or lower limb muscles affected by spasticity of any etiology in clinical and real-world evidence studies. From the 1781 unique records identified from the electronic databases and conference proceedings screened, 49 unique studies represented across 56 publications (53 full-text articles, 3 conference abstracts) were eligible for inclusion. Evidence from these studies suggested that AboBoNT-A dose given per muscle in clinical practice varies considerably, with only a slight trend toward a relationship between dose and muscle volume. Expert-based consensus is needed to inform recommendations for standardizing AboBoNT-A treatment initiation doses based on muscle volume.
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Affiliation(s)
- Alexis Schnitzler
- PRM Department, GH St Louis Lariboisière F. Widal, Paris University, 75010 Paris, France
| | - Clément Dince
- Ipsen, 92100 Boulogne-Billancourt, France
- Correspondence:
| | | | | | | | | | | | | | - David Gasq
- Department of Functional Physiological Explorations, University Hospital of Toulouse, 31400 Toulouse, France
- ToNIC, Toulouse NeuroImaging Center, Université de Toulouse, Inserm, UPS, 31300 Toulouse, France
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Ko EJ, Kim DY. Pharmacological management of muscle spasticity. JOURNAL OF THE KOREAN MEDICAL ASSOCIATION 2022. [DOI: 10.5124/jkma.2022.65.2.117] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022] Open
Abstract
Background: Muscle spasticity is a neurologic disorder, which is considered one of the positive signs of upper motor neuron diseases. Spasticity is common after brain or spinal cord injury. Since spasticity results in tendon retraction, muscle weakness, pain, ankylosis, and disability in activities of daily living, treatment is warranted.Current Concepts: Spasticity is usually assessed using the Modified Ashworth Scale or Modified Tardieu Scale. It is treated with various methods, including physical therapy, occupational therapy, orthosis, medication, and surgery. Pharmacological management should be selected according to the location and severity of the symptom and includes oral medications, chemical nerve block, and intrathecal baclofen pump insertion. Oral medications include baclofen, benzodiazepine, dantrolene, and tizanidine. Chemoneurolysis of spasticity is done with botulinum toxin or a mixture of phenol and alcohol.Discussion and Conclusion: Since muscle spasticity affects motor function and activities of daily living, understanding of this symptom and choosing an optimal treatment are necessary. Pharmacologic treatments should be administered with caution especially with the side effects. Optimal treatment of spasticity will bring the best neurological outcome for the patients.
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Ojardias E, Ollier E, Lafaie L, Celarier T, Giraux P, Bertoletti L. Time course response after single injection of botulinum toxin to treat spasticity after stroke: Systematic review with pharmacodynamic model-based meta-analysis. Ann Phys Rehabil Med 2021; 65:101579. [PMID: 34634514 DOI: 10.1016/j.rehab.2021.101579] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2020] [Revised: 07/09/2021] [Accepted: 07/19/2021] [Indexed: 10/19/2022]
Abstract
BACKGROUND The time-course response after a single injection of botulinum toxin (BoNT) for post-stroke spasticity is debated. We addressed this issue by conducting a systematic review and a pharmacodynamic model-based meta-analysis. METHODS We searched Medline, PeDro and Google Scholar databases up to March 2020, selecting randomized controlled trials of post-stroke and traumatic brain injury patients with arm or leg muscle hypertonia, comparing BoNT to placebo, or different BoNT preparations. The main outcome was change in Modified Ashworth Scale (MAS) score. A non-linear mixed effect model was used to estimate maximal toxin and placebo effects (Emax and EPlacebo), the effect disappearance half-life (T1/2off) of BoNT and the doses achieving 50 and 80% of Emax (D50 and D80). The equivalence ratios between different BoNT preparations were calculated from D50 values. Adverse events were recorded. RESULTS Altogether, 2,236 unique records were screened by 2 independent reviewers: 35 eligible trials including 3011 patients (95% post-stroke) were identified. For all BoNT preparations, the BoNT Emax of -1.11 (95% credible interval -1.31; -0.29) was reached at 5 weeks; the maximal placebo effect was -0.30 (-0.37; -0.22). Both D50 and D80 differed significantly by muscle volume. At D50, the equivalence ratio was significantly higher for abobotulinumtoxinA (3.35) than onabotulinumtoxinA and lower for letibotulinumtoxinA (0.41). T1/2off was longer for abobotulinumtoxinA than for onabotulinumtoxinA and the other preparations (13.1 weeks [95% credible interval 7.7; 19.3] vs 8.6 weeks [7.1; 10.1]). Adverse events were minor, with a weak, but significant, dose-response relation for muscle weakness. CONCLUSIONS This first pharmacodynamic model-based meta-analysis of individuals with stroke revealed that for all BoNT-A preparations, BoNT-A injections to treat spasticity have maximal effect at 5 weeks. The T1/2off was longer for abobotulinumtoxinA than other preparations. Differences between certain BoNT unit scales were also confirmed.
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Affiliation(s)
- Etienne Ojardias
- Clinical Gerontology Department, University Hospital of Saint-Étienne, Saint-Étienne, France; U1059 INSERM - SAINBIOSE, Innovation Campus, Saint-Étienne, France + INSERM CIC1408, University Hospital of Saint-Étienne, Saint-Etienne, France.
| | - Edouard Ollier
- U1059 INSERM - SAINBIOSE, Innovation Campus, Saint-Étienne, France + INSERM CIC1408, University Hospital of Saint-Étienne, Saint-Etienne, France; Clinical Research, Innovation and Pharmacology Unit, North Hospital, University Hospital of Saint-Étienne, France
| | - Ludovic Lafaie
- Clinical Gerontology Department, University Hospital of Saint-Étienne, Saint-Étienne, France
| | - Thomas Celarier
- Clinical Gerontology Department, University Hospital of Saint-Étienne, Saint-Étienne, France
| | - Pascal Giraux
- Physical Medicine and Rehabilitation Department, University Hospital of Saint-Étienne, Saint-Étienne, France; Lyon Neuroscience Research Center, Trajectoires team (Inserm UMR-S 1028, CNRS UMR 5292, Lyon1 & Saint-Etienne Universities), France
| | - Laurent Bertoletti
- Vascular and Therapeutic Medicine Department, North Hospital, University Hospital of Saint-Étienne, Saint-Étienne, France; U1059 INSERM - SAINBIOSE, Innovation Campus, Saint-Étienne, France + INSERM CIC1408, University Hospital of Saint-Étienne, Saint-Etienne, France
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Hefter H, Nickels W, Rosenthal D, Samadzadeh S, Albrecht P. Continuous Increase of Efficacy under Repetitive Injections of Botulinum Toxin Type/A beyond the First Treatment for Adult Spastic Foot Drop. Toxins (Basel) 2021; 13:toxins13070466. [PMID: 34357938 PMCID: PMC8310361 DOI: 10.3390/toxins13070466] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/04/2021] [Revised: 06/27/2021] [Accepted: 06/30/2021] [Indexed: 11/16/2022] Open
Abstract
The objective of this study was to quantify the increase in efficacy during the first four cycles of treatment with botulinum toxin type/A (BoNT/A) in 24 free-walking BoNT/A naïve adult patients with post-stroke hemispasticity and spastic foot drop. Patients were followed over 390 days and received five injections of 800 U aboBoNT/A every three months. Patients assessed the treatment effect at eight visits using a global assessment scale, physicians scored the muscle tone at the ankle joint, measured active and passive ranges of motion (aRoMs, pRoMs) at the knee and ankle joint and determined the distance patients succeeded to walk during a minute. Patients' assessments significantly (p < 0.006) increased with time and significantly correlated with all parameters measured. The best correlation (r = 0.927; p < 0.0001) was found with the sum of the aRoMs of knee and ankle joint. After one year of treatment outcome measures were better than and significantly correlated with the peak effect of the first injection. This correlation was higher for pRoMs (r = 0.855; p < 0.00001) compared to aRoMs (r = 0.567; p < 0.009). When BoNT/A treatment of the spastic foot in chronic hemispasticity is performed regularly every three months for at least one year, patients will experience a significant increase of benefit beyond the first treatment, but have to learn how to adapt to and use the new degree of freedom induced by the injections.
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Affiliation(s)
- Harald Hefter
- Department of Neurology, University Hospital, Moorenstrasse 5, D-40225 Düsseldorf, Germany; (W.N.); (D.R.); (S.S.); (P.A.)
- Correspondence:
| | - Werner Nickels
- Department of Neurology, University Hospital, Moorenstrasse 5, D-40225 Düsseldorf, Germany; (W.N.); (D.R.); (S.S.); (P.A.)
- Department of Neurology, Ruland-Kliniken, Neuenbürger Strasse 49, D-75335 Dobel, Germany
| | - Dietmar Rosenthal
- Department of Neurology, University Hospital, Moorenstrasse 5, D-40225 Düsseldorf, Germany; (W.N.); (D.R.); (S.S.); (P.A.)
| | - Sara Samadzadeh
- Department of Neurology, University Hospital, Moorenstrasse 5, D-40225 Düsseldorf, Germany; (W.N.); (D.R.); (S.S.); (P.A.)
| | - Philipp Albrecht
- Department of Neurology, University Hospital, Moorenstrasse 5, D-40225 Düsseldorf, Germany; (W.N.); (D.R.); (S.S.); (P.A.)
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13
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Efficacy and Optimal Dose of Botulinum Toxin A in Post-Stroke Lower Extremity Spasticity: A Systematic Review and Meta-Analysis. Toxins (Basel) 2021; 13:toxins13060428. [PMID: 34207357 PMCID: PMC8234518 DOI: 10.3390/toxins13060428] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/27/2021] [Revised: 06/12/2021] [Accepted: 06/16/2021] [Indexed: 11/17/2022] Open
Abstract
Post-stroke spasticity impedes patients’ rehabilitation progress. Contradictory evidence has been reported in using Botulinum Neurotoxin type A (BoNT-A) to manage post-stroke lower extremity spasticity (PLES); furthermore, an optimum dose of BoNT-A for PLES has not yet been established. Therefore, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to identify the efficacy and optimal dose of BoNT-A on PLES. "Meta" and "Metafor" packages in R were used to analyze the data. Hedges’ g statistic and random effect model were used to calculate and pool effect sizes. Twelve RCTs met the eligibility criteria. Muscle tone significantly improved in week four, week eight, and maintained to week twelve after BoNT-A injection. Improvements in functional outcomes were found, some inconsistencies among included studies were noticed. Dosage analysis from eight studies using Botox® and three studies using Dysport® indicated that the optimum dose for the commonest pattern of PLES (spastic plantar flexors) is medium-dose (approximately 300U Botox® or 1000 U Dysport®). BoNT-A should be regarded as part of a rehabilitation program for PLES. Furthermore, an optimal rehabilitation program combined with BoNT-A management needs to be established. Further studies should also focus on functional improvement by BoNT-A management in the early stage of stroke.
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14
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Hefter H, Nickels W, Samadzadeh S, Rosenthal D. Comparing soleus injections and gastrocnemius injections of botulinum toxin for treating adult spastic foot drop: a monocentric observational study. J Int Med Res 2021; 49:300060521998208. [PMID: 33784844 PMCID: PMC8020232 DOI: 10.1177/0300060521998208] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/03/2022] Open
Abstract
Objective Outcome differences between selective abobotulinumtoxin type A (aboBoNT/A)
injections into the soleus (SOL) and gastrocnemius (GAS) muscles were
investigated in post-stroke patients with spastic foot drop. Methods A monocentric observational study was conducted at a university hospital
botulinum toxin clinic including 24 free-walking adult, botulinum
toxin-naive patients with post-stroke hemiplegia. AboBoNT/A (800 MU in 4 mL
saline) was injected into the SOL or GAS muscle under electromyographic
guidance. After 30 days post-injection, the effect of aboBoNT/A injection
was assessed by patients. The treating physician scored spasticity and
measured angles at the knee and ankle joint and gait speed. Results After 30 days, significant improvements of subjective and objective outcome
measures were observed. No significant difference was observed in the
modified Ashworth scale, gait speed, ankle and knee angles, or their angle
combinations between the SOL and GAS groups. Tendencies toward greater
active range of motion (RoM) improvement in the SOL group and passive RoM
improvement in the GAS group were observed. The difference between active
and passive ankle extensions plus knee flexions was significantly larger in
the SOL group. Conclusions Selective 800 MU aboBoNT/A injections into the SOL or GAS muscle were
effective but without relevant clinical difference.
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Affiliation(s)
- Harald Hefter
- Department of Neurology, University of Düsseldorf, Düsseldorf, Germany
| | - Werner Nickels
- Department of Neurology, SRH Health Center, Bad Wimpfen, Germany
| | - Sara Samadzadeh
- Department of Neurology, University of Düsseldorf, Düsseldorf, Germany
| | - Dietmar Rosenthal
- Department of Neurology, University of Düsseldorf, Düsseldorf, Germany
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15
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Choudhry S, Patritti BL, Woodman R, Hakendorf P, Huang L. Goal Attainment: A Clinically Meaningful Measure of Success of Botulinum Toxin-A Treatment for Lower Limb Spasticity in Ambulatory Patients. Arch Rehabil Res Clin Transl 2021; 3:100129. [PMID: 34124643 PMCID: PMC8175278 DOI: 10.1016/j.arrct.2021.100129] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
Abstract
Objectives The objectives of this study were to evaluate whether botulinum toxin type A (BoNT-A) treatment for lower limb spasticity leads to patient goal attainment and identify factors associated with positive goal attainment and to assess the effect of BoNT-A treatment on patients’ gait. Design Retrospective cohort study between June 2014 and February 2019. Setting Public outpatient spasticity clinic in a tertiary hospital. Participants Thirty patients (N=30; 50% female; average age, 50.5y) with lower limb spasticity of heterogenous etiologies (96.7% cerebral±spinal origin and 3.3% isolated spinal origin); 73.3% (N=22) of patients had previously received BoNT-A treatment. Interventions BoNT-A injection to lower limb muscles. Main Outcome Measures The primary outcome measure was goal attainment measured using Goal Attainment Scaling. The Modified Ashworth Scale (MAS) was used to assess spasticity. Gait was characterized by spatiotemporal parameters. Results Fifty-six treatment episodes were analyzed and showed that BoNT-A treatment resulted in a significant reduction in spasticity (pretreatment MAS=3.18±0.73; posttreatment MAS=2.27±0.89; P<.001) with no associated change in gait parameters. Logistic regression revealed that most patients (74.1%) achieved all of their goals, with younger patients having a high likelihood of goal attainment regardless of their gait profile identified by latent profile analysis of the gait parameters. Patients considered to have a low functioning gait profile demonstrated a significantly greater likelihood of goal attainment than patients with the other gait profiles combined (odds ratio, 45.6; 95% confidence interval, 1.3-1602.1; P=.036). Chronic spasticity and pretreatment severity of spasticity (MAS) and its reduction were not associated with likelihood of goal attainment. Conclusions The success and efficacy of BoNT-A treatment in improving patient perceived gait quality and reducing the negative symptoms of spasticity were best measured using Goal Attainment Scaling. The study emphasizes the importance of measuring patient goals as a clinical outcome. Gait parameters were most informative when used collectively to classify patients based on their overall gait profile, which assisted in identifying differences between patients’ likelihood of goal attainment after treatment.
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Affiliation(s)
- Subbuh Choudhry
- Division of Rehabilitation, Aged and Palliative Care, Flinders Medical Centre, Adelaide
| | - Benjamin L Patritti
- Division of Rehabilitation, Aged and Palliative Care, Flinders Medical Centre, Adelaide.,College of Medicine and Public Health, Flinders University, Adelaide
| | - Richard Woodman
- Flinders Health and Medical Research Institute, Health Data Sciences, College of Medicine and Public Health, Flinders University, Adelaide
| | - Paul Hakendorf
- Flinders Health and Medical Research Institute, Health Data Sciences, College of Medicine and Public Health, Flinders University, Adelaide.,Clinical Epidemiology Unit, Flinders Medical Centre, Adelaide, Australia
| | - Lydia Huang
- Division of Rehabilitation, Aged and Palliative Care, Flinders Medical Centre, Adelaide.,College of Medicine and Public Health, Flinders University, Adelaide
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16
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Esquenazi A, Bavikatte G, Bandari DS, Jost WH, Munin MC, Tang SFT, Largent J, Adams AM, Zuzek A, Francisco GE. Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity. PM R 2020; 13:1079-1093. [PMID: 33151636 PMCID: PMC8519010 DOI: 10.1002/pmrj.12517] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/04/2019] [Revised: 09/24/2020] [Accepted: 10/23/2020] [Indexed: 11/05/2022]
Abstract
INTRODUCTION OnabotulinumtoxinA treatment for spasticity varies according to numerous factors and is individualized to meet treatment goals. OBJECTIVE To explore real-world onabotulinumtoxinA utilization and effectiveness in patients with lower limb spasticity from the Adult Spasticity International Registry (ASPIRE) study. DESIGN Two-year, multicenter, prospective, observational registry (NCT01930786). SETTING Fifty-four international clinical sites. PATIENTS Adults (naïve or non-naïve to botulinum toxin[s] treatment for spasticity, across multiple etiologies) with lower limb spasticity related to upper motor neuron syndrome. INTERVENTIONS OnabotulinumtoxinA administered at the clinician's discretion. MAIN OUTCOME MEASURES OnabotulinumtoxinA treatment utilization, clinician- and patient-reported satisfaction. RESULTS In ASPIRE, 530 patients received ≥1 onabotulinumtoxinA treatment for lower limb spasticity (mean age, 52 years; stroke, 49.4%; multiple sclerosis, 20.4%). Equinovarus foot was treated most often (80.9% of patients), followed by flexed knee (26.0%), stiff extended knee (22.5%), and flexed toes (22.3%). OnabotulinumtoxinA doses ranged between 10 and 1100 U across all presentations. Electromyography (EMG) was most commonly used for injection localization (≥41.1% of treatment sessions). Despite low patient response on the satisfaction questionnaire, clinicians (94.6% of treatment sessions) and patients (84.5%) reported satisfaction/extreme satisfaction that treatment helped manage spasticity, and clinicians (98.3%) and patients (91.6%) would probably/definitely continue onabotulinumtoxinA treatment. These data should be interpreted with care. Twenty-one adverse events (AEs) in 18 patients (3.4%) were considered treatment-related. Sixty-seven patients (12.6%) reported 138 serious AEs; 3 serious AEs in two patients (0.4%) were considered treatment-related. No new safety signals were identified. CONCLUSIONS ASPIRE provides long-term observational data on the treatment of lower limb spasticity with onabotulinumtoxinA. Real-world data from this primary analysis can help to guide the clinical use of onabotulinumtoxinA to improve spasticity management.
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Affiliation(s)
| | | | | | - Wolfgang H Jost
- Department of Neurology, University of Freiburg, Freiburg im Breisgau, Germany.,Parkinson-Klinik Ortenau, Wolfach, Germany
| | - Michael C Munin
- Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
| | - Simon Fuk Tan Tang
- Department of Physical Medicine and Rehabilitation, Lotung Poh-Ai Hospital, Yilan, Taiwan
| | - Joan Largent
- IQVIA Real-World Evidence Solutions, Cambridge, MA, USA
| | | | | | - Gerard E Francisco
- University of Texas Health Science Center McGovern Medical School and TIRR Memorial Hermann, Houston, TX, USA
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17
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Patel AT, Ward AB, Geis C, Jost WH, Liu C, Dimitrova R. Impact of early intervention with onabotulinumtoxinA treatment in adult patients with post-stroke lower limb spasticity: results from the double-blind, placebo-controlled, phase 3 REFLEX study. J Neural Transm (Vienna) 2020; 127:1619-1629. [PMID: 33106968 PMCID: PMC7666298 DOI: 10.1007/s00702-020-02251-6] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2020] [Accepted: 08/31/2020] [Indexed: 11/24/2022]
Abstract
The aim of this study in patients with post-stroke lower limb spasticity (PSLLS) was to evaluate the relationship between time of onabotulinumtoxinA treatment relative to stroke and efficacy outcomes. This was a phase 3, international, multicenter, randomized, 12-week, double-blind study, followed by a repeated treatment, open-label extension. Patients were aged 18–85 years with PSLLS (Modified Ashworth Scale [MAS] ≥ 3) of the ankle with the most recent stroke occurring ≥ 3 months before screening. Patients (double-blind phase) were randomized (n = 468) to onabotulinumtoxinA 300–400 U (300 U, mandatory ankle muscles (gastrocnemius, soleus, tibialis posterior); and ≤ 100 U, optional lower limb muscles (flexor digitorum longus, flexor hallucis longus, flexor digitorum brevis, extensor hallucis, and rectus femoris]) or placebo. Primary endpoint: MAS change from baseline (average score of weeks 4 and 6). Secondary endpoints: physician-assessed Clinical Global Impression of Change (CGI) average score of weeks 4 and 6 and physician-assessed Goal Attainment Scale (GAS; active and passive, weeks 8 and 12). When stratified by time since stroke (≤ 24 months, n = 153; > 24 months, n = 315, post hoc), patients treated ≤ 24 months post-stroke experienced greater improvements from baseline versus placebo in MAS (− 0.31 vs − 0.17), CGI (0.49 vs 0.12), and passive GAS scores (week 12, 0.37 vs 0.26). A ≥ − 1-point improvement in active (week 12; p = 0.04) and passive (week 8; p = 0.02) GAS scores versus placebo was achieved by more patients treated ≤ 24 months post-stroke; in patients treated > 24 months post-stroke, improvements were only observed in active scores (week 8; p = 0.04). OnabotulinumtoxinA 300–400 U was well tolerated, with no new safety findings.
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Affiliation(s)
- Atul T Patel
- Kansas City Bone and Joint Clinic, Overland Park, KS, USA.
| | - Anthony B Ward
- Faculty of Health and North Staffordshire Rehabilitation Centre, Haywood Hospital, Staffordshire University, Stoke on Trent, UK
| | - Carolyn Geis
- Brooks Rehabilitation/Physician Group, Halifax Health, Daytona Beach, FL, USA
| | - Wolfgang H Jost
- Department of Neurology, University of Freiburg, Freiburg, Baden-Württemberg, Germany.,Parkinson-Klinik Ortenau GmbH & Co KG, Kreuzbergstr. 12-16, 77709, Wolfach, Germany
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18
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Fujita K, Kobayashi Y, Hitosugi M, Nomura T, Nishida T, Tsushima Y, Ogawa T, Kinoshita H, Hori H. Factors Influencing Gait Velocity Improvement Following Botulinum Toxin Injection for Spasticity of the Plantar Flexors in Patients with Stroke. Prog Rehabil Med 2020; 5:20200024. [PMID: 33033774 PMCID: PMC7536357 DOI: 10.2490/prm.20200024] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2020] [Accepted: 09/24/2020] [Indexed: 11/20/2022] Open
Abstract
Objective: In patients with hemiplegia, botulinum toxin type A injection for ankle spasticity of the plantar flexors reportedly improves walking speed. This improvement may be affected by background factors and patient baseline physical performance. This study aimed to clarify the factors affecting gait velocity improvement after botulinum toxin type A injection. Methods: Background and evaluation data were collected for 60 patients with stroke who received botulinum toxin type A injection for spasticity of the plantar flexors. The patients were divided into improvement (n=27) and non-improvement (n=33) groups based on the gait velocity change from before injection to 2 weeks after injection. Logistic regression analysis was performed with the improvement and non-improvement groups as response variables and background data and evaluation data at baseline as explanatory variables. Results: The presence or absence of physical therapy following botulinum toxin type A injection (odds ratio: 7.82) was the only significant explanatory variable for gait velocity change. Conclusion: Background factors and physical performance at baseline did not affect gait velocity improvement after botulinum toxin type A injection. If botulinum treatment of the ankle plantar flexors in patients with stroke is targeted at walking performance improvement, then physical therapy following botulinum toxin type A injection should be an essential part of the treatment strategy.
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Affiliation(s)
- Kazuki Fujita
- Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, Fukui, Japan
| | - Yasutaka Kobayashi
- Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, Fukui, Japan
| | - Masahito Hitosugi
- Department of Legal Medicine, Shiga University of Medical Science, Otsu, Japan
| | - Tomomi Nomura
- Department of Rehabilitation Physical Therapy, Fukui General Hospital, Fukui, Japan
| | - Tomoko Nishida
- Department of Rehabilitation Physical Therapy, Fukui General Hospital, Fukui, Japan
| | - Yuichi Tsushima
- Department of Rehabilitation Physical Therapy, Fukui General Hospital, Fukui, Japan
| | - Tomoki Ogawa
- Department of Rehabilitation Physical Therapy, Fukui General Hospital, Fukui, Japan
| | - Hirotaka Kinoshita
- Department of Rehabilitation Physical Therapy, Fukui General Hospital, Fukui, Japan
| | - Hideaki Hori
- Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, Fukui, Japan
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Esquenazi A, Brashear A, Deltombe T, Rudzinska-Bar M, Krawczyk M, Skoromets A, O'Dell MW, Grandoulier AS, Vilain C, Picaut P, Gracies JM. The Effect of Repeated abobotulinumtoxinA (Dysport®) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury. PM R 2020; 13:488-495. [PMID: 32741133 PMCID: PMC8246752 DOI: 10.1002/pmrj.12459] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2019] [Revised: 06/29/2020] [Accepted: 07/13/2020] [Indexed: 11/11/2022]
Abstract
Background Botulinum toxin (BoNT) injections were shown to improve muscle tone of limbs in patients with spasticity. However, limited data are available regarding the effects of repeated BoNT injections on walking ability. Objective To assess changes in walking velocity (WV), step length, and cadence under different test conditions after repeated treatment with abobotulinumtoxinA (aboBoNT‐A; Dysport) in spastic lower limb muscles. Design Secondary analysis of an open‐label, multiple‐cycle extension (National Clinical Trials number NCT01251367) to a phase III, double‐blind, randomized, placebo‐controlled, single‐treatment cycle study, in adults with chronic hemiparesis (NCT01249404). Setting Fifty‐two centers across Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia, and the United States. Patients 352 Ambulatory adults (18‐80 years) with spastic hemiparesis and gait dysfunction caused by stroke or traumatic brain injury, with a comfortable barefoot WV of 0.1 to 0.8 m/s. Interventions Up to four aboBoNT‐A treatment cycles, administered to spastic lower limb muscles. Main Outcome Measurements Changes from baseline in comfortable and maximal barefoot and with shoes WV (m/s), step length (m/step), and cadence (steps/minutes). Results At Week 12 after four injections, WV improved by 0.08 to 0.10 m/s, step length by 0.03 to 0.04 m/step, and cadence by 3.9 to 6.2 steps/minutes depending on test condition (all P < .0001 to .0003 vs baseline). More patients (7% to 17%) became unlimited community ambulators (WV ≥0.8 m/s) across test conditions compared with baseline, with 39% of 151 patients classified as unlimited community ambulators in at least one test condition and 17% in all four test conditions. Conclusions Clinically meaningful and statistically significant improvements in WV, step length, and cadence under all four test conditions were observed in patients with spastic hemiparesis after each aboBoNT‐A treatment cycle.
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Affiliation(s)
| | | | - Thierry Deltombe
- Service de Médecine Physique et Réadaptation, Centre Hospitalier Universitaire UCL, Yvoir, Belgium
| | - Monika Rudzinska-Bar
- Department of Neurology, Faculty of Medicine and Health Service, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland
| | | | | | - Michael W O'Dell
- Department of Rehabilitation Medicine, Weill Cornell Medicine, New York, NY, USA
| | | | | | | | - Jean-Michel Gracies
- EA 7377 BIOTN, Université Paris-Est Créteil, Service de Rééducation Neurolocomotrice, Hôpitaux Universitaires Henri Mondor, Créteil, France
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20
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Hara T, Momosaki R, Niimi M, Yamada N, Hara H, Abo M. Botulinum Toxin Therapy Combined with Rehabilitation for Stroke: A Systematic Review of Effect on Motor Function. Toxins (Basel) 2019; 11:toxins11120707. [PMID: 31817426 PMCID: PMC6950173 DOI: 10.3390/toxins11120707] [Citation(s) in RCA: 27] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/11/2019] [Revised: 11/29/2019] [Accepted: 12/03/2019] [Indexed: 11/16/2022] Open
Abstract
Aim: The purpose of this study was to examine the effectiveness of botulinum toxin A (BoNT-A) therapy combined with rehabilitation on motor function in post-stroke patients. Methods: The following sources up to December 31, 2018, were searched from inception for articles in English: Pubmed, Scopus, CINAHL, Embase, PsycINFO, and CENTRAL. Trials using injections of BoNT-A for upper and lower limb rehabilitation were examined. We excluded studies that were not performed for rehabilitation or were not evaluated for motor function. Results: Twenty-six studies were included. In addition to rehabilitation, nine studies used adjuvant treatment to improve spasticity or improve motor function. In the upper limbs, two of 14 articles indicated that significant improvement in upper limb motor function was observed compared to the control group. In the lower limbs, seven of 14 articles indicated that significant improvement in lower limb motor function was observed compared to the control group. Conclusions: The effect of combined with rehabilitation is limited after stroke, and there is not sufficient evidence, but results suggest that BoNT-A may help to improve motor function. In future studies, the establishment of optimal rehabilitation and evaluation times of BoNT-A treatment will be necessary for improving motor function and spasticity.
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Affiliation(s)
- Takatoshi Hara
- Department of Rehabilitation Medicine The Jikei University School of Medicine 3-25-8, Nishi-Shinbashi, Minato-Ku, Tokyo 105-8461, Japan
- Correspondence: ; Tel.: +81-3-3433-1111; Fax: +81-3-3431-1206
| | - Ryo Momosaki
- Department of Rehabilitation Medicine, Teikyo University School of Medicine University Hospital, Mizonokuchi, Kanagawa 213-8507, Japan
| | - Masachika Niimi
- Department of Rehabilitation Medicine The Jikei University School of Medicine 3-25-8, Nishi-Shinbashi, Minato-Ku, Tokyo 105-8461, Japan
| | - Naoki Yamada
- Department of Rehabilitation Medicine The Jikei University School of Medicine 3-25-8, Nishi-Shinbashi, Minato-Ku, Tokyo 105-8461, Japan
| | - Hiroyoshi Hara
- Rehabilitation Center, Ainomiyako Neurosurgery Hospital, Osaka 538-0044, Japan
| | - Masahiro Abo
- Department of Rehabilitation Medicine The Jikei University School of Medicine 3-25-8, Nishi-Shinbashi, Minato-Ku, Tokyo 105-8461, Japan
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21
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Kerzoncuf M, Viton JM, Pellas F, Cotinat M, Calmels P, Milhe de Bovis V, Delarque A, Bensoussan L. Poststroke Postural Sway Improved by Botulinum Toxin: A Multicenter Randomized Double-blind Controlled Trial. Arch Phys Med Rehabil 2019; 101:242-248. [PMID: 31469982 DOI: 10.1016/j.apmr.2019.04.024] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/24/2018] [Revised: 04/09/2019] [Accepted: 04/23/2019] [Indexed: 11/25/2022]
Abstract
OBJECTIVE To assess the effects of injecting botulinum toxin into the lower limb muscles of people with hemiparesis post stroke in terms of their sway areas. DESIGN A multicenter randomized double-blind trial on the effects of active botulinum toxin treatment vs placebo. SETTING Clinical examinations and postural sway assessments were performed before botulinum toxin injection and again 4-6 weeks after the injection. PARTICIPANTS People with hemiparesis with chronic post stroke lower limb spasticity (N=40). INTERVENTIONS Intramuscular injection of a placebo (physiological serum) was performed on the control group, and botulinum toxin injections were performed on the treatment group. Participants and physical and rehabilitation medicine specialists were given no information as to which of the 2 treatments was applied. MAIN OUTCOME MEASURES The sway area of the center of pressure was recorded for 30 seconds in 3 conditions: eyes open, eyes open in a dual task (a postural control task combined with an arithmetic task), and eyes closed. Spasticity was measured using the Modified Ashworth Scale. RESULTS Forty people post stroke were enrolled and randomized into 2 groups, one of which was treated with botulinum toxin (n=19) and the other with placebo (n=21). Spasticity decreased significantly in the treatment group (-0.7, P=.049 in the soleus muscles; -0.8, P=.035 in the gastrocnemii muscles). The sway area did not differ significantly between the 2 groups before treatment. The most conspicuous effect was observed in the case of the dual task, where a significant decrease (P=.005) in the sway area occurred in the treatment group (-3.11±6.92) in comparison with the placebo group (+0.27±3.57). CONCLUSION Treating spasticity by injecting botulinum toxin into people's lower limb muscles post stroke seems to improve their postural sway. The dual task used here to assess sway seems to be a useful, sensitive test for this purpose.
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Affiliation(s)
- Marjorie Kerzoncuf
- Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France.
| | - Jean-Michel Viton
- Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France
| | - Frédéric Pellas
- Physical and Rehabilitation Medicine Department, University Hospital of Nîmes, Nîmes, France
| | - Maeva Cotinat
- Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France
| | - Paul Calmels
- Physical and Rehabilitation Medicine Department, University Hospital of Saint Etienne, Saint Etienne, France
| | - Virginie Milhe de Bovis
- Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France
| | - Alain Delarque
- Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France
| | - Laurent Bensoussan
- Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France
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Santamato A, Cinone N, Panza F, Letizia S, Santoro L, Lozupone M, Daniele A, Picelli A, Baricich A, Intiso D, Ranieri M. Botulinum Toxin Type A for the Treatment of Lower Limb Spasticity after Stroke. Drugs 2019; 79:143-160. [PMID: 30623347 DOI: 10.1007/s40265-018-1042-z] [Citation(s) in RCA: 37] [Impact Index Per Article: 6.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/09/2023]
Abstract
Post-stroke lower limb spasticity impairs balance and gait leading to reduced walking speed, often increasing wheelchair use and caregiver burden. Several studies have shown that appropriate treatments for lower limb spasticity after stroke include injections of botulinum toxin type A (BoNT-A), phenol or alcohol, surgical correction and a rehabilitation program. In the present article, we review the safety and effectiveness of BoNT-A for the treatment of lower limb spasticity after stroke, with a focus on higher doses of BoNT-A. The cumulative body of evidence coming from the randomized clinical trials and open-label studies selected in the article suggest BoNT-A to be safe and efficacious in reducing lower limb spasticity after stroke. Studies of high doses of BoNT-A also showed a greater reduction of severe post-stroke spasticity. In stroke survivors with spasticity of the ankle plantar-flexor muscles, a combined approach between surgery and BoNT-A can be indicated. However, controversy remains about improvement in motor function relative to post-stroke spasticity reduction after BoNT-A treatment.
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Affiliation(s)
- Andrea Santamato
- Physical Medicine and Rehabilitation Section, "OORR Hospital", University of Foggia, Viale Pinto, 71100, Foggia, Italy.
- "Fondazione Turati" Rehabilitation Centre, Vieste, Foggia, Italy.
| | - Nicoletta Cinone
- Physical Medicine and Rehabilitation Section, "OORR Hospital", University of Foggia, Viale Pinto, 71100, Foggia, Italy
| | - Francesco Panza
- Neurodegenerative Disease Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro", Bari, Italy
- Department of Clinical Research in Neurology, Center for Neurodegenerative Diseases and the Aging Brain, University of Bari "Aldo Moro", "Pia Fondazione Cardinale G. Panico", Tricase, Lecce, Italy
- Geriatric Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Foggia, Italy
| | - Sara Letizia
- Physical Medicine and Rehabilitation Section, "OORR Hospital", University of Foggia, Viale Pinto, 71100, Foggia, Italy
| | - Luigi Santoro
- Physical Medicine and Rehabilitation Section, "OORR Hospital", University of Foggia, Viale Pinto, 71100, Foggia, Italy
| | - Madia Lozupone
- Neurodegenerative Disease Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro", Bari, Italy
| | - Antonio Daniele
- Institute of Neurology, Catholic University of Sacred Heart, Rome, Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
| | - Alessandro Picelli
- Department of Neurosciences, Biomedicine and Movement Sciences, Neuromotor and Cognitive Rehabilitation Research Center, University of Verona, Verona, Italy
- Neurorehabilitation Unit, Department of Neurosciences, Hospital Trust of Verona, Verona, Italy
| | - Alessio Baricich
- Health Sciences Department, Università del Piemonte Orientale, Novara, Italy
| | - Domenico Intiso
- Department of Neuro-Rehabilitation IRCCS, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy
| | - Maurizio Ranieri
- Physical Medicine and Rehabilitation Section, "OORR Hospital", University of Foggia, Viale Pinto, 71100, Foggia, Italy
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Roche N, Bonnyaud C, Reynaud V, Bensmail D, Pradon D, Esquenazi A. Motion analysis for the evaluation of muscle overactivity: A point of view. Ann Phys Rehabil Med 2019; 62:442-452. [PMID: 31276837 DOI: 10.1016/j.rehab.2019.06.004] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/16/2018] [Revised: 06/04/2019] [Accepted: 06/10/2019] [Indexed: 11/15/2022]
Abstract
Muscle overactivity is a general term for pathological increases in muscle activity such as spasticity. It is caused by damage to the central nervous system at the cortical, subcortical or spinal levels, leading to an upper motor neuron syndrome. In routine clinical practice, muscle overactivity, which induces abnormal muscle tone, is usually evaluated by using the Modified Ashworth Scale or the Tardieu Scale. However, both of these scales involve testing in passive conditions that do not always reflect muscle activity during dynamic tasks such as gait or reaching. To determine appropriate treatment strategies, muscle overactivity should be evaluated by using objective measures in dynamic conditions. Instrumental motion analysis systems that include 3-D motion analysis and electromyography are very useful for this purpose. The method can be used to identify patterns of abnormal muscle activity that can be related to abnormal kinematic patterns. It allows for objective and accurate assessment of the effects of treatments to reduce muscle overactivity on the movement to be improved. The aim of this point-of-view article is to describe the utility of instrumental motion analysis and to outline both its numerous advantages in evaluating muscle overactivity and to present the current limitations for its use (e.g., cost, the need for an engineer, errors relating to marker placement and cross talk between electromyography sensors).
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Affiliation(s)
- N Roche
- U1179, service de physiologie et d'explorations fonctionnelles, Assistance publique des Hôpitaux de Paris, Raymond Poincaré Hospital, Garches, France.
| | - C Bonnyaud
- U1179, service de physiologie et d'explorations fonctionnelles, Assistance publique des Hôpitaux de Paris, Raymond Poincaré Hospital, Garches, France
| | - V Reynaud
- U1179, service de physiologie et d'explorations fonctionnelles, Assistance publique des Hôpitaux de Paris, Raymond Poincaré Hospital, Garches, France
| | - D Bensmail
- U1179, service de physiologie et d'explorations fonctionnelles, Assistance publique des Hôpitaux de Paris, Raymond Poincaré Hospital, Garches, France
| | - D Pradon
- U1179, service de physiologie et d'explorations fonctionnelles, Assistance publique des Hôpitaux de Paris, Raymond Poincaré Hospital, Garches, France
| | - A Esquenazi
- Gait and Motion Analysis Laboratory, Department of Physical Medicine and Rehabilitation, MossRehab, Elkins Park, PA, USA
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Efficacy of botulinum toxin in modifying spasticity to improve walking and quality of life in post-stroke lower limb spasticity - a randomized double-blind placebo controlled study. BMC Neurol 2019; 19:96. [PMID: 31078139 PMCID: PMC6511142 DOI: 10.1186/s12883-019-1325-3] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/03/2018] [Accepted: 05/03/2019] [Indexed: 01/01/2023] Open
Abstract
Background Post-stroke lower limb spasticity (PSLLS) has a prevalence of 28–37%. PSLLS can cause difficulty in walking and reduce quality of life (QOL). Post stroke spasticity impairs the ability to intervene to improve walking ability. Botulinum Toxin A (BT) is an effective intervention for focal spasticity, but its use is currently restricted in many countries by their reimbursement system stating that the evidence for improvement in walking and quality of life (QOL) is not robust for treatment in the lower limb. This randomized control trial (RCT) will investigate the effectiveness of BT in modifying spasticity, and improving functioning (mobility, walking, activities of daily living (ADL’s) and QOL. Methods/design A double-blind placebo-controlled trial injection will assess the effect of BT compared with a placebo (normal saline) in a sample of n = 94 patients. Following treatment of spasticity measured by Modified Ashworth Scale (MAS), the primary outcome of gait velocity will be measured by i) Gait Rite (Electronic Walkway); ii) walking by 2 Min Walk Test; iii) balance by Berg Balance Scale; mobility by iv) Timed Up and Go (TUG); v) lower limb function by ABILICO; vi) patient related goal by Goal Attainment Scale (GAS); vii) QOL by SF 12 (Rand version); viii) activities of daily living by the Functional Autonomy Measurement System (SMAF). There will be an associated health economic analysis. Discussion The study methodology is based on our systematic review 2026 studies, which concluded the evidence for improving mobility following use of BT to reduce spasticity was not robust. The results of this study could establish the use of BT in improving gait and lower limb function in PSLLS. This study could provide the evidence needed for reimbursement schemes to consider and changes to its funding policy for BT in PSLLS. Trial registration The trial is registered with the Australia New Zealand Clinical Trails Registry (ANZCTR)-ANZCTRN12617001603303. Registered 07/12/2017.
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25
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Beyond speed: Gait changes after botulinum toxin injections in chronic stroke survivors (a systematic review). Gait Posture 2019; 70:389-396. [PMID: 30974394 DOI: 10.1016/j.gaitpost.2019.03.035] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2018] [Revised: 03/03/2019] [Accepted: 03/31/2019] [Indexed: 02/02/2023]
Abstract
BACKGROUND The mechanisms by which spasticity reductions after botulinum toxin A (BoNT) affect gait in stroke are not well understood. We systematically reviewed the effects of BoNT on spatiotemporal, kinematic, kinetic and electromyographic (EMG) measures during gait. QUESTION What are the effects of botulinum toxin on gait mechanics in stroke patients? METHODS Systematic search using PubMed and Web of Science. We considered all studies that reported laboratory-based and instrumented gait measures as primary or secondary outcomes to determine the effects of BoNT on walking performance in stroke populations only. Selected studies were classified and analysed based on the injection sites. RESULTS A total of 240 articles were identified of which 22 were selected for analysis. Overall, 91% of the studies reported spatiotemporal, 64% kinematics, 23% kinetics, 32% EMG and 23% other gait measures. All but one study found significant effects of BoNT on gait measures using instrumented assessments even when clinical measures (i.e. speed) did not significantly improve. However, the majority of the studies had a high risk of bias. Overall, BoNT improved: a) dorsiflexion during stance, propulsive forces and timing and activity of more proximal musculature with injections in the plantarflexors; b) hip, knee and ankle angles and velocities, coordination and energetic cost with injections in the rectus femoris; c) segmental coordination and energetic cost when several lower limb muscles were injected; and, d) elbow and trunk angles when upper limb muscles were injected. CONCLUSION Instrumented and laboratory measures of gait improve after BoNT injections in different muscle groups even in the absence of clinical changes.
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Efficacy and Safety of Botulinum Toxin Type A for Limb Spasticity after Stroke: A Meta-Analysis of Randomized Controlled Trials. BIOMED RESEARCH INTERNATIONAL 2019; 2019:8329306. [PMID: 31080830 PMCID: PMC6475544 DOI: 10.1155/2019/8329306] [Citation(s) in RCA: 38] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 10/19/2018] [Revised: 01/22/2019] [Accepted: 03/13/2019] [Indexed: 01/10/2023]
Abstract
Background Inconsistent data have been reported for the effectiveness of intramuscular botulinum toxin type A (BTXA) in patients with limb spasticity after stroke. This meta-analysis of available randomized controlled trials (RCTs) aimed to determine the efficacy and safety of BTXA in adult patients with upper and lower limb spasticity after stroke. Methods An electronic search was performed to select eligible RCTs in PubMed, Embase, and the Cochrane library through December 2018. Summary standard mean differences (SMDs) and relative risk (RR) values with corresponding 95% confidence intervals (CIs) were employed to assess effectiveness and safety outcomes, respectively. Results Twenty-seven RCTs involving a total of 2,793 patients met the inclusion criteria, including 16 and 9 trials assessing upper and lower limb spasticity cases, respectively. For upper limb spasticity, BTXA therapy significantly improved the levels of muscle tone (SMD=-0.76; 95% CI -0.97 to -0.55; P<0.001), physician global assessment (SMD=0.51; 95% CI 0.35-0.67; P<0.001), and disability assessment scale (SMD=-0.30; 95% CI -0.40 to -0.20; P<0.001), with no significant effects on active upper limb function (SMD=0.49; 95% CI -0.08 to 1.07; P=0.093) and adverse events (RR=1.18; 95% CI 0.72-1.93; P=0.509). For lower limb spasticity, BTXA therapy was associated with higher Fugl-Meyer score (SMD=5.09; 95%CI 2.16-8.01; P=0.001), but had no significant effects on muscle tone (SMD=-0.12; 95% CI -0.83 to 0.59; P=0.736), gait speed (SMD=0.06; 95% CI -0.02 to 0.15; P=0.116), and adverse events (RR=1.01; 95% CI 0.71-1.45; P=0.949). Conclusions BTXA improves muscle tone, physician global assessment, and disability assessment scale in upper limb spasticity and increases the Fugl-Meyer score in lower limb spasticity.
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Fujita K, Miaki H, Hori H, Kobayashi Y, Nakagawa T. How effective is physical therapy for gait muscle activity in hemiparetic patients who receive botulinum toxin injections? Eur J Phys Rehabil Med 2019; 55:8-18. [DOI: 10.23736/s1973-9087.18.05168-7] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/17/2023]
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Riedel P, Marino MH. Pharmacologic Treatment Tools: Systemic Medications and Toxins, Opportunities, and Pitfalls. Phys Med Rehabil Clin N Am 2019; 29:501-517. [PMID: 30626511 DOI: 10.1016/j.pmr.2018.04.008] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Treatment of pathologic muscle overactivity associated with upper motor neuron syndrome can be multifaceted. One of the initial decisions to be made when formulating an overarching treatment plan is selecting a combination of strategies that is most applicable. Strategies may include physical interventions, such as stretching or splinting modalities, or surgery, whereas pharmacotherapeutic strategies encompass oral/systemic medications as well as agents, such as toxins and alcohols, used for focal chemodenervation. This article reviews the oral/systemic therapies as well as toxins that are used focally. Although medication can also be administered via intrathecal pumps, this treatment approach is discussed elsewhere.
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Affiliation(s)
- Peter Riedel
- Physical Medicine and Rehabilitation, Moss Rehab, 60 Township Line Road, Elkins Park, PA 19027, USA
| | - Michael H Marino
- Physical Medicine and Rehabilitation, Moss Rehab, 60 Township Line Road, Elkins Park, PA 19027, USA; Physical Medicine and Rehabilitation, ReMed, 16 Industrial Boulevard, Paoli, PA 19301, USA.
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Hara T, Abo M, Hara H, Sasaki N, Yamada N, Niimi M, Shimamoto Y. The Effect of Repeated Botulinum Toxin A Therapy Combined with Intensive Rehabilitation on Lower Limb Spasticity in Post-Stroke Patients. Toxins (Basel) 2018; 10:toxins10090349. [PMID: 30200281 PMCID: PMC6162421 DOI: 10.3390/toxins10090349] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/15/2018] [Revised: 08/28/2018] [Accepted: 08/30/2018] [Indexed: 11/29/2022] Open
Abstract
Objectives: This study is a retrospective investigation of the effects of repetitive botulinum toxin A therapy (BoNT-A) and intensive rehabilitation (IR) on lower limb spasticity in post-stroke patients. Methods: Thirty-five post-stroke patients was included in this study and received BoNT-A for the first time. A 12-day inpatient protocol was with 4 cycles of the treatment protocol. The severity of spasticity, motor function and brace status were evaluated. Results: The modified Ashworth Scale (MAS) score of ankle dorsiflexors, range of motion, walking speed and balancing ability were significantly improved after cycle 1. The improvement of spasticity and motor function was persistent through cycles 2–4. One-third of brace users were able to discontinue the use of a brace. All of these brace users showed a forward gait pattern prior to therapy. Conclusions: Repeated BoNT-A combined with IR improved lower limb spasticity in post-stroke patients. Our results suggest that patients who show the forward gait pattern prior to therapy may be able to discontinue the use of their brace after therapy.
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Affiliation(s)
- Takatoshi Hara
- Department of Rehabilitaion Medicine, The Jikei University School of Medicine, 1058461 Tokyo, Japan.
- Department of Rehabilitaion Medicine, Kikyogahara Hospital 1295, 3996461 Nagano, Japan.
| | - Masahiro Abo
- Department of Rehabilitaion Medicine, The Jikei University School of Medicine, 1058461 Tokyo, Japan.
| | - Hiroyoshi Hara
- Department of Rehabilitaion Medicine, Kikyogahara Hospital 1295, 3996461 Nagano, Japan.
| | - Nobuyuki Sasaki
- Department of Rehabilitaion Medicine, The Jikei University School of Medicine, 1058461 Tokyo, Japan.
| | - Naoki Yamada
- Department of Rehabilitaion Medicine, The Jikei University School of Medicine, 1058461 Tokyo, Japan.
| | - Masachika Niimi
- Department of Rehabilitaion Medicine, The Jikei University School of Medicine, 1058461 Tokyo, Japan.
| | - Yusuke Shimamoto
- Department of Rehabilitaion Medicine, Kikyogahara Hospital 1295, 3996461 Nagano, Japan.
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Bonnyaud C, Gallien P, Decavel P, Marque P, Aymard C, Pellas F, Isner ME, Boyer FC, Muller F, Daviet JC, Dehail P, Perrouin-Verbe B, Bayle N, Coudeyre E, Perennou D, Laffont I, Ropers J, Domingo-Saidji NY, Bensmail D, Roche N. Effects of a 6-month self-rehabilitation programme in addition to botulinum toxin injections and conventional physiotherapy on limitations of patients with spastic hemiparesis following stroke (ADJU-TOX): protocol study for a randomised controlled, investigator blinded study. BMJ Open 2018; 8:e020915. [PMID: 30166290 PMCID: PMC6119443 DOI: 10.1136/bmjopen-2017-020915] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
Abstract
INTRODUCTION Home-based self-rehabilitation programmes combined with botulinum toxin injections (BTIs) appear to be a relevant approach to increase the recommended intensive rehabilitation of patients with spasticity following a stroke. The literature highlights a lack of evidence of beneficial effects of this adjuvant therapy to reduce limitations of patients with stroke. The aim of this study is to assess the effects of a 6-month self-rehabilitation programme in adjunction to BTI, in comparison with BTI alone, to reduce limitations of patients with spasticity following a stroke. METHODS AND ANALYSIS 220 chronic patients will participate to this multicentre, prospective, randomised, controlled, assessor blinded study. All patients will benefit from two successive BTI (3 months apart), and patients randomised in the self-rehabilitation group will perform in adjunction 6 months of self-rehabilitation at home. All patients continue their conventional physiotherapy. The main outcome is the primary treatment goal (PTG), which will be determined jointly by the patient and the medical doctor using Goal Attainment Scaling. Impairments and functions, quality of life, mood and fatigue will be assessed. Botulinum toxin will be injected into the relevant muscles according to the PTG. Patients in the self-rehab group will be taught the self-rehabilitation programme involving respectively 10 min of stretching, 10 min of strengthening and 10 min of task-oriented exercises, corresponding to their PTG. Compliance to the self-rehabilitation programme will be monitored. ETHICS AND DISSEMINATION Patients will sign written informed consent. Ethical approval was obtained from ethics committee. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients. TRIAL REGISTRATION NUMBER NCT02944929.
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Affiliation(s)
- Celine Bonnyaud
- Service de Physiologie et d’exploration Fonctionnelle, Hôpital Raymond Poincaré APHP, Garches, Université Versailles Saint Quentin en Yvelines, Garches, France
| | - Philippe Gallien
- Service de Médecine Physique et de Réadaptation, Pole Saint-Helier, Rennes, Bretagne, France
| | - Pierre Decavel
- Service de Médecine Physique et de Réadaptation, Hôpital Jean-Minjoz, Besançon, France
| | - Philippe Marque
- Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, Toulouse, France
| | - Claire Aymard
- Service de Médecine Physique et de Réadaptation, Fondation Hospitaliere Sainte-Marie, Paris, France
| | - Frédéric Pellas
- Service Rééducation Post Réanimation, Unité Cérébro-Lésés, Hopital Carémeau, Nimes, France
| | - Marie-Eve Isner
- Service de Médecine Physique et de Réadaptation, Institut Réadaptation Clémenceau, Strasbourg, France
| | | | - François Muller
- Service de Médecine Physique et de Réadaptation, Clinique Les Embruns, Bidart, France
| | | | - Patrick Dehail
- Service de Médecine Physique et de Réadaptation, Hôpital Pellegrin, Bordeaux, France
| | | | - Nicolas Bayle
- Service de Médecine Physique et de Réadaptation, Albert Chenevier, Hôpital Henri Mondor, Créteil, France
| | - Emmanuel Coudeyre
- Service de Médecine Physique et de Réadaptation, Hôpital Nord, Clermont-Ferrand, France
| | - Dominic Perennou
- Service de Médecine Physique et de Réadaptation, Neurologie, Centre Hospitalier Universitaire, Grenoble, France
| | - Isabelle Laffont
- Service de Médecine Physique et de Réadaptation, Centre Hospitalier Regional Universitaire de Montpellier, Montpellier, France
| | - Jacques Ropers
- Unité de Recherche Clinique, Paris Île-de-France Ouest (URCPO), Hôpital Raymond Poincaré, APHP, Garches, France
| | | | - Djamel Bensmail
- Service de Physiologie et d’exploration Fonctionnelle, Hôpital Raymond Poincaré APHP, Garches, Université Versailles Saint Quentin en Yvelines, Garches, France
| | - Nicolas Roche
- Service de Physiologie et d’exploration Fonctionnelle, Hôpital Raymond Poincaré APHP, Garches, Université Versailles Saint Quentin en Yvelines, Garches, France
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Uchiyama Y, Koyama T, Wada Y, Katsutani M, Kodama N, Domen K. Botulinum Toxin Type A Treatment Combined with Intensive Rehabilitation for Gait Poststroke: A Preliminary Study. J Stroke Cerebrovasc Dis 2018; 27:1975-1986. [PMID: 29610039 DOI: 10.1016/j.jstrokecerebrovasdis.2018.02.054] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2017] [Revised: 02/12/2018] [Accepted: 02/23/2018] [Indexed: 12/13/2022] Open
Abstract
GOAL To examine the effects of botulinum toxin type A (BoNT-A) treatment combined with intensive rehabilitation for gait compared with intensive rehabilitation alone in patients with chronic stroke. MATERIALS AND METHODS A comparative case series design was used. Subjects were 19 patients with chronic stroke and spastic hemiplegia. In 9 patients (group I), BoNT-A was injected into spastic muscles of the affected lower limbs, followed by a 4-week inpatient intensive rehabilitation program. In the other 10 patients (group II), a 4-week inpatient intensive rehabilitation program alone was first provided (control period) followed by the same treatment protocol in group I. The Modified Ashworth Scale (MAS) scores, range of motion (ROM), gait speed in the 10-Meter Walking Test, 6-Minute Walking Distance Test (6MD) scores, Timed Up and Go Test (TUG) scores, and Berg Balance Scale scores were evaluated every 4 weeks following baseline assessments. RESULTS All results except for the MAS score of knee flexor and the ROM of knee flexion improved in group I and the gait speed, 6MD, and TUG scores improved in group II. Intergroup comparisons at week 4 showed significantly greater improvements in the MAS score of ankle plantar flexor, ROM of ankle dorsiflexion, and 6MD in group I than in group II (P = .016, .011, and .009, respectively). CONCLUSIONS BoNT-A treatment for lower-limb spasticity, combined with intensive rehabilitation, was effective in improving spasticity and the 6MD compared with intensive rehabilitation alone in patients with chronic stroke.
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Affiliation(s)
- Yuki Uchiyama
- Department of Rehabilitation Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
| | - Tetsuo Koyama
- Department of Rehabilitation Medicine, Nishinomiya Kyoritsu Neurosurgical Hospital, Nishinomiya, Hyogo, Japan
| | - Yosuke Wada
- Department of Rehabilitation Medicine, Sasayama Medical Center Hyogo College of Medicine, Sasayama, Hyogo, Japan
| | - Masashi Katsutani
- Department of Rehabilitation Medicine, Nishinomiya Kyoritsu Rehabilitation Hospital, Nishinomiya, Hyogo, Japan
| | - Norihiko Kodama
- Department of Rehabilitation Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan
| | - Kazuhisa Domen
- Department of Rehabilitation Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan
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Gupta AD, Chu WH, Howell S, Chakraborty S, Koblar S, Visvanathan R, Cameron I, Wilson D. A systematic review: efficacy of botulinum toxin in walking and quality of life in post-stroke lower limb spasticity. Syst Rev 2018; 7:1. [PMID: 29304876 PMCID: PMC5755326 DOI: 10.1186/s13643-017-0670-9] [Citation(s) in RCA: 95] [Impact Index Per Article: 13.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/17/2017] [Accepted: 12/20/2017] [Indexed: 11/25/2022] Open
Abstract
BACKGROUND Improved walking is one of the highest priorities in people living with stroke. Post-stroke lower limb spasticity (PSLLS) impedes walking and quality of life (QOL). The understanding of the evidence of improved walking and QOL following botulinum toxin (BoNTA) injection is not clear. We performed a systematic review of the randomized control trials (RCT) to evaluate the effectiveness of BoNTA injection on walking and QOL in PSLLS. METHODS We searched PubMed, Web of Science, Embase, CINAHL, ProQuest Thesis and Dissertation checks, Google Scholar, WHO International Clinical Trial Registry Platform, ClinicalTrials.gov , Cochrane, and ANZ and EU Clinical Trials Register for RCTs looking at improvement in walking and QOL following injection of BoNTA in PSLLS. The original search was carried out prior to 16 September 2015. We conducted an additional verifying search on CINHAL, EMBASE, and MEDLINE (via PubMed) from 16 September 2015 to 6 June 2017 using the same clauses as the previous search. Methodological quality of the individual studies was critically appraised using Joanna Briggs Institute's instrument. Only placebo-controlled RCTs looking at improvement in walking and QOL were included in the review. RESULTS Of 2026 records, we found 107 full-text records. Amongst them, we found five RCTs qualifying our criteria. No new trials were found from the verifying search. Two independent reviewers assessed methodological validity prior to inclusion in the review using Joanna Briggs Institute's appraisal instrument. Two studies reported significant improvement in gait velocity (p = 0.020) and < 0.05, respectively. One study showed significant improvement in 2-min-walking distance (p < 0.05). QOL was recorded in one study without any significant improvement. Meta-analysis of reviewed studies could not be performed because of different methods of assessing walking ability, small sample size with large confidence interval and issues such as lack of power calculations in some studies. Findings from our systematic and detailed study identify the need for a well-designed RCT to adequately investigate the issues highlighted. CONCLUSIONS This review could not conclude there was sufficient evidence to support or refute improvement on walking or QOL following BoNTA injection. Reasons for this are discussed, and methods for future RCTs are developed.
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Affiliation(s)
- Anupam Datta Gupta
- Department of Rehabilitation Medicine, The Queen Elizabeth Hospital, 28 Woodville Road, Adelaide, South Australia, 5011, Australia.
| | - Wing Hong Chu
- School of Medicine, University of Adelaide, Adelaide, South Australia, Australia
| | - Stuart Howell
- Data, Design and Statistics Service, University of Adelaide, Adelaide, South Australia, 5005, Australia
| | | | - Simon Koblar
- South Australian Health and Medical Research Institute (SAHMRI), GPO Box 11060, Adelaide, South Australia, 5001, Australia
| | - Renuka Visvanathan
- The Queen Elizabeth Hospital, 28 Woodville Road, Adelaide, South Australia, 5011, Australia
| | - Ian Cameron
- Head John Walsh Centre for Rehabilitation Research, Sydney Medical School, University of Sydney, Sydney, NSW, 2006, Australia
| | - David Wilson
- Department of Medicine, University of Adelaide, Adelaide, South Australia, 5011, Australia
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Klochkova OA, Kurenkov AL, Mamontova NA. [Treatment of spasticity after traumatic brain injury in children: the role of botulinum toxin therapy]. Zh Nevrol Psikhiatr Im S S Korsakova 2017; 117:114-121. [PMID: 29171499 DOI: 10.17116/jnevro2017117101114-121] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Traumatic brain injury (TBI) is one of the main reasons of death and disability in children and adolescents in Russia and abroad. Spasticity is a frequent outcome of the TBI that influences on the rehabilitation prognosis, degree of movement disorders and quality of life after trauma. Early spasticity correction and complex rehabilitation lead to the optimal recovery and prevent secondary complications. This review presents the current data about the prognostic role of the spasticity in children after TBI, methods of its correction and their scientific evidence. Limitations and challenges of per-oral antispastic agents are described especially for the patients with local spasticity. Attention is focused on the methods of treatment of local hypertonus, in particular botulinum toxin A (BTA) injections proved to be effective in adults with acquired brain injury. The article summarizes the results of international investigations, systematic reviews and consensus statements about the efficacy and safety of botulinum toxin treatment in children after the TBI. The authors describe an algorithm of the optimal patient selection and goal setting for BTA injections in children with acquired brain injury.
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Affiliation(s)
- O A Klochkova
- National Medical Research Center of Children's Health of the Ministry of Health of the Russian Federation, Moscow, Russia
| | - A L Kurenkov
- National Medical Research Center of Children's Health of the Ministry of Health of the Russian Federation, Moscow, Russia
| | - N A Mamontova
- Moscow Scientific Research Institute of Emergency Children's Surgery and Traumatology, Moscow, Russia
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Synnot A, Chau M, Pitt V, O'Connor D, Gruen RL, Wasiak J, Clavisi O, Pattuwage L, Phillips K, Cochrane Injuries Group. Interventions for managing skeletal muscle spasticity following traumatic brain injury. Cochrane Database Syst Rev 2017; 11:CD008929. [PMID: 29165784 PMCID: PMC6486165 DOI: 10.1002/14651858.cd008929.pub2] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND Skeletal muscle spasticity is a major physical complication resulting from traumatic brain injury (TBI), which can lead to muscle contracture, joint stiffness, reduced range of movement, broken skin and pain. Treatments for spasticity include a range of pharmacological and non-pharmacological interventions, often used in combination. Management of spasticity following TBI varies from other clinical populations because of the added complexity of behavioural and cognitive issues associated with TBI. OBJECTIVES To assess the effects of interventions for managing skeletal muscle spasticity in people with TBI. SEARCH METHODS In June 2017, we searched key databases including the Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE (Ovid), Embase (Ovid) and others, in addition to clinical trials registries and the reference lists of included studies. SELECTION CRITERIA We included randomised controlled trials (RCTs) and cross-over RCTs evaluating any intervention for the management of spasticity in TBI. Only studies where at least 50% of participants had a TBI (or for whom separate data for participants with TBI were available) were included. The primary outcomes were spasticity and adverse effects. Secondary outcome measures were classified according to the World Health Organization International Classification of Functioning, Disability and Health including body functions (sensory, pain, neuromusculoskeletal and movement-related functions) and activities and participation (general tasks and demands; mobility; self-care; domestic life; major life areas; community, social and civic life). DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane. Data were synthesised narratively; meta-analysis was precluded due to the paucity and heterogeneity of data. MAIN RESULTS We included nine studies in this review which involved 134 participants with TBI. Only five studies reported between-group differences, yielding outcome data for 105 participants with TBI. These five studies assessed the effects of a range of pharmacological (baclofen, botulinum toxin A) and non-pharmacological (casting, physiotherapy, splints, tilt table standing and electrical stimulation) interventions, often in combination. The studies which tested the effect of baclofen and tizanidine did not report their results adequately. Where outcome data were available, spasticity and adverse events were reported, in addition to some secondary outcome measures.Of the five studies with results, three were funded by governments, charities or health services and two were funded by a pharmaceutical or medical technology company. The four studies without useable results were funded by pharmaceutical or medical technology companies.It was difficult to draw conclusions about the effectiveness of these interventions due to poor reporting, small study size and the fact that participants with TBI were usually only a proportion of the overall total. Meta-analysis was not feasible due to the paucity of data and heterogeneity of interventions and comparator groups. Some studies concluded that the intervention they tested had beneficial effects on spasticity, and others found no difference between certain treatments. The most common adverse event was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all outcomes. AUTHORS' CONCLUSIONS The very low quality and limited amount of evidence about the management of spasticity in people with TBI means that we are uncertain about the effectiveness or harms of these interventions. Well-designed and adequately powered studies using functional outcome measures to test the interventions used in clinical practice are needed.
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Affiliation(s)
- Anneliese Synnot
- Monash UniversityCochrane Australia, School of Public Health and Preventive MedicineL4 551 St Kilda RdMelbourneVictoriaAustralia3004
- National Trauma Research Institute, Alfred Hospital, Monash UniversityLevel 4, 89 Commercial RoadMelbourneVictoriaAustralia3004
| | - Marisa Chau
- National Trauma Research Institute, Alfred Hospital, Monash UniversityLevel 4, 89 Commercial RoadMelbourneVictoriaAustralia3004
| | - Veronica Pitt
- Australian & New Zealand Intensive Care Research Centre (ANZIC‐RC), Monash UniversityLevel 6, The Alfred Centre, 99 Commercial RoadMelbourneVictoriaAustralia3004
| | - Denise O'Connor
- Monash UniversitySchool of Public Health and Preventive MedicineThe Alfred Centre99 Commercial RoadMelbourneVictoriaAustralia3004
| | - Russell L Gruen
- Nanyang Technological UniversityLee Kong Chian School of Medicine11 Mandalay RoadSingaporeSingapore308232
| | - Jason Wasiak
- University of MelbourneMelbourne School of Health SciencesGrattan Street, ParkvilleMelbourneVictoriaAustralia
| | - Ornella Clavisi
- MOVE muscle, bone & joint health263‐265 Kooyong Rd ElsternwickMelbourneVICAustralia3185
| | - Loyal Pattuwage
- Centre for Evidence and ImplementationEast MelbourneVICAustralia3175
| | - Kate Phillips
- Monash UniversitySchool of Public Health & Preventive MedicineThe Alfred Centre99 Commercial RoadMelbourneVictoriaAustralia3004
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Gracies JM, Esquenazi A, Brashear A, Banach M, Kocer S, Jech R, Khatkova S, Benetin J, Vecchio M, McAllister P, Ilkowski J, Ochudlo S, Catus F, Grandoulier AS, Vilain C, Picaut P. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology 2017; 89:2245-2253. [PMID: 29093068 PMCID: PMC5705248 DOI: 10.1212/wnl.0000000000004687] [Citation(s) in RCA: 63] [Impact Index Per Article: 7.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/30/2017] [Accepted: 09/09/2017] [Indexed: 11/15/2022] Open
Abstract
OBJECTIVE To demonstrate single abobotulinumtoxinA injection efficacy in lower limb vs placebo for adults with chronic hemiparesis and assess long-term safety and efficacy of repeated injections. METHODS In a multicenter, double-blind, randomized, placebo-controlled, single-cycle study followed by a 1-year open-label, multiple-cycle extension, adults ≥6 months after stroke/brain injury received one lower limb injection (abobotulinumtoxinA 1,000 U, abobotulinumtoxinA 1,500 U, placebo) followed by ≤4 open-label cycles (1,000, 1,500 U) at ≥12-week intervals. Efficacy measures included Modified Ashworth Scale (MAS) in gastrocnemius-soleus complex (GSC; double-blind primary endpoint), physician global assessment (PGA), and comfortable barefoot walking speed. Safety was the open-label primary endpoint. RESULTS After a single injection, mean (95% confidence interval) MAS GSC changes from baseline at week 4 (double-blind, n = 381) were as follows: -0.5 (-0.7 to -0.4) (placebo, n = 128), -0.6 (-0.8 to -0.5) (abobotulinumtoxinA 1,000 U, n = 125; p = 0.28 vs placebo), and -0.8 (-0.9 to -0.7) (abobotulinumtoxinA 1,500 U, n = 128; p = 0.009 vs placebo). Mean week 4 PGA scores were as follows: 0.7 (0.5, 0.9) (placebo), 0.9 (0.7, 1.1) (1,000 U; p = 0.067 vs placebo), and 0.9 (0.7, 1.1) (1,500 U; p = 0.067); walking speed was not significantly improved vs placebo. At cycle 4, week 4 (open-label), mean MAS GSC change reached -1.0. Incremental improvements in PGA and walking speed occurred across open-label cycles; by cycle 4, week 4, mean PGA was 1.9, and walking speed increased +25.3% (17.5, 33.2), with 16% of participants walking >0.8 m/s (associated with community mobility; 0% at baseline). Tolerability was good and consistent with the known abobotulinumtoxinA safety profile. CONCLUSIONS In chronic hemiparesis, single abobotulinumtoxinA (Dysport Ipsen) administration reduced muscle tone. Repeated administration over a year was well-tolerated and improved walking speed and likelihood of achieving community ambulation. CLINICALTRIALGOV IDENTIFIERS NCT01249404, NCT01251367. CLASSIFICATION OF EVIDENCE The double-blind phase of this study provides Class I evidence that for adults with chronic spastic hemiparesis, a single abobotulinumtoxinA injection reduces lower extremity muscle tone.
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Affiliation(s)
| | | | | | - Marta Banach
- Author affiliations are provided at the end of the article
| | - Serdar Kocer
- Author affiliations are provided at the end of the article
| | - Robert Jech
- Author affiliations are provided at the end of the article
| | | | - Ján Benetin
- Author affiliations are provided at the end of the article
| | | | | | - Jan Ilkowski
- Author affiliations are provided at the end of the article
| | | | - France Catus
- Author affiliations are provided at the end of the article
| | | | - Claire Vilain
- Author affiliations are provided at the end of the article
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Hara T, Abo M, Hara H, Kobayashi K, Shimamoto Y, Shibata Y, Sasaki N, Yamada N, Niimi M. Effects of botulinum toxin A therapy and multidisciplinary rehabilitation on lower limb spasticity classified by spastic muscle echo intensity in post-stroke patients. Int J Neurosci 2017; 128:412-420. [PMID: 28985683 DOI: 10.1080/00207454.2017.1389927] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
Abstract
OBJECTIVES The purpose of the present study was to investigate retrospectively the relationship between botulinum toxin type A plus multidisciplinary rehabilitation and muscle echo intensity in post-stroke patients with spasticity. The primary aim was to investigate whether the effects of the intervention on the improvement of spasticity depend on muscle echo intensity, and the secondary aim was to investigate whether the motor function of the lower limbs depends on muscle echo intensity. METHODS A 12-day inpatient protocol was designed for 102 post-stroke patients with spasticity due to lower limb paralysis. Muscle echo intensity of the triceps surae muscle was measured by ultrasonography, and the patients were categorized into four groups based on Heckmatt scale grades (Grades I-IV). RESULTS All four groups classified by the Heckmatt scale showed significant pre-to-post-intervention differences in the knee and ankle modified Ashworth scale scores (p < 0.05). Grades I-III patient groups showed a significant improvement in lower limb motor function following intervention. Grade IV patients did not show a significant improvement in lower limb motor function. CONCLUSIONS We observed significant improvements in the modified Ashworth scale scores after botulinum toxin type A and multidisciplinary rehabilitation therapy on post-stroke patients with spasticity. Although patients with lower muscle echo intensity demonstrated improvements in motor function, the improvement was poor in those with higher muscle echo intensity.
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Affiliation(s)
- Takatoshi Hara
- a Department of Rehabilitaion Medicine , The Jikei University School of Medicine , Tokyo , Japan.,b Department of Rehabilitaion Medicine , Kikyougahara Hospital , Nagano , Japan
| | - Masahiro Abo
- a Department of Rehabilitaion Medicine , The Jikei University School of Medicine , Tokyo , Japan
| | - Hiroyoshi Hara
- b Department of Rehabilitaion Medicine , Kikyougahara Hospital , Nagano , Japan
| | - Kazushige Kobayashi
- a Department of Rehabilitaion Medicine , The Jikei University School of Medicine , Tokyo , Japan
| | - Yusuke Shimamoto
- b Department of Rehabilitaion Medicine , Kikyougahara Hospital , Nagano , Japan
| | - Yamato Shibata
- b Department of Rehabilitaion Medicine , Kikyougahara Hospital , Nagano , Japan
| | - Nobuyuki Sasaki
- a Department of Rehabilitaion Medicine , The Jikei University School of Medicine , Tokyo , Japan
| | - Naoki Yamada
- a Department of Rehabilitaion Medicine , The Jikei University School of Medicine , Tokyo , Japan
| | - Masachika Niimi
- a Department of Rehabilitaion Medicine , The Jikei University School of Medicine , Tokyo , Japan
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Geiger M, Supiot A, Zory R, Aegerter P, Pradon D, Roche N. The effect of transcranial direct current stimulation (tDCS) on locomotion and balance in patients with chronic stroke: study protocol for a randomised controlled trial. Trials 2017; 18:492. [PMID: 29061169 PMCID: PMC5654046 DOI: 10.1186/s13063-017-2219-6] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/20/2017] [Accepted: 09/29/2017] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Following stroke, patients are often left with hemiparesis that reduces balance and gait capacity. A recent, non-invasive technique, transcranial direct current stimulation, can be used to modify cortical excitability when used in an anodal configuration. It also increases the excitability of spinal neuronal circuits involved in movement in healthy subjects. Many studies in patients with stroke have shown that this technique can improve motor, sensory and cognitive function. For example, anodal tDCS has been shown to improve motor performance of the lower limbs in patients with stroke, such as voluntary quadriceps strength, toe-pinch force and reaction time. Nevertheless, studies of motor function have been limited to simple tasks. Surprisingly, the effects of tDCS on the locomotion and balance of patients with chronic stroke have never been evaluated. In this study, we hypothesise that anodal tDCS will improve balance and gait parameters in patients with chronic stroke-related hemiparesis through its effects at cortical and spinal level. METHODS/DESIGN This is a prospective, randomised, placebo-controlled, double-blinded, single-centre, cross-over study over 36 months. Forty patients with chronic stroke will be included. Each patient will participate in three visits: an inclusion visit, and two visits during which they will all undergo either one 30-min session of transcranial direct current stimulation or one 30-min session of placebo stimulation in a randomised order. Evaluations will be carried out before, during and twice after stimulation. The primary outcome is the variability of the displacement of the centre of mass during gait and a static-balance task. Secondary outcomes include clinical and functional measures before and after stimulation. A three-dimensional gait analysis, and evaluation of static balance on a force platform will be also conducted before, during and after stimulation. DISCUSSION These results should constitute a useful database to determine the aspects of complex motor function that are the most improved by transcranial direct current stimulation in patients with hemiparesis. It is the first essential step towards validating this technique as a treatment, coupled with task-oriented training. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT02134158 . First received on 18 December 2013; last updated on 14 September 2016. Other study ID numbers: P120135 / AOM12126, 2013-A00952-43.
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Affiliation(s)
- M Geiger
- Inserm Unit 1179, Team 3: Technologies and Innovative Therapies Applied to Neuromuscular diseases, UVSQ, CIC 805, Physiology-Functional Testing Ward, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France. .,CIAMS, Université Paris-Sud, Université Paris-Saclay, 91405, Orsay Cedex, France. .,CIAMS, Université d'Orléans, 45067, Orléans, France.
| | - A Supiot
- Inserm Unit 1179, Team 3: Technologies and Innovative Therapies Applied to Neuromuscular diseases, UVSQ, CIC 805, Physiology-Functional Testing Ward, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.,CIAMS, Université Paris-Sud, Université Paris-Saclay, 91405, Orsay Cedex, France.,CIAMS, Université d'Orléans, 45067, Orléans, France
| | - R Zory
- Laboratory of Human Motricity, Sport, Education and Health (EA 6312), University of Nice Sophia Antipolis, Nice, France
| | - P Aegerter
- Assistance Publique-Hôpitaux de Paris, Hôpital Ambroise Paré, Unité de Recherche Clinique (URC), Boulogne, France
| | - D Pradon
- Inserm Unit 1179, Team 3: Technologies and Innovative Therapies Applied to Neuromuscular diseases, UVSQ, CIC 805, Physiology-Functional Testing Ward, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France
| | - N Roche
- Inserm Unit 1179, Team 3: Technologies and Innovative Therapies Applied to Neuromuscular diseases, UVSQ, CIC 805, Physiology-Functional Testing Ward, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France
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So E, Hlad LM. Modified Lambrinudi Arthrodesis for the Acute Treatment of Neurogenic Clubfoot: A Case Report. Foot Ankle Spec 2017; 10:372-376. [PMID: 27920102 DOI: 10.1177/1938640016681070] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
UNLABELLED Neurogenic contracture often results in spastic, nonreducible equinovarus deformity. Rigid contracture leads to pain, instability, and bracing difficulties. This case report details the utilization of the modified Lambrinudi triple arthrodesis intended to create a plantigrade, functional limb that is amenable to an extremity brace in a case of an acquired neurologic clubfoot. LEVELS OF EVIDENCE Therapeutic, Level IV: Case Report.
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Affiliation(s)
- Eric So
- Grant Medical Center, Columbus, Ohio (ES, LMH).,Step Lively Foot and Ankle Center, Columbus, Ohio (LMH)
| | - Lee M Hlad
- Grant Medical Center, Columbus, Ohio (ES, LMH).,Step Lively Foot and Ankle Center, Columbus, Ohio (LMH)
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Naro A, Leo A, Russo M, Casella C, Buda A, Crespantini A, Porcari B, Carioti L, Billeri L, Bramanti A, Bramanti P, Calabrò RS. Breakthroughs in the spasticity management: Are non-pharmacological treatments the future? J Clin Neurosci 2017; 39:16-27. [DOI: 10.1016/j.jocn.2017.02.044] [Citation(s) in RCA: 47] [Impact Index Per Article: 5.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2016] [Accepted: 02/12/2017] [Indexed: 12/16/2022]
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OnabotulinumtoxinA for Lower Limb Spasticity: Guidance From a Delphi Panel Approach. PM R 2017; 9:960-968. [DOI: 10.1016/j.pmrj.2017.02.014] [Citation(s) in RCA: 26] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/04/2016] [Revised: 02/11/2017] [Accepted: 02/17/2017] [Indexed: 11/24/2022]
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Abstract
Clinical and political responses to the worldwide epidemic of traumatic brain injury (TBI) need to recognize that the quality of outcome depends on both phases of treatment: acute care and rehabilitation. The growing scientific evidence for neural repair and regeneration has supported growing interest about what rehabilitation can offer to restore function and independence to disabled individuals. Clinicians who treat acutely head-injured patients should develop some understanding of the reality and potential of rehabilitation, to put their own work into perspective. This article reviews the common problems that follow TBI, unpacks the rehabilitation box to see what can be done about them, and considers the scientific evidence for the efficacy of the rehabilitation process.
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Affiliation(s)
- Douglas Gentleman
- Centre for Brain Injury Rehabilitation, Royal Victoria Hospital, Dundee, UK
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Hara T, Abo M, Hara H, Kobayashi K, Shimamoto Y, Samizo Y, Sasaki N, Yamada N, Niimi M. Effects of botulinum toxin A therapy and multidisciplinary rehabilitation on upper and lower limb spasticity in post-stroke patients. Int J Neurosci 2016; 127:469-478. [DOI: 10.1080/00207454.2016.1196204] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
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OnabotulinumtoxinA Injection for Poststroke Upper-Limb Spasticity: Guidance for Early Injectors From a Delphi Panel Process. PM R 2016; 9:136-148. [PMID: 27346090 DOI: 10.1016/j.pmrj.2016.06.016] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/08/2015] [Revised: 06/02/2016] [Accepted: 06/07/2016] [Indexed: 11/22/2022]
Abstract
BACKGROUND OnabotulinumtoxinA reduces muscle hypertonia associated with poststroke spasticity (PSS). PSS manifests as several common postures. OBJECTIVE To define treatment paradigms for PSS upper-limb common postures. DESIGN Modified Delphi method. SETTING Expert panel. PARTICIPANTS Ten injectors experienced in the treatment and clinical research of PSS (physiatrists and neurologists) were invited to participate in the Delphi panel. METHODS The Delphi panel reviewed an electronic worksheet with PSS upper-limb postures to define onabotulinumtoxinA treatment paradigms (Round 1). During Round 2, panel members discussed in person Round 1 results and voted until consensus (≥66% agreement). Recommendations were geared toward those with new or early injection experience. MAIN OUTCOME MEASUREMENTS Expert consensus on onabotulinumtoxinA treatment parameters for PSS including muscles to inject, dose per muscle and posture, and treatment adjustments for suboptimal response. RESULTS For each posture, consensus was reached on targeted subsets of muscles. Doses ranged for individual muscles (10-100 U) and total doses per posture (50-200 U). An onabotulinumtoxinA dilution 50 U/mL (2:1 dilution ratio) was considered most appropriate; dilution ratios of 1:1 to 4:1 may be appropriate in some circumstances. The majority (89%) of panel members would increase the dose and/or the number of muscles treated for a suboptimal response to onabotulinumtoxinA. The panel identified 3 common aggregate upper-limb postures: (1) adducted shoulder + flexed elbow + pronated forearm + flexed wrist + clenched fist; (2) flexed elbow + pronated forearm + flexed wrist + clenched fist; and (3) flexed wrist + clenched fist. The recommended starting dose per aggregate was 300 U, 300 U, and 200 U, with a total maximum dose of 400 U, 400 U, and 300 U, respectively. Localization guidance techniques were considered essential for all postures. CONCLUSIONS Consensus on common muscles and onabotulinumtoxinA treatment paradigms for postures associated with upper-limb PSS was achieved via a modified Delphi method. The purpose of this analysis is to educate early onabotulinumtoxinA injectors rather than provide an evidence-based review. LEVEL OF EVIDENCE V.
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Kaku M, Simpson DM. Spotlight on botulinum toxin and its potential in the treatment of stroke-related spasticity. DRUG DESIGN DEVELOPMENT AND THERAPY 2016; 10:1085-99. [PMID: 27022247 PMCID: PMC4789850 DOI: 10.2147/dddt.s80804] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 11/24/2022]
Abstract
Poststroke spasticity affects up to one-half of stroke patients and has debilitating effects, contributing to diminished activities of daily living, quality of life, pain, and functional impairments. Botulinum toxin (BoNT) is proven to be safe and effective in the treatment of focal poststroke spasticity. The aim of this review is to highlight BoNT and its potential in the treatment of upper and lower limb poststroke spasticity. We review evidence for the efficacy of BoNT type A and B formulations and address considerations of optimal injection technique, patient and caregiver satisfaction, and potential adverse effects of BoNT.
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Affiliation(s)
- Michelle Kaku
- Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA
| | - David M Simpson
- Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA
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Choi JY, Jung S, Rha DW, Park ES. Botulinum Toxin Type A Injection for Spastic Equinovarus Foot in Children with Spastic Cerebral Palsy: Effects on Gait and Foot Pressure Distribution. Yonsei Med J 2016; 57:496-504. [PMID: 26847306 PMCID: PMC4740546 DOI: 10.3349/ymj.2016.57.2.496] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/29/2015] [Revised: 07/09/2015] [Accepted: 08/06/2015] [Indexed: 11/27/2022] Open
Abstract
PURPOSE To investigate the effect of intramuscular Botulinum toxin type A (BoNT-A) injection on gait and dynamic foot pressure distribution in children with spastic cerebral palsy (CP) with dynamic equinovarus foot. MATERIALS AND METHODS Twenty-five legs of 25 children with CP were investigated in this study. BoNT-A was injected into the gastrocnemius (GCM) and tibialis posterior (TP) muscles under the guidance of ultrasonography. The effects of the toxin were clinically assessed using the modified Ashworth scale (MAS) and modified Tardieu scale (MTS), and a computerized gait analysis and dynamic foot pressure measurements using the F-scan system were also performed before injection and at 1 and 4 months after injection. RESULTS Spasticity of the ankle plantar-flexor in both the MAS and MTS was significantly reduced at both 1 and 4 months after injection. On dynamic foot pressure measurements, the center of pressure index and coronal index, which represent the asymmetrical weight-bearing of the medial and lateral columns of the foot, significantly improved at both 1 and 4 months after injection. The dynamic foot pressure index, total contact area, contact length and hind foot contact width all increased at 1 month after injection, suggesting better heel contact. Ankle kinematic data were significantly improved at both 1 and 4 months after injection, and ankle power generation was significantly increased at 4 months after injection compared to baseline data. CONCLUSION Using a computerized gait analysis and foot scan, this study revealed significant benefits of BoNT-A injection into the GCM and TP muscles for dynamic equinovarus foot in children with spastic CP.
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Affiliation(s)
- Ja Young Choi
- Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - Soojin Jung
- Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - Dong Wook Rha
- Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - Eun Sook Park
- Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea.
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Wu T, Li JH, Song HX, Dong Y. Effectiveness of Botulinum Toxin for Lower Limbs Spasticity after Stroke: A Systematic Review and Meta-Analysis. Top Stroke Rehabil 2016; 23:217-23. [DOI: 10.1080/10749357.2016.1139294] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/24/2023]
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Dashtipour K, Chen JJ, Walker HW, Lee MY. Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Lower Limb Spasticity. Medicine (Baltimore) 2016; 95:e2468. [PMID: 26765447 PMCID: PMC4718273 DOI: 10.1097/md.0000000000002468] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
To elucidate clinical trial efficacy, safety, and dosing practices of AbobotulinumtoxinA (ABO) treatment in adult patients with lower limb spasticity.A systematic literature review was performed to identify randomized controlled trials of ABO in the treatment of adult lower limb spasticity.Of the 295 records identified, 6 primary publications evaluated ABO for the management of lower limb spasticity of various etiologies and were evaluated. Total ABO doses ranged between 500 and 2000 U for lower limb spasticity, depending on the muscles injected. All studies in lower limb spasticity showed statistically significant reduction in muscle tone based on Modified Ashworth Scale of ABO versus placebo. Significant effects on active movement and pain were demonstrated albeit less consistently. ABO was generally well tolerated across the individual studies; most adverse events reported were considered unrelated to treatment. Treatment-related adverse events included but not limited to fatigue, local pain at injection site, hypertonia, dry mouth, weakness of the noninjected muscle, abnormal gait, and urinary tract infection.These data from 6 randomized clinical studies provide the beginnings of an evidence base for the use of ABO to reduce lower limb spasticity. Ongoing studies in this area will add to this evidence base.
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Affiliation(s)
- Khashayar Dashtipour
- From the School of Medicine, Loma Linda University, Loma Linda, CA (KD, JJC); College of Pharmacy, Marshall B. Ketchum University, Fullerton, CA (JJC); and Department of Physical Medicine and Rehabilitation, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC (HWW, MYL)
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Tanikawa H, Kagaya H, Saitoh E, Ozaki K, Hirano S, Itoh N, Yamada J, Kanada Y. Efficacy of Botulinum Toxin A Treatment for Pes Varus during Gait. J Stroke Cerebrovasc Dis 2015; 24:2416-22. [DOI: 10.1016/j.jstrokecerebrovasdis.2015.06.035] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/11/2015] [Revised: 06/20/2015] [Accepted: 06/28/2015] [Indexed: 11/25/2022] Open
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Distribution of Lower Limb Spasticity Does Not Influence Mobility Outcome Following Traumatic Brain Injury. J Head Trauma Rehabil 2015; 30:E49-57. [DOI: 10.1097/htr.0000000000000094] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/24/2022]
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Baker JA, Pereira G. The efficacy of Botulinum Toxin A for limb spasticity on improving activity restriction and quality of life: a systematic review and meta-analysis using the GRADE approach. Clin Rehabil 2015; 30:549-58. [DOI: 10.1177/0269215515593609] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2014] [Accepted: 06/07/2015] [Indexed: 01/23/2023]
Abstract
Objectives: A systematic review and meta analysis using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. The aim was to evaluate the efficacy of Botulinum Toxin type A for limb spasticity on improving activity restriction and quality of life outcomes. Data sources: Pubmed, Cinahl, Amed, Embase and Cochrane databases. English Language. Search to January 2015. Review methods: All randomized, placebo controlled trials on adults with active function or quality of life measures for the arm and leg relating to spasticity of any origin and treated with a single dose of Botulinum Toxin A. Evidence quality was assessed by GRADE. Results: Twenty-five studies were reviewed. Meta analysis was carried out on six upper limb and six lower limb studies. Evidence quality for the upper limb was low/very low. A significant result for Botulinum Toxin A was found at four to twelve weeks for the upper limb for active function (SMD 0.32 CI 0.01, 0.62, P=0.04) These effects were maintained for up to six months for Active Research Arm Test (ARAT) only (MD 1.87 CI 0.53, 3.21, P=0.006). Evidence quality was very low for the lower limb. No significant effect was found. Meta analysis was not possible for quality of life measures. Conclusion: Botulinum Toxin A may improve active outcomes in the upper limb but further evidence is needed. No conclusion can be drawn about the effect on active outcomes for the lower limb or for quality of life measures in either limb.
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