Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Aug 26, 2024; 12(24): 5523-5533
Published online Aug 26, 2024. doi: 10.12998/wjcc.v12.i24.5523
Effectiveness of the A3 robot on lower extremity motor function in stroke patients: A prospective, randomized controlled trial
Lin-Jian Zhang, Xin Wen, Yang Peng, Wei Hu, Hui Liao, Zi-Cai Liu, Hui-Yu Liu
Lin-Jian Zhang, Xin Wen, Yang Peng, Wei Hu, Hui Liao, Department of Rehabilitation Medicine, Yuebei People's Hospital, Shaoguan 512000, Guangdong Province, China
Zi-Cai Liu, Department of Rehabilitation Medicine, Shaoguan First People's Hospital, Shaoguan 512000, Guangdong Province, China
Hui-Yu Liu, Department of Rehabilitation Medicine, Yuebei Second People's Hospital, Shaoguan 512026, Guangdong Province, China
Co-corresponding authors: Zi-Cai Liu and Hui-Yu Liu.
Author contributions: Liu ZC, Zhang LJ, and Liu HY designed the research study; Zhang LJ, Wen X, Peng Y, Hu W, and Liao H performed the study; Liu ZC and Zhang LJ analyzed the data and wrote the manuscript; All authors have read and approved the final manuscript.
Supported by Shaoguan Municipal Health Bureau, No. Y22058; and Shaoguan City Science and Technology Plan Project, No. 220517164531600.
Institutional review board statement: The clinical trial was approved by the Ethics Committee of the Yuebei People's Hospital (No. KY-2021-327).
Clinical trial registration statement: The program was registered online in the Chinese Clinical Trial Registry (Registration No. ChiCTR2100052767).
Informed consent statement: Informed consent has been signed and submitted by all participants and the procedures are carried out following the Helsinki Declaration.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
Data sharing statement: Data to support this study are available through the corresponding author if required.
CONSORT 2010 statement: The manuscript references and conforms to the CONSURT checklist and has also been provided with completed documentation.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Zi-Cai Liu, MS, Physiotherapist, Researcher, Department of Rehabilitation Medicine, Shaoguan First People's Hospital, No. 3 Dongdi South Road, Zhenjiang District, Shaoguan 512000, Guangdong Province, China. 1454262065@qq.com
Received: April 18, 2024
Revised: May 29, 2024
Accepted: June 12, 2024
Published online: August 26, 2024
Processing time: 83 Days and 19.5 Hours
Abstract
BACKGROUND

The results of existing lower extremity robotics studies are conflicting, and few relevant clinical trials have examined short-term efficacy. In addition, most of the outcome indicators in existing studies are scales, which are not objective enough. We used the combination of objective instrument measurement and scale to explore the short-term efficacy of the lower limb A3 robot, to provide a clinical reference.

AIM

To investigate the improvement of lower limb walking ability and balance in stroke treated by A3 lower limb robot.

METHODS

Sixty stroke patients were recruited prospectively in a hospital and randomized into the A3 group and the control group. They received 30 min of A3 robotics training and 30 min of floor walking training in addition to 30 min of regular rehabilitation training. The training was performed five times a week, once a day, for 2 wk. The t-test or non-parametric test was used to compare the three-dimensional gait parameters and balance between the two groups before and after treatment.

RESULTS

The scores of basic activities of daily living, Stroke-Specific Quality of Life Scale, FM balance meter, Fugl-Meyer Assessment scores, Rivermead Mobility Index, Stride speed, Stride length, and Time Up and Go test in the two groups were significantly better than before treatment (19.29 ± 12.15 vs 3.52 ± 4.34; 22.57 ± 17.99 vs 4.07 ± 2.51; 1.21 ± 0.83 vs 0.18 ± 0.40; 3.50 ± 3.80 vs 0.96 ± 2.08; 2.07 ± 1.21 vs 0.41 ± 0.57; 0.89 ± 0.63 vs 0.11 ± 0.32; 12.38 ± 9.00 vs 2.80 ± 3.43; 18.84 ± 11.24 vs 3.80 ± 10.83; 45.12 ± 69.41 vs 8.41 ± 10.20; 29.45 ± 16.62 vs 8.68 ± 10.74; P < 0.05). All outcome indicators were significantly better in the A3 group than in the control group, except the area of the balance parameter.

CONCLUSION

For the short-term treatment of patients with subacute stroke, the addition of A3 robotic walking training to conventional physiotherapy appears to be more effective than the addition of ground-based walking training.

Keywords: Stroke; Robotics; Gait; Robot-assisted gait training; Neurological rehabilitation; Walking training

Core Tip: In this study, two groups of stroke patients underwent 2 wk of A3 lower extremity robotics and ground walking training, respectively, and gait spatiotemporal and balance parameters were recorded before and after the 2-wk intervention, which were compared by statistical analysis. It was finally concluded that for the short-term treatment of patients with subacute stroke, the addition of A3 robotic walking training to conventional physiotherapy appears to be more effective than the addition of ground-based walking training.