Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III)

针对多发性硬化症患者,使用动力外骨骼进行平衡训练的可行性和安全性:单组初步研究(Rapper III)

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Abstract

OBJECTIVE: To evaluate the feasibility, usability, safety, and potential health benefits of using an exoskeleton device for rehabilitation of people living with multiple sclerosis. DESIGN: Single-group preliminary study. SUBJECTS: Eleven adults living with multiple sclerosis, with Expanded Disability Status Scores that ranged from 6 to 7.5 (mean age (standard deviation; SD) 54.2 (11.8) years), were recruited. METHODS: Individual participants undertook a balance rehabilitation exercise programme using the Rex Rehab robotic exoskeleton device. Each participant undertook 4 × 45-60 min supervised, balance exercise sessions. Primary outcomes were: (i) the number of participants who completed the trial protocol safely, and (ii) the number and nature of adverse events reported. Secondary outcomes were: mobility; balance; spasticity; sleep; functional independence; quality of life; and device satisfaction. RESULTS: Ten out of 11 participants completed the trial protocol safely. Four adverse events were recorded (1 serious), all of which were deemed unrelated to the trial. Secondary outcomes showed allied improvements in balance, joint mobility, spasticity and quality of life. All participants found the device acceptable to use. CONCLUSION: These results suggest that it is feasible and safe to use the Rex Rehab exoskeleton device to assist with balance rehabilitation for people living with multiple sclerosis.

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