Effect of an exosuit on daily life gait performance in individuals with incomplete spinal cord injury: a randomized controlled trial

外骨骼对不完全性脊髓损伤患者日常生活步态表现的影响:一项随机对照试验

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Abstract

INTRODUCTION: Individuals with incomplete spinal cord injury (iSCI) often have impaired gait capacity, limiting their gait performance at home and in the community. Lightweight lower extremity exosuits, such as the Myosuit (MyoSwiss AG, Zurich, Switzerland), may offer functional support to improve daily life gait performance. The aim of this randomized controlled trial was to investigate the effect of the Myosuit on daily life gait performance and its usability in individuals with iSCI. METHODS: Thirty-four individuals with chronic iSCI were randomized (1:1) to either the intervention or control group. The intervention group received a Myosuit program consisting of five gait training sessions, followed by a 6-week home period in which the Myosuit was used as an assistive device. The control group received a conventional program consisting of four gait training sessions, followed by a 6-week home period without the device. Walking time per day was assessed, using an activity monitor, at baseline and during week one, three, and six of the home period. In addition, usability was assessed using the Dutch version of the System Usability Scale (D-SUS) and the Dutch version of the Quebec User Evaluation of Satisfaction with assistive Technology (D-QUEST) questionnaire after the home period. RESULTS: No significant group difference in walking time per day during the home period was observed (estimate=9 min, robust standard error=8, p=0.23). The average D-SUS score was 56 ± 21 and the D-QUEST score was 3.4 ± 0.5. CONCLUSION: Myosuit use at home and in the community did not lead to improved daily life gait performance in individuals with iSCI. Usability was marginal, suggesting that further improvements of exosuit design and functionality are necessary to enhance its effectiveness and user acceptance in real-world settings. Trial registration Clinicaltrials.gov NCT05605912. Registered on October 19, 2022. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12984-026-01941-8.

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