Efficacy of Wearable Exoskeleton for Gait Recovery in Patients With Stroke: A Multicenter Randomized Controlled Trial
Abstract
BACKGROUND: Robot-assisted gait training (RAGT) with wearable exoskeletons has the potential to enhance walking in patients with stroke; however, large-scale evidence is inconclusive. The aim of this study was to determine the effect of overground gait training using a torque-assisted exoskeleton in patients with subacute stroke on the recovery of ambulatory function. METHODS: This international, multicenter, randomized controlled trial enrolled 151 patients with subacute stroke who presented with severe gait impairment but relatively preserved trunk control. Participants were randomized to the RAGT group (30 minutes of conventional gait training plus 30 minutes of exoskeleton) or the control group (60 minutes of conventional gait training), 5 times per week for 4 weeks. The primary outcome was the change in ambulatory function, assessed by the Functional Ambulation Category (FAC) before and immediately after the 4-week intervention. Secondary outcomes included the lower limb strength, balance function. Independent ambulation was reassessed 3 months after the intervention. RESULTS: A total of 127 participants (56 female (44.1%), mean age, 60.1±13.6 years) completed the 4-week intervention. There were no serious adverse events related to the interventions, and dropout rates tended to be higher in the RAGT group without statistical significance. Both groups showed significant improvement in FAC after the intervention; however, no significant difference between groups (mean…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 151 participants or records.
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