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 change (range), 3.0 (1-5) and 2.5 (1-4) in the RAGT and control group). Both groups exhibited significant gains in lower limb motor function; however, the RAGT group demonstrated a significantly greater improvement in lower limb strength (mean change, 15.9 +/- 14.2 and 11.1 +/- 11.2 in the RAGT and control group, P=0.034).CONCLUSIONS:Overground gait training using an exoskeleton was not superior to conventional rehabilitation for improving ambulatory function in subacute stroke patients; however, it could provide additional lower extremity motor improvement. These findings suggest that the overground gait training with an exoskeleton might be a potential intervention for patients with subacute stroke.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT05157347.