Exoskeleton-Assisted Therapy Enhances Upper Limb Motor Recovery in Early Subacute Stroke: A Multicenter, Single-Blind Randomized Controlled Trial

BACKGROUND: Robot-assisted therapy (RAT) with exoskeletons is believed to enhance motor recovery in stroke survivors. RAT offers intensive, feedback-based, task-oriented training to improve function. This study evaluated exoskeleton-based RAT integrated into usual rehabilitation care for individuals in early subacute stroke. METHODS: This multicenter randomized controlled trial was conducted across 8 stroke neurorehabilitation units over a 3-year period (December 2020–March 2024). Inpatients with moderate-to-severe upper limb impairment postsubacute stroke (<3 months poststroke) were randomized (1:1) to 25 sessions (5/week for 5 weeks) of exoskeleton-assisted RAT (robotic group) or conventional rehabilitation (control group). Outcome assessors were blinded. The primary outcome was the change in the Fugl-Meyer Assessment for Upper Limb (motor section, 0–66) from baseline to treatment end. Secondary outcomes addressed body function, activity (capacity/performance), and participation. Clinical assessments were at baseline (T0), posttreatment (T1), and 6-month telephone follow-up (T2). Odds ratio for achieving a minimal clinically important difference (≥10 points) on the Fugl-Meyer Assessment for Upper Limb was calculated. RESULTS: A total of 109 individuals with subacute stroke were screened. Of these, 94 (35% women; mean age 62.5±13.5 years; mean onset 34±28 days) were eligible and randomized, and 82 completed the intervention (12% dropout). No significant differences were observed at baseline, despite the median Fugl-Meyer score being 16 in the robotic group and 10 in the control group. The robotic group showed significantly greater improvement in Fugl-Meyer Assessment for Upper Limb motor score than the control group, with a median between-group difference of 22 points ( P <0.001). Minimal clinically important difference was reached by 68.4% in the robotic group versus 31.8% in the control group (odds ratio, 4.64 [95% CI, 1.83–11.8]; P <0.001). All secondary outcomes improved significantly in both groups with no significant differences between groups, except for spasticity, which showed no significant change. CONCLUSIONS: Exoskeleton-assisted RAT offers significant clinical benefits in early poststroke upper limb recovery, yielding higher minimal clinically important difference rates on impairment outcomes but not on specific functional measures compared with conventional therapy. Further research should evaluate long-term effects and optimize protocols based on patient characteristics. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04697368.