OBJECTIVE: To compare virtual reality (VR) combined with functional electrical stimulation (FES) with cyclic FES for improving upper extremity function and health-related quality of life in patients with chronic stroke. DESIGN: A pilot, randomized, single-blind, controlled trial. SETTING: Stroke rehabilitation inpatient unit. PARTICIPANTS: Participants (n = 48) with hemiplegia secondary to a unilateral stroke for > 3 months and with a hemiplegic wrist extensor Medical Research Council scale score ranging from 1 to 3. INTERVENTIONS: FES was applied to the wrist extensors and finger extensors. A VR-based wearable rehabilitation device was used combined with FES and virtual activity-based training for the intervention group. The control group received cyclic FES only. Both groups completed 20 sessions over a 4-week period. MAIN OUTCOME MEASURES: Primary outcome measures were changes in Fugl-Meyer Assessment-Upper Extremity and Wolf Motor Function Test scores. Secondary outcome measures were changes in Box and Block Test, Jebsen-Taylor Hand Function Test, and Stroke Impact Scale scores. Assessments were performed at baseline (t0) and at 2 weeks (t1), 4 weeks (t4), and 8 weeks (t8). Between-group comparisons were evaluated using a repeated-measures analysis of variance. RESULTS: Forty-one participants were included in the analysis. Compared with FES alone, VR-FES produced a substantial increase in Fugl-Meyer Assessment-distal score (p = 0.011) and marginal improvement in Jebsen-Taylor Hand Function Test-gross score (p = 0.057). VR-FES produced greater, although nonsignificant, improvements in all other outcome measures, except in the Stroke Impact Scale-activities of daily living/instrumental activities of daily living score. CONCLUSIONS: FES with VR-based rehabilitation may be more effective than cyclic FES in improving distal upper extremity gross motor performance poststroke.

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