Effects of a Wearable-Based Intervention on the Hemiparetic Upper Limb in Persons With Stroke: A Randomized Controlled Trial

Introduction Wearables have emerged as a transformative rehabilitation tool to provide self-directed training in the home. Objective. In this study, we examined the efficacy of a novel wearable device, "Smart Reminder" (SR), to provide home-based telerehabilitation for hemiparetic upper limb (UL) training in persons with stroke.Methods Forty stroke survivors from community support groups were randomized (stratified by the period after stroke onset and impairment severity) to either the SR group or the sham device group. Participants received either 20 hours of telerehabilitation using the SR device or training with pictorial handouts and a sham device over 4 weeks. In addition, all participants wore a standard accelerometer for 3 hours each day, 5 times a week, outside the prescribed training. Participants were assessed by a masked assessor at baseline, post-intervention (week 4), and follow-up (week 8). The outcome measures included Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Action Research Arm Test, Motor Activity Log, muscle strength, active range of motion and amount of movement of the UL, and compliance rate of training.Results The SR group improved substantially in their FMA-UE scores after treatment (mean difference = 2.05, P = .036) compared to the sham group. Also, adherence to the training using the SR device was significantly higher, 97%, than the sham group, 82.3% (P = .038).Conclusion The 4-week telerehabilitation program using a "SR" device demonstrated potential efficacy in improving FMA-UE scores of the hemiparetic upper limb. However, it did not significantly enhance the performance of the affected limb in daily activities. The trial was registered on ClinicalTrial.gov (URL: http://www.clinicaltrials.gov) with the identifier NCT05877183.