Effects of Upper-Extremity Rehabilitation Using Smart Glove in Patients With Subacute Stroke: Results of a Prematurely Terminated Multicenter Randomized Controlled Trial

Background: Although there have been many trials and interventions for reducing upper-extremity impairment in stroke survivors, it remains a challenge. A novel intervention is needed to provide high-repetition task-specific training early after stroke. Objective: This study aimed to investigate the effect of smart glove training (SGT) for upper-extremity rehabilitation in patients with subacute stroke. Methods: A prospective, multicenter, randomized, controlled study was conducted in patients with upper-extremity hemiparesis with Brunnstrom stage for arm 2–5 in the subacute phase after stroke. Eligible participants were randomly allocated to the SGT group or the control group. The SGT group underwent 30 min of standard occupational therapy plus 30 min of upper-extremity training with smart glove. The control group underwent standard occupational therapy for 30 min plus upper-extremity self-training (homework tasks at bedside) for 30 min. All participants underwent each intervention 5 days/week for 2 consecutive weeks. They were evaluated before, immediately after, and 4 weeks after the intervention. The primary outcome measure was the change in the score of the Fugl-Meyer assessment of the upper extremity (FMA-UE). Results: Twenty-three patients were enrolled. Repeated-measures analysis of covariance after controlling for age and disease duration showed significant time × group interaction effects in the FMA-UE, FMA-distal, and FMA-coordination/speed (p = 0.018, p = 0.002, p = 0.006). Repeated-measures analysis of variance showed significant time × group interaction effects in the FMA-UE, FMA-distal, and Box and Block Test (p = 0.034, p = 0.010, p = 0.046). Mann-Whitney U-test showed a statistically higher increase in the FMA-UE and FMA-distal in the SGT group than in the control group (p = 0.023, p = 0.032). Conclusion: Upper-extremity rehabilitation with a smart glove may reduce upper-extremity impairment in patients with subacute stroke. Clinical Trial Registration: ClinicalTrials.gov (NCT02592759).