Abstract Body: Introduction: Upper extremity impairment is common after stroke. The Neofect Smart Glove is a novel virtual reality-based portable rehabilitation system that may help restore hand and arm function.
Objective: To assess the effect of the Smart Glove on functional recovery and total dose of rehabilitation among subacute and chronic stroke patients with upper extremity impairment.
Design: Multi-center, prospective, randomized, open-label, blinded-endpoint (PROBE) phase 2 trial consisting of a 12-week active treatment period followed by a 12-week follow-up period.
Methods/Interventions: Patients in the intervention group were instructed to use the Smart Glove for at least one session per day for at least 5 days per week in addition to their usual care during the 12-week active treatment period. Patients in the control group received their usual care only.
Outcomes: The change from baseline to week 12 in the Jebsen-Taylor Hand Function Test (JTHFT) was the primary efficacy outcome and the change in the Upper Extremity Fugl-Meyer Assessment (UE-FMA) was secondary. Feasibility was assessed by determining the total dose of rehabilitation.
Statistics: Differences between treatment arms were compared using analysis of covariance (ANCOVA) in the overall population and, separately, in the subset of patients with mild to moderate upper extremity impairment (baseline JTHFT ≤ 500).
Results: During the 12-week active treatment period, there were no differences between the intervention (n = 18) and control (n = 24) groups in the change in the JTHFT (median -64 vs. -69 sec, P = 0.88), the change in the UE-FMA (median 8 vs. 8 points, P = 0.61), or the total dose of rehabilitation (median 1434 vs. 584 min, P = 0.18) (Figure 1). Among the subset of patients with mild to moderate symptoms (baseline JTHFT ≤ 500, n = 31), Smart Glove assignment was associated with a greater improvement in the JTHFT (median -72 vs. -40 sec, P = 0.01) and a greater dose of rehabilitation (median 1739 vs. 510 min, P = 0.04) during the active treatment period (Figure 2). There was a trend toward a greater improvement in the UE-FMA (median 10 vs. 8 points, P = 0.15).
Conclusion: While the trial did not show a benefit in the overall study population, Smart Glove use was associated with enhanced recovery of hand and arm function and a higher dose of rehabilitation among patients with mild to moderate upper extremity impairment, suggesting that the Smart Glove may be an effective treatment in this population.