Virtual reality glove for home-based hand and arm stroke rehabilitation (vREHAB).

Abstract

Background: Upper extremity impairment is common after stroke. Virtual-reality rehabilitation systems may help restore hand and arm function.

Objective: To assess the feasibility of the Neofect Smart Glove and its effect on functional recovery.

Design: Multicenter, prospective, randomized, open-label, blinded-endpoint phase 2 trial consisting of a 12-week active treatment period followed by a 12-week follow-up period.

Study population: Patients with subacute and chronic stroke with upper extremity impairment.

Interventions: Patients assigned to the intervention group were instructed to use the Smart Glove for a minimum of one session per day for at least 5 days per week during the 12-week active treatment period, in addition to their usual care. Patients in the control group received their usual care only.

Outcomes: Feasibility was assessed by the total dose of rehabilitation. The change from baseline to week 12 on the Jebsen-Taylor Hand Function Test (JTHFT) was the primary efficacy outcome and the change on the Upper Extremity Fugl-Meyer Assessment (UE-FMA) was secondary.

Statistics: Differences between treatment arms were compared using analysis of covariance in the overall population and, separately, in a post-hoc and exploratory analysis consisting of a 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 seconds, p = .88), the change in the UE-FMA (median 8 vs. 8 points, p = .61), or the total dose of rehabilitation (median 1434 vs. 584 minutes, p = .18). Among the subgroup of patients with mild to moderate symptoms (baseline JTHFT ≤500, n = 31), Smart Glove assignment was associated with a greater improvement on the JTHFT (median -72 vs. -40 seconds, p = .01) and a greater dose of rehabilitation (median 1739 vs. 510 minutes, p = .04) during the active treatment period, but there was no difference in the change in the UE-FMA (median 10 vs. 8 points, p = .15).

Conclusion: The addition of the Smart Glove to traditional rehabilitation therapy did not improve hand and arm function in the overall study population but may increase the dose of rehabilitation and improve hand and arm function for patients with mild to moderate upper extremity impairment.