Poststroke Neurorehabilitation Using a Soft Robotic Glove Combined With a Virtual Environment: Preliminary Study on Feasibility, Safety, Effects, and User Satisfaction.

Background: Optimizing rehabilitation intensity using a robotic-assisted hand rehabilitation exercise (RAHRE) program coupled with a virtual environment is a promising intervention as it aligns with key neuroplasticity principles. Objective: The aim of the study is to assess the feasibility, safety, preliminary effects, and satisfaction of the 2-week RAHRE program offered as an adjunct to conventional rehabilitation. Methods: In total, 11 adults with hand hemiparesis following a recent stroke and undergoing intensive functional rehabilitation were randomized into experimental and control groups. Both groups received conventional rehabilitation therapy over a 2-week period. The experimental group received 10 additional 30-minute sessions of the RAHRE program (5 times per week), incorporating 4 hand opening and closing exercises with personalized glove assistance or resistance levels with virtual reality over the same period. Measures of feasibility (ie, attendance rate, compliance rate, repetitions per session, active training time, therapist verbal cueing, and support required), safety (ie, discomfort and adverse effects), and satisfaction (ie, satisfaction questionnaire) were collected. Functional outcomes (ie, Action Research Arm Test [ARAT], Fugl-Meyer Assessment for the Upper Extremity [FMA-UE], Box and Block Test, ABILHAND) were also assessed before and after the intervention in both groups. Results: Attendance and compliance rates in the experimental group reached 96% (48 completed training sessions of 50 planned sessions) and 95% (1432 completed training minutes of 1500 planned minutes), respectively. Participants performed a median of 2543 (IQR 2368-2951) additional movement repetitions during the RAHRE program (median repetitions per session 260, IQR 173-365; median active training time 24 minutes 39 seconds, IQR 22 minutes 26 seconds-25 minutes 51 seconds). Minimal therapist verbal cueing and support were necessary for technology use (median glove donning time 46, IQR 27-60 seconds; median independence achieved in 6, IQR 4-7 sessions). No abnormal discomfort or adverse effects were reported. Both groups showed functional improvements in ARAT, FMA-UE, Box and Block Test, and ABILHAND. For the primary outcomes (ie, ARAT and FMA-UE), the median score changes were, respectively, 4.50 (IQR 0-9) and 4.00 (IQR 3-4) in the control group, and 4.00 (IQR 1-7.5) and 5.00 (IQR 5-6) in the experimental group. Excellent overall program satisfaction (median 5/5, IQR 5-5) was reported for the RAHRE program. Conclusions: The RAHRE program, as an adjunct to conventional rehabilitation therapy, emerges as being feasible, safe, beneficial, and satisfying for adults with hand hemiparesis following a recent stroke. However, careful interpretation of the results remains recommended given the strength of the evidence. Future studies providing higher-quality evidence are needed.