Effectiveness, safety and patients' perceptions of an immersive virtual reality-based exercise system for poststroke upper limb motor rehabilitation: A proof-of-concept and feasibility randomized controlled trial.

Objective: This study aimed to examine the effectiveness, safety and patients' perceptions of an immersive virtual reality (VR)-based exercise system for poststroke upper limb rehabilitation. Methods: A proof-of-concept, 2-week randomized controlled trial was conducted. Fifty stroke patients were randomly assigned to either use the immersive VR-based exercise system to perform upper limb exercises for 2 weeks (intervention) or play commercial games (control). Effectiveness, safety and patients' perceptions of the exercise system were assessed at baseline and at 1- and 2-week follow-ups. Results: Intention-to-treat analysis revealed that after 2 weeks, statistically significant improvements in shoulder flexion active range of motion (AROM), shoulder abduction AROM, perceived upper limb motor function and quality of life (QoL) were observed in one or both groups, but not between the groups. Per-protocol analysis showed that after 2 weeks: (i) statistically significant improvement in shoulder abduction AROM was obtained in the intervention group, and the difference in the mean changes between the groups was statistically significant; (ii) statistically significant improvements in coordination/speed (Fugl-Meyer Assessment for Upper Extremity), shoulder flexion AROM, perceived upper limb motor function and QoL were obtained in one or both groups, but not between the groups. Conclusions: The immersive VR-based exercise system is a potentially effective, safe and acceptable approach for supporting poststroke motor rehabilitation. These findings can serve as a basis for larger-scale studies on the application of VR for poststroke exercises.