2018 年 3 巻
Objective: The ability to walk is one of the most important basic functional activities of daily living, and the number of patients with walking disability who need rehabilitation is increasing worldwide. The purpose of this first-in-man study was to evaluate the safety and feasibility of an off-label, tailor-made, dual-task rehabilitation program for body trunk balance using the mediVR01 system (mediVR, Inc. Osaka, Japan), which incorporates virtual reality (VR) and three-dimensional tracking technologies. Methods: We prospectively enrolled 31 healthy volunteers to take part in the trial (Trial Registration UMIN000029659). After an assessment of body trunk balance, a tailor-made, dual-task, rehabilitation training program lasting 10–15 min was provided. The primary endpoint was the postprocedural number of simulator sickness questionnaire (SSQ) symptoms. The secondary endpoints were adverse events and satisfaction with the program. Results: The median age of participants was 68 years, with 67.7% being elderly (>65 years) and 54.8% being male. The number of SSQ symptoms immediately after the rehabilitation programs significantly increased from 0 (interquartile range 0–0) to 0 (0–1.5) (P=0.009), with a significant difference between the young and elderly participants (P-interaction<0.001). The most frequent symptom was sweating (22.6%), followed by fatigue (19.4%). All participants successfully completed the rehabilitation programs without significant adverse events such as fall or injuries. Moreover, all participants considered the VR rehabilitation programs to be enjoyable, and 93.5% of participants reported a sense of achievement. Group attendance was associated with higher levels of satisfaction (P=0.049). Conclusion: The tailor-made, dual-task rehabilitation training programs for body trunk balance using VR and three-dimensional tracking technologies were safe and feasible even for elderly participants.