Hara Masahiko, Kitamura Tetsuhisa, Murakawa Yuichiro, Shimba Kyosuke, Yamaguchi Shimpei, Tamaki Masatake
Center for Community-based Healthcare Research and Education, Shimane University, Izumo, Japan.
Department of Medical Device Development, mediVR, Inc., Osaka, Japan.
Prog Rehabil Med. 2018 Oct 24;3:20180016. doi: 10.2490/prm.20180016. eCollection 2018.
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.
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.
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).
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.
行走能力是日常生活中最重要的基本功能活动之一,全球范围内需要康复治疗的行走障碍患者数量正在增加。这项首次人体研究的目的是评估使用mediVR01系统(日本大阪的mediVR公司)进行的非标签、量身定制的双任务康复计划对身体躯干平衡的安全性和可行性,该系统融合了虚拟现实(VR)和三维跟踪技术。
我们前瞻性招募了31名健康志愿者参与试验(试验注册号UMIN000029659)。在评估身体躯干平衡后,提供了一个持续10 - 15分钟的量身定制的双任务康复训练计划。主要终点是程序后模拟器不适问卷(SSQ)症状的数量。次要终点是不良事件和对该计划的满意度。
参与者的中位年龄为68岁,其中67.7%为老年人(>65岁),54.8%为男性。康复计划结束后立即出现的SSQ症状数量从0(四分位间距0 - 0)显著增加到0(0 - 1.5)(P = 0.009),青年和老年参与者之间存在显著差异(P交互作用<0.001)。最常见的症状是出汗(22.6%),其次是疲劳(19.4%)。所有参与者均成功完成康复计划,未发生跌倒或受伤等重大不良事件。此外,所有参与者都认为VR康复计划很有趣,93.5%的参与者报告有成就感。团队参与与更高的满意度相关(P = 0.049)。
使用VR和三维跟踪技术的量身定制的双任务康复训练计划对身体躯干平衡是安全可行的,即使对于老年参与者也是如此。