Datasheet1_Home-based virtual reality-enhanced upper limb training system in children with brain injury: a randomized controlled trial.pdf

BackgroundRehabilitation of upper limb function can be challenging in children with brain lesion. Recent virtual reality (VR) rehabilitation may be an additional treatment option in pediatric rehabilitation.
ObjectivesTo assess the feasibility and effectiveness of a home-based VR-enhanced rehabilitation program with wearable multi-inertial measurement unit (IMU) sensors on upper limb functions in children with brain injury.
MethodsThis multicenter single blind randomized controlled trial included 40 children with cerebral palsy (CP) or static brain injury. Subjects were randomized 1:1 to experimental and control group. Both the groups maintained the same therapeutic content and dose of occupational therapy during the intervention period. The experimental group performed additional training at home using the VR-enhanced program for at least 30 min/day, 5 days/week, for 6 weeks. VR training consisted of daily activities or games promoting wrist and forearm articular movements using wearable IMU sensors. The Melbourne Assessment of Unilateral Upper Limb Function-version 2 (MA2), Upper Limb Physician's Rating Scale (ULPRS), Pediatric Evaluation of Disability Inventory-computer adaptive test (PEDI-CAT), computerized 3D motion analysis, and user satisfaction survey were performed. Mann–Whitney U test was used to compare treatment effects between groups, and Friedman and Wilcoxon signed-rank tests were used to compare pre and post intervention.
ResultsOverall 35 children (15 in VR group and 20 in control group) completed the protocol. In the experimental group, an average VR training time was 855 min. The accuracy of motion measured by MA2, segmental movements by ULPRS, daily living capability and social cognitive function by PEDI-CAT, movement time and shoulder movement pattern by motion analysis showed significant improvements. However, there were no significant differences in any of the functional outcome measures compared to the control group. All the children and parents reported positive experiences.
ConclusionsHome-based VR training though it had limited impact on improving upper limb function, it could help improve social cognitive function, movement pattern, and efficiency in children with brain injury and could be an effective means of extending clinical therapy to the home.
Clinical Trial RegistrationCRIS.nih.go.kr: identifier KCT0003172.

背景
脑损伤患儿的上肢功能康复往往颇具挑战。近年来，虚拟现实（Virtual Reality, VR）康复技术有望成为儿科康复领域的补充治疗方案。

研究目的
本研究旨在评估基于家庭场景、搭载可穿戴多惯性测量单元（Multi-inertial Measurement Unit, IMU）传感器的VR强化康复方案，对脑损伤患儿上肢功能的可行性与有效性。

研究方法
本多中心单盲随机对照试验共纳入40名脑瘫（Cerebral Palsy, CP）或静态性脑损伤患儿。受试者按1:1比例随机分配至试验组与对照组。干预期间，两组均保持一致的作业治疗内容与剂量。试验组额外在家中开展VR强化康复训练，每周训练5天，每日至少30分钟，持续6周。该VR训练依托可穿戴IMU传感器，设计为旨在促进腕部与前臂关节活动的日常活动类任务或游戏。评估工具包括Melbourne单侧上肢功能评估第二版（Melbourne Assessment of Unilateral Upper Limb Function-version 2, MA2）、上肢医师评定量表（Upper Limb Physician's Rating Scale, ULPRS）、儿童残疾评定量表-计算机自适应测试（Pediatric Evaluation of Disability Inventory-computer adaptive test, PEDI-CAT）、计算机化三维运动分析系统，以及用户满意度调查问卷。组间治疗效果比较采用曼-惠特尼U检验，干预前后比较采用弗里德曼检验与威尔科克森符号秩检验。

研究结果
最终共有35名患儿完成试验方案（VR组15名，对照组20名）。试验组受试者的平均VR训练时长为855分钟。MA2评估的运动准确性、ULPRS评估的节段性运动能力、PEDI-CAT评估的日常生活能力与社会认知功能、运动分析测得的运动时长与肩部运动模式均出现显著改善。但与对照组相比，两组在各项功能结局指标上均未出现显著差异。所有患儿及家长均反馈训练体验良好。

研究结论
基于家庭场景的VR训练虽对上肢功能改善的效果有限，但可帮助脑损伤患儿改善社会认知功能、运动模式与运动效率，有望成为将临床康复延伸至家庭场景的有效手段。

临床试验注册
临床试验注册平台：CRIS.nih.go.kr，标识符为KCT0003172。