Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India.
Department of Physiotherapy, College of Health Sciences, University of Sharjah, P.O. Box.27272, Sharjah, United Arab Emirates; Sustainable Engineering Asset Management Research Group, RISE-Research Institute of Sciences and Engineering, University of Sharjah, P.O.Box: 27272, Sharjah, United Arab Emirates; Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India.
Contemp Clin Trials. 2021 Jun;105:106381. doi: 10.1016/j.cct.2021.106381. Epub 2021 Apr 20.
Game-based rehabilitation is an emerging therapeutic intervention that allows intensive, repetitive, task-based training to improve upper limb (UL) function following stroke, based on the principles of neuro-plasticity and motor (re)learning. Rehabilitation using commercial gaming system will be motivating, enjoyable, challenging and affordable. Therefore, the present study aims at assessing the effectiveness of an intensive, functional, gamified rehabilitation program using the ArmAble™ device in improving UL motor function in people with stroke.
In this single-blinded, multi-centric, randomized clinical trial, 120 adults with acute/sub-acute unilateral stroke will be randomized to receive an intensive, functional, gamified training program using the ArmAble™ or task-based training along with a conventional therapy for 2 h/day, 6 days/week for 2 weeks, followed by a home-based, functional rehabilitation program for another 4 weeks (~30 min/day, 6 days/week). Primary outcomes evaluated by a blinded assessor at the baseline, 2 weeks and 6 weeks' post-intervention will include the Fugl-Meyer assessment - upper extremity and the action research arm test. A linear mixed effect regression model or relevant non-parametric tests will be used to analyze the data for all outcomes. An intention-to-treat analysis will be used with missing data handled by multiple imputation.
Rehabilitation provided with the ArmAble™ device, if found effective, can be used from the early stages post-stroke to provide intensive, repetitive, gamified training to improve UL motor function.
CTRI/2020/09/027651.
基于神经可塑性和运动（再）学习原理，游戏康复是一种新兴的治疗干预方法，可通过基于游戏的康复训练来改善脑卒中后的上肢（UL）功能。该方法通过使用商业游戏系统进行强化、重复、基于任务的训练。使用商业游戏系统进行康复治疗具有激励性、趣味性、挑战性和可负担性。因此，本研究旨在评估使用 ArmAble™ 设备进行强化、功能性、游戏化康复计划对脑卒中患者 UL 运动功能的有效性。
在这项单盲、多中心、随机临床试验中，将 120 名急性/亚急性单侧脑卒中成年人随机分为两组，分别接受使用 ArmAble™ 的强化、功能性、游戏化训练计划或基于任务的训练，同时接受常规治疗，每天 2 小时，每周 6 天，持续 2 周，然后进行为期 4 周的家庭功能性康复计划（每天约 30 分钟，每周 6 天）。由盲法评估员在基线、2 周和 6 周干预后评估主要结局，包括 Fugl-Meyer 上肢评估和动作研究上肢测试。将使用线性混合效应回归模型或相关非参数检验来分析所有结局的数据。将采用意向治疗分析，对缺失数据进行多重插补处理。
如果 ArmAble™ 设备提供的康复治疗被证明有效，它可以在脑卒中后早期使用，提供强化、重复、游戏化的训练，以改善 UL 运动功能。
CTRI/2020/09/027651。
