Department of Neuroscience and Rehabilitation, Ferrara University Hospital, Ferrara, Italy.
Doctoral Program in Translational Neurosciences and Neurotechnologies, University of Ferrara, Ferrara, Italy.
BMJ Open. 2021 Oct 21;11(10):e052005. doi: 10.1136/bmjopen-2021-052005.
Multiple sclerosis (MS) is one of the major causes of disability in young adults and affects mobility, compromising daily living activities and participation in social life. Cognitive domain is also frequently impaired in people with MS (PwMS), particularly the capacity to perform dual-task activities. Impaired cognitive processing abilities need to be treated, and motor and cognitive aspects need to be considered together. Recently, video game therapy (VGT) has been used in rehabilitation to improve motor outcomes and cognitive processing speed. The aim of this study is to test the efficacy of commercially available VGT on mobility and dual tasking in PwMS compared with standardised balance platform training (BPT).
This will be a parallel-assignment, double-blinded, randomised control trial. Forty-eight (24 per arm) PwMS with Expanded Disability Status Scale 4-5.5 will be randomly assigned to receive 1 hour training session over 4 weeks (three sessions/week) of either: (1) VGT on commercial video game console to train balance and mobility-related activities or (2) BPT to perform balance, postural stability and weight-shifting exercises with and without visual feedback. The same assessor will evaluate outcome measures at points: before and after the 12 training sessions and at 3 months of follow-up. The primary outcome will be functional mobility, assessed by the Timed Up and Go test. We will also evaluate gait, risk of fall, fatigue and health-related quality of life as well as cognitive and psychological aspects (depression, anxiety and attentional performance) and stability through posturographic evaluation. Dual-tasking assessment will be performed combining posturographic and neuropsychological tests. Data analysis will be performed to compare the efficacy of the two treatments.
Ethical approval have been granted from the local Ethics Committee. Study results will be communicated through high-quality journals and national and international conferences.
NCT03353974.
多发性硬化症（MS）是导致年轻人残疾的主要原因之一，会影响到移动能力，从而影响日常活动和参与社会生活。多发性硬化症患者（PwMS）的认知领域也经常受到损害，特别是执行双重任务活动的能力。受损的认知处理能力需要治疗，并且需要同时考虑运动和认知方面。最近，视频游戏疗法（VGT）已被用于康复治疗中，以改善运动结果和认知处理速度。本研究的目的是测试市售 VGT 在 PwMS 的移动能力和双重任务方面与标准化平衡平台训练（BPT）相比的疗效。
这将是一项平行分配、双盲、随机对照试验。将 48 名（每组 24 名）扩展残疾状况量表 4-5.5 的 PwMS 随机分配，接受 4 周（每周 3 次）的 1 小时训练，包括：（1）在商业视频游戏控制台进行 VGT 训练平衡和移动相关活动，或（2）在 BPT 下进行平衡、姿势稳定性和体重转移练习，有和没有视觉反馈。同一位评估员将在以下时间点评估结果测量值：在 12 次训练课程前后和 3 个月随访时。主要结局将是功能性移动性，通过计时起立行走测试评估。我们还将评估步态、跌倒风险、疲劳和健康相关生活质量以及认知和心理方面（抑郁、焦虑和注意力表现）以及通过姿势描记术评估的稳定性。双重任务评估将通过姿势描记术和神经心理学测试相结合来进行。将进行数据分析以比较两种治疗方法的疗效。
已获得当地伦理委员会的伦理批准。研究结果将通过高质量期刊以及国家和国际会议进行交流。
NCT03353974。
