Department of Neurology, Fujian Medical University Union Hospital, Institute of Clinical Neurology, Fujian Medical University, Fuzhou, 350001, Fujian, China.
Department of Clinical Medicine, Fujian Medical University, Fuzhou, 350001, Fujian, China.
Trials. 2021 Jan 25;22(1):91. doi: 10.1186/s13063-021-05031-z.
The high incidence of cerebral apoplexy makes it one of the most important causes of adult disability. Gait disorder is one of the hallmark symptoms in the sequelae of cerebral apoplexy. The recovery of walking ability is critical for improving patients' quality of life. Innovative virtual reality technology has been widely used in post-stroke rehabilitation, whose effectiveness and safety have been widely verified. To date, however, there are few studies evaluating the effect of immersive virtual reality on stroke-related gait rehabilitation. This study outlines the application of immersive VR-assisted rehabilitation for gait rehabilitation of stroke patients for comparative evaluation with traditional rehabilitation.
The study describes a prospective, randomized controlled clinical trial. Thirty-six stroke patients will be screened and enrolled as subjects within 1 month of initial stroke and randomized into two groups. The VRT group (n = 18) will receive VR-assisted training (30 min) 5 days/week for 3 weeks. The non-VRT group (n = 18) will receive functional gait rehabilitation training (30 min) 5 days/week for 3 weeks. The primary outcomes and secondary outcomes will be conducted before intervention, 3 weeks after intervention, and 6 months after intervention. The primary outcomes will include time "up & go" test (TUGT). The secondary outcomes will include MMT muscle strength grading standard (MMT), Fugal-Meyer scale (FMA), motor function assessment scale (MAS), improved Barthel index scale (ADL), step with maximum knee angle, total support time, step frequency, step length, pace, and stride length.
Virtual reality is an innovative technology with broad applications, current and prospective. Immersive VR-assisted rehabilitation in patients with vivid treatment scenarios in the form of virtual games will stimulate patients' interest through active participation. The feedback of VR games can also provide patients with performance awareness and effect feedback, which could be incentivizing. This study may reveal an improved method of stroke rehabilitation which can be helpful for clinical decision-making and future practice.
Chinese Clinical Trial Registry ChiCTR1900025375 . Registered on 25 August 2019.
脑卒中发病率高,是成人残疾的重要原因之一。步态障碍是脑卒中后遗症的标志性症状之一。步行能力的恢复对于提高患者的生活质量至关重要。创新的虚拟现实技术已广泛应用于脑卒中后的康复治疗,其有效性和安全性已得到广泛验证。然而,迄今为止,评估沉浸式虚拟现实对脑卒中相关步态康复影响的研究较少。本研究概述了沉浸式虚拟现实在脑卒中患者步态康复中的应用,并与传统康复进行了比较评估。
本研究为前瞻性、随机对照临床试验。将在脑卒中发病后 1 个月内筛选并纳入 36 例脑卒中患者作为研究对象,并随机分为两组。虚拟现实组(n=18)将接受虚拟现实辅助训练(30 分钟),每周 5 天,共 3 周。非虚拟现实组(n=18)将接受功能性步态康复训练(30 分钟),每周 5 天,共 3 周。主要结局和次要结局将在干预前、干预后 3 周和干预后 6 个月进行。主要结局将包括“起立-行走”测试(TUGT)时间。次要结局将包括改良的 MMT 肌肉力量分级标准(MMT)、 Fugl-Meyer 量表(FMA)、运动功能评估量表(MAS)、改良的 Barthel 指数量表(ADL)、最大膝关节角度步、总支撑时间、步频、步长、步速和步长。
虚拟现实是一种具有广泛应用前景的创新技术。沉浸式虚拟现实辅助康复以虚拟游戏的形式为患者提供生动的治疗场景,通过积极参与激发患者的兴趣。虚拟现实游戏的反馈还可以为患者提供绩效意识和效果反馈,从而起到激励作用。本研究可能揭示一种改善脑卒中康复的方法,有助于临床决策和未来实践。
中国临床试验注册中心 ChiCTR1900025375 。注册于 2019 年 8 月 25 日。