A Randomized Controlled Trial of a Virtual Reality Training Program for Ambulatory Patients With Mild-to-moderate Chronic Gait Deficits After Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Community ambulation using Step Activity Monitor (SAM)
研究概览
简要总结
The purpose of this study is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.
详细描述
Virtual reality (VR) systems enable the learning of simple and complex skills in a controlled virtual environment; i.e., one in which the different components (constraints) of the environment can be displayed, graded, changed and monitored in a quantitative manner.
Small preliminary studies suggest that VR may be used to augment chronic stroke rehabilitation and may enhance cortical reorganization. Our aim is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke. Study design-a single center randomized controlled trial of an experimental group and a usual care group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Stroke within 3-72 months.
- •Mild-to-moderate residual gait deficits after the index stroke with preserved capacity for ambulation without or with an assistive device (e.g., walker, cane) or orthotics (e.g. AFO).
排除标准
- •Unstable cardiac or other medical condition or aphasia, dementia or other significant neurological disease limiting ability to train.
研究组 & 干预措施
A,
Virtual Reality training for an overall of 18 sessions 2/week + usual care.
干预措施: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands). (Device)
B,
Usual care
结局指标
主要结局
Community ambulation using Step Activity Monitor (SAM)
时间窗: Baseline X2, post training (week 9-10), retention (week 20-24)
Gait analysis (GaitRite system) including dual task
时间窗: Baseline X2, post training (week 9-10), retention (week 20-24)
Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform.
时间窗: Baseline X2, post training (week 9-10), retention (week 20-24)
Timed Up and Go
时间窗: Baseline X2, post training (week 9-10), retention (week 20-24)
次要结局
- Functional Reach(Baseline X2, post training (week 9-10), retention (week 20-24))
- Four Stick Stepping Test (FSST)(Baseline X2, post training (week 9-10), retention (week 20-24))
- 3DGait Analysis system(Baseline X2, post training (week 9-10), retention (week 20-24))
- 6 minute walk(Baseline X2, post training (week 9-10), retention (week 20-24))
- Self-induced perturbations and reaction to perturbations on platform(Baseline X2, post training (week 9-10), retention (week 20-24))