NCT02699398已完成不适用
Domiciliary VR Rehabilitation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical
研究概览
简要总结
The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Hemorrhagic or ischemic stroke
- •Subject had the stroke more than 12 months ago.
- •Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale>2) secondary to a first-ever stroke.
- •Age between 45 and 85 years old.
- •Subject has previous experience using the RGS system in the clinic.
排除标准
- •Subject presents a major cognitive impairment (Mini-Mental State Evaluation> 22).
结局指标
主要结局
Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical
时间窗: At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.
次要结局
- Change in cognitive function as measured by the Mini-mental State Evaluation test(At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.)
- Change in depression as measured by the Hamilton scale(At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.)
- Change in motor function as measured by the upper extremity Fugl-Meyer Assessment(At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.)
- Change in spasticity for the upper arms as measured by the Ashworth scale(At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.)
- Change in shoulder pain as measured by the Visual Analog Assessment scale(At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.)
- Change in motor function as measured by the Medical Research Council scale(At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.)
- Change in Grip Force as measured by a grip dynamometer(At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up.)
研究者
Paul Verschure
PhD
Universitat Pompeu Fabra
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