Trial: Interactive Intention-Driven Upper-Limb Training Robotic System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Action Research Arm Test
研究概览
简要总结
The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.
详细描述
This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system.
Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy.
There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
排除标准
- •Excessive spasticity of the affected arm
- •Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
结局指标
主要结局
Action Research Arm Test
时间窗: Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Fugl-Meyer Assessment
时间窗: Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months. Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
次要结局
- modified Ashworth Scale(Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months)
- Wolf Motor Function Test(Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months)
研究者
Raymond KY Tong
Prof.
The Hong Kong Polytechnic University