The Effect of Proximal and Distal Training on Stroke Recovery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Fugl-Meyer
研究概览
简要总结
We will test on persons with chronic impairment due to stroke:
- whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
- whether we should train the shoulder, elbow, and wrist at the same time or on different days.
详细描述
The Effect of Proximal and Distal Training on Stroke Recovery:
Specific Aim 1. Test whether task specific wrist robotic training improves motor performance among persons with chronic impairment after stroke.
Specific Aim 2. Test whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
Specific Aim 3. Test whether there is generalization across different joints (shoulder & elbow vs wrist).
Specific Aim 4: Test whether there is any interference between training across different joints among persons with chronic impairment after stroke.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the study if they meet the following criteria:
- •naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients;
- •first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that has occurred at least 6 months prior;
- •cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects);
- •average Motor Power score >= 1/5 or <= 3/5 (neither hemiplegic nor fully recovered motor function in 6 muscles of the shoulder, elbow, and wrist);
- •informed written consent to participate in the study.
排除标准
- •Patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.
结局指标
主要结局
Fugl-Meyer
时间窗: 3 times at baseline, midpoint, completion intervention, and at follow-up
Motor Power
时间窗: 3 times at baseline, midpoint, completion intervention, and at follow-up
次要结局
- Wolf Motor Function(3 times at baseline, midpoint, completion intervention, and at follow-up)
- SIS(3 times at baseline, midpoint, completion intervention, and at follow-up)