Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Action Research Arm Test
研究概览
简要总结
The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Had stroke between 11-26 weeks ago
- •Have some weakness in one of your wrists or hands due to stroke
- •Did not have too much disability prior to stroke
- •Do not have major depression
排除标准
- •Non-English speaking
- •If you have trouble keeping good attention
- •Pregnant, advanced liver, kidney, heart, or lung disease
- •Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
- •Cannot undergo MRI scanning
- •Have history of brain surgery or seizures
结局指标
主要结局
Action Research Arm Test
时间窗: change from baseline to 1 month post-end treatment, Intention To Treat
The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.
Arm Motor Fugl-Meyer Test
时间窗: change from baseline to 1 month post-end treatment, Intention To Treat
The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.
次要结局
未报告次要终点
研究者
Steven C. Cramer, MD
Professor
University of California, Irvine