NCT00906477终止3 期
Intensive Training of Arm and Hand Function in People With Stroke - A Randomized Controlled Multisite Trial.
University Hospital of North Norway5 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2008年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 47
- 试验地点
- 5
- 主要终点
- Wolf Motor function test
研究概览
简要总结
The purpose of this study is to determine whether modified CI therapy treatment is suitable and effective in the early rehabilitation after stroke, and to compare early CI intervention with a later CI intervention 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
- Single (Outcomes Assessor)
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
- •Stroke at more than 5 and less than 26 days ago.(Either first stroke or second stroke without detectable arm weakness after the first stroke).
- •Modified ranking scale 0-2 before admission
- •Persistent unilateral arm or hand paresis (Scandinavian Strokes scale (SSS) arm motor function 2-5 or SSS hand motor function 2-4)
- •Able to lift two fingers with the forearm pronated on the table or able to extend the wrist at least 10 degrees from fully flexed position.
- •Able to follow a two step command.
- •Mini Mental State examination score of more than 20 (or more than 16 in combination with expressive aphasia)
排除标准
- •Modified Rankin Scale > 4
- •Unable to give informed consent
- •Large hemispatial neglect (more than two cm on the Line Bisection Test)
- •Not expected to survive one year due to other illnesses (eg cardiac, malignancy)
- •Injury or condition in the affected upper extremity that limited use prior to the stroke.
- •Other neurological condition affecting motor function
研究组 & 干预措施
Early intervention
Experimental
Modified CI therapy starting between 7 and 28 days post stroke.
干预措施: Modified CI therapy (Procedure)
Delayed intervention
Active Comparator
Modified CI Therapy starting 6 months post stroke
干预措施: Modified CI therapy (Procedure)
结局指标
主要结局
Wolf Motor function test
时间窗: 6 months post inclusion
次要结局
- Wolf Motor Function Test(12 months)
- Nine Hole Peg Test(12 months)
- Nine hole peg test(6 months)
- Arm use accelerometry(12 months)
- Fugl Meyer Motor Assessment(12 months)
- Arm use accelerometry(6 months)
- Fugl Meyer Motor Assessment(6 months)
研究者
研究点 (5)
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