Light Constraint Induced Therapy Experiment (LICITE)
Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.
研究概览
详细说明
Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. However, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit.
The aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by Taub et al. (360 minutes of motor training with a physical or occupational therapist).
Patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. The treatment will last two weeks, five days per week. The evaluations will include clinical measure of motor function and functional MRI of the brain. The brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Paris Cedex 18
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Paris、Paris Cedex 18、法国、75877
- Service de Médecine Physique et de Réadaptation - Hôpital BICHAT
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
INCLUSION CRITERIA:
- Age > 18 years
- First ischemic or hemorrhagic stroke between 2 and 12 months
- at least 10°of active wrist extension and at least 10° of thumb abduction/ extension, and at least 10° of extension in at least 2 additional digits.
- adequate balance while wearing the restraint
EXCLUSION CRITERIA:
- Major cognitive impairment
- Prior stroke
- Excessive fatigability
- Severe aphasia
- MAL score ≥ 2,5
- Specific exclusion criteria for fMRI ancillary study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:标准疗法
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360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks
其他名称:
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有源比较器:Modified Therapy
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90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Motor activity log scale
大体时间:10 days before inclusion, 10 days and 3 months after treatment achievement
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10 days before inclusion, 10 days and 3 months after treatment achievement
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Wolf Motor Function test Stroke impact scale Functional MRI HAD scale
大体时间:10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)
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10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)
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合作者和调查者
调查人员
- 首席研究员:Olivier SIMON, MD, PhD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
- 1- Constraint induced therapy
- 2- Stroke
- 3- Upper limb
- 4- Rehabilitation
- 5- Motor training
- 1- First time clinical ischemic or hemorrhagic stroke
- 2- At least 10° of active wrist extension
- 3- At least 10° of thumb abduction/ extension
- 4- At least 10° of extension in at least 2 additional digits
- 3- Adequate balance while wearing the restraint.
其他研究编号
- P070161
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