跳至主要内容
临床试验/NCT00839670
NCT00839670终止3 期

Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
3 期
状态
终止
入组人数
34
试验地点
2
主要终点
Motor activity log scale

研究概览

简要总结

The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method.

详细描述

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 (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Motor activity log scale

时间窗: 10 days before inclusion, 10 days and 3 months after treatment achievement

次要结局

  • Wolf Motor Function test Stroke impact scale Functional MRI HAD scale(10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验