跳至主要内容
临床试验/NCT00851123
NCT00851123终止不适用

Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training for Subacute Stroke Patients. A Randomized Controlled Trial

University of Bergen0 个研究点目标入组 30 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
主要终点
Action Reach Arm Test

研究概览

简要总结

The purpose of the study is to evaluate the benefit of two different treatment approaches for the hemiplegic arm, modified Constraint-Induced Movement Therapy and task-related bimanual training.

详细描述

Detailed description:

Constrained-Induced Movement Therapy seems to be an efficacious treatment approach for a certain subgroup of patients with moderate to mild hemiparesis after stroke. Still it remains unclear whether the training intensity or restriction of the better arm plays the bigger role. CIMT or mCIMT is usually compared to standard care of lower intensity with no constraint of the better arm, or other treatments that do not focus on functional (task-specific) training for the hemiplegic arm. Bimanual training, implying training of activities requiring use of both arms, may however, be even more effective than mCIMT, provided that the training is of similar intensity. The purposes of this study are:

  1. To compare the functional effect of mCIMT to bimanual training of equal intensity in order to examine if one of the treatment approaches is superior to the other regarding the regaining of motor abilities.
  2. Based on fMRI scans of a subgroup of patients, to examine whether cortical reorganization after stroke differs depending on the type of treatment received (mCIMT vs bimanual training).
  3. To examine the rationale for implementing new treatment approaches in primary- and secondary health care, and thereby contribute to improved coordination between specialist and municipal health care systems.

Patients in both groups will participate in a 4 week training program, either mCIMT or bimanual. In both groups cognitive techniques will be used to increase adherence. The patients will be examined when screening, before and after the intervention, and 3 months after completed intervention.

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

入选标准

  • Upper extremity hemiparesis
  • Between 2 and 16 weeks post-stroke
  • At least 10º active extension of the wrist and at least 10º active extension of the thumb and at least 2 additional fingers

排除标准

  • Cognitive problems, Mini Mental Status < 24
  • Excessive pain in the paretic extremity
  • Major medical problems

结局指标

主要结局

Action Reach Arm Test

时间窗: 3 years

次要结局

  • Motor Activity Log(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Iris Ch. Brunner

Research fellow, MSc

University of Bergen

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