Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training

Terminated

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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.

Trial Stopped: Due to recruitment difficulties the trial was stopped after an interim analysis at 30 patients.

Conditions

Interventions

  • Modified Constraint-Induced Movement Therapy Behavioral
    Intervention Desc: Four hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing the affected arm. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own. A restraining mitt has to be worn 5 hours a day.
    ARM 1: Kind: Experimental
    Label: 1. Modified Constraint-Induced Movement therapy
    Description: Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.
  • Task-specific bimanual training Behavioral
    Intervention Desc: Four hours of treatment a week for four weeks by a physiotherapist or an occupational therapist emphasizing bimanual tasks. Patients will receive an individually tailored home training program and are supposed to train 2-3 hours daily on their own.
    ARM 1: Kind: Experimental
    Label: 2.Task-specific bimanual training
    Description: Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Action Reach Arm Test 3 years No
Secondary Motor Activity Log 3 years No

Sponsors