Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Behavioral: Task-specific bimanual training; Behavioral: Modified Constraint-Induced Movement therapy

• Registration Number: NCT00851123
• Lead Sponsor: University of Bergen

Brief Summary

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-23
• Study First Posted: 2009-02-25
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.Task-specific bimanual training	Task-specific bimanual training	Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic.
1. Modified Constraint-Induced Movement therapy	Modified Constraint-Induced Movement therapy	Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.

Primary Outcome Measures

Name	Time	Method
Action Reach Arm Test	3 years

Secondary Outcome Measures

Name	Time	Method
Motor Activity Log	3 years