Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training

NCT ID: NCT00851123

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-01-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1. Modified Constraint-Induced Movement therapy

Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.

Group Type: EXPERIMENTAL

Modified Constraint-Induced Movement therapy

Intervention Type: BEHAVIORAL

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.

2.Task-specific bimanual training

Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic.

Group Type: EXPERIMENTAL

Task-specific bimanual training

Intervention Type: BEHAVIORAL

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.

Interventions

Modified Constraint-Induced Movement therapy

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.

Intervention Type: BEHAVIORAL

Task-specific bimanual training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Iris Ch. Brunner

Research fellow, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iris C. Brunner, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Other Identifiers

UiB24126

Identifier Type: -

Identifier Source: org_study_id