Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training

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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Modified Constraint-Induced Movement therapy; Behavioral: Task-specific 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. Modified Constraint-Induced Movement therapy; Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.	Behavioral: 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.
Experimental: 2.Task-specific bimanual training; Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Action Reach Arm Test	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Motor Activity Log	3 years

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: Haukeland University Hospital; Norwegian Fund for Postgraduate Training in Physiotherapy
• Investigators: Principal Investigator: Iris C. Brunner, MSc, University of Bergen

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 23, 2009
• First Submitted That Met QC Criteria: February 23, 2009
• First Posted (Estimate): February 25, 2009

Study Record Updates

• Last Update Posted (Estimate): January 6, 2014
• Last Update Submitted That Met QC Criteria: January 3, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Stroke; rehabilitation; bimanual training; arm paresis; mCIMT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: UiB24126