Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training
Primary Purpose
Stroke
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified Constraint-Induced Movement therapy
Task-specific bimanual training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, arm paresis, mCIMT, bimanual training, rehabilitation
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1. Modified Constraint-Induced Movement therapy
2.Task-specific bimanual training
Arm Description
Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.
Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic.
Outcomes
Primary Outcome Measures
Action Reach Arm Test
Secondary Outcome Measures
Motor Activity Log
Full Information
NCT ID
NCT00851123
First Posted
February 23, 2009
Last Updated
January 3, 2014
Sponsor
University of Bergen
Collaborators
Haukeland University Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy
1. Study Identification
Unique Protocol Identification Number
NCT00851123
Brief Title
Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training
Official Title
Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training for Subacute Stroke Patients. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Due to recruitment difficulties the trial was stopped after an interim analysis at 30 patients.
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
Haukeland University Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, arm paresis, mCIMT, bimanual training, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Modified Constraint-Induced Movement therapy
Arm Type
Experimental
Arm Description
Modified Constraint-Induced Movement Therapy at the rehabilitation unit or in an outpatient clinic.
Arm Title
2.Task-specific bimanual training
Arm Type
Experimental
Arm Description
Task-specific bimanual training at the rehabilitation unit or in an outpatient clinic.
Intervention Type
Behavioral
Intervention Name(s)
Modified Constraint-Induced Movement therapy
Intervention Description
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
Intervention Name(s)
Task-specific bimanual training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Action Reach Arm Test
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Motor Activity Log
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris C. Brunner, MSc
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training
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