Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training
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|ClinicalTrials.gov Identifier: NCT00851123|
Recruitment Status : Terminated (Due to recruitment difficulties the trial was stopped after an interim analysis at 30 patients.)
First Posted : February 25, 2009
Last Update Posted : January 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: Modified Constraint-Induced Movement therapy Behavioral: Task-specific bimanual training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training for Subacute Stroke Patients. A Randomized Controlled Trial|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
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.
- Action Reach Arm Test [ Time Frame: 3 years ]
- Motor Activity Log [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851123
|Principal Investigator:||Iris C. Brunner, MSc||University of Bergen|