Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients

Study Overview
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Brief Summary
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The findings of this study will advance movement reorganization mechanism underlying treatment approaches and clinical intervention techniques. These findings may inform rehabilitation professionals about which treatment approach is superior to another one in certain aspect of outcome and who can benefit most from certain treatment approach. Accordingly, the results of this project may help us move quickly to design and develop efficient and effective rehabilitation programs for individualized patients.

Detailed Description
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The first purpose is to investigate the relative effects of modified constraint-induced therapy (mCIT) vs. bilateral isokinematic training (BIT) vs. traditional or therapist-based training (TR) on movement reorganization, motor performance, functional ability, and quality of life (QoL) immediately and six months later after treatment delivered at hospitals. Movement reorganization will be evaluated by kinematic instrument. Motor performance, functional ability, and QoL will be assessed using clinical assessment tools. By the same token, we also investigate the relative effects of these two approaches delivered at home. The second purpose is to study whether home-based mCIT is efficacious in various aspects of outcomes described above immediately and six months later following treatment, compared to home-based TR, and hospital-based mCIT and TR.We also study the same question regarding home-based BIT efficacy. The third purpose is to establish predictive models to predict functional and QoL outcomes immediately and six months later following mCIT and BIT.

Official Title
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Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients Delivered in Hospital-based and Home-based Settings

Conditions
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Cerebrovascular Accidents

Intervention / Treatment
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* Other: Hospital-based mCIT
* Other: Hospital-based BIT
* Other: Hospital-based TR
* Other: Home-based mCIT
* Other: Home-based BAT
* Other: Home-based TR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the onset duration more than 6 months Brunnstrom stage III above for the proximal part and distal part of UL no serious cognitive deficits no balance problems sufficient to compromise safety when wearing the project's constraint device no excessive spasticity in any of the joints of the affected UL exclusion criteria: a score of less than 24 on the Mini Mental State Exam

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospital-based mCIT<br>Hospital-based modified constraint-induced therapy(mCIT) | Other: Hospital-based mCIT<br>* restraint of the unaffected arm and practice of the affected arm<br>* Other names: Hospital-based modified constraint-induced therapy(mCIT);|
| Experimental: Hospital-based BIT<br>Hospital-based bilateral isokinematic training (BIT) | Other: Hospital-based BIT<br>* bilateral symmetric, repetitive arm training<br>* Other names: Hospital-based bilateral isokinematic training (BIT);|
| Experimental: Hospital-based TR<br>Hospital-based traditional rehabilitation (TR) | Other: Hospital-based TR<br>* hospital-based traditional rehabilitation : OT or PT or therapist-based training<br>* Other names: Hospital-based traditional rehabilitation (TR);|
| Experimental: Home-based BAT<br>Home-based bilateral arm training(BAT) | Other: Home-based BAT<br>* bilateral symmetric, repetitive arm training<br>* Other names: Home-based bilateral arm training (BAT);|
| Experimental: Home-based TR<br>Home-based traditional rehabilitation (TR) | Other: Home-based TR<br>* home-based traditional rehabilitation:OT or PT or therapist-based training<br>* Other names: Home-based traditional rehabilitation (TR);|
| Experimental: Home-based mCIT<br>Home-based modified constraint-induced therapy (mCIT) | Other: Home-based mCIT<br>* restraint of the unaffected arm and practices of the affected arm<br>* Other names: Home-based modified constraint-induced therapy (mCIT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kinematic analysis |  | 2008-2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical measures |  | 2008-2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke rehabilitation, kinematic analysis, upper extremity training, predictors