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Sponsors and Collaborators: |
Chang Gung Memorial Hospital National Science Council, Taiwan National Health Research Institutes, Taiwan |
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Information provided by: | Chang Gung Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00778453 |
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.
Condition | Intervention |
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Cerebrovascular Accidents |
Other: modified constraint-induced therapy(mCIT) Other: home-based BIT Other: hospital-based TR Other: home-based mCIT Other: home-based TR |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients Delivered in Hospital-Based and Home-Based Settings |
Estimated Enrollment: | 180 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
hospital-based modified constraint-induced therapy(mCIT)
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Other: modified constraint-induced therapy(mCIT)
restraint of the unaffected arm and practice of the affected arm
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2: Experimental
hospital-based bilateral isokinematic training (BIT)
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Other: home-based BIT
bilateral symmetric, repetitive arm training
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3: Experimental
hospital-based traditional rehabilitation (TR)
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Other: hospital-based TR
hospital-based traditional rehabilitation : OT or PT
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5: Experimental
home-based BIT
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Other: home-based BIT
bilateral symmetric, repetitive arm training
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6: Experimental
home-based TR
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Other: home-based TR
home-based traditional rehabilitation:OT or PT
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4: Experimental
home-based mCIT
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Other: home-based mCIT
restraint of the unaffected arm and practices of the affected arm
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The first purpose is to investigate the relative effects of modified constraint-induced therapy (mCIT) vs. bilateral isokinematic training (BIT) 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 traditional rehabilitation (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.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contact: Ching-yi Wu Wu, ScD | 886-3-2118800 ext 5761 | cywu@mail.cgu.edu.tw |
Taiwan, Toayuan | |
Chang Gung Memorial Hospital | Recruiting |
Kwei-shan, Toayuan, Taiwan | |
Contact: Chia-ling Chen, MD/PhD 886-3-3281200 ext 8148 |
Principal Investigator: | Ching-yi Wu, ScD | Department of Occupational Therapy, Chang Gung Univ |
Responsible Party: | Chang Gung University ( Ching-yi Wu ) |
Study ID Numbers: | NSC97-2314-B-182-004-MY3, 96-1754B |
Study First Received: | October 5, 2008 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00778453 History of Changes |
Health Authority: | Taiwan: Institutional Review Board |
stroke rehabilitation kinematic analysis upper extremity training predictors |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Brain Ischemia |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Brain Ischemia Cardiovascular Diseases Brain Infarction Brain Diseases Cerebrovascular Disorders |