Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients - Full Text View

Sponsors and Collaborators:	Chang Gung Memorial Hospital National Science Council, Taiwan National Health Research Institutes, Taiwan
Information provided by:	Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00778453

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:

kinematic analysis [ Time Frame: 2008-2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

clinical measures [ Time Frame: 2008-2010 ] [ Designated as safety issue: Yes ]

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
1: Experimental hospital-based modified constraint-induced therapy(mCIT)	Other: modified constraint-induced therapy(mCIT) restraint of the unaffected arm and practice of the affected arm
2: Experimental hospital-based bilateral isokinematic training (BIT)	Other: home-based BIT bilateral symmetric, repetitive arm training
3: Experimental hospital-based traditional rehabilitation (TR)	Other: hospital-based TR hospital-based traditional rehabilitation : OT or PT
5: Experimental home-based BIT	Other: home-based BIT bilateral symmetric, repetitive arm training
6: Experimental home-based TR	Other: home-based TR home-based traditional rehabilitation:OT or PT
4: Experimental home-based mCIT	Other: home-based mCIT restraint of the unaffected arm and practices of the affected arm

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778453

Contacts

Contact: Ching-yi Wu Wu, ScD

886-3-2118800 ext 5761

cywu@mail.cgu.edu.tw

Locations

Taiwan, Toayuan
Chang Gung Memorial Hospital	Recruiting
Kwei-shan, Toayuan, Taiwan
Contact: Chia-ling Chen, MD/PhD 886-3-3281200 ext 8148

Sponsors and Collaborators

Chang Gung Memorial Hospital

National Science Council, Taiwan

National Health Research Institutes, Taiwan

Investigators

Principal Investigator:

Ching-yi Wu, ScD

Department of Occupational Therapy, Chang Gung Univ

More Information

No publications provided

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:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00778453 History of Changes
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:

stroke rehabilitation
kinematic analysis
upper extremity training
predictors

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia

Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases

Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on September 01, 2009