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Mechanism and Efficacy of Rehabilitation Approaches

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00564005
First received: November 25, 2007
Last updated: May 25, 2010
Last verified: May 2010
History of Changes
  Purpose

Identify the possible mechanisms and the relative effectiveness of existing rehabilitation approaches that target upper extremity deficits of stroke patients on the ground that these approaches are based on neuroplasticity principles and sound motor control theories.


Condition Intervention
Cerebrovascular Accidents
 Other: Constraint-induced therapy (CIT)
Other: Bilateral arm training (BAT)
Other: Combined therapy (CT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanisms and Long-term Effects of Separate vs. Coupled Rehabilitation Approaches After Stroke

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:
  • Cortical reorganization and kinematic analysis [ Time Frame: 2008-2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical measures at the impairment, activity, participation levels [ Time Frame: 2008-2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
constraint-induced therapy
 Other: Constraint-induced therapy (CIT)
restraint of the unaffected arm and practice of the affected arm
Experimental: 2
bilateral arm training
 Other: Bilateral arm training (BAT)
bilateral symmetric, repetitive arm training
Experimental: 3
combined therapy
 Other: Combined therapy (CT)
combined different treatment approaches

Detailed Description:

Comparisons of constraint-induced therapy vs. bilateral arm training vs. combined therapy were made. Stroke patients will receive one of these three approaches and be evaluated pre- and post-treatment. the treatment will last 3 weeks and 5 days per week. The evaluation will include clinical measures of motor function, ADL, and quality of life, kinematic performance, and activation patterns of cortex.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a first-ever clinical cerebrovascular accident patients
  • at least 6 months post-stroke onset
  • premorbid right-hand dominance
  • demonstration of Brunnstrom stage III of the affected upper extremity
  • no excessive spasticity in the joints of the affected upper extremity

Exclusion Criteria:

  • a score of less than 24 on the Mini Mental State Exam
  • poor physical conditions that would interfere with participation
  • excessive pain in any joint that might limit participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564005

Contacts
Contact: Ching-yi Wu, ScD 886-3-2118800 ext 5761 cywu@mail.cgu.edu.tw

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Kwei-shan, Toayuan county, Taiwan, 333
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 by Chang Gung Memorial Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ching-yi Wu, Chang Gung University
ClinicalTrials.gov Identifier: NCT00564005     History of Changes
Other Study ID Numbers: NHRI-EX97-9742PI, 96-0252B
Study First Received: November 25, 2007
Last Updated: May 25, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
stroke rehabilitation
cortical reorganization
kinematic analysis

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013