Mechanism and Efficacy of Rehabilitation Approaches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00564005
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : February 11, 2015
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Cerebrovascular Accidents Other: Constraint-induced therapy (CIT) Other: Bilateral arm training (BAT) Other: Combined therapy (CT) Behavioral: Control intervention Not Applicable

Detailed Description:
Comparisons of constraint-induced therapy (CIT) vs. bilateral arm training (BIT)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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanisms and Long-term Effects of Separate vs. Coupled Rehabilitation Approaches After Stroke
Study Start Date : January 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
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
Active Comparator: Control intervention Behavioral: Control intervention
Conventional treatment program

Primary Outcome Measures :
  1. Cortical reorganization and kinematic analysis [ Time Frame: 2008-2010 ]

Secondary Outcome Measures :
  1. clinical measures at the impairment, activity, participation levels [ Time Frame: 2008-2010 ]

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00564005

Chang Gung Memorial Hospital
Kwei-shan, Toayuan county, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Principal Investigator: Ching-yi Wu, ScD Department of Occupational Therapy, Chang Gung Univ.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chang Gung Memorial Hospital Identifier: NCT00564005     History of Changes
Other Study ID Numbers: NHRI-EX97-9742PI
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: September 2014

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

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases