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

This study has been completed.
Sponsor:
Collaborators:
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
Ching-yi Wu, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00778453
First received: October 5, 2008
Last updated: July 31, 2012
Last verified: July 2012
  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: Hospital-based mCIT
Other: Hospital-based BIT
Other: Hospital-based TR
Other: Home-based mCIT
Other: Home-based BAT
Other: Home-based TR

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: 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:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • kinematic analysis [ Time Frame: 2008-2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical measures [ Time Frame: 2008-2011 ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: August 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hospital-based mCIT
Hospital-based modified constraint-induced therapy(mCIT)
Other: Hospital-based mCIT
restraint of the unaffected arm and practice of the affected arm
Other Name: Hospital-based modified constraint-induced therapy(mCIT)
Experimental: Hospital-based BIT
Hospital-based bilateral isokinematic training (BIT)
Other: Hospital-based BIT
bilateral symmetric, repetitive arm training
Other Name: Hospital-based bilateral isokinematic training (BIT)
Experimental: Hospital-based TR
Hospital-based traditional rehabilitation (TR)
Other: Hospital-based TR
hospital-based traditional rehabilitation : OT or PT or therapist-based training
Other Name: Hospital-based traditional rehabilitation (TR)
Experimental: Home-based BAT
Home-based bilateral arm training(BAT)
Other: Home-based BAT
bilateral symmetric, repetitive arm training
Other Name: Home-based bilateral arm training (BAT)
Experimental: Home-based TR
Home-based traditional rehabilitation (TR)
Other: Home-based TR
home-based traditional rehabilitation:OT or PT or therapist-based training
Other Name: Home-based traditional rehabilitation (TR)
Experimental: Home-based mCIT
Home-based modified constraint-induced therapy (mCIT)
Other: Home-based mCIT
restraint of the unaffected arm and practices of the affected arm
Other Name: Home-based modified constraint-induced therapy (mCIT)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Taiwan
Chang Gung Memorial Hospital
Kwei-shan, Toayuan, Taiwan
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, Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00778453     History of Changes
Other Study ID Numbers: NSC97-2314-B-182-004-MY3, 96-1754B
Study First Received: October 5, 2008
Last Updated: July 31, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
stroke rehabilitation
kinematic analysis
upper extremity training
predictors

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

ClinicalTrials.gov processed this record on October 22, 2014