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

July 31, 2012 updated by: Ching-yi Wu, Chang Gung Memorial Hospital

Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients Delivered in Hospital-based and Home-based Settings

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Toayuan
      • Kwei-shan, Toayuan, Taiwan
        • Chang Gung memorial hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Home-based modified constraint-induced therapy (mCIT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
kinematic analysis
Time Frame: 2008-2011
2008-2011

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical measures
Time Frame: 2008-2011
2008-2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

National Science Council, Taiwan
National Health Research Institutes, Taiwan

Investigators

  • Principal Investigator: Ching-yi Wu, ScD, Department of Occupational Therapy, Chang Gung Univ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

October 5, 2008

First Submitted That Met QC Criteria

October 21, 2008

First Posted (Estimate)

October 23, 2008

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSC97-2314-B-182-004-MY3
  • 96-1754B (Other Identifier: Institutional Review Board / Chang Gung Memorial Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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