Mechanism and Efficacy of Rehabilitation Approaches

February 10, 2015 updated by: Chang Gung Memorial Hospital

Mechanisms and Long-term Effects of Separate vs. Coupled Rehabilitation Approaches After Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

90

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 county
      • Kwei-shan, Toayuan county, Taiwan, 333
        • 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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cortical reorganization and kinematic analysis
Time Frame: 2008-2010
2008-2010

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical measures at the impairment, activity, participation levels
Time Frame: 2008-2010
2008-2010

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

January 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 25, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (Estimate)

November 27, 2007

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHRI-EX97-9742PI
  • 96-0252B

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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