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

Primary Purpose

Cerebrovascular Accidents

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hospital-based mCIT
Hospital-based BIT
Hospital-based TR
Home-based mCIT
Home-based BAT
Home-based TR
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accidents focused on measuring stroke rehabilitation, kinematic analysis, upper extremity training, predictors

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Hospital-based mCIT

Hospital-based BIT

Hospital-based TR

Home-based BAT

Home-based TR

Home-based mCIT

Arm Description

Hospital-based modified constraint-induced therapy(mCIT)

Hospital-based bilateral isokinematic training (BIT)

Hospital-based traditional rehabilitation (TR)

Home-based bilateral arm training(BAT)

Home-based traditional rehabilitation (TR)

Home-based modified constraint-induced therapy (mCIT)

Outcomes

Primary Outcome Measures

kinematic analysis

Secondary Outcome Measures

clinical measures

Full Information

First Posted
October 5, 2008
Last Updated
July 31, 2012
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00778453
Brief Title
Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients
Official Title
Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients Delivered in Hospital-based and Home-based Settings
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accidents
Keywords
stroke rehabilitation, kinematic analysis, upper extremity training, predictors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospital-based mCIT
Arm Type
Experimental
Arm Description
Hospital-based modified constraint-induced therapy(mCIT)
Arm Title
Hospital-based BIT
Arm Type
Experimental
Arm Description
Hospital-based bilateral isokinematic training (BIT)
Arm Title
Hospital-based TR
Arm Type
Experimental
Arm Description
Hospital-based traditional rehabilitation (TR)
Arm Title
Home-based BAT
Arm Type
Experimental
Arm Description
Home-based bilateral arm training(BAT)
Arm Title
Home-based TR
Arm Type
Experimental
Arm Description
Home-based traditional rehabilitation (TR)
Arm Title
Home-based mCIT
Arm Type
Experimental
Arm Description
Home-based modified constraint-induced therapy (mCIT)
Intervention Type
Other
Intervention Name(s)
Hospital-based mCIT
Other Intervention Name(s)
Hospital-based modified constraint-induced therapy(mCIT)
Intervention Description
restraint of the unaffected arm and practice of the affected arm
Intervention Type
Other
Intervention Name(s)
Hospital-based BIT
Other Intervention Name(s)
Hospital-based bilateral isokinematic training (BIT)
Intervention Description
bilateral symmetric, repetitive arm training
Intervention Type
Other
Intervention Name(s)
Hospital-based TR
Other Intervention Name(s)
Hospital-based traditional rehabilitation (TR)
Intervention Description
hospital-based traditional rehabilitation : OT or PT or therapist-based training
Intervention Type
Other
Intervention Name(s)
Home-based mCIT
Other Intervention Name(s)
Home-based modified constraint-induced therapy (mCIT)
Intervention Description
restraint of the unaffected arm and practices of the affected arm
Intervention Type
Other
Intervention Name(s)
Home-based BAT
Other Intervention Name(s)
Home-based bilateral arm training (BAT)
Intervention Description
bilateral symmetric, repetitive arm training
Intervention Type
Other
Intervention Name(s)
Home-based TR
Other Intervention Name(s)
Home-based traditional rehabilitation (TR)
Intervention Description
home-based traditional rehabilitation:OT or PT or therapist-based training
Primary Outcome Measure Information:
Title
kinematic analysis
Time Frame
2008-2011
Secondary Outcome Measure Information:
Title
clinical measures
Time Frame
2008-2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-yi Wu, ScD
Organizational Affiliation
Department of Occupational Therapy, Chang Gung Univ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kwei-shan
State/Province
Toayuan
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20848369
Citation
Lin KC, Chuang LL, Wu CY, Hsieh YW, Chang WY. Responsiveness and validity of three dexterous function measures in stroke rehabilitation. J Rehabil Res Dev. 2010;47(6):563-71. doi: 10.1682/jrrd.2009.09.0155.
Results Reference
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Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients

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