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

NCT ID: NCT00778453

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Cerebrovascular Accidents

Keywords

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stroke rehabilitation kinematic analysis upper extremity training predictors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hospital-based mCIT

Hospital-based modified constraint-induced therapy(mCIT)

Group Type EXPERIMENTAL

Hospital-based mCIT

Intervention Type OTHER

restraint of the unaffected arm and practice of the affected arm

Hospital-based BIT

Hospital-based bilateral isokinematic training (BIT)

Group Type EXPERIMENTAL

Hospital-based BIT

Intervention Type OTHER

bilateral symmetric, repetitive arm training

Hospital-based TR

Hospital-based traditional rehabilitation (TR)

Group Type EXPERIMENTAL

Hospital-based TR

Intervention Type OTHER

hospital-based traditional rehabilitation : OT or PT or therapist-based training

Home-based BAT

Home-based bilateral arm training(BAT)

Group Type EXPERIMENTAL

Home-based BAT

Intervention Type OTHER

bilateral symmetric, repetitive arm training

Home-based TR

Home-based traditional rehabilitation (TR)

Group Type EXPERIMENTAL

Home-based TR

Intervention Type OTHER

home-based traditional rehabilitation:OT or PT or therapist-based training

Home-based mCIT

Home-based modified constraint-induced therapy (mCIT)

Group Type EXPERIMENTAL

Home-based mCIT

Intervention Type OTHER

restraint of the unaffected arm and practices of the affected arm

Interventions

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Hospital-based mCIT

restraint of the unaffected arm and practice of the affected arm

Intervention Type OTHER

Hospital-based BIT

bilateral symmetric, repetitive arm training

Intervention Type OTHER

Hospital-based TR

hospital-based traditional rehabilitation : OT or PT or therapist-based training

Intervention Type OTHER

Home-based mCIT

restraint of the unaffected arm and practices of the affected arm

Intervention Type OTHER

Home-based BAT

bilateral symmetric, repetitive arm training

Intervention Type OTHER

Home-based TR

home-based traditional rehabilitation:OT or PT or therapist-based training

Intervention Type OTHER

Other Intervention Names

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Hospital-based modified constraint-induced therapy(mCIT) Hospital-based bilateral isokinematic training (BIT) Hospital-based traditional rehabilitation (TR) Home-based modified constraint-induced therapy (mCIT) Home-based bilateral arm training (BAT) Home-based traditional rehabilitation (TR)

Eligibility Criteria

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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

Exclusion Criteria

* a score of less than 24 on the Mini Mental State Exam
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ching-yi Wu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ching-yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Department of Occupational Therapy, Chang Gung Univ

Locations

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Chang Gung Memorial Hospital

Kwei-shan, Toayuan, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 20848369 (View on PubMed)

Other Identifiers

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96-1754B

Identifier Type: OTHER

Identifier Source: secondary_id

NSC97-2314-B-182-004-MY3

Identifier Type: -

Identifier Source: org_study_id