Mechanism and Efficacy of Rehabilitation Approaches

NCT ID: NCT00564005

Last Updated: 2015-02-11

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebrovascular Accidents

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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1

constraint-induced therapy

Group Type EXPERIMENTAL

Constraint-induced therapy (CIT)

Intervention Type OTHER

restraint of the unaffected arm and practice of the affected arm

2

bilateral arm training

Group Type EXPERIMENTAL

Bilateral arm training (BAT)

Intervention Type OTHER

bilateral symmetric, repetitive arm training

3

combined therapy

Group Type EXPERIMENTAL

Combined therapy (CT)

Intervention Type OTHER

combined different treatment approaches

Control intervention

Group Type ACTIVE_COMPARATOR

Control intervention

Intervention Type BEHAVIORAL

Conventional treatment program

Interventions

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Constraint-induced therapy (CIT)

restraint of the unaffected arm and practice of the affected arm

Intervention Type OTHER

Bilateral arm training (BAT)

bilateral symmetric, repetitive arm training

Intervention Type OTHER

Combined therapy (CT)

combined different treatment approaches

Intervention Type OTHER

Control intervention

Conventional treatment program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Responsibility Role SPONSOR

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 County, Taiwan

Site Status

Countries

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Taiwan

References

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Wu CY, Chen YA, Lin KC, Chao CP, Chen YT. Constraint-induced therapy with trunk restraint for improving functional outcomes and trunk-arm control after stroke: a randomized controlled trial. Phys Ther. 2012 Apr;92(4):483-92. doi: 10.2522/ptj.20110213. Epub 2012 Jan 6.

Reference Type DERIVED
PMID: 22228607 (View on PubMed)

Other Identifiers

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96-0252B

Identifier Type: -

Identifier Source: secondary_id

NHRI-EX97-9742PI

Identifier Type: -

Identifier Source: org_study_id

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