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Effects of Forms of Modified CIT on Upper Extremity Performance in Cerebral Palsy

NCT ID: NCT01643239

Last Updated: 2013-02-28

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-08-31

Brief Summary

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The purpose of this study will employ clinical assessment tools to examine the effects of modified constraint-induced therapy (mCIT) on the more affected upper extremity of children with cerebral palsy.

Detailed Description

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The study included threefold: (1) It will employ kinematic analysis, along with clinical assessment tools to examine the effects of mCIT on the more affected upper extremity of children with cerebral palsy with asymmetric motor impairments after treatment immediately and 1 year following. The clinical tools will include Motor Activity Log (MAL), Bruininks-Oseretsky Test of Motor Proficiency (BOTMP),Peabody-Developmental Motor Scales (PDMS-II), and Wee-FIM. (2) This study looked at the intervention impact on bimanual coordination and the less affected upper extremity. (3) It investigated the effects of forms (group vs. individual intervention) on upper extremity performance.

Conditions

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Cerebral Palsy

Keywords

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Modified constraint-induced therapy Children with cerebral palsy Kinematic analysis Group therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Hospital-based mCIT with individualized intervention

Hospital-based modified constraint-induced therapy(mCIT)

Group Type EXPERIMENTAL

Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm

Intervention Type OTHER

the mCIT group with individualized intervention

Hospital-based mCIT with group therapy

Hospital-based modified constraint-induced therapy(mCIT)

Group Type EXPERIMENTAL

Hospital-based mCIT

Intervention Type OTHER

the mCIT group with individualized intervention

Hospital-based TR

Hospital-based traditional rehabilitation (TR)

Group Type OTHER

Hospital-based TR

Intervention Type OTHER

OT or PT or therapist-based training

Interventions

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Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm

the mCIT group with individualized intervention

Intervention Type OTHER

Hospital-based mCIT

the mCIT group with individualized intervention

Intervention Type OTHER

Hospital-based TR

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 modified constraint-induced therapy(mCIT) Hospital-based traditional rehabilitation (TR)

Eligibility Criteria

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Inclusion Criteria

1. clinical diagnosis of spastic CP
2. age between 4 and 10 years old
3. shoulder flexion of the affected upper limb more than 90 degrees, elbow extension over 160 degrees, wrist extension to 10 degrees at least, and fingers full flexion to 10 degrees at least
4. basic balance ability: sitting on the chair without arm support; feet stay on the floor consistently; performing the affected upper limb movement without losing balance
5. ability to follow simple oral commands
6. no related musculoskeletal surgery of the affected upper limb
7. not have injected the Botox into the affected upper extremity during the past 6 months
8. no visual or auditory disability
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung University

OTHER

Sponsor Role collaborator

National Science and Technology Council, Taiwan

OTHER_GOV

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

Other Identifiers

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94-1052B

Identifier Type: -

Identifier Source: org_study_id