Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy

NCT ID: NCT03858335

Last Updated: 2020-07-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-14

Study Completion Date

2019-09-28

Brief Summary

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This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

Detailed Description

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This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

Participants will be randomly assigned to either CIMT group or control group. Children of the CIMT group will wear forearm splint 24 hours for 3 weeks to inhibit use of the unaffected arm.

Conditions

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Cerebral Palsy Spastic Hemiplegic

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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Constraint-induced movement therapy

Children in constraint-induced movement therapy (CIMT) group will wear forearm splint on the unaffected arm 24 hours for 3 weeks, and receive 15 mCIMT sessions(30-hour dosage)

Group Type EXPERIMENTAL

Constraint-induced movement therapy

Intervention Type OTHER

The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks.

Control

Children in control group will receive only traditional rehab therapies without wearing splint

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Constraint-induced movement therapy

The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* spastic hemiplegic cerebral palsy patients
* 7\~36 months old

Exclusion Criteria

* cognitive impairment severe enough to make participation impossible
* uncontrolled epilepsy
* visual or hearing impairment
* musculoskeletal disorders
Minimum Eligible Age

7 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong Yi Kwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Yi Kwon, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2015-06-100-008

Identifier Type: -

Identifier Source: org_study_id

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