A Comparative Analysis on Physical Activity Performance and Motor Function of Affected Upper Extremity Before and After a CIMT Program in Young Children With Hemiparetic Cerebral Palsy

NCT ID: NCT03418519

Last Updated: 2019-02-27

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2019-12-30

Brief Summary

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This study evaluates CIMT(Constraint Induced Movement Therapy) in the treatment of physical activity performance and motor function of the weaker extremity in young children with cerebral palsy. Half of participants will receive CIMT while the other half will receive no treatment.

Detailed Description

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Constraint-induced movement therapy (CIMT) is a short-term, intensive treatment to promote functional arm and hand skills in people with hemiparesis. It usually involves constraint of the non-involved extremity and intensive movement practice of the weaker extremity.

Conditions

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Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)

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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CIMT group

Two-hour mCIMT per day for 15 days (dosage = 30 hours)

24-hour restraint for 3 weeks

Group Type EXPERIMENTAL

Constraint Induced Movement Therapy

Intervention Type OTHER

Constraint-induced movement therapy (CIMT) is a high-dosage, efficacious, rehabilitation approach used for children with hemiplegic cerebral palsy

Control group

no CIMT

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Constraint Induced Movement Therapy

Constraint-induced movement therapy (CIMT) is a high-dosage, efficacious, rehabilitation approach used for children with hemiplegic cerebral palsy

Intervention Type OTHER

Other Intervention Names

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CIMT

Eligibility Criteria

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Inclusion Criteria

* diagnosed with spastic hemiplegic cerebral palsy
* age between 18 months and 36 months
* Mini-MACS level 1-4

Exclusion Criteria

* botox injection in upper extremity within 6 months
* poor cooperation with cognitive impairment
* any musculoskeletal disease
* visual or hearing impairment
* uncontrollable epilepsy
* skin damage that makes impossible for participant to wear a splint
* Mini-MACS level 5
Minimum Eligible Age

18 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

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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YoungSub Hwang, researcher

Role: CONTACT

+821027182034

Facility Contacts

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JEONG-YI KWON, MD, PHD

Role: primary

+8210-4591-1039

References

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Hwang YS, Kwon JY. Effects of Modified Constraint-Induced Movement Therapy in Real-World Arm Use in Young Children with Unilateral Cerebral Palsy: A Single-Blind Randomized Trial. Neuropediatrics. 2020 Aug;51(4):259-266. doi: 10.1055/s-0040-1702220. Epub 2020 Mar 6.

Reference Type DERIVED
PMID: 32143221 (View on PubMed)

Other Identifiers

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2017-11-120

Identifier Type: -

Identifier Source: org_study_id

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