Constraint Induced Movement Therapy (CIMT) in Babies Home Program

NCT ID: NCT01214902

Last Updated: 2011-06-21

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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The research objectives are to test the efficacy of a Modified CIMT treatment in babies diagnosed with hemiplegia, treated in a home program, as compared to a control group of babies receiving a parallel home program but with no CIMT.

Detailed Description

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Conditions

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Hemiplegia Cerebral Palsy

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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Experimental CIMT

Two month home program that includes restricting the non hemiplegic hand an hour a day during play

Group Type EXPERIMENTAL

Constraint induced movement therapy (CIMT)

Intervention Type DEVICE

soft mitten worn on the non hemiplegic hand

Active Play

Two month home program that includes active use of hemiplegic hand during play one hour a day

Group Type ACTIVE_COMPARATOR

play

Intervention Type BEHAVIORAL

play which encourages the use of the hemiplegic hand

Interventions

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Constraint induced movement therapy (CIMT)

soft mitten worn on the non hemiplegic hand

Intervention Type DEVICE

play

play which encourages the use of the hemiplegic hand

Intervention Type BEHAVIORAL

Other Intervention Names

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Modifide constraint induced movoment therapy

Eligibility Criteria

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Inclusion Criteria

* Babies age 7-18 months diagnosed with Hemiplegic cerebral palsy

Exclusion Criteria

* Epilepsy not treated
Minimum Eligible Age

7 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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SHAARE ZEDEK MEDICAL CENTER

Locations

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ShaareZMC

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Rena Shara chamudot, Ms.c

Role: CONTACT

References

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Chamudot R, Parush S, Rigbi A, Horovitz R, Gross-Tsur V. Effectiveness of Modified Constraint-Induced Movement Therapy Compared With Bimanual Therapy Home Programs for Infants With Hemiplegia: A Randomized Controlled Trial. Am J Occup Ther. 2018 Nov/Dec;72(6):7206205010p1-7206205010p9. doi: 10.5014/ajot.2018.025981.

Reference Type DERIVED
PMID: 30760393 (View on PubMed)

Chamudot R, Parush S, Rigbi A, Gross-Tsur V. Brain Lesions as a Predictor of Therapeutic Outcomes of Hand Function in Infants With Unilateral Cerebral Palsy. J Child Neurol. 2018 Dec;33(14):918-924. doi: 10.1177/0883073818801632. Epub 2018 Oct 11.

Reference Type DERIVED
PMID: 30307370 (View on PubMed)

Other Identifiers

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chamudotctil

Identifier Type: -

Identifier Source: org_study_id

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