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Constraint Induced Movement Therapy (CIMT) in Babies Home Program

Primary Purpose

Hemiplegia, Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Constraint induced movement therapy (CIMT)
play
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia

Eligibility Criteria

7 Months - 18 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Epilepsy not treated

Sites / Locations

  • ShaareZMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental CIMT

Active Play

Arm Description

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

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

Outcomes

Primary Outcome Measures

Assistive Hand Assessment
Evaluation of the use of the hemiplegic hand as an assiting hand in bilateral activities

Secondary Outcome Measures

Full Information

First Posted
July 27, 2010
Last Updated
June 20, 2011
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01214902
Brief Title
Constraint Induced Movement Therapy (CIMT) in Babies Home Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental CIMT
Arm Type
Experimental
Arm Description
Two month home program that includes restricting the non hemiplegic hand an hour a day during play
Arm Title
Active Play
Arm Type
Active Comparator
Arm Description
Two month home program that includes active use of hemiplegic hand during play one hour a day
Intervention Type
Device
Intervention Name(s)
Constraint induced movement therapy (CIMT)
Other Intervention Name(s)
Modifide constraint induced movoment therapy
Intervention Description
soft mitten worn on the non hemiplegic hand
Intervention Type
Behavioral
Intervention Name(s)
play
Intervention Description
play which encourages the use of the hemiplegic hand
Primary Outcome Measure Information:
Title
Assistive Hand Assessment
Description
Evaluation of the use of the hemiplegic hand as an assiting hand in bilateral activities
Time Frame
after two months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Babies age 7-18 months diagnosed with Hemiplegic cerebral palsy Exclusion Criteria: Epilepsy not treated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rena Shara chamudot, Ms.c
Email
chamudot@012.net.il
Facility Information:
Facility Name
ShaareZMC
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Varda Gross-Tzur, Prof.

12. IPD Sharing Statement

Citations:
PubMed Identifier
30760393
Citation
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.
Results Reference
derived
PubMed Identifier
30307370
Citation
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.
Results Reference
derived

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Constraint Induced Movement Therapy (CIMT) in Babies Home Program

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