Constraint Induced Movement Therapy (CIMT) in Babies Home Program

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2010 by Shaare Zedek Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Shaare Zedek Medical Center

ClinicalTrials.gov Identifier:

NCT01214902

First received: July 27, 2010

Last updated: June 20, 2011

Last verified: June 2010

History of Changes

Purpose

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.

Condition	Intervention
Hemiplegia Cerebral Palsy	Device: Constraint induced movement therapy (CIMT) Behavioral: play

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cerebral Palsy Paralysis

U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

Assistive Hand Assessment [ Time Frame: after two months of treatment ] [ Designated as safety issue: No ]
Evaluation of the use of the hemiplegic hand as an assiting hand in bilateral activities

Estimated Enrollment:	30
Study Start Date:	May 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental CIMT Two month home program that includes restricting the non hemiplegic hand an hour a day during play	Device: Constraint induced movement therapy (CIMT) soft mitten worn on the non hemiplegic hand Other Name: Modifide constraint induced movoment therapy
Active Comparator: Active Play Two month home program that includes active use of hemiplegic hand during play one hour a day	Behavioral: play play which encourages the use of the hemiplegic hand

Eligibility

Ages Eligible for Study:	7 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Babies age 7-18 months diagnosed with Hemiplegic cerebral palsy

Exclusion Criteria:

Epilepsy not treated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214902

Contacts

Contact: Rena Shara chamudot, Ms.c

chamudot@012.net.il

Locations

Israel
ShaareZMC	Recruiting
Jerusalem, Israel
Principal Investigator: Varda Gross-Tzur, Prof.

Sponsors and Collaborators

Shaare Zedek Medical Center

More Information

No publications provided

Responsible Party:	Prof. Gross- Tsur Varda, SHAARE ZEDEK MEDICAL CENTER
ClinicalTrials.gov Identifier:	NCT01214902 History of Changes
Other Study ID Numbers:	chamudotctil
Study First Received:	July 27, 2010
Last Updated:	June 20, 2011
Health Authority:	Israel: Ethics Commission

Additional relevant MeSH terms:

Cerebral Palsy
Hemiplegia
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013

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