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Constraint Induced Movement Therapy (CIMT) in Babies Home Program

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ClinicalTrials.gov Identifier: NCT01214902
Recruitment Status : Unknown
Verified June 2010 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : October 5, 2010
Last Update Posted : June 21, 2011
Sponsor:
Information provided by:
Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Hemiplegia Cerebral Palsy Device: Constraint induced movement therapy (CIMT) Behavioral: play Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Assistive Hand Assessment [ Time Frame: after two months of treatment ]
    Evaluation of the use of the hemiplegic hand as an assiting hand in bilateral activities



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Ages Eligible for Study:   7 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Epilepsy not treated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Prof. Gross- Tsur Varda, SHAARE ZEDEK MEDICAL CENTER
ClinicalTrials.gov Identifier: NCT01214902     History of Changes
Other Study ID Numbers: chamudotctil
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: June 2010

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