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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neurologic Manifestations
Paralysis
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014