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NCT01214902 Clinical Trial

Constraint Induced Movement Therapy (CIMT) in Babies Home Program

Cerebral Palsy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01214902
Other study ID # chamudotctil
Secondary ID
Status Recruiting
Phase N/A
First received July 27, 2010
Last updated June 20, 2011
Start date May 2011
Est. completion date December 2012

Study information
Verified date June 2010
Source Shaare Zedek Medical Center
Contact Rena Shara chamudot, Ms.c
Email chamudot@012.net.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 7 Months to 18 Months
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Epilepsy not treated

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Constraint induced movement therapy (CIMT)
soft mitten worn on the non hemiplegic hand
Behavioral:
• play
play which encourages the use of the hemiplegic hand

Locations
Country Name City State
Israel ShaareZMC Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assistive Hand Assessment Evaluation of the use of the hemiplegic hand as an assiting hand in bilateral activities after two months of treatment No
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