Constraint Induced Movement Therapy (CIMT) in Babies Home Program

Sponsors

Lead sponsor: Shaare Zedek Medical Center

Source 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.

Overall Status Unknown status
Start Date May 2011
Completion Date December 2012
Primary Completion Date December 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Assistive Hand Assessment after two months of treatment
Enrollment 30
Condition
Intervention

Intervention type: Device

Intervention name: Constraint induced movement therapy (CIMT)

Description: soft mitten worn on the non hemiplegic hand

Arm group label: Experimental CIMT

Other name: Modifide constraint induced movoment therapy

Intervention type: Behavioral

Intervention name: play

Description: play which encourages the use of the hemiplegic hand

Arm group label: Active Play

Eligibility

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Epilepsy not treated

Gender: All

Minimum age: 7 Months

Maximum age: 18 Months

Healthy volunteers: No

Overall Contact

Last name: Rena Shara chamudot, Ms.c

Email: [email protected]

Location
facility status investigator
ShaareZMC Recruiting Varda Gross-Tzur, Prof. Principal Investigator
Location Countries

Israel

Verification Date

June 2010

Responsible Party

Name title: Prof. Gross- Tsur Varda

Organization: SHAARE ZEDEK MEDICAL CENTER

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Experimental CIMT

Arm group type: Experimental

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

Arm group label: Active Play

Arm group type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov