Constraint Induced Movement Therapy (CIMT) in Babies Home Program

June 20, 2011 updated by: Shaare Zedek Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Epilepsy not treated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after two months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

October 4, 2010

First Posted (ESTIMATE)

October 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chamudotctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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