Constraint-Induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy - Tabular View

Tracking Information

First Received Date ^ICMJE

March 20, 2006

Last Updated Date

April 14, 2009

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Level of impairment, functional independence [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Level of impairment, functional independence

Change History

Complete list of historical versions of study NCT00305006 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Constraint-Induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

Official Title ^ICMJE

Constraint-Induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

Brief Summary

A randomized control trial of constraint-induced movement therapy and bimanual training. The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1998 with constraint-induced movement therapy in children with cerebral palsy.

Detailed Description

A randomized control trial to test the efficacy of constraint-induced movement therapy and a new treatment involving bimanual (Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1998 with constraint-induced movement therapy in children with cerebral palsy. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. The aim is to promote the use of and improve the coordination of movement of both hands together. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cerebral Palsy
Hemiplegia
Children
Pediatric

Intervention ^ICMJE

Procedure: Constraint-Induced Movement Therapy
Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT)

Study Arms / Comparison Groups

Experimental: CIMT

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2011

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

1) willingness to agree to intervention and testing procedures and travel to the University for participation and testing.

Exclusion Criteria:

1) health problems not associated with CP, 2) uncontrollable seizures, 3) visual problems that would interfere with carrying out the intervention or testing, 4) botulinum toxin therapy in the upper extremity musculature during the last six months or who wish to receive it within the period of study

Gender

Both

Ages

30 Months to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Andrew M Gordon, Ph.D.

212-678-3326

ag275@columbia.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00305006

Responsible Party

Andrew Gordon, Columbia University

Study ID Numbers ^ICMJE

HABIT

Study Sponsor ^ICMJE

Columbia University

Collaborators ^ICMJE

Thrasher Research Fund
Emory University

Investigators ^ICMJE

Principal Investigator:

Andrew M Gordon, Ph.D.

Columbia University

Information Provided By

Columbia University

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP