Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy - Full Text View

Sponsor:	Columbia University
Collaborators:	Thrasher Research Fund Emory University
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00305006

Purpose

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.

Condition	Intervention	Phase
Cerebral Palsy Hemiplegia Children Pediatric	Procedure: Constraint-Induced Movement Therapy Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT)	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

Resource links provided by NLM:

MedlinePlus related topics: Cerebral Palsy Paralysis Rehabilitation

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	July 2007
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A CIMT	Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIMT, CIT, CI Therapy, restraint therapy, PT, OT, rehab Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab

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/

Eligibility

Ages Eligible for Study:	30 Months to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305006

Contacts

Contact: Andrew M Gordon, Ph.D.

212-678-3326

ag275@columbia.edu

Locations

United States, New York
Teachers College, Columbia University	Recruiting
New York, New York, United States, 10027
Contact: Andrew M Gordon, Ph.D. 212-678-3326 ag275@columbia.edu
Principal Investigator: Andrew M Gordon, Ph.D.
Sub-Investigator: Jeanne Charles, PhD, PT, MSW

Sponsors and Collaborators

Columbia University

Thrasher Research Fund

Emory University

Investigators

Principal Investigator:

Andrew M Gordon, Ph.D.

Columbia University

More Information

Additional Information:

Center for cerebral palsy research This link exits the ClinicalTrials.gov site

Center for Cerebral Palsy Research This link exits the ClinicalTrials.gov site

Publications:

Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. Review.

Charles JR, Wolf SL, Schneider JA, Gordon AM. Efficacy of a child-friendly form of constraint-induced movement therapy in hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2006 Aug;48(8):635-42.

Gordon AM, Charles J, Wolf SL. Efficacy of constraint-induced movement therapy on involved upper-extremity use in children with hemiplegic cerebral palsy is not age-dependent. Pediatrics. 2006 Mar;117(3):e363-73.

Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8.

Steenbergen B, Charles J, Gordon AM. Fingertip force control during bimanual object lifting in hemiplegic cerebral palsy. Exp Brain Res. 2008 Mar;186(2):191-201. Epub 2008 Jan 26.

Schertz M, Gordon AM. Changing the model: a call for a re-examination of intervention approaches and translational research in children with developmental disabilities. Dev Med Child Neurol. 2009 Jan;51(1):6-7. No abstract available.

Gordon AM, Chinnan A, Gill S, Petra E, Hung YC, Charles J. Both constraint-induced movement therapy and bimanual training lead to improved performance of upper extremity function in children with hemiplegia. Dev Med Child Neurol. 2008 Dec;50(12):957-8. No abstract available.

Responsible Party:	Andrew Gordon, Columbia University
ClinicalTrials.gov Identifier:	NCT00305006 History of Changes
Other Study ID Numbers:	08126
Study First Received:	March 20, 2006
Last Updated:	January 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

cerebral palsy
constraint-induced therapy
constraint-induced movement therapy
CP
hemiplegia
hand
forced use
motor control
children
HABIT
Hand-arm bimanual intensive therapy

Bilateral training
Bimanual training
functional therapy
physical therapy
occupational therapy
intensive
pediatric
development
upper extremity
hemiplegic

Additional relevant MeSH terms:

Cerebral Palsy
Hemiplegia
Paralysis
Brain Damage, Chronic
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012