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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Columbia University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Thrasher Research Fund
Emory University
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00305006
First received: March 20, 2006
Last updated: January 12, 2011
Last verified: January 2011
History of Changes
  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 1

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:

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:

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 May 22, 2013