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

This study is currently recruiting participants.
Verified by Columbia University, July 2008

Sponsors and Collaborators: Columbia University
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

MedlinePlus related topics:   Cerebral Palsy    Paralysis    Rehabilitation   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Constraint-Induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

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:   50
Study Start Date:   July 2007
Estimated Study Completion Date:   February 2011
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
CIMT
Procedure: Constraint-Induced Movement Therapy
90 hours
Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT)
90 hours

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 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 1) ability to extend the wrist at least 20º and the fingers at least 10degs at the metacarpophalangeal joints from full flexion, 2) a 50% difference between the involved and non-involved hand on the Jebsen-Taylor Test of Hand Function provided twice during screening, 3) score within one standard deviation from the mean on the Kaufman Brief Intelligence Test, and 4) willingness to agree to intervention and testing procedures and travel to the University for participation.

Exclusion Criteria:

  • 1) health problems not associated with CP, 2) seizures, 3) visual problems that would interfere with carrying out the intervention or testing, 4) severe muscle tone (Modified Ashworth score > 3.5) orthopedic surgery on their involved upper extremity, 6) a dorsal rhizotomy, 7) botulinum toxin therapy in the upper extremity musculature during the last six months or who wish to receive it within the period of study, 8) intrathecal Baclofen, and finally, 9) balance problems.
  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


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

Publications:

Responsible Party:   Columbia University ( Andrew Gordon )
Study ID Numbers:   HABIT
First Received:   March 20, 2006
Last Updated:   July 21, 2008
ClinicalTrials.gov Identifier:   NCT00305006
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

Study placed in the following topic categories:
Paralysis
Signs and Symptoms
Hemiplegia
Cerebral Palsy
Brain Damage, Chronic
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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