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Bimanual Training in Children With Hemiplegia (HABIT)

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ClinicalTrials.gov Identifier: NCT01413594
Recruitment Status : Unknown
Verified September 2011 by Andrew M. Gordon, Columbia University.
Recruitment status was:  Recruiting
First Posted : August 10, 2011
Last Update Posted : September 12, 2011
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Andrew M. Gordon, Columbia University

Brief Summary:
A randomized control trial of bimanual training in children with hemiplegia. The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy. The investigators will test the hypothesis that bimanual training (HABIT) will result in improved hand function in children with hemiplegia.

Condition or disease Intervention/treatment Phase
Hemiplegia Cerebral Palsy Children Behavioral: HABIT Phase 1 Phase 2

Detailed Description:
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 1997 with constraint-induced movement therapy in children with cerebral palsy. The investigators developed HABIT in 2004 as an alternative to constraint-therapy that avoids use of a restraint. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. The investigators have conducted 24 day camps to date since 2002, and are now collaborating with clinicians worldwide to expand our treatment availability. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Hand Arm Bimanual Intensive Therapy (HABIT)
Study Start Date : July 2011
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HABIT
Hand-Arm Bimanual Intensive Therapy (HABIT)
Behavioral: HABIT
90 hours of bimanual training over 3 weeks in a day camp environment
Other Name: constraint-induced movement therapy, bimanual training, occupational therapy, physical therapy

No Intervention: Ongoing usual and customary rehabilitation care
Subjects are tested over 6 months while receiving their ongoing usual and customary care schedule of physical and occupational therapy or following constraint-induced movement therapy received as usual and customary care independent of the study, and then are crossed-over to receive HABIT.



Primary Outcome Measures :
  1. Change from baseline in quality of bimanual hand use at 12 months [ Time Frame: 12 months ]
    Changes in quality of how the two hands are used during manual activity as determined from video analysis.

  2. Change from baseline in manual dexterity at 12 months [ Time Frame: 12 months ]
    Change from baseline in timed performance of standardized manual activities


Secondary Outcome Measures :
  1. Change from baseline in upper extremity strength at 12 months [ Time Frame: 12 months ]
  2. Change from baseline in range of upper extremity motion at 12 months [ Time Frame: 12 months ]
  3. Change from baseline in goal achievement at 12 months [ Time Frame: 12 months ]
    Change in caregiver ratings of activities identified as important goals by the caregiver



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Ages Eligible for Study:   18 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

*willingness to agree to intervention and testing procedures and travel to the University for participation and testing

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413594


Contacts
Contact: Andrew M Gordon, PhD 212-678-3332 cpresearch@tc.columbia.edu

Locations
United States, New York
Teachers College, Columbia University Recruiting
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
Thrasher Research Fund
Investigators
Principal Investigator: Andrew M Gordon, PhD Teachers College, Columbia University

Additional Information:
Publications:
Responsible Party: Andrew M. Gordon, Professor, Columbia University
ClinicalTrials.gov Identifier: NCT01413594     History of Changes
Other Study ID Numbers: 11204
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: September 2011

Keywords provided by Andrew M. Gordon, 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
childhood stroke

Additional relevant MeSH terms:
Cerebral Palsy
Hemiplegia
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms