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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

August 8, 2011
August 10, 2011
September 12, 2011
July 2011
August 2014   (Final data collection date for primary outcome measure)
  • 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.
  • Change from baseline in manual dexterity at 12 months [ Time Frame: 12 months ]
    Change from baseline in timed performance of standardized manual activities
Same as current
Complete list of historical versions of study NCT01413594 on ClinicalTrials.gov Archive Site
  • Change from baseline in upper extremity strength at 12 months [ Time Frame: 12 months ]
  • Change from baseline in range of upper extremity motion at 12 months [ Time Frame: 12 months ]
  • 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
Same as current
Not Provided
Not Provided
 
Bimanual Training in Children With Hemiplegia
Randomized Clinical Trial of Hand Arm Bimanual Intensive Therapy (HABIT)
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.
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/
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Hemiplegia
  • Cerebral Palsy
  • Children
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
  • Experimental: HABIT
    Hand-Arm Bimanual Intensive Therapy (HABIT)
    Intervention: Behavioral: HABIT
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Same as current
December 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Months to 16 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01413594
11204
No
Not Provided
Not Provided
Andrew M. Gordon, Columbia University
Columbia University
Thrasher Research Fund
Principal Investigator: Andrew M Gordon, PhD Teachers College, Columbia University
Columbia University
September 2011

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