Randomized Clinical Trial of Hand Arm Bimanual Intensive Therapy (HABIT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Change from baseline in manual dexterity at 12 months
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Months to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change from baseline in manual dexterity at 12 months
Time Frame: 12 months
Change from baseline in timed performance of standardized manual activities
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.
Secondary Outcomes
- Change from baseline in range of upper extremity motion at 12 months(12 months)
- Change from baseline in upper extremity strength at 12 months(12 months)
- Change from baseline in goal achievement at 12 months(12 months)
Investigators
Andrew Gordon
Professor
Columbia University