Clinical trial NCT00305006: Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy
Official title: Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Hemiplegia
Children
Pediatric
Keywords: 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
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
name: Emory University
First posted: 2006-03-21
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized control trial of bimanual training. 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.

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 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. We 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/.

Eligibility 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

Primary outcomes:
measure: Change in Score on Assisting Hand Assessment (AHA)
timeFrame: Baseline, 6 months
measure: Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF)
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Andrew M Gordon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.
citation: Charles JR, Wolf SL, Schneider JA, Gordon AM. Efficacy of a child-friendly form of constraint-induced movement therapy in hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2006 Aug;48(8):635-42. doi: 10.1017/S0012162206001356.
citation: Gordon AM, Charles J, Wolf SL. Efficacy of constraint-induced movement therapy on involved upper-extremity use in children with hemiplegic cerebral palsy is not age-dependent. Pediatrics. 2006 Mar;117(3):e363-73. doi: 10.1542/peds.2005-1009.
citation: Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.
citation: Steenbergen B, Charles J, Gordon AM. Fingertip force control during bimanual object lifting in hemiplegic cerebral palsy. Exp Brain Res. 2008 Mar;186(2):191-201. doi: 10.1007/s00221-007-1223-6. Epub 2008 Jan 26.
citation: Schertz M, Gordon AM. Changing the model: a call for a re-examination of intervention approaches and translational research in children with developmental disabilities. Dev Med Child Neurol. 2009 Jan;51(1):6-7. doi: 10.1111/j.1469-8749.2008.03220.x. No abstract available.
citation: Gordon AM, Chinnan A, Gill S, Petra E, Hung YC, Charles J. Both constraint-induced movement therapy and bimanual training lead to improved performance of upper extremity function in children with hemiplegia. Dev Med Child Neurol. 2008 Dec;50(12):957-8. doi: 10.1111/j.1469-8749.2008.03166.x. No abstract available.
citation: Hung YC, Casertano L, Hillman A, Gordon AM. The effect of intensive bimanual training on coordination of the hands in children with congenital hemiplegia. Res Dev Disabil. 2011 Nov-Dec;32(6):2724-31. doi: 10.1016/j.ridd.2011.05.038. Epub 2011 Jun 28.
citation: Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.