Clinical trial NCT01413594: Bimanual Training in Children With Hemiplegia
Official title: Randomized Clinical Trial of Hand Arm Bimanual Intensive Therapy (HABIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Cerebral Palsy
Children
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
childhood stroke
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2011-08-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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/

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 from baseline in quality of bimanual hand use at 12 months
timeFrame: 12 months
measure: Change from baseline in manual dexterity at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in upper extremity strength at 12 months
timeFrame: 12 months
measure: Change from baseline in range of upper extremity motion at 12 months
timeFrame: 12 months
measure: Change from baseline in goal achievement at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
affiliation: Teachers College, Columbia University
name: Andrew M Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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: 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: 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: Gordon AM. Two hands are better than one: bimanual skill development in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2010 Apr;52(4):315-6. doi: 10.1111/j.1469-8749.2009.03390.x. Epub 2009 Oct 7. No abstract available.