Bimanual Training in Children With Hemiplegia

Cerebral Palsy Clinical Trial

— HABIT  

Official title:

Randomized Clinical Trial of Hand Arm Bimanual Intensive Therapy (HABIT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413594
• Other study ID #: 11204
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2021
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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/

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Children
• Hemiplegia

Intervention

Behavioral:
• HABIT
90 hours of bimanual training over 3 weeks in a day camp environment

Locations

Country	Name	City	State
United States	Teachers College, Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Teachers College, Columbia University	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in quality of bimanual hand use at 12 months	Changes in quality of how the two hands are used during manual activity as determined from video analysis.	12 months
Primary	Change from baseline in manual dexterity at 12 months	Change from baseline in timed performance of standardized manual activities	12 months
Secondary	Change from baseline in upper extremity strength at 12 months		12 months
Secondary	Change from baseline in range of upper extremity motion at 12 months		12 months
Secondary	Change from baseline in goal achievement at 12 months	Change in caregiver ratings of activities identified as important goals by the caregiver	12 months

External Links

•   Center for Cerebral Palsy Research, TC, Columbia University