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

Bimanual Training in Children With Hemiplegia

Sponsors

Lead sponsor: Columbia University

Collaborator: Thrasher Research Fund

Source Columbia University
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/

Overall Status Unknown status
Start Date July 2011
Completion Date December 2014
Primary Completion Date August 2014
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in quality of bimanual hand use at 12 months 12 months
Change from baseline in manual dexterity at 12 months 12 months
Secondary Outcome
Measure Time Frame
Change from baseline in upper extremity strength at 12 months 12 months
Change from baseline in range of upper extremity motion at 12 months 12 months
Change from baseline in goal achievement at 12 months 12 months
Enrollment 40
Condition
Intervention

Intervention type: Behavioral

Intervention name: HABIT

Description: 90 hours of bimanual training over 3 weeks in a day camp environment

Arm group label: HABIT

Other name: constraint-induced movement therapy, bimanual training, occupational therapy, physical therapy

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

Gender: All

Minimum age: 18 Months

Maximum age: 16 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Andrew M Gordon, PhD Principal Investigator Teachers College, Columbia University
Overall Contact

Last name: Andrew M Gordon, PhD

Phone: 212-678-3332

Email: [email protected]

Location
facility status
Teachers College, Columbia University Recruiting
Location Countries

United States

Verification Date

September 2011

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Columbia University

Investigator full name: Andrew M. Gordon

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: HABIT

Arm group type: Experimental

Description: Hand-Arm Bimanual Intensive Therapy (HABIT)

Arm group label: Ongoing usual and customary rehabilitation care

Arm group type: No Intervention

Description: 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.

Acronym HABIT
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov