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Clinical Trials/NCT01413594
NCT01413594
Completed
Not Applicable

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

Teachers College, Columbia University1 site in 1 country22 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegia
Sponsor
Teachers College, Columbia University
Enrollment
22
Locations
1
Primary Endpoint
Change from baseline in manual dexterity at 12 months
Status
Completed
Last Updated
5 years ago

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/

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
December 2014
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrew Gordon

Professor

Columbia University

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

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)

Study Sites (1)

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