Bimanual Training in Children With Hemiplegia

Not Applicable

Completed

• Conditions: Children; Cerebral Palsy; Hemiplegia
• Interventions: Behavioral: HABIT

• Registration Number: NCT01413594
• Lead Sponsor: Teachers College, 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/

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HABIT	HABIT	Hand-Arm Bimanual Intensive Therapy (HABIT)

Primary Outcome Measures

Name	Time	Method
Change from baseline in manual dexterity at 12 months	12 months	Change from baseline in timed performance of standardized manual activities
Change from baseline in quality of bimanual hand use at 12 months	12 months	Changes in quality of how the two hands are used during manual activity as determined from video analysis.

Secondary Outcome Measures

Name	Time	Method
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	Change in caregiver ratings of activities identified as important goals by the caregiver

Trial Locations

Locations (1)

Teachers College, Columbia University; 🇺🇸 New York, New York, United States