Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

Not Applicable

Completed

• Conditions: Pediatric; Cerebral Palsy; Hemiplegia; Children
• Interventions: Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT); Procedure: Constraint-Induced Movement Therapy (CIMT)

• Registration Number: NCT00305006
• Lead Sponsor: Teachers College, Columbia University

Brief Summary

A randomized control trial of bimanual training. 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.

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 1998 with constraint-induced movement therapy in children with cerebral palsy. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. We 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 First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-21
• Study Start: 2007-07
• Primary Completion: 2009-12
• Study Completion: 2011-02
• Results First Submitted: 2011-08-08
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-06
• Last Update Submitted: 2021-05-06
• Results First Posted: 2021-06-01
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 Intervention	Hand-Arm Bimanual Intensive Therapy (HABIT)	Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.
CIMT Intervention	Constraint-Induced Movement Therapy (CIMT)	Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.

Primary Outcome Measures

Name	Time	Method
Change in Score on Assisting Hand Assessment (AHA)	Baseline, 6 months	The Assisting Hand Assessment (AHA) quantifies the effectiveness with which a child with unilateral disability uses his/her affected (assisting) hand in bimanual activity. Scores range from 0-100 units, with higher scores signifying better bimanual performance.
Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF)	Baseline, 6 months	The Jebsen-Taylor Test of Hand Function (JTTHF) is a standardized test of simulated functional tasks quantifying the time to complete a battery of unimanual tasks. The activities performed include flipping index cards, object placement, simulated eating, stacking checkers, and manipulating empty and full cans. Scores range from 0-1080 seconds, with a lower score signifying better hand function.

Trial Locations

Locations (1)

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