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Completed

NCT Number: NCT00305006

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

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.

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Key information

Conditions

Cerebral Palsy Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Children Habits Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Pediatric Signs and Symptoms

Age range

30 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Teachers College, Columbia University

New York, 10027, United States

About this study

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/.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Constraint-Induced Movement Therapy (CIMT)

Procedure

90 hours

Hand-Arm Bimanual Intensive Therapy (HABIT)

Procedure

90 hours

Primary outcomes

  1. Change in Score on Assisting Hand Assessment (AHA)

    Time frame: 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.

  2. Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Teachers College, Columbia University

Other

Collaborators

  • Emory University
  • Thrasher Research Fund

Registry information

Official study title

Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Mar 21, 2006
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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