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Completed

NCT Number: NCT01413594

Bimanual Training in Children With Hemiplegia

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.

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Key information

Conditions

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

Age range

18 month–16 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 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/

Who can participate

Healthy volunteers accepted: Yes

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

HABIT

Behavioral

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

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

Primary outcomes

  1. 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.

  2. Change from baseline in manual dexterity at 12 months

    Time frame: 12 months

    Change from baseline in timed performance of standardized manual activities

Secondary outcomes

  1. Change from baseline in upper extremity strength at 12 months

    Time frame: 12 months

  2. Change from baseline in range of upper extremity motion at 12 months

    Time frame: 12 months

  3. Change from baseline in goal achievement at 12 months

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Teachers College, Columbia University

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

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

Acronym: HABIT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 10, 2011
Registry last updated
Apr 19, 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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