Bimanual Training in Children With Hemiplegia (HABIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Columbia University
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Andrew M. Gordon, Columbia University
ClinicalTrials.gov Identifier:
NCT01413594
First received: August 8, 2011
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Hemiplegia
Cerebral Palsy
Children
Behavioral: HABIT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Hand Arm Bimanual Intensive Therapy (HABIT)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change from baseline in quality of bimanual hand use at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Changes in quality of how the two hands are used during manual activity as determined from video analysis.

  • Change from baseline in manual dexterity at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in timed performance of standardized manual activities


Secondary Outcome Measures:
  • Change from baseline in upper extremity strength at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in range of upper extremity motion at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in goal achievement at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in caregiver ratings of activities identified as important goals by the caregiver


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HABIT
Hand-Arm Bimanual Intensive Therapy (HABIT)
Behavioral: HABIT
90 hours of bimanual training over 3 weeks in a day camp environment
Other Name: constraint-induced movement therapy, bimanual training, occupational therapy, physical therapy
No Intervention: Ongoing usual and customary rehabilitation care
Subjects are tested over 6 months while receiving their ongoing usual and customary care schedule of physical and occupational therapy or following constraint-induced movement therapy received as usual and customary care independent of the study, and then are crossed-over to receive HABIT.

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/

  Eligibility

Ages Eligible for Study:   18 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413594

Contacts
Contact: Andrew M Gordon, PhD 212-678-3332 cpresearch@tc.columbia.edu

Locations
United States, New York
Teachers College, Columbia University Recruiting
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
Thrasher Research Fund
Investigators
Principal Investigator: Andrew M Gordon, PhD Teachers College, Columbia University
  More Information

Additional Information:
Publications:
Responsible Party: Andrew M. Gordon, Professor, Columbia University
ClinicalTrials.gov Identifier: NCT01413594     History of Changes
Other Study ID Numbers: 11204
Study First Received: August 8, 2011
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
occupational therapy
cerebral palsy
constraint-induced therapy
constraint-induced movement therapy
CP
hemiplegia
hand
forced use
motor control
children
HABIT
Hand-arm bimanual intensive therapy
bilateral training
bimanual training
functional therapy
physical therapy
intensive
pediatric
development
upper extremity
hemiplegic
childhood stroke

Additional relevant MeSH terms:
Cerebral Palsy
Hemiplegia
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014