Bimanual Training in Children With Hemiplegia (HABIT)
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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) |
- 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
- 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 |
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| Contact: Andrew M Gordon, PhD | 212-678-3332 | cpresearch@tc.columbia.edu |
| United States, New York | |
| Teachers College, Columbia University | Recruiting |
| New York, New York, United States, 10027 | |
| 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:
|
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 occupational 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 May 21, 2013