Bimanual Training in Children With Hemiplegia (HABIT)
| Tracking Information | |||||
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| First Received Date ICMJE | August 8, 2011 | ||||
| Last Updated Date | September 8, 2011 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01413594 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bimanual Training in Children With Hemiplegia | ||||
| Official Title ICMJE | Randomized Clinical Trial of Hand Arm Bimanual Intensive Therapy (HABIT) | ||||
| Brief Summary | 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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| 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/ |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: *willingness to agree to intervention and testing procedures and travel to the University for participation and testing Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Months to 16 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01413594 | ||||
| Other Study ID Numbers ICMJE | 11204 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Andrew M. Gordon, Columbia University | ||||
| Study Sponsor ICMJE | Columbia University | ||||
| Collaborators ICMJE | Thrasher Research Fund | ||||
| Investigators ICMJE |
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| Information Provided By | Columbia University | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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