Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia

Study Overview
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Brief Summary
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A randomized control trial examining the relationship between changes in hand function and brain plasticity following intensive therapy. Two treatment approaches are used: constraint-induced movement therapy (CIMT) or Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at TC Columbia University to be child friendly and draw upon our extensive experience with constraint-induced movement therapy in children with cerebral palsy. Our center has been providing interventions camps for children with cerebral palsy since 1998. The interventions are performed in a 15 day day-camp setting with several children and at least one interventionist per child. The aim of the intervention is to improve the use of the affected hand and quality of overall movement in a fun, social setting. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/

Detailed Description
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Constraint-induced Movement Therapy and Bimanual training are motor-learning based approaches to engage children in fun activities. This study looks at what areas of the brain are responsible for recovery after intensive training. We are trying to understand how the brain responds to movement training and hope that in the future we can develop new treatments for hemiplegia based on what we learn about the brain in this study. To study the areas of the brain we will use Magnetic Resonance Imaging (MRI) to take pictures of the brain and Transcranial Magnetic Stimulation (TMS) to determine parts of the brain involved in using the hand. TMS uses a brief magnetic field over the scalp by using a wand that looks like a figure 8. The wand can make brief magnetic fields over a series of spots on your child's head to activate the brain cells under the wand. Non-invasive, single pulse TMS will be used in this study, which is considered minimal risk and tolerable to children. If your child has a recurrent history of seizures after two years of age, he/she might not qualify.

Official Title
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Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia

Conditions
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Cerebral Palsy, Hemiplegia, Children

Intervention / Treatment
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* Other: Constraint-induced Movement Therapy
* Other: Hand-arm Bimanual Intensive Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of unilateral cerebral palsy Exclusion Criteria: Current medical illness unrelated to CP Seizure disorder Current use of medications know to lower the seizure threshold Metallic object(s) in body, other than dental fillings Pregnancy Claustrophobia

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIMT<br>Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab | Other: Constraint-induced Movement Therapy<br> <br> |
| Experimental: HABIT<br>Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab | Other: Hand-arm Bimanual Intensive Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jebsen-Taylor Test of Hand Function |  | Change from baseline to immediately after intervention | 
| Assisting Hand Assessment |  | Change from baseline to immediately after intervention | 
| Box and Blocks test |  | Change from baseline to immediately after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure |  | Change from baseline to immediately after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, HABIT, CIMT, Cerebral Palsy, Hemiplegia, Children, Therapy