Children With Hemiparesis Arm and Hand Movement Project (CHAMP Study)

Study Overview
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Brief Summary
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What is the CHAMP Study? The CHAMP Study is a multisite clinical trial funded by the National Institutes of Health that is comparing the efficacy of alternative therapies for young children with unilateral spastic cerebral palsy (or hemiparetic cerebral palsy). Children who meet study eligibility criteria at one of the three clinical sites (Roanoke, VA; Charlottesville, VA, and Columbus, OH) will be invited to enroll, and their parents will be provided all necessary paperwork along with informed consent documentation. Assignment to one of the alternative therapy conditions will be random. Participation in the study includes assessment of each child prior to treatment, close monitoring of the child's progress during treatment, and post-treatment evaluation at the end of therapy, as well as, 6 and 12 months later. Parents will have an active role in the project, both observing their child during therapy sessions and then engaging in home-based activities that allow the child to practice and extend new motor skills. There will be no charge for the therapy provided. What are the therapies being tested? In the past decade or so, a new form of therapy for children with hemiparetic cerebral palsy was developed and has shown to produce positive changes in individual children and in small clinical trials (e.g., DeLuca, Echols, Ramey, & Taub, 2003; DeLuca, Echols, Law, & Ramey, 2006; Case-Smith, DeLuca, Stevenson, & Ramey, 2012). The therapy is named Constraint-Induced Movement Therapy (CIMT) and refers to a multi-component form of therapy in which the child has the unimpaired or less impaired upper extremity constrained (by a cast or a splint) while also receiving active therapy from a specially trained therapist who shapes new skills and functional activities with the child's more impaired upper extremity. Traditionally, CIMT therapy dosages have been high - often lasting many hours per day, 5 days a week, for 4 consecutive weeks. There are important clinical and scientific questions that need to be answered about the effects of different dosage levels and about different types of constraint on the child's more functional (less impaired) arm and hand. This study will be the first that will directly compare different amounts of therapy and different types of constraint to evaluate what works best for young children. The therapy is very play-like and engaging for children, and no negative effects of casting or the high dosages have been detected in previous clinical trials. Who is eligible: Children between 2 and 8 years of age with a diagnosis of unilateral spastic cerebral palsy or hemiparetic cerebral palsy. Children must be relatively healthy, not currently receiving Botox (or other similar medications), and able to understand simple communication and instructions. In advance, the treatment will be explained in detail to parents and a written protocol available to share with the child's physician and other current therapist for review. During the one month of treatment, children will not receive other forms of physical or occupational therapy.

Official Title
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A Multisite Trial of Pediatric Constraint-Induced Movement Therapy

Conditions
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Hemiparesis, Cerebral Palsy, Brain Injury

Intervention / Treatment
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* Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are 2 years - 8 years old do not have any serious complicating conditions or acute medical concerns are diagnosed with cerebral palsy with hemiparesis (prior to age 2) have not had botox injections in the last 6 months and have not received Constraint-Induced Movement Therapy in the last 6 months have a clinical MRI that can be provided in digital format for research project Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 9 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group with continuous constraint and daily therapy<br> | Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation<br>* Types of constraint and dosage amounts will be varied.<br>|
| Experimental: Group with continuous constrainit and 3 days a week therapy<br> | Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation<br>* Types of constraint and dosage amounts will be varied.<br>|
| Experimental: Group with part-time constraint and daily therapy<br> | Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation<br>* Types of constraint and dosage amounts will be varied.<br>|
| Experimental: Group with part-time constraint and 3 days a week therapy<br> | Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation<br>* Types of constraint and dosage amounts will be varied.<br>|
| Active Comparator: Usual and customary treatment group<br> | Behavioral: Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation<br>* Types of constraint and dosage amounts will be varied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional measurements of change across time in the child's abilities with their arms and hands will be measured using the Assisting Hand Assessment, the Peabody Developmental Motor Scales, and the Pediatric Evaluation and Disability Inventory. | Functional measurements of arm use | Pretreatment; Post-Treatment, 6 and 12 months Follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified version of Quality of Upper Extremity Skills Test (QUEST) | Functional range of motion measure | Pre treatment; Post-Treatment (end of 4 weeks of treatment), 6 and 12 months Follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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P-CIMT, Pediatric Constraint Induced Movement Therapy, Hemiparesis, Cerebral Palsy, Children