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

Study Summary

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 scien

Primary Outcome

Functional measurements of arm use

Interventions

• BEHAVIORAL Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation