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

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.