Children With Hemiparesis Arm and Hand Movement Project (CHAMP Study)
Condition: Hemiparesis; Cerebral Palsy; Brain Injury
MeSH terms: Brain Injuries; Cerebral Palsy; Paresis
Study type: Interventional
Phase: Phase 2

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 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.
    


Intervention name(s): Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation
Intervention type(s): Behavioral
Intervention description(s): Types of constraint and dosage amounts will be varied.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: P-CIMT; Pediatric Constraint Induced Movement Therapy; Hemiparesis; Cerebral Palsy; Children