Current Research Studies
The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 24 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 240 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS.
The world’s first large-scale, multisite randomized controlled trial, the CHAMP Study directly compares four different forms of pediatric constraint-induced movement therapy. The different therapy protocols vary in intensity of therapy and in the type of constraint used. Children range from two to eight years old. This study will ultimately follow the progress of 135 children for 12 months after therapy. In addition to our research clinic, the study sites include the University of Virginia, led by Dr. Richard Stevenson, and the Ohio State University, led by Dr. Jane Case-Smith. This $4.2-million study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. To learn more, you can download the CHAMP Study flyer, which has contact information for three sites: Roanoke, Virginia; Columbus, Ohio; and Charlottesville, Virginia.
This study will be the first randomized controlled trial of pediatric constraint-induced movement therapy for children aged six to eighteen months. Pilot research findings already confirm that infants adjust well to the therapy protocol. The study will not only compare different dosages and constraint conditions, but it will also include neuroimaging of the infants’ brains before and after treatment. Ninety infants will be enrolled at the Virginia Tech Carilion Research Institute and at the Ohio State University. Like the CHAMP Study, this $3.1-million study will be funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
“Besides better movement, we’ve seen children get much better in a language and cognition, and we’ve seen improvements in their social and emotional development. For a family looking at a lifetime ahead of them with a child who has had a stroke, these changes in multiple aspects are perhaps the most profound and consequential transformation.”
Selected Publications
- Ramey SL, Coker-Bolt P, DeLuca SC. (Eds.). (2013). Handbook of Pediatric Constraint-Induced Movement Therapy (CIMT): A Guide for Occupational Therapy and Health Care Clinicians, Researchers, and Educators. Bethesda, MD: The American Occupational Therapy Association.
- DeLuca SC, Ramey SL, Trucks MR, Wallace DA, Lutenbacher R. (2013). ACQUIREc protocol: What we have learned from a decade of delivering a signature form of pediatric constraint-induced movement therapy. In: Ramey SL, Coker-Bolt P, DeLuca SC. (Eds.). (2013). Handbook of Pediatric Constraint-Induced Movement Therapy (CIMT): A Guide for Occupational Therapy and Health Care Clinicians, Researchers, and Educators. Bethesda, MD: The American Occupational Therapy Association.
- DeLuca SC, Case-Smith J, Stevenson R, Ramey SL. (2012). Constraint-induced movement therapy (CIMT) for young children with cerebral palsy: Effects of therapeutic dosage. Journal of Pediatric Rehabilitation Medicine, 5, 133–42.
- Ramey SL, DeLuca SC, Case-Smith J, Stevenson R. (2012). Caution is warranted in interpreting data from a recent trial of modified constraint-induced therapy. Developmental Medicine and Child Neurology, 54(5), 477–79.
- DeLuca SC, Echols K, Ramey SL. (2007). ACQUIREc Therapy: A Training Manual for Effective Application of Pediatric Constraint-Induced Movement Therapy. Hillsborough, NC: MindNurture.
- DeLuca SC, Echols K, Law CR, Ramey SL. (2006). Intensive pediatric constraint-induced therapy for children with cerebral palsy: A randomized, controlled, crossover trial. Journal of Child Neurology, 21, 931–38.
- DeLuca S, Echols K, Ramey SL, Taub E. (2003). Pediatric constraint-induced movement therapy for a young child with cerebral palsy: Two episodes of care. Physical Therapy, 83, 1003–13.