The Shadow
BLACKSBURG, Va. – Infants and toddlers with unilateral cerebral palsy, which affects the brain’s control of muscles on one side of the body, show lasting improvements in hand and arm function when they receive early, high-dose therapy, according to a new multisite clinical trial led by Virginia Tech researchers at the Fralin Biomedical Research Institute at VTC.
The Baby CHAMP study — short for Children with Hemiparesis Arm-and-Hand Movement Project — directly compared three therapist-delivered interventions: two forms of constraint-induced movement therapy, which limit the stronger arm to encourage use of the weaker one when combined with therapy, and bimanual therapy, which promotes coordinated use of both hands.
The researchers found that children ages 6 to 24 months showed similar gains whether therapy involved full-time casting, a splint worn during sessions, or bimanual training without constraining the stronger arm.
Published in Pediatrics Open Science, the study addresses a long-standing gap in clinical evidence.
“The brain in the first two years of life is remarkably plastic,” said Stephanie DeLuca, associate professor at the Fralin Biomedical Research Institute at VTC and co-principal investigator of the trial. “By delivering high-dose, play-based therapy early, we’re capitalizing on a window of opportunity when the nervous system is especially responsive to experience.”
While both constraint-induced movement therapy and bimanual therapy are widely recommended for children older than 2 years with unilateral cerebral palsy, limited data have been available to guide treatment decisions for infants and toddlers.
“This gives families and clinicians evidence-based options,” said Sharon Landesman Ramey, a Virginia Tech Distinguished Scholar, professor at the Fralin Biomedical Research Institute at VTC, and co-principal investigator of the Baby CHAMP trial. “The encouraging message is that early, intensive therapy works — and multiple approaches can help children build critical motor skills. Caregivers and families now have actionable evidence that can shape care during one of the most important periods of brain development.”
Unilateral cerebral palsy affects movement on one side of the body and can result in lifelong impairment of upper extremity function. Early intervention is considered critical because the brain is especially adaptable during the first two years of life.
DeLuca is director of the Fralin Biomedical Research Institute at VTC Neuromotor Research Clinic, which investigates novel treatments for children with a range of biomedical conditions and provides worldwide training for therapists to become certified in new evidence-based therapies.
All children received three hours of therapy per day, five days a week, for four consecutive weeks, totaling 60 hours of structured intervention. Parents also supported additional guided home practice.
Fifty-eight children were enrolled in the randomized controlled trial, funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Fifty-three completed treatment and end-of-therapy assessments, and 41 returned for evaluation six months later.
Across all three groups, children demonstrated significant improvements in the ability to use both hands, individually and together. Improvements were measured using standardized developmental assessments administered by evaluators who were unaware of each child’s treatment assignment.
Children also showed gains in fine motor skills in their less-affected arm. Improvements were most pronounced at the six-month follow-up, suggesting that benefits continued to build after formal therapy ended.
Researchers had hypothesized that bimanual therapy might lead to greater improvements in two-handed skills and that full-time casting might yield stronger gains in the affected arm. The data did not support those predictions. Instead, outcomes were broadly comparable across approaches.
The study also addressed concerns that constraining the stronger arm could impair its development. No evidence of harm was observed. In fact, children in the full-time cast group showed slightly greater gains in fine motor skills in their non-affected arm at six months compared with the bimanual group.
“This is important to the field because many people have worried that the use of a constraint might slow the developmental process of the less-affected arm,” DeLuca said. “Our findings confirm that this did not occur and this therapy may even help promote improvements in skills on the less-affected arm and hand.”
Some parents reported their child showed short-term frustration wearing a cast or splint, and minor skin irritation occurred in a small number of children using casts, but no were caused by the therapy itself.
The trial was conducted in collaboration with researchers at Virginia Tech, The Ohio State University, and Nationwide Children’s Hospital. Therapists were centrally trained to deliver structured, play-based interventions grounded in motor learning principles, including repetition, reinforcement, and progressively challenging activities.
Longer-term studies will be needed to better understand how early therapy influences development across many dimensions of a child’s life.
Original study: 10.1542/pedsos.2025-000676
