A new treatment approach for infants and toddlers who have suffered a stroke before birth or as a newborn has demonstrated significant and lasting improvements in arm and hand function, according to preliminary research presented at the American Stroke Association’s International Stroke Conference 2026. The study focused on Perinatal Arterial Ischemic Stroke (PAIS), the most common form of stroke in children, which often results in hemiparesis—limited voluntary motor control on one side of the body.
The research evaluated a therapy called I-ACQUIRE, a form of Constraint-Induced Movement Therapy (CIMT) adapted for very young children. This rehabilitation approach is designed to rewire the brain after injury by restricting the use of the child's stronger arm and hand with a lightweight cast, thereby encouraging use of the stroke-affected limb. The therapy was delivered in the child’s home or natural settings and included a parent program, making it the first study to evaluate this specific form of CIMT for this age group after perinatal strokes. More information on stroke in children is available from the American Stroke Association at https://www.stroke.org.
In this Phase 3 randomized clinical trial, researchers enrolled 216 children aged 8 to 36 months at 15 U.S. sites, with outcomes from 167 children included in the analysis. Participants were randomly assigned to one of three groups: a high-dose I-ACQUIRE group receiving six hours of therapy daily for four weeks; a moderate-dose group receiving three hours daily for four weeks; or a usual care group receiving about one hour each of physical and occupational therapy weekly from community therapists.
The findings revealed that at the end of treatment, both the high- and moderate-dose groups showed improvements in neuromotor skills, gaining a median of 3 new skills compared to a median gain of 1 skill in the usual care group. However, the most significant results emerged six months post-treatment. Children in the high-dose group had substantially larger skill gains than those in either the moderate-dose or usual care groups. These differences were even more pronounced for children whose treatment most closely followed the therapy protocol.
Parents of children in both I-ACQUIRE groups reported meaningful improvements in their children's everyday functional use of the weaker arm and hand. These new skills included exploring and manipulating toys, using communication gestures, and performing self-help tasks that were previously impossible. The study's abstract is available in the https://professional.heart.org online program planner.
An unexpected finding was that children in the usual care group also showed clinically important improvement in specific arm and hand skills at the six-month mark, such as reaching, grasping, and using the impaired arm for balance. However, unlike the I-ACQUIRE groups, parents of these children did not report seeing real-world functional improvements in daily activities at either assessment point.
"This research fills a knowledge gap," said study author Sharon Ramey, Ph.D., of the Fralin Biomedical Research Institute. Previously, treatment recommendations relied on data from older children with cerebral palsy, lacking sufficient evidence for infants and toddlers specifically. The study confirms the treatment was well-received, safe, and produced measurable benefits. Ramey noted the potential for recovery "far exceeds what was once considered a fairly grim prognosis," with parents reporting changes that exceeded prior expectations and increasing their hopes for their child's future participation in typical activities.
The study's implications are substantial for clinical practice and families. It provides the first robust evidence for a targeted, intensive therapy protocol for a vulnerable population with limited treatment options. The home-based delivery model involving parents could make effective intervention more accessible. Furthermore, the research challenges previous assumptions about recovery limits after early brain injury, suggesting a greater capacity for neuroplasticity and functional gain than previously recognized.
While the findings are promising, the authors note limitations, including that the 15 study sites may not represent all care settings and that the final sample size was reduced. The research was funded by the National Institute of Neurological Disorders and Stroke. As the study was presented at a scientific meeting, the findings are considered preliminary until published in a peer-reviewed journal. The American Heart Association provides overall financial information https://www.heart.org.
