A new treatment combining constraint of the stronger arm with intensive, goal-directed therapy led to immediate and lasting functional improvements for infants and toddlers who experienced a stroke before or soon after birth, according to preliminary research presented at the American Stroke Association's International Stroke Conference 2026. The study focused on children under 3 years old with marked impairment in one arm and represents a significant advance in addressing perinatal arterial ischemic stroke (PAIS), the most common form of stroke in children.
Researchers enrolled 167 children ages 8 months to 36 months in a Phase 3 randomized clinical trial testing the I-ACQUIRE treatment protocol. Children were randomly assigned to one of three groups: high-dose I-ACQUIRE therapy (six hours daily for four weeks), moderate-dose I-ACQUIRE therapy (three hours daily for four weeks), or usual care (approximately two hours of weekly therapy). All therapy was delivered in the child's home or natural settings and included a parent program to support rehabilitation.
At the six-month post-treatment assessment, children in the high-dose group showed significantly larger skill gains than those in either the moderate-dose or usual care groups. These gains became 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 everyday functional use of the weaker arm and hand, including exploring toys, communication gestures, and self-help skills previously beyond the child's capability.
"We think the potential for an infant to recover from an early stroke far exceeds what was once considered a fairly grim prognosis," said study author Sharon Ramey, Ph.D., of the Fralin Biomedical Research Institute. "We repeatedly heard from parents that the many changes they saw in their children exceeded what they had been told was likely for their child." The American Heart Association provides comprehensive stroke information at https://www.stroke.org.
Unexpectedly, children in the usual care group also showed clinically important improvement in their arm and hand skills at six months, though parent ratings did not indicate they saw real-world improvements in everyday use of the more-impaired limb. Researchers noted that the skill gains from I-ACQUIRE therapy were smaller than expected, possibly reflecting greater individual variation in response among children with PAIS compared to other clinical populations studied previously.
The study's findings fill a critical knowledge gap, as previous treatment recommendations relied on data from mostly older children with cerebral palsy and hemiparesis. "Now, we confidently know that this treatment, at both dosages, was well-received, safe and produced measurable benefits," Ramey said. The research abstract is available through the American Stroke Association International Stroke Conference 2026 Online Program Planner at https://professional.heart.org/en/meetings/international-stroke-conference.
Study limitations include that the 15 U.S. sites may not represent all locations where children with PAIS receive care, and the final sample size was reduced from the original enrollment. The research was funded by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health. The findings are considered preliminary until published as a full manuscript in a peer-reviewed scientific journal.
