A new treatment approach for infants and toddlers who have experienced a stroke before birth or as a newborn has shown promising results in improving function and skill on the affected side of the body. Preliminary findings from a large-scale clinical trial indicate that a high-dose regimen of a specific therapy led to larger gains in skills and daily function six months after treatment compared to moderate-dose therapy or standard care.
The treatment, known as I-ACQUIRE, is a form of Constraint-Induced Movement Therapy (CIMT) adapted for very young children. It combines restricting the use of the child's stronger arm and hand with a lightweight cast with intensive, task-oriented motor therapy guided by learning principles. The goal is to rewire the brain after injury and improve motor function, coordination, and independence in daily activities. This study is the first to evaluate the impact of this home-delivered therapy, which includes a parent program, specifically for infants and toddlers after perinatal strokes.
Perinatal arterial ischemic stroke (PAIS) is the most common form of stroke in children, often resulting in hemiparesis, or limited voluntary motor control on one side of the body. The Phase 3, randomized clinical trial enrolled 216 children, ages 8 months to 36 months, at 15 different U.S. universities and hospitals, with outcomes from 167 children included in the analysis presented at the American Stroke Association’s International Stroke Conference 2026.
Children 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 two hours of weekly therapy from community therapists. Certified, blinded assessors measured arm and hand skills before treatment, immediately after, and six months later.
The analysis revealed that at the end of treatment, both I-ACQUIRE dose groups showed improvements in neuromotor skills, gaining a median of 3 new skills compared to 1 in the usual care group. Crucially, six months post-treatment, children in the high-dose group had significantly larger skill gains than those in the moderate-dose or usual care groups. These differences were more pronounced for children whose treatment most closely followed the protocol.
Parent ratings indicated that children in both I-ACQUIRE groups gained meaningful improvement in everyday functional use of their weaker arm and hand, including exploring toys, using communication gestures, and performing new self-help skills. Study author Sharon Ramey, Ph.D., noted, "We think the potential for an infant to recover from an early stroke far exceeds what was once considered a fairly grim prognosis." Parents reported that observed improvements exceeded prior expectations, increasing their hopes for their child's future participation in typical activities.
An unexpected finding was that children in the usual care group also showed clinically important improvement in specific arm and hand skills at six months, such as reaching and grasping. However, their parents' ratings did not indicate they saw real-world functional improvements at home. The study authors suggest that children with PAIS may show greater variability in treatment response, and identifying which children benefit most will be important for future care.
The study, funded by the National Institute of Neurological Disorders and Stroke, demonstrates that such intensive, home-based trials can be conducted carefully and that families can follow the treatment plan effectively. It focused on a young clinical population not previously examined in this way. Limitations include that the 15 trial sites may not represent all care settings and that the final treated sample was 167 children. The findings are considered preliminary until published in a peer-reviewed journal.
For business and technology leaders in healthcare, this research highlights the tangible impact of targeted, data-driven therapeutic interventions. It underscores the potential for advanced rehabilitation protocols, supported by rigorous clinical trials and digital health monitoring, to transform outcomes in pediatric neurology. The development and validation of such intensive, home-based models could influence future care standards, insurance reimbursements, and investment in neuro-rehabilitation technologies. The study's use of blinded assessors and parent-reported outcomes also points to the growing importance of integrating objective metrics and real-world data into therapeutic evaluation, a trend relevant to health tech innovation and value-based care models.
