High-dose therapy had lasting benefits for infants with stroke before or soon after birth

Research Highlights:

• For infants and toddlers who have had a stroke, a new treatment that restricted the use of their stronger arm and hand to encourage them to use their stroke-affected arm and hand, combined with high-dosage and a specific type of goal-directed therapy, led to immediate improvement in function and more skills gained.
• The findings are based on 167 stroke survivors younger than 3 years old with marked impairment in using one arm. They were enrolled in the trial and randomly assigned to one of three treatments: A high dose of the new therapy, a moderate dose of the same therapy, or a continuation in the usual treatment they were receiving.
• Six months later, children who received the high-dose of the particular form of therapy for infants and toddlers called I-ACQUIRE, showed larger gains in skills and daily function compared to those in the moderate-dose or usual care group.
• Unexpectedly, and fortunately, many children in the usual care group - typically a one-hour session of occupational therapy and a one-hour session of physical therapy each week - also showed significant improvement in their arm and hand skills at the six-month post-treatment mark.
• Note: The study featured in this news release is a research abstract. Abstracts presented at the American Heart Association's scientific meetings are not peer-reviewed, and the findings are considered preliminary until published as a full manuscript in a peer-reviewed scientific journal.

Embargoed until 11:57 a.m. CT/12:57 p.m. ET Friday, Feb. 6, 2026

Note: This news release includes updated information not available in the abstract.

NEW ORLEANS, Feb. 6, 2026 - In infants and toddlers who had a stroke before birth or as a newborn (28 days or younger), a treatment that combined restricting the use of the stronger arm with intensive task-oriented physical therapy led to improved function and skill gained on the weak side compared to standard care, according to preliminary late-breaking science presented today at the American Stroke Association's International Stroke Conference 2026. The meeting, Feb. 4 - 6, 2026, in New Orleans, is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

Perinatal arterial ischemic stroke (PAIS) is the most common form of stroke in children, which causes functional impairment and limited voluntary motor control on one side of the body, a condition known as hemiparesis.

Constraint-induced Movement Therapy (CIMT) is a rehabilitation approach to improve use of an impaired upper extremity, helping to rewire the brain after injury such as a stroke. In this study, treatment with CIMT for very young children after a stroke was designed to increase the use of the more-affected arm and hand. The treatment included intensive motor therapy that was task-oriented and guided by learning principles to improve motor function, coordination and independence in daily activities by restricting the use of the stronger arm and hand with a lightweight cast.

This study is the first to evaluate the potential impact of this form of CIMT, which is delivered in the child's home or natural settings and includes a parent program to help children in this age range after perinatal strokes.

"This research fills a knowledge gap," said study author Sharon Ramey, Ph.D., co-director of the Fralin Biomedical Research Institute Neuromotor Research Clinic, a distinguished scholar and professor at the Fralin Biomedical Research Institute, and professor in the department of psychiatry and behavioral medicine at the Virginia Tech Carilion School of Medicine in Roanoke, Virginia. "Previously, parents and physicians relied on findings from a mixed group of mostly older children with cerebral palsy and hemiparesis to make treatment recommendations; however, these findings lacked sufficient data about benefits for this clinical population of infants and toddlers. Now, we confidently know that this treatment, at both dosages, was well-received, safe and produced measurable benefits."

In this Phase 3, randomized clinical trial (a large-scale study to evaluate the effectiveness of a treatment) testing the I-ACQUIRE treatment, researchers enrolled 216 children, ages 8 months to 36 months, at 15 different U.S. universities and hospitals; outcomes from 167 children were included in today's presentation. Parents granted permission for their children to participate.

The children were randomly placed into one of three groups:

1. Moderate-dose I-ACQUIRE therapy: three hours of therapy per day together with constraint of the less-affected limb for five days a week for four consecutive weeks.
2. High-dose I-ACQUIRE therapy: six hours of therapy with constraint of the less-affected arm and hand five days a week, for four consecutive weeks.
3. Usual care: about 1 hour of physical therapy and 1 hour of occupational therapy each week from community therapists for most cases.

All therapy was focused on helping children gain new skills and increase their daily use of their more-impaired arm and hand.

Certified assessors, who were unaware (blinded) of which treatment group the child was enrolled in, measured each child's arm and hand skills before treatment, at the end of treatment, and at six months after treatment. The focus was on specific skills related to using the hand and arm for fine and some larger movements. In addition, parents provided ratings of their child's functional performance in a wide range of typical home activities.

The analysis found:

• At the end of the treatment, both dose groups showed improvements in neuromotor skills, with a median gain of 3 new skills each (mean gain of 2.94 moderate dose and 3.30 high dose compared to usual care). This increase was significantly higher than the usual care group, which only gained a median of 1 skill. However, it is important to note that these gains were smaller than expected.
• Children in the high-dose group had significantly larger skill gains at six months post-treatment than those in the moderate-dose group or the usual care group. These differences became even more apparent for children whose treatment most closely followed the therapy protocol.
• The parents' ratings for children in both the high and moderate-dose I-ACQUIRE groups indicated that their children gained meaningful improvement in their everyday functional use of their weaker arm and hand. These new skills included exploring and manipulating toys, communication gestures, and many self-help skills that the child could not perform before therapy.

"Unexpectedly, children in the usual care group also showed clinically important improvement in their arm and hand skills at six months," Ramey said. These included changes such as reaching out, grasping and releasing an object, using the more impaired arm in activities that promote balance, crawling and protective extension. However, the parent ratings for their children's everyday use of the more-impaired limb did not indicate that parents saw real-world improvements at either the end of treatment or six months later for those receiving the usual care.

"We had expected a larger number of skills to be gained from the I-ACQUIRE therapy," Ramey said. "We think this finding may reflect two likely reasons: first, as a group, children with Perinatal Arterial Ischemic Stroke may show greater differences in their responses to this treatment - some benefit much more than others - compared to findings from prior studies on other clinical populations. Identifying which children benefit the most, or the least, will be very important going forward."

"We think the potential for an infant to recover from an early stroke far exceeds what was once considered a fairly grim prognosis," Ramey said. "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. In turn, when they saw these improvements, they increased their own expectations for the future and their child's likely success in participating in a wider range of age-typical activities at home and in the community."

The study showed that researchers can conduct these studies carefully and that families and clinicians can follow the treatment plan effectively. Other study strengths included the ability to closely monitor participants to ensure proper enrollment, therapy implementation, adherence to assessment standards and data quality. The study focused on a group of young children who had not been specifically examined in previous research to improve arm strength and mobility.

The study's limitations include that the 15 U.S. sites were selected based on their interest levels and if they had the resources needed to conduct the trial. These sites may not be representative of all the places where children with PAIS receive care and rehabilitation. Another limitation is that researchers enrolled and treated a small number of children whose parents stated that the child had PAIS, yet the independent specialist review did not confirm that the child had this form of stroke. This led to a reduced study sample size of only 167 children.

Study details, background and design:

• Overall, the final sample with PAIS who were treated was 167 children, ages 8 months to 36 months (about half were male), in 15 U.S. cities. With parental approval, participants were randomly placed into one of the 3 study groups.
  1. High-dose I-ACQUIRE treatment was 120 hours total of therapist-delivered treatment in the child's home or home-like setting;
  2. Moderate dose I-ACQUIRE treatment was defined as a total of 60 hours of therapist-delivered treatment in the child's home or home-like setting; and
  3. The usual care group received an average of 2.2 hours of weekly therapy to improve arm-and-hand use - with most children seeing both an occupational therapist and a physical therapist every week for about an hour.
• Parents of children assigned to the usual care group were offered an option for their child to receive the same I-ACQUIRE treatment (randomly assigned (1:1) to either moderate- or high-dose) after completing the six-month post-treatment assessment by enrolling in the Delayed Treatment Study.
• Statisticians at the National Data Management Center led the analysis, and the entire trial received oversight and monitoring from a Data Safety and Monitoring Board. A physician was also appointed as an independent medical monitor. Any adverse or unexpected events were documented and treated, if needed.

Study co-authors and disclosures are listed in the abstract.

The study authors reported funding from the National Institute of Neurological Disorders and Stroke, an institute in the National Institutes of Health.

Statements and conclusions of studies that are presented at the American Heart Association/American Stroke Association's scientific meetings are solely those of the study authors and do not necessarily reflect the Association's policy or position. The Association makes no representation or guarantee as to their accuracy or reliability. Abstracts presented at the Association's scientific meetings are not peer-reviewed, rather, they are curated by independent review panels and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting. The findings are considered preliminary until published as a full manuscript in a peer-reviewed scientific journal.

The Association receives more than 85% of its revenue from sources other than corporations. These sources include contributions from individuals, foundations and estates, as well as investment earnings and revenue from the sale of our educational materials. Corporations (including pharmaceutical, device manufacturers and other companies) also make donations to the Association. The Association has strict policies to prevent any donations from influencing its science content and policy positions. Overall financial information is available here.

Additional Resources:

• Multimedia is available on the right column of release link.
• Link to abstract in the American Stroke Association International Stroke Conference 2026 Online Program Planner
• According to the American Heart Association's 2026 Heart Disease and Stroke Statistics, stroke is now the #4 leading cause of death in the U.S. Learn more at www.stroke.org.
• American Heart Association/American Stroke Association Guideline: 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke (Jan. 2026)
• American Stroke Association news release: Stroke may increase risk of anxiety, depression and more in children (Jan. 2025)
• American Stroke Association health information: Stroke in Children
• For more news at American Stroke Association International Stroke Conference 2026, follow us on X @HeartNews #ISC26

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About the American Stroke Association

The American Stroke Association is a relentless force for a world with fewer strokes and longer, healthier lives. We team with millions of volunteers and donors to ensure equitable health and stroke care in all communities. We work to prevent, treat and beat stroke by funding innovative research, fighting for the public's health, and providing lifesaving resources. The Dallas-based association was created in 1998 as a division of the American Heart Association. To learn more or to get involved, call 1-888-4STROKE or visit stroke.org. Follow us on Facebook and X.

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