# Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)

> **NIH NIH U01** · VIRGINIA POLYTECHNIC INST AND ST UNIV · 2020 · $2,817,543

## Abstract

Perinatal arterial stroke (PAS) includes infants with neonatal arterial ischemic stroke and presumed
perinatal arterial stroke and has an estimated incidence of 1 in 1150. The majority will develop hemiparesis,
often resulting in lifelong and debilitating disability, including lowered cognition and quality of life. There are no
evidence-based forms of rehabilitation designated as standard-of-care for these infants.
 We propose a Phase III trial to address this lack of evidence-based treatments. The I-ACQUIRE Trial is a
rigorous, adequately powered, multi-site randomized controlled trial comparing 2 dosages of a pediatric
rehabilitation - known as Infant ACQUIRE - to Usual and Customary treatment (U&CT). Prior studies of I-
ACQUIRE show high safety, patient acceptability, and evidence of significant and enduring benefits. Briefly, I-
ACQUIRE will be used to treat 8 – 24 mth old infants with PAS in either 3 hrs/day (Moderate Dose) or 6
hrs/day (High Dose), for 5 days/wk for 4 wks. Treatment occurs in a home or natural setting where operant
conditioning techniques are applied to achieve goals paced for each infant. I-ACQUIRE includes the core
features of pediatric Constraint-Induced Movement Therapy (CIMT). Standardized treatment at all sites is
monitored weekly via a Fidelity of CIMT Implementation tool. Clinical Trial Design: 240 infants (N=80/group)
will be randomly assigned to: 1) Moderate Dose I-ACQUIRE, 2) High Dose I-ACQUIRE, or 3) U&CT. (N=80).
Double-blinded assessments occur at baseline, end of 4 wks of treatment, and 6 mos post-treatment. A Parent
Council will be active throughout the trial, supporting NIH's goal of increased stakeholder engagement in
clinical trials.
 The specific aims are: 1) Primary: Determine the efficacy of I-ACQUIRE at 2 dosage levels compared to
U&CT to increase upper extremity skills on the hemiparetic side (using a minimal clinically meaningful
threshold that is achieved at end of treatment and 6 mos later); 2) Secondary: Determine the efficacy of I-
ACQUIRE at 2 dosage levels compared to U&CT to improve use of the hemiparetic upper extremity as an
“assisting hand” in bimanual activities; and 3) Exploratory: Explore the association between I-ACQUIRE
treatment at Moderate and/or High Doses and the infant's gross motor development and cognition (i.e.,
potential cross-domain effects of treatment). The Statistical Analysis Plan controls for multiple comparisons;
after testing the major study hypotheses, sensitivity analyses will consider factors that may contribute to
variation in treatment outcomes.
 Public Health Impact: Each year, an estimated 3400+ infants in the U.S. have PAS with high likelihood of
lifelong impairment in neuromotor and often cognitive functioning resulting in a high cost burden for families,
the healthcare system, and society. If I-ACQUIRE proves efficacious, then the field will have the critically
needed Phase III confirmatory evidence and the specific clinical protocol needed to transform reh...

## Key facts

- **NIH application ID:** 9859475
- **Project number:** 5U01NS106655-02
- **Recipient organization:** VIRGINIA POLYTECHNIC INST AND ST UNIV
- **Principal Investigator:** Warren David Lo
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,817,543
- **Award type:** 5
- **Project period:** 2019-02-01 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9859475

## Citation

> US National Institutes of Health, RePORTER application 9859475, Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE) (5U01NS106655-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9859475. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*