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NCT03910075: I-ACQUIRE

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

Completed Phase 3 Last updated 16 January 2026
What this trial tests

Phase 3 trial testing I-ACQUIRE - High Dosage in Perinatal Stroke in 216 participants. Completed in 31 July 2025.

Timeline
10 October 2019
Primary endpoint
31 July 2025
31 July 2025

Quick facts

Lead sponsorVirginia Polytechnic Institute and State University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingsingle
Primary purposetreatment
Enrollment216
Start date10 October 2019
Primary completion31 July 2025
Estimated completion31 July 2025
Sites15 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Virginia Polytechnic Institute and State University

Who can join

Adults 8 Months to 36 Months, any sex, with Perinatal Stroke or Hemiparesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effect of Motor Intervention for Infants and Toddlers With Cerebral Palsy: A Systematic Review and Meta-analysis.
    Baker A, Niles N, Kysh L, Sargent B. · · 2022 · cited 19× · PMID 35671383 · DOI 10.1097/pep.0000000000000914
  2. Optimal Randomization Designs for Large Multicenter Clinical Trials: From the National Institutes of Health Stroke Trials Network Funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke Experience.
    Zhao W, Yeatts SD, Broderick JP, Selim MH, et al · · 2023 · cited 6× · PMID 37078281 · DOI 10.1161/strokeaha.122.040743
  3. Parent Council for a Pediatric Stroke Rehabilitation Clinical Trial.
    Yale MM, Birch TB, Murray J, Dodds N, et al · · 2024 · cited 2× · PMID 39228362 · DOI 10.1542/peds.2023-064477
  4. Ten years of Central IRB review for an NIH-funded large clinical trial network by an academic IRB: The NIH StrokeNet experience.
    Linke M, Braggs-Brown A, Roll SK, Mills K, et al · · 2026 · PMID 41657754 · DOI 10.1017/cts.2025.10231
  5. Perinatal Arterial Ischemic Stroke Phase 3 Trial Protocol for Intensive Infant-Toddler Rehabilitation (I-ACQUIRE).
    Ramey SL, Lo WD, DeLuca SC, Heathcock JC, et al · · 2026 · PMID 41649967 · DOI 10.1161/strokeaha.125.053375

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