NCT03910075CompletedPhase 3
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 216 (actual)
- First submitted
- 3 Apr 2019
- Start date
- 10 Oct 2019
- Primary completion date
- 16 Jul 2025
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Diseases
- Stroke
- NCT number
- NCT03910075
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 216
- From 10 Oct 2019 to the primary completion date, 16 Jul 2025
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- child previously received Constraint-Induced Movement Therapy (CIMT) or modified CIMT with a dose of at least 2 hrs/day for ≥10 days
- child received botulinum toxin in past 3 months
Other illness
- child has medical or sensory condition(s) that prevent(s) full therapy participation (e.g., frequent uncontrolled seizures, fragile health)
Other
- child is a ward of the state or other agency
Who the study is looking for
- child will be 8 - 36 months old when study treatment will be delivered
- child has a diagnosis of Perinatal Arterial Stroke (PAS)
- parent permission to provide the child's clinical MRI to the study
- child has hemiparesis
- parent(s) willing to participate in the home therapy component
- one parent English language proficient and will take the lead in interacting with study staff and completing self-administered forms and interviews in English
Age in the registry: 8 months to 36 months · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| C S Mott Children's Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Kennedy Krieger Institute - Fairmount Rehabilitation Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The Medical University of South Carolina (MUSC) Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Martha Morehouse Medical Plaza Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Scottish Rite for Children - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Memorial Hermann Texas Medical Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| USCD Health La Jolla Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| University of Wisconsin School of Medicine and Public Health Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Yale-New Haven Children's Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Fralin Biomedical Research Institute at Virginia Tech Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| Washington University School of Medicine/St. Louis Children's Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
Related publications
- Parent Perspectives on I-ACQUIRE Therapy.Stroke · 2026 · PMID 42852504
- Perinatal Arterial Ischemic Stroke Phase 3 Trial Protocol for Intensive Infant-Toddler Rehabilitation (I-ACQUIRE).Stroke · 2026 · PMID 41649967
This page is information, not medical advice. Discuss any trial with your doctor.