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

Completed · Phase 3

Conditions studied: Perinatal Stroke, Hemiparesis

In brief

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).

Key facts

Study ID

NCT03910075

Run by

Virginia Polytechnic Institute and State University

People needed

216

Starts

2019-10-10

Expected to finish

2025-07-31

Last updated by the study team

2026-06-01

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• child has medical or sensory condition(s) that prevent(s) full therapy participation (e.g., frequent uncontrolled seizures, fragile health)
• 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
• child is a ward of the state or other agency

Where it is running

• USCD Health La Jolla — La Jolla, California, United States
• Yale New Haven Children's Hospital — New Haven, Connecticut, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Kennedy Krieger Institute - Fairmount Rehabilitation — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
• Washington University School of Medicine, St. Louis Children's Hospital — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Martha Morehouse Medical Plaza — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• The Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• Scottish Rite for Children - Dallas — Dallas, Texas, United States
• Memorial Hermann Texas Medical Center — Houston, Texas, United States
• Fralin Biomedical Research Institute at Virginia Tech — Roanoke, Virginia, United States
• University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.