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Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Sponsor: Virginia Polytechnic Institute and State University
Summary
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 Details
Gender
All
Age Range
8 Months - 36 Months
Study Type
INTERVENTIONAL
Enrollment
216
Start Date
2019-10-10
Completion Date
2025-07-31
Last Updated
2026-06-01
Healthy Volunteers
No
Conditions
Interventions
I-ACQUIRE - High Dosage
Children in this group will receive 6 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist.
I-ACQUIRE - Moderate Dosage
Children in this group will receive 3 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist.
Usual & Customary Treatment (U&CT)
Children in this group will receive the same U\&CT that they had been receiving prior to the baseline assessment. The type and dosage of treatment(s) will be documented weekly.
Locations (15)
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