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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

October 10, 2019

Primary Completion Date

October 1, 2025

Study Completion Date

May 1, 2026

Conditions
Perinatal StrokeHemiparesis
Interventions
BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Trial Locations (15)

19104

Children's Hospital of Philadelphia, Philadelphia

21231

Kennedy Krieger Institute - Fairmount Rehabilitation, Baltimore

24016

Fralin Biomedical Research Institute at Virginia Tech, Roanoke

29425

The Medical University of South Carolina (MUSC), Charleston

43210

Martha Morehouse Medical Plaza, Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

48109

C.S. Mott Children's Hospital, Ann Arbor

53792

University of Wisconsin School of Medicine and Public Health, Madison

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

63110

Washington University School of Medicine, St. Louis Children's Hospital, St Louis

75219

Scottish Rite for Children - Dallas, Dallas

77030

Memorial Hermann Texas Medical Center, Houston

92037

USCD Health La Jolla, La Jolla

06511

Yale New Haven Children's Hospital, New Haven

02115

Boston Children's Hospital, Boston

All Listed Sponsors
collaborator

Ohio State University

OTHER

collaborator

Nationwide Children's Hospital

OTHER

collaborator

Stanford University

OTHER

collaborator

University of Cincinnati

OTHER

collaborator

Medical University of South Carolina

OTHER

lead

Virginia Polytechnic Institute and State University

OTHER