Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
I-ACQUIRE
1 other identifier
interventional
216
1 country
15
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2019
Longer than P75 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 10, 2019
CompletedStudy Start
First participant enrolled
October 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedJanuary 16, 2026
January 1, 2026
5.8 years
April 3, 2019
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Emerging Behaviors Scale (EBS) Score
The primary efficacy is measured by the Emerging Behaviors Scale (EBS) that counts the number of upper extremity skills on the hemiparetic side that the child displays (from 0 to 30). The source for observation comes from a battery of standardized age-appropriate neuromotor assessment tools (Gross Motor Function Measure-66, The Bayley III Fine and Gross Motor scales, unilateral skills during the Mini AHA) and independent observational coding of the videotaped assessment session with supplemental parent ratings on the Infant Motor Activity Log and daily skills on the MacArthur-Bates Communicative Development Inventory. A favorable outcome is defined as a gain of ≥7 new EBS skills above the child's baseline (pre-treatment) score. The EBS requires evidence of each skill from at least two independent sources.
Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Secondary Outcomes (1)
Changes in Bilateral Use of the Hemiparetic Upper Extermity based on the Mini-Assisting Hand Assessment (Mini-AHA) play assessment
Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Study Arms (3)
I-ACQUIRE High Dose
EXPERIMENTALHigh Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)
I-ACQUIRE Moderate Dose
EXPERIMENTALModerate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)
Usual & Customary Treatment
ACTIVE COMPARATORUsual \& Customary Treatment
Interventions
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.
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitycollaborator
- Nationwide Children's Hospitalcollaborator
- Stanford Universitycollaborator
- University of Cincinnaticollaborator
- Medical University of South Carolinacollaborator
- Virginia Polytechnic Institute and State Universitylead
Study Sites (15)
USCD Health La Jolla
La Jolla, California, 92037, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, 06511, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Kennedy Krieger Institute - Fairmount Rehabilitation
Baltimore, Maryland, 21231, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Washington University School of Medicine, St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Martha Morehouse Medical Plaza
Columbus, Ohio, 43210, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
The Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Scottish Rite for Children - Dallas
Dallas, Texas, 75219, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
Fralin Biomedical Research Institute at Virginia Tech
Roanoke, Virginia, 24016, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792, United States
Related Publications (1)
Ramey SL, Lo WD, DeLuca SC, Heathcock JC, Darragh AR, Ramey CT, Wintermark M, Martin RH, Conaway MR, Wolf SL, Janis LS, Broderick JP. Perinatal Arterial Ischemic Stroke Phase 3 Trial Protocol for Intensive Infant-Toddler Rehabilitation (I-ACQUIRE). Stroke. 2026 Mar;57(3):614-621. doi: 10.1161/STROKEAHA.125.053375. Epub 2026 Feb 6.
PMID: 41649967DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon L Ramey, Ph.D.
Virginia Polytechnic Institute and State University
- PRINCIPAL INVESTIGATOR
Warren Lo, M.D.
Children's National Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Research Scholar and Professor
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 10, 2019
Study Start
October 10, 2019
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Approximately 1 year after primary data analysis publications
- Access Criteria
- standard NIH criteria
Public use dataset from the study data will be made available.