Intensive Infant Rehabilitation for Perinatal Stroke

(I-ACQUIRE Trial)

Recruiting at16 trial locations

Overseen by Warren Lo, M.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Virginia Polytechnic Institute and State University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new therapy program called I-ACQUIRE for infants who have had a stroke. The program involves intensive sessions with therapists to help improve movement and strength. The study will compare two different amounts of therapy to usual treatments to see which works best.

Research Team

Sharon L Ramey, Ph.D.

Principal Investigator

Virginia Polytechnic Institute and State University

Warren Lo, M.D.

Principal Investigator

Children's National Research Institute

Eligibility Criteria

This trial is for infants aged 8-36 months who have had a Perinatal Arterial Stroke, resulting in hemiparesis. They must not have received certain previous treatments like high-dose movement therapy or botulinum toxin within the last three months. One parent must be English-speaking to interact with study staff and manage home therapy.

Inclusion Criteria

My child has weakness on one side of their body.

My parent(s) agree to be part of the home therapy.

My child was diagnosed with a stroke that occurred around the time of birth.

Exclusion Criteria

My child was given botulinum toxin in the last 3 months.

My child has undergone intensive movement therapy for at least 2 hours a day over 10 days.

My child's health condition prevents them from fully participating in therapy.

Treatment Details

Interventions

• I-ACQUIRE - High Dosage (Behavioral Intervention)
• I-ACQUIRE - Moderate Dosage (Behavioral Intervention)
• Usual & Customary Treatment (U&CT) (Behavioral Intervention)

Trial Overview The trial tests two different doses of a new infant rehabilitation protocol called I-ACQUIRE against standard rehab methods for babies who've had strokes. It aims to see which dosage improves motor skills better.

Participant Groups

Group I: I-ACQUIRE Moderate Dose Experimental Treatment 1 Intervention

Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)

Group II: I-ACQUIRE High Dose Experimental Treatment 1 Intervention

High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)

Group III: Usual & Customary Treatment Active Control 1 Intervention

Usual \& Customary Treatment

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Dr. Cyril Clarke

Virginia Polytechnic Institute and State University

Chief Medical Officer since 2018

DVM from University of Pretoria

Dr. Timothy Sands

Virginia Polytechnic Institute and State University

Chief Executive Officer since 2014

PhD in Materials Science from University of California, Berkeley

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Dr. John J. Warner

Ohio State University

Chief Executive Officer since 2023

MD, MBA

Dr. Peter Mohler

Ohio State University

Chief Medical Officer since 2023

PhD in Molecular Biology

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Catherine Krawczeski

Nationwide Children's Hospital

Chief Medical Officer

MD

Timothy C. Robinson

Nationwide Children's Hospital

Chief Executive Officer since 2019

BSc in Psychology and Business Administration from Indiana University

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Dr. Greg Postel

University of Cincinnati

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Dr. Neville G. Pinto

University of Cincinnati

Chief Executive Officer since 2017

PhD in Chemistry from the University of Virginia

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA