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

Last updated: October 9, 2024
Sponsor: Virginia Polytechnic Institute and State University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Stroke

Cerebral Ischemia

Treatment

Usual & Customary Treatment (U&CT)

I-ACQUIRE - High Dosage

I-ACQUIRE - Moderate Dosage

Clinical Study ID

NCT03910075
1U01NS106655-01A1
  • Ages 8-36
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 withstudy staff and completing self-administered forms and interviews in English

Exclusion

Exclusion Criteria:

  • 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 modifiedCIMT 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

Study Design

Total Participants: 216
Treatment Group(s): 3
Primary Treatment: Usual & Customary Treatment (U&CT)
Phase: 3
Study Start date:
October 10, 2019
Estimated Completion Date:
May 01, 2026

Study Description

The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 36 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 216 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS.

Connect with a study center

  • Children's Hospital of Alabama

    Birmingham, Alabama 35249
    United States

    Site Not Available

  • USCD Health La Jolla

    La Jolla, California 92037
    United States

    Site Not Available

  • Yale New Haven Children's Hospital

    New Haven, Connecticut 06511
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Kennedy Krieger Institute - Fairmount Rehabilitation

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

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

    Saint Louis, Missouri 63110
    United States

    Site Not Available

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

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Martha Morehouse Medical Plaza

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • The Medical University of South Carolina (MUSC)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Scottish Rite for Children - Dallas

    Dallas, Texas 75219
    United States

    Site Not Available

  • Memorial Hermann Texas Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Fralin Biomedical Research Institute at Virginia Tech

    Roanoke, Virginia 24016
    United States

    Site Not Available

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin 53792
    United States

    Site Not Available

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