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

• ClinicalTrials.gov Identifier: NCT03910075
• Recruitment Status: Recruiting
• First Posted: April 10, 2019
• Last Update Posted: December 2, 2022
• Sponsor: Virginia Polytechnic Institute and State University
• Collaborators: Ohio State University; Nationwide Children's Hospital; Stanford University; University of Cincinnati; Medical University of South Carolina
• Information provided by (Responsible Party): Sharon Ramey, Virginia Polytechnic Institute and State University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Perinatal Stroke; Hemiparesis	Behavioral: I-ACQUIRE - High Dosage; Behavioral: I-ACQUIRE - Moderate Dosage; Behavioral: Usual & Customary Treatment (U&CT)	Phase 3

Detailed 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 240 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
• Actual Study Start Date: October 10, 2019
• Estimated Primary Completion Date: January 31, 2025
• Estimated Study Completion Date: March 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: I-ACQUIRE High Dose; High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)	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.; Other Names: ACQUIRE; Pediatric Constraint-Induced Movement Therapy; P-CIMT
Experimental: I-ACQUIRE Moderate Dose; Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)	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.; Other Names: ACQUIRE; Pediatric Constraint-Induced Movement Therapy; P-CIMT
Active Comparator: Usual & Customary Treatment; Usual & Customary Treatment	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.

Outcome Measures

Primary Outcome Measures :

1. Changes in Emerging Behaviors Scale (EBS) Score [ Time Frame: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment ]
   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.

Secondary Outcome Measures :

1. Changes in Bilateral Use of the Hemiparetic Upper Extermity based on the Mini-Assisting Hand Assessment (Mini-AHA) play assessment [ Time Frame: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment ]
   The secondary efficacy outcome is measured by increases in the use of the hemiparetic upper extremity while engaged in bilateral activities during the interactive play session of the Mini-AHA. Each item is scored on a 4-pt scale where the points are behaviorally anchored and adjusted for the child's age range. Raw scores are converted into a summary Logit score (0 to 100) based on Item Response Theory analyses, indicating the relative difficulty and sequence in which certain levels of performance appear. For this metric, higher scores are considered better.

Eligibility Criteria

• Ages Eligible for Study: 8 Months to 36 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 with study staff and completing self-administered forms and interviews in English

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 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

Contacts and Locations

Contacts

Contact: Laura Bateman, B.S.; 540-526-2033; laurapb2@vt.edu

Contact: Stephanie DeLuca, Ph.D.; 540-526-2098; Stephdeluca@vt.edu

Locations

United States, California

USCD Health La Jolla; Recruiting

La Jolla, California, United States, 92037

Contact: Doris Trauner, MD 858-966-5819 dtrauner@ucsd.edu

Contact: Kathleen Scarvie 858-246-5113 kscarvie@ucsd.edu

Principal Investigator: Doris Trauner, MD

Sub-Investigator: Jeff Gold, MD, PhD

Sub-Investigator: Dylan Chen, MD, PhD

United States, Connecticut

Yale New Haven Children's Hospital; Recruiting

New Haven, Connecticut, United States, 06511

Contact: Laura Ment, MD 203-785-5708 laura.ment@yale.edu

Contact: Sara Jasak, BSN 413-896-3429 sara.jasak@yale.edu

Principal Investigator: Laura Ment, MD

Sub-Investigator: Ana Albuja, MD

Sub-Investigator: Betty Vohr, MD

Sub-Investigator: Tina Burton, MD

Sub-Investigator: Cristina Ionita, MD

United States, Illinois

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

Chicago, Illinois, United States, 60611

Contact: Sadie Rose, MPH 312-227-4292 sgrose@luriechildrens.org

Principal Investigator: Andra Pardo, MD

United States, Maryland

Kennedy Krieger Institute - Fairmount Rehabilitation; Recruiting

Baltimore, Maryland, United States, 21231

Contact: Joan Carney, Ed.D 443-913-4554 carney@kennedykrieger.org

Contact: Jana Becker beckerja@kennedykrieger.org

Principal Investigator: Joan Carney, Ed.D

Sub-Investigator: Ryan Felling, MD

United States, Massachusetts

Boston Children's Hospital; Recruiting

Boston, Massachusetts, United States, 02115

Contact: Laura Lehman, MD 617-355-2758 laura.lehman@childrens.harvard.edu

Contact: Julie Meadows 617-919-1446 julie.meadows@childrens.harvard.edu

Principal Investigator: Laura Lehman, MD

Sub-Investigator: Patricia Musolino, MD

Sub-Investigator: Michael Rivkin, MD

United States, Michigan

C.S. Mott Children's Hospital; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Jessica Pruente, MD 734-936-7175 jpruente@med.umich.edu

Contact: Elise Kwasniewsk ekwasnie@med.umich.edu

Principal Investigator: Jessica Pruente, MD

Sub-Investigator: Edward Hurvitz, MD

United States, Missouri

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

Saint Louis, Missouri, United States, 63110

Contact: Alyssa Smith, MD smithalyssa@wustl.edu

Contact: Jill Newgent 314-747-3795 newgentj@wustl.edu

Principal Investigator: Alyssa Smith, MD

Sub-Investigator: Catherine Hoyt, PhD

United States, Ohio

Cincinnati Children's Hospital Medical Center; Recruiting

Cincinnati, Ohio, United States, 45229

Contact: Michael Taylor, MD 513-636-4222 JM.Taylor@cchmc.org

Contact: Madeleine Robben 513-803-1988 Madeleine.Robben@cchmc.org

Principal Investigator: Michael Taylor, MD

Sub-Investigator: Karen Harpster, PhD/OTR/L

Martha Morehouse Medical Plaza; Recruiting

Columbus, Ohio, United States, 43210

Contact: Amy Darragh, PhD 614-293-3760 amy.darragh@osumc.edu

Contact: Petra Sternberg 614-366-7648 petra.sternberg@osumc.edu

Principal Investigator: Amy Darragh, PhD

Sub-Investigator: Jill Heathcock, PhD

United States, Pennsylvania

Children's Hospital of Philadelphia; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Laura Prosser, PT, PhD 215-301-4301 prosserl@chop.edu

Contact: Noor Ruwaih 267-426-7032 ruwaihn@chop.edu

Principal Investigator: Laura Prosser, PT, PhD

Sub-Investigator: Rebecca Ichord, MD

United States, South Carolina

The Medical University of South Carolina (MUSC); Recruiting

Charleston, South Carolina, United States, 29425

Contact: Cynthia Dodds, PhD doddscb@musc.edu

Contact: Valerie Salisbury 843-792-8533 eichbr@musc.edu

Sub-Investigator: Patty Coker-Bolt, PhD

Principal Investigator: Cynthia Dodds, PhD

United States, Texas

Memorial Hermann Texas Medical Center; Active, not recruiting

Houston, Texas, United States, 77030

United States, Virginia

Fralin Biomedical Research Institute at Virginia Tech; Recruiting

Roanoke, Virginia, United States, 24016

Contact: Stephanie DeLuca, PhD 540-526-2098 stephdeluca@vt.edu

Contact: Mary Lou Schwarzer, OTA 540-526-2202 mary73@vt.edu

Principal Investigator: Stephanie DeLuca, PhD

Sponsors and Collaborators

Virginia Polytechnic Institute and State University

Ohio State University

Nationwide Children's Hospital

Stanford University

University of Cincinnati

Medical University of South Carolina

Investigators

• Principal Investigator: Sharon L Ramey, Ph.D.; Virginia Polytechnic Institute and State University
• Principal Investigator: Warren Lo, M.D.; Children's National Research Institute

More Information

Study Data/Documents: Study Protocol 

• Responsible Party: Sharon Ramey, Distinguished Research Scholar and Professor, Virginia Polytechnic Institute and State University
• ClinicalTrials.gov Identifier: NCT03910075
• Other Study ID Numbers: 1U01NS106655-01A1 ( U.S. NIH Grant/Contract )
• First Posted: April 10, 2019
• Last Update Posted: December 2, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Public use dataset from the study data will be made available.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Approximately 1 year after primary data analysis publications
• Access Criteria: standard NIH criteria

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sharon Ramey, Virginia Polytechnic Institute and State University:

P-CIMT; Pediatric Constraint-Induced Movement Therapy; Hemiparesis; Perinatal Stroke; Neonatal Stroke; Pediatric rehabilitation; Infant therapy; Cerebral Palsy; ACQUIRE; I-ACQUIRE

Additional relevant MeSH terms:

Stroke; Paresis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations