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

Hemiparesis Clinical Trial

— I-ACQUIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03910075
• Other study ID #: 1U01NS106655-01A1
• Status: Recruiting
• Phase: Phase 3
• Start date: October 10, 2019
• Est. completion date: May 1, 2026

Study information

• Verified date: May 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Laura Bateman, B.S.
• Phone: 540-526-2033
• Email: laurapb2[@]vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Perinatal Stroke
• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Kennedy Krieger Institute - Fairmount Rehabilitation	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	The Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Martha Morehouse Medical Plaza	Columbus	Ohio
United States	Scottish Rite for Children - Dallas	Dallas	Texas
United States	Memorial Hermann Texas Medical Center	Houston	Texas
United States	USCD Health La Jolla	La Jolla	California
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	Yale New Haven Children's Hospital	New Haven	Connecticut
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Fralin Biomedical Research Institute at Virginia Tech	Roanoke	Virginia
United States	Washington University School of Medicine, St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (6)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	Medical University of South Carolina, Nationwide Children's Hospital, Ohio State University, Stanford University, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Bilateral Use of the Hemiparetic Upper Extermity based on the Mini-Assisting Hand Assessment (Mini-AHA) play assessment	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.	Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment