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

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

Sponsors

Lead sponsor: Virginia Polytechnic Institute and State University

Collaborator: Ohio State University
Nationwide Children's Hospital
Stanford University
University of Cincinnati
Medical University of South Carolina

Source Virginia Polytechnic Institute and State University
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).

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 24 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.

Overall Status Suspended
Start Date October 10, 2019
Completion Date January 31, 2024
Primary Completion Date September 30, 2023
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in Emerging Behaviors Scale (EBS) Score Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Secondary Outcome
Measure Time Frame
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
Enrollment 240
Condition
Intervention

Intervention type: Behavioral

Intervention name: I-ACQUIRE - High Dosage

Description: 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.

Arm group label: I-ACQUIRE High Dose

Intervention type: Behavioral

Intervention name: I-ACQUIRE - Moderate Dosage

Description: 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.

Arm group label: I-ACQUIRE Moderate Dose

Intervention type: Behavioral

Intervention name: Usual & Customary Treatment (U&CT)

Description: 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.

Arm group label: Usual & Customary Treatment

Eligibility

Criteria:

Inclusion Criteria:

- child will be 8 - 24 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

Gender: All

Minimum age: 8 Months

Maximum age: 24 Months

Healthy volunteers: No

Overall Official
Location
facility
USCD Health La Jolla | La Jolla, California, 92037, United States
Yale New Haven Children's Hospital | New Haven, Connecticut, 06511, United States
Boston Children's Hospital | Boston, Massachusetts, 02115, United States
C.S. Mott Children's Hospital | Ann Arbor, Michigan, 48109, 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
Fralin Biomedical Research Institute at Virginia Tech | Roanoke, Virginia, 24016, United States
Location Countries

United States

Verification Date

March 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Virginia Polytechnic Institute and State University

Investigator full name: Sharon Ramey

Investigator title: Distinguished Research Scholar and Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: I-ACQUIRE High Dose

Arm group type: Experimental

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

Arm group label: I-ACQUIRE Moderate Dose

Arm group type: Experimental

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

Arm group label: Usual & Customary Treatment

Arm group type: Active Comparator

Description: Usual & Customary Treatment

Acronym I-ACQUIRE
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Factorial Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov