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

Phase 3

Active, not recruiting

Interventions: Behavioral: Usual & Customary Treatment (U&CT)
Behavioral: I-ACQUIRE - High Dosage
Behavioral: I-ACQUIRE - Moderate Dosage

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 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 & 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

Arm && Interventions

Group	Intervention	Description
Usual & Customary Treatment	Usual & Customary Treatment (U&CT)	Usual \& Customary Treatment
I-ACQUIRE High Dose	I-ACQUIRE - High Dosage	High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)
I-ACQUIRE Moderate Dose	I-ACQUIRE - Moderate Dosage	Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)

Primary Outcome Measures

Name	Time	Method
Changes in Emerging Behaviors Scale (EBS) Score	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

Name	Time	Method
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	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.

Locations (15): USCD Health La Jolla
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La Jolla, California, United States
Yale New Haven Children's Hospital
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New Haven, Connecticut, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, United States
Kennedy Krieger Institute - Fairmount Rehabilitation
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Baltimore, Maryland, United States
Boston Children's Hospital
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Boston, Massachusetts, United States
C.S. Mott Children's Hospital
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Ann Arbor, Michigan, United States
Washington University School of Medicine, St. Louis Children's Hospital
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Saint Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
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Cincinnati, Ohio, United States
Martha Morehouse Medical Plaza
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Columbus, Ohio, United States
Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States
The Medical University of South Carolina (MUSC)
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Charleston, South Carolina, United States
Scottish Rite for Children - Dallas
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Dallas, Texas, United States
Memorial Hermann Texas Medical Center
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Houston, Texas, United States
Fralin Biomedical Research Institute at Virginia Tech
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Roanoke, Virginia, United States
University of Wisconsin School of Medicine and Public Health
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Madison, Wisconsin, United States