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

Virginia Polytechnic Institute and State University216 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

216

Conditions

Perinatal Stroke Hemiparesis

Interventions

I-ACQUIRE - High DosageBEHAVIORAL

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 DosageBEHAVIORAL

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)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 8 MonthsMax age: 36 Months

Medical Language ↔ Plain English

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

Locations (15)

USCD Health La Jolla

La Jolla, California, United States

Yale New Haven Children's Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment

Secondary Outcomes

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.

Time frame: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment

Data from ClinicalTrials.gov

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