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Completed

NCT Number: NCT03910075

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

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).

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Key information

Conditions

Perinatal Stroke Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

USCD Health La Jolla, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-ACQUIRE - High Dosage

Behavioral

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

I-ACQUIRE - Moderate Dosage

Behavioral

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

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

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

Registry information

Acronym: I-ACQUIRE

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2019
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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