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

Phase: Active, not recruiting

Condition(s): Hemiplegic cerebral palsy due to perinatal arterial ischemic stroke

NCT Number: NCT03910075 Other Study ID Number(s): I-ACQUIRE

Study 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).

To learn more, visit https://clinicaltrials.gov/study/NCT03910075

Participation Criteria

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

Study Plan

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.

For more information about the I-ACQUIRE trial for infants with hemiplegic cerebral palsy due to perinatal arterial ischemic stroke visit NIH Stroke Net or ClinicalTrials.gov.

Click here to visit the I-ACQUIRE trial national center.

Site Collaborator

Warren D. Lo
MD

Neurology

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