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Phase III

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

  • Study HIC#:2000025348
  • Last Updated:07/15/2021

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).

  • Age8 months - 2 years
  • GenderBoth
  • Start Date09/02/2020
  • End Date02/28/2023

Trial Purpose and Description

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).

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 

Principal Investigator

Sub-Investigators

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