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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:11/11/2022

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).

Treatment is also available in Rhode Island:  The Yale Site PI Laura Ment, MD has partnered with Ana Albuja Ponce, MD at Rhode Island Hospital and Dr. Betty Vohr, MD at Women and Infants Hospital. 

  • Age8 months - 3 years
  • GenderBoth
  • Start Date11/25/2019
  • End Date02/15/2024

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).

Treatment is also available in Rhode Island:  The Yale Site PI Laura Ment, MD has partnered with Ana Albuja Ponce, MD at Rhode Island Hospital and Dr. Betty Vohr, MD at Women and Infants Hospital. 

Eligibility 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

Principal Investigator

Sub-Investigators

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