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

Not Recruiting

Trial ID: NCT03910075


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).

Official Title

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

Stanford Investigator(s)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


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


behavioral: I-ACQUIRE - High Dosage

behavioral: I-ACQUIRE - Moderate Dosage

behavioral: Usual & Customary Treatment (U&CT)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305