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Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Not Recruiting
Trial ID: NCT03910075
Purpose
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
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
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
Intervention(s):
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