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

Trial ID or NCT#

NCT03910075

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: 8 Months to 36 Months
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Clara Lo
Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

View on ClinicalTrials.gov