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).
Conditions
Perinatal Stroke, Hemiparesis
Recruitment Status
Recruiting
Detailed Description
The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 36 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 240 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS.
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
Intervention
Intervention Type
Intervention Name
Behavioral
I-ACQUIRE - High Dosage
Behavioral
I-ACQUIRE - Moderate Dosage
Behavioral
Usual & Customary Treatment (U&CT)
Phase
Phase 3
Gender
All
Min Age
8 Months
Max Age
36 Months
Download Date
February 23, 2024
Principal Investigator
Sharon Ramey
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: