Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
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).
- Perinatal Stroke
- Eligible Ages
- Between 8 Months and 36 Months
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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
- Phase 3
- Study Type
- Intervention Model
- Factorial Assignment
- Primary Purpose
- Single (Outcomes Assessor)
I-ACQUIRE High Dose
|High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)||
I-ACQUIRE Moderate Dose
|Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)||
Usual & Customary Treatment
|Usual & Customary Treatment||
- Virginia Polytechnic Institute and State University
Study ContactLaura Bateman, B.S.
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.