Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hemiparesis
- Perinatal Stroke
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 836 years
- Gender
- Both males and females
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 grou...
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.
Tracking Information
- NCT #
- NCT03910075
- Collaborators
- Ohio State University
- Nationwide Children's Hospital
- Stanford University
- University of Cincinnati
- Medical University of South Carolina
- Investigators
- Principal Investigator: Sharon L Ramey, Ph.D. Virginia Polytechnic Institute and State University Principal Investigator: Warren Lo, M.D. Children's National Research Institute