NCT03910075

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 8 Months – 36 Months
• Healthy volunteers: Not accepted

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).

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 216 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.

Conditions

• Perinatal Stroke
• Hemiparesis

Interventions

Type	Name	Description
BEHAVIORAL	I-ACQUIRE - High Dosage	Children in this group will receive 6 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist.
BEHAVIORAL	I-ACQUIRE - Moderate Dosage	Children in this group will receive 3 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist.
BEHAVIORAL	Usual & Customary Treatment (U&CT)	Children in this group will receive the same U\&CT that they had been receiving prior to the baseline assessment. The type and dosage of treatment(s) will be documented weekly.

Timeline

• Start date: 2019-10-10
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2019-04-10
• Last updated: 2026-01-16

Locations

15 sites across 1 country: United States