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

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

Interventions

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.

Sponsors & Collaborators

• Ohio State University

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Virginia Polytechnic Institute and State University

  lead OTHER

Principal Investigators

• Sharon L Ramey, Ph.D. · Virginia Polytechnic Institute and State University

• Warren Lo, M.D. · Children's National Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

8 Months

Max Age

36 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-10

Primary Completion

2025-07-16

Completion

2025-07-31

Countries

• United States

Study Locations