Summary

for people ages 8 months to 24 months (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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).

Details

The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 24 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.

Keywords

Perinatal Stroke Hemiparesis P-CIMT Pediatric Constraint-Induced Movement Therapy Neonatal Stroke Pediatric rehabilitation Infant therapy Cerebral Palsy ACQUIRE I-ACQUIRE Stroke Paresis I-ACQUIRE - High Dosage I-ACQUIRE - Moderate Dosage I-ACQUIRE Moderate Dose

Eligibility

You can join if…

Open to people ages 8 months to 24 months

  • child will be 8 - 24 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

You CAN'T join if...

  • 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

Locations

  • USCD Health La Jolla accepting new patients
    La Jolla California 92037 United States
  • Cincinnati Children's Hospital Medical Center accepting new patients
    Cincinnati Ohio 45229 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Virginia Polytechnic Institute and State University
ID
NCT03910075
Phase
Phase 3
Study Type
Interventional
Last Updated