Intensive Infant Rehabilitation for Perinatal Stroke
(I-ACQUIRE Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen BySharon L Ramey, Ph.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Virginia Polytechnic Institute and State University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new therapy program called I-ACQUIRE for infants who have had a stroke. The program involves intensive sessions with therapists to help improve movement and strength. The study will compare two different amounts of therapy to usual treatments to see which works best.

Eligibility Criteria

This trial is for infants aged 8-36 months who have had a Perinatal Arterial Stroke, resulting in hemiparesis. They must not have received certain previous treatments like high-dose movement therapy or botulinum toxin within the last three months. One parent must be English-speaking to interact with study staff and manage home therapy.

Inclusion Criteria

My child has weakness on one side of their body.

My parent(s) agree to be part of the home therapy.

My child was diagnosed with a stroke that occurred around the time of birth.

+3 more

Exclusion Criteria

My child was given botulinum toxin in the last 3 months.

My child has undergone intensive movement therapy for at least 2 hours a day over 10 days.

My child's health condition prevents them from fully participating in therapy.

+1 more

Participant Groups

The trial tests two different doses of a new infant rehabilitation protocol called I-ACQUIRE against standard rehab methods for babies who've had strokes. It aims to see which dosage improves motor skills better.

3Treatment groups

Experimental Treatment

Active Control

Group I: I-ACQUIRE Moderate DoseExperimental Treatment1 Intervention

Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)

Group II: I-ACQUIRE High DoseExperimental Treatment1 Intervention

High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)

Group III: Usual & Customary TreatmentActive Control1 Intervention

Usual \& Customary Treatment