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

Phase 3
Recruiting
Led By Warren Lo, M.D.
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child has hemiparesis
Child has a diagnosis of Perinatal Arterial Stroke (PAS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Awards & highlights

I-ACQUIRE Trial Summary

This trial is testing a new infant rehabilitation protocol to see if it is more effective than usual methods in infants who had a stroke before birth.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is an intensive rehabilitation program rather than a drug treatment, side effects may include fatigue or frustration during exercises, but specific side effects will depend on the child's individual response to therapy.

I-ACQUIRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child has weakness on one side of their body.
Select...
My child was diagnosed with a stroke that occurred around the time of birth.
Select...
My parent(s) agree to be part of the home therapy.

I-ACQUIRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Emerging Behaviors Scale (EBS) Score
Secondary outcome measures
Hand

I-ACQUIRE Trial Design

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

Find a Location

Who is running the clinical trial?

Virginia Polytechnic Institute and State UniversityLead Sponsor
142 Previous Clinical Trials
27,517 Total Patients Enrolled
Ohio State UniversityOTHER
829 Previous Clinical Trials
505,503 Total Patients Enrolled
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,220,266 Total Patients Enrolled

Media Library

I-ACQUIRE - High Dosage Clinical Trial Eligibility Overview. Trial Name: NCT03910075 — Phase 3
Perinatal Stroke Research Study Groups: I-ACQUIRE Moderate Dose, I-ACQUIRE High Dose, Usual & Customary Treatment
Perinatal Stroke Clinical Trial 2023: I-ACQUIRE - High Dosage Highlights & Side Effects. Trial Name: NCT03910075 — Phase 3
I-ACQUIRE - High Dosage 2023 Treatment Timeline for Medical Study. Trial Name: NCT03910075 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people who are older than 25 eligible to participate in this research project?

"Children that are 8 months to 3 years old can be enrolled in this trial. Out of the 1,119 total clinical trials, 48 are for people under 18 and 1071 are for senior citizens."

Answered by AI

Are new patients still being accepted for this experiment?

"The most recent information from clinicaltrials.gov indicates that this study is still looking for participants. The posting date was October 10th, 2019 and the listing has been edited as recently as November 4th, 2020."

Answered by AI

I-ACQUIRE - High Dosage FDA approved?

"I-ACQUIRE - High Dosage received a safety score of 3 from our Power team. Phase 3 trials have shown some efficacy and multiple rounds of data support safety."

Answered by AI

How many people are enrolled in this experiment?

"Yes, that is accurate. The trial was posted on October 10th, 2019 and was last updated November 4th, 2022. They are looking for 240 patients to enroll at 12 different sites."

Answered by AI

How many different medical clinics are participating in this research project today?

"There are a total of 12 enrolling patients for this trial. The locations include Boston Children's Hospital in Boston, C.S. Mott Children's Hospital in Ann Arbor, and Fralin Biomedical Research Institute at Virginia Tech in Roanoke among others."

Answered by AI

If I meet the requirements, can I sign up for this experiment?

"This particular study needs to recruit 240 individuals that have hemiparesis and are aged between 8 months to 36 months. The main requirements for participants include: being the age specified above, one parent must be proficient in English, child has a diagnosis of Perinatal Arterial Stroke (PAS), parent permission to provide the child's clinical MRI to the study, hemiparesis, and finally, parent(s) willing to participate in the home therapy component."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Sharon Ramey 2019. "Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03910075.
~57 spots leftby Oct 2025
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