I-ACQUIRE - High Dosage for Hemiparesis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hemiparesis+3 More
I-ACQUIRE - High Dosage - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Hemiparesis
  • Perinatal Stroke

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment

Month 6
Hand
Changes in Emerging Behaviors Scale (EBS) Score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Usual & Customary Treatment
1 of 3
I-ACQUIRE Moderate Dose
1 of 3
I-ACQUIRE High Dose
1 of 3
Active Control
Experimental Treatment

240 Total Participants · 3 Treatment Groups

Primary Treatment: I-ACQUIRE - High Dosage · No Placebo Group · Phase 3

I-ACQUIRE Moderate Dose
Behavioral
Experimental Group · 1 Intervention: I-ACQUIRE - Moderate Dosage · Intervention Types: Behavioral
I-ACQUIRE High Dose
Behavioral
Experimental Group · 1 Intervention: I-ACQUIRE - High Dosage · Intervention Types: Behavioral
Usual & Customary Treatment
Behavioral
ActiveComparator Group · 1 Intervention: Usual & Customary Treatment (U&CT) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment

Who is running the clinical trial?

Ohio State UniversityOTHER
704 Previous Clinical Trials
382,063 Total Patients Enrolled
11 Trials studying Hemiparesis
4,122 Patients Enrolled for Hemiparesis
Stanford UniversityOTHER
2,148 Previous Clinical Trials
35,678,928 Total Patients Enrolled
Nationwide Children's HospitalOTHER
305 Previous Clinical Trials
5,209,802 Total Patients Enrolled
1 Trials studying Hemiparesis
4 Patients Enrolled for Hemiparesis
University of CincinnatiOTHER
385 Previous Clinical Trials
630,258 Total Patients Enrolled
Virginia Polytechnic Institute and State UniversityLead Sponsor
110 Previous Clinical Trials
25,554 Total Patients Enrolled
2 Trials studying Hemiparesis
182 Patients Enrolled for Hemiparesis
Medical University of South CarolinaOTHER
833 Previous Clinical Trials
5,372,984 Total Patients Enrolled
1 Trials studying Hemiparesis
26 Patients Enrolled for Hemiparesis
Warren Lo, M.D.Principal InvestigatorChildren's National Research Institute
Sharon L Ramey, Ph.D.Principal InvestigatorVirginia Polytechnic Institute and State University

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Child will be 8 - 36 months old when study treatment will be delivered.
You are 18 years old or older and one parent is English language proficient.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.