I-ACQUIRE - High Dosage for Hemiparesis
Phase-Based Progress Estimates
Effectiveness
Safety
Hemiparesis+3 More
I-ACQUIRE - High Dosage - BehavioralEligibility
< 18
All Sexes
What conditions do you have?
Select
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
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
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: BehavioralI-ACQUIRE High Dose
Behavioral
Experimental Group · 1 Intervention: I-ACQUIRE - High Dosage · Intervention Types: BehavioralUsual & Customary Treatment
Behavioral
ActiveComparator Group · 1 Intervention: Usual & Customary Treatment (U&CT) · Intervention Types: BehavioralTrial 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 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.
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