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Intensive Infant Rehabilitation for Perinatal Stroke (I-ACQUIRE Trial)
Phase 3
Recruiting
Led By Sharon L Ramey, Ph.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)
Must not have
Child previously received Constraint-Induced Movement Therapy (CIMT) or modified CIMT with a dose of at least 2 hrs/day for ≥10 days
Child has medical or sensory condition(s) that prevent(s) full therapy participation (e.g., frequent uncontrolled seizures, fragile health)
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
Summary
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.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child has undergone intensive movement therapy for at least 2 hours a day over 10 days.
Select...
My child's health condition prevents them from fully participating in therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Emerging Behaviors Scale (EBS) Score
Secondary study objectives
Hand
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The I-ACQUIRE trial focuses on intensive infant rehabilitation techniques for treating Perinatal Arterial Stroke (PAS). These rehabilitation techniques primarily aim to enhance neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections.
This is crucial for infants with PAS as it can help compensate for the damaged areas of the brain, thereby improving motor and cognitive functions. Early and intensive rehabilitation can lead to better long-term outcomes by maximizing the potential for recovery during a critical period of brain development.
Drug therapy in hypoxic-ischemic cerebral insults and intraventricular hemorrhage of the newborn.Effect of single family rooms for preterm infants on neurodevelopment: study protocol for a systematic review.Therapeutic Hypothermia: How Can We Optimize This Therapy to Further Improve Outcomes?
Drug therapy in hypoxic-ischemic cerebral insults and intraventricular hemorrhage of the newborn.Effect of single family rooms for preterm infants on neurodevelopment: study protocol for a systematic review.Therapeutic Hypothermia: How Can We Optimize This Therapy to Further Improve Outcomes?
Find a Location
Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
149 Previous Clinical Trials
30,299 Total Patients Enrolled
Ohio State UniversityOTHER
863 Previous Clinical Trials
654,144 Total Patients Enrolled
Nationwide Children's HospitalOTHER
348 Previous Clinical Trials
5,228,316 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 given botulinum toxin in the last 3 months.My child was diagnosed with a stroke that occurred around the time of birth.My child will be between 8 and 36 months old at the time of treatment.One of my parents is fluent in English and will handle all communications for the study.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.
Research Study Groups:
This trial has the following groups:- Group 1: I-ACQUIRE Moderate Dose
- Group 2: I-ACQUIRE High Dose
- Group 3: Usual & Customary Treatment
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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