Perinatal StrokePhase 3I-ACQUIRENCT03910075
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
A Phase 3 study testing I-ACQUIRE - High Dosage, I-ACQUIRE - Moderate Dosage and Usual & Customary Treatment (U&CT) in people with Perinatal Stroke and Hemiparesis, run by Virginia Polytechnic Institute and State University at 15 sites in United States.
Trial summary
This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS). Read more about this study
- Who is it for?
- Ages 8 to 36 months
- Conditions the study is for
- Perinatal Stroke, Hemiparesis
- What is being tested?
- I-ACQUIRE - High Dosage, I-ACQUIRE - Moderate Dosage and Usual & Customary Treatment (U&CT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 15 sitesUnited States
- Study dates
- 10 Oct 2019to 31 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child will be 8 - 36 months old when study treatment will be delivered
- child has a diagnosis of Perinatal Arterial Stroke (PAS)
- parent permission to provide the child's clinical MRI to the study
- child has hemiparesis
- parent(s) willing to participate in the home therapy component
- one parent English language proficient and will take the lead in interacting with study staff and completing self-administered forms and interviews in English
Who cannot join
- child has medical or sensory condition(s) that prevent(s) full therapy participation (e.g., frequent uncontrolled seizures, fragile health)
- child previously received Constraint-Induced Movement Therapy (CIMT) or modified CIMT with a dose of at least 2 hrs/day for ≥10 days
- child received botulinum toxin in past 3 months
- child is a ward of the state or other agency
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Kennedy Krieger Institute - Fairmount Rehabilitation
Baltimore, Maryland, 21231
Boston Children's Hospital
Boston, Massachusetts, 02115
The Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Martha Morehouse Medical Plaza
Columbus, Ohio, 43210
Scottish Rite for Children - Dallas
Dallas, Texas, 75219
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
USCD Health La Jolla
La Jolla, California, 92037
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
Yale New Haven Children's Hospital
New Haven, Connecticut, 06511
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Fralin Biomedical Research Institute at Virginia Tech
Roanoke, Virginia, 24016
Washington University School of Medicine, St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS).
Read the detailed description
The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 36 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 216 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U\&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U\&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS.
- Conditions
- Perinatal Stroke, Hemiparesis
- Being tested
- I-ACQUIRE - High Dosage, I-ACQUIRE - Moderate Dosage, Usual & Customary Treatment (U&CT)
- Keywords
- P-CIMT, Pediatric Constraint-Induced Movement Therapy, Hemiparesis, Perinatal Stroke, Neonatal Stroke, Pediatric rehabilitation, Infant therapy, Cerebral Palsy, ACQUIRE, I-ACQUIRE
- Medical subject headings
- Paresis, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-ACQUIRE - High DosageBehavioural
Also called ACQUIRE, Pediatric Constraint-Induced Movement Therapy, P-CIMT
Children in this group will receive 6 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist.
I-ACQUIRE - Moderate DosageBehavioural
Also called ACQUIRE, Pediatric Constraint-Induced Movement Therapy, P-CIMT
Children in this group will receive 3 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist.
Usual & Customary Treatment (U&CT)Behavioural
Children in this group will receive the same U\&CT that they had been receiving prior to the baseline assessment. The type and dosage of treatment(s) will be documented weekly.
| Study group | Role | What they receive |
|---|---|---|
| I-ACQUIRE High Dose | Experimental | High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks) Receives: Behavioral: I-ACQUIRE - High Dosage |
| I-ACQUIRE Moderate Dose | Experimental | Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks) Receives: Behavioral: I-ACQUIRE - Moderate Dosage |
| Usual & Customary Treatment | Active comparator | Usual \& Customary Treatment Receives: Behavioral: Usual & Customary Treatment (U&CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Emerging Behaviors Scale (EBS) Score
The primary efficacy is measured by the Emerging Behaviors Scale (EBS) that counts the number of upper extremity skills on the hemiparetic side that the child displays (from 0 to 30). The source for observation comes from a battery of standardized age-appropriate neuromotor assessment tools (Gross Motor Function Measure-66, The Bayley III Fine and Gross Motor scales, unilateral skills during the Mini AHA) and independent observational coding of the videotaped assessment session with supplemental parent ratings on the Infant Motor Activity Log and daily skills on the MacArthur-Bates Communicative Development Inventory. A favorable outcome is defined as a gain of ≥7 new EBS skills above the child's baseline (pre-treatment) score. The EBS requires evidence of each skill from at least two independent sources.
Measured: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Secondary outcomes (1)
Changes in Bilateral Use of the Hemiparetic Upper Extermity based on the Mini-Assisting Hand Assessment (Mini-AHA) play assessment
The secondary efficacy outcome is measured by increases in the use of the hemiparetic upper extremity while engaged in bilateral activities during the interactive play session of the Mini-AHA. Each item is scored on a 4-pt scale where the points are behaviorally anchored and adjusted for the child's age range. Raw scores are converted into a summary Logit score (0 to 100) based on Item Response Theory analyses, indicating the relative difficulty and sequence in which certain levels of performance appear. For this metric, higher scores are considered better.
Measured: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start10 Oct 2019
- Primary completion16 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perinatal StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, Nationwide Children's Hospital, Stanford University, University of Cincinnati, Medical University of South Carolina
- Responsible party
- Principal investigator, Sharon Ramey, Virginia Polytechnic Institute and State University
- Investigators
- Sharon L Ramey, Ph.D., Principal investigator, Virginia Polytechnic Institute and State UniversityWarren Lo, M.D., Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910075
- Sponsor's protocol ID
- 1U01NS106655-01A1
- Acronym
- I-ACQUIRE
- Status last verified
- May 2026
- First submitted
- 3 Apr 2019
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public use dataset from the study data will be made available.
Publications
Ramey SL, Lo WD, DeLuca SC, Heathcock JC, Darragh AR, Ramey CT, Wintermark M, Martin RH, Conaway MR, Wolf SL, Janis LS, Broderick JP. Perinatal Arterial Ischemic Stroke Phase 3 Trial Protocol for Intensive Infant-Toddler Rehabilitation (I-ACQUIRE). Stroke. 2026 Mar;57(3):614-621. doi: 10.1161/STROKEAHA.125.053375. Epub 2026 Feb 6.
PubMed 41649967Yale MM, Hindery KA, Murray JF, Darragh AR, Ramey CT, DeLuca SC, Pauls Q, Heathcock JC, Lo WD, Martin RH, Trucks MR, Ramey SL. Parent Perspectives on I-ACQUIRE Therapy. Stroke. 2026 Oct 9. doi: 10.1161/STROKEAHA.126.055913. Online ahead of print.
PubMed 42852504
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
- ClinicalTrials.gov ID
- NCT03910075
- Acronym / sponsor ID
- I-ACQUIRE / 1U01NS106655-01A1
- Conditions
- Perinatal Stroke, Hemiparesis
- Keywords
- P-CIMT, Pediatric Constraint-Induced Movement Therapy, Hemiparesis, Perinatal Stroke, Neonatal Stroke, Pediatric rehabilitation, Infant therapy, Cerebral Palsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Ohio State University, Nationwide Children's Hospital, Stanford University, University of Cincinnati, Medical University of South Carolina
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS).
Detailed description
The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 36 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 216 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U\&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U\&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I-ACQUIRE High Dose | Experimental | Behavioral: I-ACQUIRE - High DosageHigh Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks) |
| I-ACQUIRE Moderate Dose | Experimental | Behavioral: I-ACQUIRE - Moderate DosageModerate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks) |
| Usual & Customary Treatment | Active comparator | Behavioral: Usual & Customary Treatment (U&CT)Usual \& Customary Treatment |
Who may qualify
- Ages
- 8 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- child will be 8 - 36 months old when study treatment will be delivered
- child has a diagnosis of Perinatal Arterial Stroke (PAS)
- parent permission to provide the child's clinical MRI to the study
- child has hemiparesis
- parent(s) willing to participate in the home therapy component
Key exclusion criteria (4 listed)
- child has medical or sensory condition(s) that prevent(s) full therapy participation (e.g., frequent uncontrolled seizures, fragile health)
- child previously received Constraint-Induced Movement Therapy (CIMT) or modified CIMT with a dose of at least 2 hrs/day for ≥10 days
- child received botulinum toxin in past 3 months
- child is a ward of the state or other agency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-ACQUIRE - High DosageAlso: ACQUIRE, Pediatric Constraint-Induced Movement Therapy, P-CIMTChildren in this group will receive 6 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist. | Behavioural | I-ACQUIRE High Dose |
| I-ACQUIRE - Moderate DosageAlso: ACQUIRE, Pediatric Constraint-Induced Movement Therapy, P-CIMTChildren in this group will receive 3 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist. | Behavioural | I-ACQUIRE Moderate Dose |
| Usual & Customary Treatment (U&CT)Children in this group will receive the same U\&CT that they had been receiving prior to the baseline assessment. The type and dosage of treatment(s) will be documented weekly. | Behavioural | Usual & Customary Treatment |
Primary outcome
Changes in Emerging Behaviors Scale (EBS) Score
Time frame: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
The primary efficacy is measured by the Emerging Behaviors Scale (EBS) that counts the number of upper extremity skills on the hemiparetic side that the child displays (from 0 to 30). The source for observation comes from a battery of standardized age-appropriate neuromotor assessment tools (Gross Motor Function Measure-66, The Bayley III Fine and Gross Motor scales, unilateral skills during the Mini AHA) and independent observational coding of the videotaped assessment session with supplemental parent ratings on the Infant Motor Activity Log and daily skills on the MacArthur-Bates Communicative Development Inventory. A favorable outcome is defined as a gain of ≥7 new EBS skills above the child's baseline (pre-treatment) score. The EBS requires evidence of each skill from at least two independent sources.
1 secondary outcome
Changes in Bilateral Use of the Hemiparetic Upper Extermity based on the Mini-Assisting Hand Assessment (Mini-AHA) play assessment
Time frame: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 41649967Ramey SL, Lo WD, DeLuca SC, Heathcock JC, Darragh AR, Ramey CT, Wintermark M, Martin RH, Conaway MR, Wolf SL, Janis LS, Broderick JP. Perinatal Arterial Ischemic Stroke Phase 3 Trial Protocol for Intensive Infant-Toddler Rehabilitation (I-ACQUIRE). Stroke. 2026 Mar;57(3):614-621. doi: 10.1161/STROKEAHA.125.053375. Epub 2026 Feb 6.
- Derived from this study: PubMed 42852504Yale MM, Hindery KA, Murray JF, Darragh AR, Ramey CT, DeLuca SC, Pauls Q, Heathcock JC, Lo WD, Martin RH, Trucks MR, Ramey SL. Parent Perspectives on I-ACQUIRE Therapy. Stroke. 2026 Oct 9. doi: 10.1161/STROKEAHA.126.055913. Online ahead of print.
- Individual participant dataSharing planned: Yes. Public use dataset from the study data will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon L Ramey, Ph.D. principal investigator
Virginia Polytechnic Institute and State University
Warren Lo, M.D. principal investigator
Children's National Research Institute
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing I-ACQUIRE - High Dosage, I-ACQUIRE - Moderate Dosage and Usual & Customary Treatment (U&CT) in people with Perinatal Stroke and Hemiparesis, run by Virginia Polytechnic Institute and State University at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Emerging Behaviors Scale (EBS) Score (time frame: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910075, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.