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| Name | Class |
|---|---|
| Ohio State University | OTHER |
| Nationwide Children's Hospital | OTHER |
| Stanford University | OTHER |
| University of Cincinnati |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-ACQUIRE High Dose | Experimental | High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks) |
|
| I-ACQUIRE Moderate Dose | Experimental | Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks) |
|
| Usual & Customary Treatment | Active Comparator | Usual & Customary Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-ACQUIRE - High Dosage | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon L Ramey, Ph.D. | Virginia Polytechnic Institute and State University | Principal Investigator |
| Warren Lo, M.D. | Children's National Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USCD Health La Jolla | La Jolla | California | 92037 | United States | ||
| Yale New Haven Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41649967 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
Public use dataset from the study data will be made available.
Approximately 1 year after primary data analysis publications
standard NIH criteria
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| OTHER |
| Medical University of South Carolina | OTHER |
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|
| I-ACQUIRE - Moderate Dosage | Behavioral | 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. |
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| Usual & Customary Treatment (U&CT) | Behavioral | 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. |
|
| Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment |
| New Haven |
| Connecticut |
| 06511 |
| United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Kennedy Krieger Institute - Fairmount Rehabilitation | Baltimore | Maryland | 21231 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Washington University School of Medicine, St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Martha Morehouse Medical Plaza | Columbus | Ohio | 43210 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| The Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Scottish Rite for Children - Dallas | Dallas | Texas | 75219 | United States |
| Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | United States |
| Fralin Biomedical Research Institute at Virginia Tech | Roanoke | Virginia | 24016 | United States |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D010291 | Paresis |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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