Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE) (I-ACQUIRE)
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|ClinicalTrials.gov Identifier: NCT03910075|
Recruitment Status : Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Stroke Hemiparesis||Behavioral: I-ACQUIRE - High Dosage Behavioral: I-ACQUIRE - Moderate Dosage Behavioral: Usual & Customary Treatment (U&CT)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)|
|Estimated Study Start Date :||October 7, 2019|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||January 31, 2024|
Experimental: I-ACQUIRE High Dose
High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)
Behavioral: I-ACQUIRE - High Dosage
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.
Experimental: I-ACQUIRE Moderate Dose
Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)
Behavioral: I-ACQUIRE - Moderate Dosage
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.
Active Comparator: Usual & Customary Treatment
Usual & Customary Treatment
Behavioral: 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.
- 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.
- 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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910075
|Contact: Laura Bateman, B.S.||firstname.lastname@example.org|
|Contact: Stephanie DeLuca, Ph.D.||540-526-2098||Stephdeluca@vt.edu|
|Principal Investigator:||Sharon L Ramey, Ph.D.||Virginia Polytechnic Institute and State University|
|Principal Investigator:||Warren Lo, M.D.||Children's National Hospital|