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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
Sponsor:
Collaborators:
Ohio State University
Nationwide Children's Hospital
Stanford University
University of Cincinnati
Medical University of South Carolina
Information provided by (Responsible Party):
Sharon Ramey, Virginia Polytechnic Institute and State University

Brief 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).

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

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 24 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 240 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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.
Other Names:
  • ACQUIRE
  • Pediatric Constraint-Induced Movement Therapy
  • P-CIMT

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.
Other Names:
  • ACQUIRE
  • Pediatric Constraint-Induced Movement Therapy
  • P-CIMT

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • child will be 8 - 24 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910075


Contacts
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Contact: Laura Bateman, B.S. 540-526-2033 laurapb2@vt.edu
Contact: Stephanie DeLuca, Ph.D. 540-526-2098 Stephdeluca@vt.edu

Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Ohio State University
Nationwide Children's Hospital
Stanford University
University of Cincinnati
Medical University of South Carolina
Investigators
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Principal Investigator: Sharon L Ramey, Ph.D. Virginia Polytechnic Institute and State University
Principal Investigator: Warren Lo, M.D. Children's National Hospital

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Responsible Party: Sharon Ramey, Distinguished Research Scholar and Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT03910075     History of Changes
Other Study ID Numbers: 1U01NS106655-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Public use dataset from the study data will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Approximately 1 year after primary data analysis publications
Access Criteria: standard NIH criteria

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sharon Ramey, Virginia Polytechnic Institute and State University:
P-CIMT
Pediatric Constraint-Induced Movement Therapy
Hemiparesis
Perinatal Stroke
Neonatal Stroke
Pediatric rehabilitation
Infant therapy
Cerebral Palsy
ACQUIRE
I-ACQUIRE
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms