Clinical trial NCT03910075: Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Official title: Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Perinatal Stroke
Hemiparesis
Keywords: P-CIMT
Pediatric Constraint-Induced Movement Therapy
Hemiparesis
Perinatal Stroke
Neonatal Stroke
Pediatric rehabilitation
Infant therapy
Cerebral Palsy
ACQUIRE
I-ACQUIRE
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: Nationwide Children's Hospital
name: Stanford University
name: University of Cincinnati
name: Medical University of South Carolina
First posted: 2019-04-10
Enrollment: 216
Sex: ALL
Minimum age (years): 8
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

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\&amp;CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U\&amp;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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Changes in Emerging Behaviors Scale (EBS) Score
timeFrame: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Secondary outcomes:
measure: Changes in Bilateral Use of the Hemiparetic Upper Extermity based on the Mini-Assisting Hand Assessment (Mini-AHA) play assessment
timeFrame: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: USCD Health La Jolla
state: California
city: New Haven
country: United States
facility: Yale New Haven Children's Hospital
state: Connecticut
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Kennedy Krieger Institute - Fairmount Rehabilitation
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine, St. Louis Children's Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Martha Morehouse Medical Plaza
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: The Medical University of South Carolina (MUSC)
state: South Carolina
city: Dallas
country: United States
facility: Scottish Rite for Children - Dallas
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at Virginia Tech
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Sharon L Ramey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's National Research Institute
name: Warren Lo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: