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).
Conditions
Perinatal Stroke, Hemiparesis
Recruitment Status
ACTIVE_NOT_RECRUITING
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.
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
Intervention
Intervention Type
Intervention Name
BEHAVIORAL
I-ACQUIRE - High Dosage
BEHAVIORAL
I-ACQUIRE - Moderate Dosage
BEHAVIORAL
Usual & Customary Treatment (U&CT)
Phase
PHASE3
Gender
ALL
Min Age
8 Months
Max Age
36 Months
Download Date
2024-10-15
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: