Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)

Virginia Polytechnic Institute and State University

Status and phase: Completed; Phase 3

Conditions: Perinatal Stroke; Hemiparesis

Treatments: Behavioral: Usual & Customary Treatment (U&CT); Behavioral: I-ACQUIRE - Moderate Dosage; Behavioral: I-ACQUIRE - High Dosage

Study type: Interventional

Funder types: Other

Identifiers

NCT03910075

1U01NS106655-01A1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 8 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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216 participants in 3 patient groups

I-ACQUIRE High Dose

Experimental group

Description:

High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)

Treatment:

Behavioral: I-ACQUIRE - High Dosage

I-ACQUIRE Moderate Dose

Experimental group

Description:

Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)

Treatment:

Behavioral: I-ACQUIRE - Moderate Dosage

Usual & Customary Treatment

Active Comparator group

Description:

Usual \& Customary Treatment

Treatment:

Behavioral: Usual & Customary Treatment (U&CT)