Purpose

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

Eligibility

Eligible Ages
Between 8 Months and 36 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Memorial Hermann Texas Medical Center
Houston, Texas 77030
Contact:
Nivedita Thakur, MD
713-500-7113
nivedita.choudhary@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
Virginia Polytechnic Institute and State University

Study Contact

Laura Bateman, B.S.
540-526-2033
laurapb2@vt.edu

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.