Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention
Boston University Charles River Campus
Summary
The emergence of crawling and walking is significantly delayed in infants with Down syndrome (DS), but the development of independent mobility provides infants with new opportunities for exploring the environment and interacting with objects and people that are important foundations for early learning. Increasing infant mobility early in development with body weight supported harness systems may support infant exploration, communication, and social interaction. This project will set the stage for the first clinical trial of a mobility-related intervention specifically tailored for infants with DS by testing the feasibility of harness systems with infants and families and identifying measures that will serve as primary outcome variables. Upon completion of this pilot project, necessary preliminary data and experience required for an in-home, high-impact clinical trial for infants with DS will have been obtained.
Description
Investigators will visit families at home both in-person and virtually via Zoom. At all sessions, infants and caregivers will be videorecorded at home while playing together with the infant's own toys (15 min) and with a standard set of age-appropriate commercially available toys provided by the research team (15 min). During the harness trial period, sessions will be divided so that the infant is observed both in and out of the harness. Parent reports of language development (MacArthur-Bates Communicative Development Inventory; 10 min) and locomotor development (Locomotor Experience Interview…
Eligibility
- Age range
- Up to 2 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * confirmed diagnosis of Trisomy 21 * younger than 24 months * English is the primary language of the home (due to use of standardized language assessments normed on English-speaking children) * able to sit without support * not yet taking any independent steps. Exclusion Criteria: * Mosaic or Translocation Down syndrome * severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy) * severe uncorrected hearing or vision impairments
Interventions
- BehavioralBody weight supported harness
A body weight supported harness will be provided to families for one month to set up in their home. Caregivers will be asked to use the harness for their infants for 30 min per day, 5 days a week. Caregivers will complete a daily log describing harness use. At the end of the month, they will complete feasibility and acceptability questionnaires.
Location
- Boston UniversityBoston, Massachusetts