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Harness-based Mobility Intervention for Infants With Down Syndrome
Sponsor: 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.
Official title: Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention
Key Details
Gender
All
Age Range
Any - 2 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2024-07-31
Completion Date
2025-09-30
Last Updated
2025-05-14
Healthy Volunteers
No
Conditions
Interventions
Body 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.
Locations (1)
Boston University
Boston, Massachusetts, United States