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Harness-based Mobility Intervention for Infants With Down Syndrome
Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention
Who can join
Up to age 2 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Body weight supported harness (behavioral)
Sponsor: Boston University Charles River Campus · Participants: 6 · Started: Jul 31, 2024
Contact the study team
- Anna Donato · Phone: (774) 275-3321
Official record on ClinicalTrials.gov — NCT06219863
Locations in the U.S.
| Massachusetts | Boston University, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.