Harness-based Mobility Intervention for Infants With Down Syndrome
Recruiting now · Not applicable
Conditions studied: Down Syndrome
In brief
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.
Key facts
- Study ID
- NCT06219863
- Run by
- Boston University Charles River Campus
- People needed
- 6
- Starts
- 2024-07-31
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Mosaic or Translocation Down syndrome
- severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
- severe uncorrected hearing or vision impairments
Where it is running
- Boston University — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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