About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Mosaic or Translocation Down syndrome
severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
severe uncorrected hearing or vision impairments
Trial design
Treatments tested in this trial
- Body weight supported harness
Treatment groups
Sponsors and collaborators
Boston University Charles River Campus
Lead sponsor
Boston Children's Hospital
Collaborator