Harness-based Mobility Intervention for Infants With Down Syndrome

ConditionDown Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorBoston University Charles River Campus

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

6 Participants
are divided into 1 treatment group

Sponsors and collaborators

Boston University Charles River Campus

Lead sponsor

Boston Children's Hospital

Collaborator