Actively Recruiting
Harness-based Mobility Intervention for Infants With Down Syndrome
Led by Boston University Charles River Campus · Updated on 2025-05-14
6
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
B
Boston University Charles River Campus
Lead Sponsor
B
Boston Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Harness-based Mobility Intervention for Infants With Down Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Trisomy 21
- Younger than 24 months
- English is the primary language of the home
- Able to sit without support
- Not yet taking any independent steps
You will not qualify if you...
- Mosaic or Translocation Down syndrome
- Severe, uncontrolled medical problems including heart disease with cardiovascular instability or uncontrolled epilepsy
- Severe uncorrected hearing or vision impairments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston University
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
A
Anna Donato
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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