Harness-based Mobility Intervention for Infants With Down Syndrome

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University Charles River Campus
Study ID
NCT06219863
Status
Recruiting
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Conditions

  • Down Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - 2 Years
Healthy Volunteers
Not accepted

Interventions

  • Body weight supported harness — BEHAVIORAL
    A body weight supported harness will be provided to families for one month to set up in their home. Caregivers will be asked to use the harness for their infants for 30 min per day, 5 days a week. Caregivers will complete a daily log describing harness use. At the end of the month, they will complete feasibility and acceptability questionnaires.

Study Details

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 Dates

Start date
Jul 31, 2024
Status verified
May 2025
Primary completion
Aug 31, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Body weight supported harness
    Harness is set up in families' homes for one month. Caregivers re asked to use the harness with their infant for 30 min/day, 5 times a week.

Primary Outcome Measure

Mean posture duration in seconds [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston UniversityBostonMassachusetts02215
Anna Donato
[email protected]
(774) 275-3321

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By research site
Boston University· Boston, MA

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