Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Maximum Age: 2
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Boston University
RECRUITING
Boston
Contact Information
Primary
Anna Donato
buicl.studies@gmail.com
(774) 275-3321
Time Frame
Start Date: 2024-07-31
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 6
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Boston University Charles River Campus
Collaborators: Boston Children's Hospital

This content was sourced from clinicaltrials.gov