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Harness-based Mobility Intervention for Infants With Down Syndrome

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Aug 31, 2025 → Dec 2027
See other at-risk trials from Boston University Charles River Campus

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 31, 2025 to Dec 2027
    • Study completion pushed from Sep 30, 2025 to Dec 2027
    • Site contact updated
    v5
  2. Primary completion date: Mar 31, 2025 to Aug 31, 2025
    • Study completion date: Mar 31, 2025 to Sep 30, 2025
    • Site contact updated
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 15, 2024 to Jul 31, 2024
    • Site details revised
    v3
  4. Start date: Feb 2024 to Jun 15, 2024
    • Primary and study completion dates: Feb 2025 to Mar 31, 2025
    • Eligibility criteria shortened, about 1 word
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06219863
Lead Sponsor Boston University Charles River Campus
Collaborators: Boston Children's Hospital
Conditions
(from sponsor)		 Down Syndrome
Related terms Down Syndrome
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov