NCT06219863 Harness-based Mobility Intervention for Infants With Down Syndrome
| NCT ID | NCT06219863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University Charles River Campus |
| Condition | Down Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6 participants in total. It began in 2024-07-31 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Mosaic or Translocation Down syndrome * severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy) * severe uncorrected hearing or vision impairments
Contact & Investigator
Jana Iverson, PhD
PRINCIPAL INVESTIGATOR
Boston University
Frequently Asked Questions
Who can join the NCT06219863 clinical trial?
This trial is open to participants of all sexes, up to 2 Years, studying Down Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06219863 currently recruiting?
Yes, NCT06219863 is actively recruiting participants. Contact the research team at buicl.studies@gmail.com for enrollment information.
Where is the NCT06219863 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06219863 clinical trial?
NCT06219863 is sponsored by Boston University Charles River Campus. The principal investigator is Jana Iverson, PhD at Boston University. The trial plans to enroll 6 participants.