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NCT06219863 · ClinicalTrials.gov registry record · NA

Harness-based Mobility Intervention for Infants With Down Syndrome

A NA study of Down Syndrome, sponsored by Boston University Charles River Campus.

Recruiting
Registry status
NA
Development phase
6
Enrollment target
1
Study location

NCT06219863: Recruiting NA study of Down Syndrome, sponsored by Boston University Charles River Campus.

NCT06219863 is a NA study of Down Syndrome that is actively recruiting participants, run by Boston University Charles River Campus. The registered enrollment target is 6 participants, below the 2,472-participant average among 54 other Down Syndrome trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06219863, a NA study of Down Syndrome, is actively recruiting participants, sponsored by Boston University Charles River Campus.

RECRUITING
Registry status
NA
Development phase
6 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Average time spent in supine, prone, sitting, standing

Conditions Studied

Interventions

  • BEHAVIORAL Body weight supported harness

Study Locations (1)

Massachusetts

  • Boston University - Boston

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2024-07-31
Est. Completion 2025-09-30
Phase NA

What NCT06219863 shows while recruiting

NCT06219863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 2,472-participant average among 54 other Down Syndrome trials with a reported enrollment target (100% lower).

The record links to 1 condition, with Down Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Body weight supported harness is the first listed.

NCT06219863 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06219863 about?

NCT06219863 is a clinical study titled "Harness-based Mobility Intervention for Infants With Down Syndrome". 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 learni...

What is the current status of trial NCT06219863?

This trial is currently recruiting. It is a NA study. The enrollment target is 6 participants. The study started on 2024-07-31. Estimated completion is 2025-09-30.

What conditions does trial NCT06219863 study?

This clinical trial studies the following conditions: Down Syndrome.

What interventions are being tested in trial NCT06219863?

The interventions under investigation include: Body weight supported harness (BEHAVIORAL).

Who is sponsoring clinical trial NCT06219863?

This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06219863 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Down Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06219863's enrollment target sits among peer trials

6 54th of 54 higher than 1 of 54 other Down Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06219863, the US trial registry maintained by the National Library of Medicine. NCT06219863 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.