Not a traditional drug phase: Body weight supported harness for 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 learning. Increasing infant mobility early in development with body weight supported harness systems may support infant exploration, communication, and social interaction.
Official registry: https://clinicaltrials.gov/study/NCT06219863 · Boston University Charles River Campus · enrollment listed as 6
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Body weight supported harness. The registry lists allocation as na. 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.
They plan to enroll about 6 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention
Interventions: Body weight supported harness
Primary outcome (registry wording): Mean posture duration in seconds
Who it is for (from inclusion criteria)
- Ages any to 2 Years
- 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
Who the registry excludes
- Mosaic or Translocation Down syndrome
- severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
- severe uncorrected hearing or vision impairments
Public study contact (from the registry)
Anna Donato
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Boston University — Boston, Massachusetts (recruiting)
FAQ about this NCT record
Is NCT06219863 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06219863?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06219863?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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