Harness-based mobility intervention for infants with Down syndrome
Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention
This study is testing a special harness to see if it can help infants with Down syndrome move better and interact more during playtime.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | N/A to 2 Years |
| Sex | All |
| Sponsor | Boston University Charles River Campus Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06219863 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance mobility in infants with Down syndrome by using body weight supported harness systems. The study will involve home visits and virtual sessions where infants and caregivers will be observed during playtime, both with and without the harness. Data will be collected on language and locomotor development, as well as the feasibility and acceptability of the harness system. The goal is to gather preliminary data to support a larger clinical trial focused on improving mobility and social interaction in these infants.
Who should consider this trial
Good fit: Ideal candidates are infants under 24 months with a confirmed diagnosis of Trisomy 21 who can sit without support and are not yet walking independently.
Not a fit: Patients with mosaic or translocation Down syndrome or those with severe uncontrolled medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mobility and developmental outcomes for infants with Down syndrome.
How similar studies have performed: While this approach is innovative, similar interventions targeting mobility in infants with developmental delays have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston University — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jana Iverson, PhD — Boston University
- Study coordinator: Anna Donato
- Email: buicl.studies@gmail.com
- Phone: (774) 275-3321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.