Harness-based Mobility Intervention for Infants With Down Syndrome (NCT06219863)
Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Boston University — Boston, Massachusetts
Age range: Not specified to 2 Years
🧪 Interventions in This Study
- Body weight supported harness (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Boston University — Boston, Massachusetts
📞 Contact the Study Coordinator
Phone: (774) 275-3321
Email: buicl.studies@gmail.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Down Syndrome
- Evaluating Treatment of ADHD in Children With Down Syndrome — Sacramento, California
- Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea — Atlanta, Georgia
- Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD) — Ottawa, Ontario
- Executive Function Play Opportunities for Children With Down Syndrome — Fort Collins, Colorado
- Escalating Doses of Memantine in Down Syndrome (MEDS-123) — Cleveland, Ohio
- Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy — Bethesda, Maryland
Explore by condition: All Down Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.