Harness-based Mobility Intervention for Infants With Down Syndrome
Key facts
- Who runs it
- Boston University Charles River Campus
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 6 people, planned
- Started
- 31 Jul 2024
- Expected to end
- Dec 2027
- Type of study
- Interventional
- Treatments tested
- Body weight supported harness
- Record updated
- 10 November 2026
Who can take part
- Age
- Up to 2 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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 cannot take part
- Mosaic or Translocation Down syndrome
- severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
- severe uncorrected hearing or vision impairments
Where in United States
- Boston UniversityBoston, United StatesContact: Anna DonatoTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Body weight supported harnessTreatment being tested
Harness is set up in families' homes for one month. Caregivers re asked to use the harness with their infant for 30 min/day, 5 times a week.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention
- Publications
- Implementation and acceptability of PUMA Playtime intervention for toddlers with Down syndrome: a feasibility study.Disability and rehabilitation. Assistive technology, 2026
- Record updated
- 10 November 2026