What this study is
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.
What's being tested
- Body weight supported harness
Intervention · BEHAVIORAL
A body weight supported harness will be provided to families for one month to set up in their home. Caregivers will be asked to use the harness for their infants for 30 min per day, 5 days a week. Caregivers will complete a daily log describing harness use. At the end of the month, they will complete feasibility and acceptability questionnaires.
Study details
- Official title
- Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention
- Sponsor
- Boston University Charles River Campus
- Conditions
- Down Syndrome
- Enrolling
- 6 people
- Starts
- 2024-07-31
- Est. completion
- 2025-09-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 2 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Mosaic or Translocation Down syndrome
- Severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
- Severe uncorrected hearing or vision impairments
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBoston University
Boston, Massachusetts, United States
- Anna Donato · Contact(774) 275-3321buicl.studies@gmail.com
Recruiting
Study team
Sponsor
Boston University Charles River Campus
Study ID 6930E
Principal investigator
Jana Iverson, PhD
Boston University
Principal investigator
Nicole Baumer, MD
Boston Children's Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.