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Search / Trial NCT06219863

Harness-based Mobility Intervention for Infants With Down Syndrome

Launched by BOSTON UNIVERSITY CHARLES RIVER CAMPUS · Jan 12, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Infant

ClinConnect Summary

This clinical trial is exploring a new way to help infants with Down syndrome (DS) learn to crawl and walk. Infants with DS often take longer to develop these important skills, which are crucial for exploring their surroundings and interacting with others. The study is testing a special harness system that supports the baby's weight, making it easier for them to move around. The goal is to see if this method can help infants become more mobile and encourage their communication and social skills. This research will help gather information for a future larger trial.

To participate in the study, infants must be younger than 24 months, diagnosed with Trisomy 21 (the most common form of Down syndrome), and able to sit up without help but not yet walking on their own. They should also speak English at home since some assessments used in the trial are designed for English-speaking children. Participants will work with their families and researchers to see how well the harness system works for them. This study is currently looking for participants, and it offers a chance to be part of important research that could benefit many infants with Down syndrome in the future.

Gender

ALL

Eligibility 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

About Boston University Charles River Campus

Boston University Charles River Campus is a prominent academic institution dedicated to advancing health and science through innovative research and education. As a sponsor of clinical trials, the campus leverages its extensive resources and interdisciplinary expertise to facilitate groundbreaking studies that aim to improve patient outcomes and contribute to the understanding of various medical conditions. With a commitment to ethical research practices and collaboration with healthcare professionals, Boston University Charles River Campus plays a vital role in translating scientific discoveries into clinical applications that benefit communities locally and globally.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Jana Iverson, PhD

Principal Investigator

Boston University

Nicole Baumer, MD

Principal Investigator

Boston Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported