Harness-based Mobility Intervention for Infants With Down Syndrome

Description

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.

Conditions

Down Syndrome

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Study Overview

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Study Details

Study overview

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.

Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention

Harness-based Mobility Intervention for Infants With Down Syndrome

Condition
Down Syndrome
Intervention / Treatment

-

Contacts and Locations

Boston

Boston University, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Mosaic or Translocation Down syndrome
  • * severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
  • * severe uncorrected hearing or vision impairments

Ages Eligible for Study

to 2 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston University Charles River Campus,

Jana Iverson, PhD, PRINCIPAL_INVESTIGATOR, Boston University

Nicole Baumer, MD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

2025-03-31