Recruiting

Mobility Intervention

Sponsor:

Boston University Charles River Campus

Code:

NCT06219863

Conditions

Down Syndrome

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Body weight supported harness

Study Details

Brief summary:

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

Study ID

NCT06219863

Start date

Jul 31, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Body weight supported harness

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.

Interventions

Body weight supported harness

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.

Primary outcome measure

  • Mean posture duration in seconds [ Time Frame: 6 months ]
  • Mean number of locomotion bouts [ Time Frame: 6 months ]
  • Mean time spent in contact with objects [ Time Frame: 6 months ]
  • Mean number of different objects contacted [ Time Frame: 6 months ]
  • Mean number of vocalizations [ Time Frame: 6 months ]
  • Mean number of gestures [ Time Frame: 6 months ]
  • Proportion of directed vocalizations [ Time Frame: 6 months ]
  • Proportion of directed gestures [ Time Frame: 6 months ]
  • Bayley Scales of Infant Development-4 [ Time Frame: Study entry, 3 months, 6 months ]
  • Early Social Communication Scales [ Time Frame: Study entry, 3 months, 6 months ]
  • MacArthur-Bates Communication Development Inventory: Words & Gestures [ Time Frame: Study entry, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Anna Donato

(774) 275-3321buicl.studies@gmail.com

Locations

Boston University

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Anna Donato

774-275-3321buicl.studies@gmail.com

More Information

Sponsor

Boston University Charles River Campus

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • infant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University Charles River Campus on 2026-07-24.