Creating Mobility-supported Home Play Environments to Enhance Development in Infants With Down Syndrome (HOME)

November 7, 2026 updated by: Boston University Charles River Campus

Harnessing Opportunities for Mobility and Exploration (HOME): Creating Mobility-supported Home Play Environments to Enhance Development in Infants With Down Syndrome

Infants with Down syndrome (DS) exhibit early developmental delays in motor skills and multiple other domains. Once infants are upright and moving, they have new opportunities for exploring the environment and interacting with objects and people that are important for early learning and development. This project will allow the investigators to assess the feasibility of a home-based mobility and play intervention for infants with DS (using a body weight supported harness system- Portable Mobility Use Aid (PUMA) for Children and characterize its impact on promoting mobility, exploration, and play with objects and caregivers. PUMA is a specialized pediatric partial body-weight support system designed to give children with developmental delays or physical disabilities the upright support they need to move, explore, and play independently.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jana M Iverson, PhD
  • Phone Number: 617.358.5480
  • Email: iversonj@bu.edu

Study Contact Backup

  • Name: Audrey Lorence, BS

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Charles River Campus, Boston University
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Infants/toddlers inclusion criteria

  • confirmed diagnosis of Down syndrome;
  • able to sit without support and not yet taking any independent steps

Primary caregiver inclusion criteria

  • proficient in English
  • has access to a computer, tablet or mobile phone with a camera and microphone
  • has access to zoom

Infants/toddlers exclusion criteria:

  • severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Portable Mobility Use Aid (PUMA) system for Children playtime

The investigators will deliver a Portable Mobility Use Aid (PUMA) system for Children playtime to the home and assist caregivers with setup.
Other: PUMA

Families will be asked to use the PUMA system with their infant 5 days/week for a minimum of 30 min (longer is permitted) for one month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant upright postures
Time Frame: baseline, 2 weeks, 1 month, 6 months, 12 months

This outcome will be assessed by the proportion of time the infant spends in an upright posture
baseline, 2 weeks, 1 month, 6 months, 12 months
Infant locomotion
Time Frame: baseline, 2 weeks, 1 month, 6 months, 12 months

This outcome will be assessed by the proportion of time the infant spends in locomotion
baseline, 2 weeks, 1 month, 6 months, 12 months
Infant initiated proximity changes
Time Frame: baseline, 2 weeks, 1 month, 6 months, 12 months

This outcome will be assessed by the proportion of Infant initiated proximity changes
baseline, 2 weeks, 1 month, 6 months, 12 months
Joint object play bouts
Time Frame: baseline, 2 weeks, 1 month, 6 months, 12 months

This outcome will be assessed by the proportion of joint object play bouts
baseline, 2 weeks, 1 month, 6 months, 12 months
Infant-initiated proximity
Time Frame: baseline, 2 weeks, 1 month, 6 months, 12 months

This outcome will be assessed by the proportion of infant-initiated proximity
baseline, 2 weeks, 1 month, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Boston Children's Hospital

Investigators

  • Principal Investigator: Jana M Iverson, PhD, Physical Therapy, Sargent College, Charles River Campus Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

November 7, 2026

First Submitted That Met QC Criteria

November 7, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 7, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8756
  • R01HD120575 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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