Harness-based Mobility Intervention for Infants With Down Syndrome

May 11, 2025 updated by: Jana M. Iverson, Boston University Charles River Campus

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Investigators will visit families at home both in-person and virtually via Zoom. At all sessions, infants and caregivers will be videorecorded at home while playing together with the infant's own toys (15 min) and with a standard set of age-appropriate commercially available toys provided by the research team (15 min). During the harness trial period, sessions will be divided so that the infant is observed both in and out of the harness. Parent reports of language development (MacArthur-Bates Communicative Development Inventory; 10 min) and locomotor development (Locomotor Experience Interview; 10 min) will be collected at the initial visit, study midpoint (3 months), and study exit (6 months). Parents will be surveyed once about the feasibility and acceptability of the body weight supported harness system at the end of the harness trial period (10 min), and they will complete a study participation satisfaction survey at study exit (10 min). In addition, infants will be administered the Bayley Scales of Infant and Toddler Development-4 (30 min) and the Early Social Communication Scales (10 min) at the beginning, middle, and end of study participation.

Participants will be observed twice a month for 6 months (one visit per month on Zoom and the other in person), for a total of 12 observations per child.

Part 2 study participation will involve a total of 12 sessions per parent/infant dyad, lasting between 30 and 70 min, depending on the visit protocol (see above).

Each family will also have a 1-month Harness Trial Period with the PUMA system in their home. These will be staggered over the course of the study period. At the beginning of the trial period, investigators will deliver the harness system to the home and assist with setup and troubleshooting. Families will be given a brief training in harness setup and use and a safety checklist to review daily before using the system with their infant. Families will be asked to use the harness with their infant for at least 30 minutes daily. The harness will be collected by the research team at the end of the trial period. Each day during the Harness Trial Period, parents will track how long they use the harness system with their infant (in minutes), what activities they engaged in (e.g., toy play, book sharing), and any challenges they encountered (e.g., infant fussiness) in a log (5 min).

The PUMA system is an FDA registered device manufactured by Enliten LLC that provides body weight support while moving around. It consists of a 9' x 9' metal canopy frame with no cover that is adjustable in height. Infants will wear custom lightweight cloth vests designed specifically for the PUMA. The vest will be connected to a beam at the top of the structure. The PUMA supports up to 60 pounds and permits movement anywhere beneath the structure. In case of an emergency, a quick release unit can be pulled to rapidly separate the harness from the support unit. For the PUMA, this device is attached to the spreader bar, out of reach of the child user.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • 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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean posture duration in seconds
Time Frame: 6 months
Average time spent in supine, prone, sitting, standing
6 months
Mean number of locomotion bouts
Time Frame: 6 months
Mean instances of crawling, cruising, walking, or other forms of locomotion
6 months
Mean time spent in contact with objects
Time Frame: 6 months
Average time infants spend touching objects
6 months
Mean number of different objects contacted
Time Frame: 6 months
Average number of unique objects touched
6 months
Mean number of vocalizations
Time Frame: 6 months
Average number of speech-like sound productions
6 months
Mean number of gestures
Time Frame: 6 months
Average number of gestures
6 months
Proportion of directed vocalizations
Time Frame: 6 months
Proportion of total vocalizations accompanied by looking to the caregiver
6 months
Proportion of directed gestures
Time Frame: 6 months
Proportion of total gestures accompanied by looking to the caregiver
6 months
Bayley Scales of Infant Development-4
Time Frame: Study entry, 3 months, 6 months
Comprehensive, standardized measure of general development for children from 1-42 months, with five subscales: Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior. Raw scores will be used. Minimum score is 0; there is no maximum score. Higher scores indicate a better outcome.
Study entry, 3 months, 6 months
Early Social Communication Scales
Time Frame: Study entry, 3 months, 6 months
Structured experimenter-administered observation of nonverbal communication skills: assesses joint attention, requesting, and social interaction skills. Minimum score is 0. There is no maximum score. Higher scores mean a better outcome.
Study entry, 3 months, 6 months
MacArthur-Bates Communication Development Inventory: Words & Gestures
Time Frame: Study entry, 3 months, 6 months

Parent questionnaire identifying words that the child only understands and those that s/he both says and understands as well as production of early gestures (e.g., showing, pointing) and actions (e.g., games, routines). There are seven subscales. Raw scores will be reported for each one, and all have a minimum score of 0. Higher scores mean better outcomes.

Words Understood (maximum score = 396) Words Produced (maximum score = 396) First Communicative Gestures (maximum score = 12) Games and Routines (maximum score = 6) Actions with Objects (maximum score = 17) Pretending to be a Parent (maximum score = 13) Imitating Other Adult Actions (maximum score = 15)
Study entry, 3 months, 6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University Charles River Campus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jana Iverson, PhD, Boston University
  • Principal Investigator: Nicole Baumer, MD, Boston Children's Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6930E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from standardized assessments will be shared with the NIH INCLUDE database.

IPD Sharing Time Frame

One year after study completion

IPD Sharing Access Criteria

Access granted to approved users of the INCLUDE database

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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