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NCT Number: NCT06219863

Harness-based Mobility Intervention for Infants With Down Syndrome

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Anna Donato

CONTACT

[email protected]

774-275-3321

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body weight supported harness

Behavioral

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 outcomes

  1. Mean posture duration in seconds

    Time frame: 6 months

    Average time spent in supine, prone, sitting, standing

  2. Mean number of locomotion bouts

    Time frame: 6 months

    Mean instances of crawling, cruising, walking, or other forms of locomotion

  3. Mean time spent in contact with objects

    Time frame: 6 months

    Average time infants spend touching objects

  4. Mean number of different objects contacted

    Time frame: 6 months

    Average number of unique objects touched

  5. Mean number of vocalizations

    Time frame: 6 months

    Average number of speech-like sound productions

  6. Mean number of gestures

    Time frame: 6 months

    Average number of gestures

  7. Proportion of directed vocalizations

    Time frame: 6 months

    Proportion of total vocalizations accompanied by looking to the caregiver

  8. Proportion of directed gestures

    Time frame: 6 months

    Proportion of total gestures accompanied by looking to the caregiver

  9. 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.

  10. 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.

  11. 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 contacts

Contact information is provided by the study sponsor or research team.

Anna Donato

CONTACT

[email protected]

(774) 275-3321

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • Boston Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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