An interventional study of Body weight supported harness in Down Syndrome, sponsored by Boston University Charles River Campus. Recruiting at 1 site in United States. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Other
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.
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.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's planned enrollment of 6 is below the median of 37 across 286 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →Boston University Charles River Campus is the lead sponsor of 159 studies on the registry; 33 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 9 (64%) have results posted.
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Exclusion Criteria:
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.
Mean posture duration in seconds
Average time spent in supine, prone, sitting, standing
Time frame: 6 months
Mean number of locomotion bouts
Mean instances of crawling, cruising, walking, or other forms of locomotion
Time frame: 6 months
Mean time spent in contact with objects
Average time infants spend touching objects
Time frame: 6 months
Mean number of different objects contacted
Average number of unique objects touched
Time frame: 6 months
Mean number of vocalizations
Average number of speech-like sound productions
Time frame: 6 months
Mean number of gestures
Average number of gestures
Time frame: 6 months
Proportion of directed vocalizations
Proportion of total vocalizations accompanied by looking to the caregiver
Time frame: 6 months
Proportion of directed gestures
Proportion of total gestures accompanied by looking to the caregiver
Time frame: 6 months
Bayley Scales of Infant Development-4
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.
Time frame: Study entry, 3 months, 6 months
Early Social Communication Scales
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.
Time frame: Study entry, 3 months, 6 months
MacArthur-Bates Communication Development Inventory: Words & Gestures
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)
Time frame: Study entry, 3 months, 6 months
Plan to share: Yes — Data from standardized assessments will be shared with the NIH INCLUDE database.
Time frame: One year after study completion
Access criteria: Access granted to approved users of the INCLUDE database
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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