Down SyndromeNCT06219863
Harness-based Mobility Intervention for Infants With Down Syndrome
A study testing Body weight supported harness in people with Down Syndrome, run by Boston University Charles River Campus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Body weight supported harness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Mosaic or Translocation Down syndrome
- severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
- severe uncorrected hearing or vision impairments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston University
Boston, Massachusetts, 02215
Anna Donato, 774-275-3321, buicl.studies@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Body weight supported harness
- Keywords
- infant
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body weight supported harnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Body weight supported harness | Experimental | 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. Receives: Behavioral: Body weight supported harness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean posture duration in seconds
Average time spent in supine, prone, sitting, standing
Measured: 6 months
Mean number of locomotion bouts
Mean instances of crawling, cruising, walking, or other forms of locomotion
Measured: 6 months
Mean time spent in contact with objects
Average time infants spend touching objects
Measured: 6 months
Mean number of different objects contacted
Average number of unique objects touched
Measured: 6 months
Mean number of vocalizations
Average number of speech-like sound productions
Measured: 6 months
Mean number of gestures
Average number of gestures
Measured: 6 months
Proportion of directed vocalizations
Proportion of total vocalizations accompanied by looking to the caregiver
Measured: 6 months
Proportion of directed gestures
Proportion of total gestures accompanied by looking to the caregiver
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Study entry, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start31 Jul 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Jana Iverson, PhD, Principal investigator, Boston UniversityNicole Baumer, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219863
- Sponsor's protocol ID
- 6930E
- Status last verified
- Jul 2026
- First submitted
- 30 Dec 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from standardized assessments will be shared with the NIH INCLUDE database.
Publications
Collimore-Doherty AN, Sutter EN, Wilkerson E, Baumer NT, Iverson JM. Implementation and acceptability of PUMA Playtime intervention for toddlers with Down syndrome: a feasibility study. Disabil Rehabil Assist Technol. 2026 Aug 18:1-12. doi: 10.1080/17483107.2026.2716555. Online ahead of print.
PubMed 42611612
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention
- ClinicalTrials.gov ID
- NCT06219863
- Acronym / sponsor ID
- 6930E
- Conditions
- Down Syndrome
- Keywords
- infant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body weight supported harness | Experimental | Behavioral: Body weight supported harnessHarness 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. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Mosaic or Translocation Down syndrome
- severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
- severe uncorrected hearing or vision impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body weight supported harnessA 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. | Behavioural | Body weight supported harness |
Primary outcome
Mean posture duration in seconds
Time frame: 6 months
Average time spent in supine, prone, sitting, standing
Mean number of locomotion bouts
Time frame: 6 months
Mean instances of crawling, cruising, walking, or other forms of locomotion
Mean time spent in contact with objects
Time frame: 6 months
Average time infants spend touching objects
Mean number of different objects contacted
Time frame: 6 months
Average number of unique objects touched
Mean number of vocalizations
Time frame: 6 months
Average number of speech-like sound productions
Mean number of gestures
Time frame: 6 months
Average number of gestures
Proportion of directed vocalizations
Time frame: 6 months
Proportion of total vocalizations accompanied by looking to the caregiver
Proportion of directed gestures
Time frame: 6 months
Proportion of total gestures accompanied by looking to the caregiver
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.
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.
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Derived from this study: PubMed 42611612Collimore-Doherty AN, Sutter EN, Wilkerson E, Baumer NT, Iverson JM. Implementation and acceptability of PUMA Playtime intervention for toddlers with Down syndrome: a feasibility study. Disabil Rehabil Assist Technol. 2026 Aug 18:1-12. doi: 10.1080/17483107.2026.2716555. Online ahead of print.
- Individual participant dataSharing planned: Yes. Data from standardized assessments will be shared with the NIH INCLUDE database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jana Iverson, PhD principal investigator
Boston University
Nicole Baumer, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body weight supported harness in people with Down Syndrome, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Donato ((774) 275-3321, buicl.studies@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean posture duration in seconds (time frame: 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.