Down SyndromeNCT06591559
Up, Down, and All Around: Evaluating Mobility Devices for Young Children With Developmental Disabilities and Delays
A study testing Permobil Explorer Mini and Portable Mobility Aid for Children (PUMA) in people with Down Syndrome and Gross Motor Delay, run by University of Washington at 1 site in United States.
Trial summary
This research study will examine young children with Down syndrome's initial experiences with mobility devices. Children's biomechanics and exploration will be quantified while they are using both an overground partial bodyweight support system and powered mobility device. Read more about this study
- Who is it for?
- Ages 12 to 60 months
- Conditions the study is for
- Down Syndrome, Gross Motor Delay, Cerebral Palsy
- What is being tested?
- Permobil Explorer Mini and Portable Mobility Aid for Children (PUMA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- are able to sit upright independently
- are able to tolerate moving through space while upright for 30 minutes
- are under 35 pounds in weight
- are under 39 inches tall in height
- developmental delays and conditions that affect mobility and muscle tone
Who cannot join
- are able to walk 10 ft independently
Trial locations and contacts
1 site in 1 country.
About this study
This research study will examine young children with Down syndrome's initial experiences with mobility devices. Children's biomechanics and exploration will be quantified while they are using both an overground partial bodyweight support system and powered mobility device.
Read the detailed description
Young children with Down syndrome experience delays in cognition, communication, and mobility. As a result of cerebellar hypoplasia, children with Down syndrome have altered balance and coordination, muscle hypotonia, decreased muscle strength, and ligament laxity. Low muscle tone and ligament laxity can lead to the adoption of unfavorable postures, putting children at risk for developing musculoskeletal disorders in the future.
While children with Down syndrome are expected to walk, they do so significantly later than their peers, creating a gap in mobility, exploration, and socialization in the first years of life. Mobility during the first years is crucial to facilitate cascades of reciprocal development in cognition, communication, and motor skills, as well as reduce developmental delays and participation disparities for children with Down syndrome compared to their peers. While early intervention is common during this time to facilitate movement, clinical practice patterns vary widely and there are few evidence-based interventions or assistive technologies to support children and their families.
Treadmill training is currently the only intervention that has demonstrated efficacy for young children with hypotonia, but only for improving walking speed among already ambulatory children. Traditional treadmill training is limited, however, in that it does not allow for the sensorimotor experiences and social interactions that occur with self-initiated mobility in enriched, and often unpredictable, natural environments. As such, treadmill training and other clinical interventions may not fully address the need for holistic and multi-modal mobility opportunities.
Augmented mobility - in the form of partial bodyweight support systems, gait trainers, and powered mobility - has been proposed as a promising and complementary intervention to support early development in Down syndrome. While these tools have the potential to bridge the gap in self-initiated mobility and accelerate the onset of independent walking, little is scientifically known about how children engage with these devices nor how these devices shape their interactions with their environment. Furthermore, there is a lack of knowledge concerning the impact of different mobility devices on a child's physical development and posture.
In this research, the investigators propose to quantify a child's exploration, posture, and motor control strategies while using two promising assistive technologies for pre-ambulatory young children with Down syndrome: a partial-bodyweight support system (PUMA, Enliten, LLC.) and a powered mobility device (Explorer Mini, Permobil) that can be used in both seated and standing postures.
Participants will attend a total of four play sessions where they will play with a) no devices, b) partial bodyweight support, c) in the Explorer Mini in a standing posture, and d) in the Explorer Mini in a seated posture.
- Conditions
- Down Syndrome, Gross Motor Delay, Cerebral Palsy
- Being tested
- Permobil Explorer Mini, Portable Mobility Aid for Children (PUMA)
- Keywords
- early intervention, mobility aid, powered mobility, partial bodyweight support
- Medical subject headings
- Down Syndrome, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permobil Explorer MiniDevice
The Explorer Mini (Permobil AB, Sweden) is a commercially available, FDA approved powered mobility device intended for young children between 12-36 months of age with mobility limitations (weight limit: 35 lbs; height limit: 39.4 inches). It is lightweight (52 lbs. including battery) and fits in most automobiles (length: 25 inches; width: 19 inches; adjustable height: 29-37 inches). The Explorer Mini runs on a 12-volt battery with a driving range of 3.5 miles and a maximum speed of 1.5 mph, is controlled via a joystick with a 360-degree turning radius, has proportional speed control with 5 speed options, and can be used in a seated or standing position.
Portable Mobility Aid for Children (PUMA)Device
The Portable Mobility Aid for Children (PUMA; Enliten LLC) is a portable canopy system that utilizes an overhead support rail structure and a counterweight. The rail structure consists of two rigid parallel beams that mount to the canopy structure and one perpendicular mobile beam that allows for freedom of movement in one direction. Freedom of movement in the opposite direction is achieved by a system of pulleys along the movable beam that connects the harness to a counterweight. The counterweight provides a passive vertical force, counteracting gravity. The PUMA provides 2-dimensional mobility support over 81 ft2 (9 ft x 9 ft). The overhead bar is connected at 4 points to a child-worn harness. Children are free to move through many postures including sitting, crawling, standing, and walking.
| Study group | Role | What they receive |
|---|---|---|
| No Device | No intervention | Children will play for 30 minutes using no mobility device. |
| Explorer Mini in a Seated Posture | Active comparator | Children will play for 30 minutes using the Explorer Mini a seated posture. Receives: Device: Permobil Explorer Mini |
| Explorer Mini in a Standing Posture | Active comparator | Children will play for 30 minutes using the Explorer Mini a standing posture. Receives: Device: Permobil Explorer Mini |
| Portable Mobility Aid Partial Body Weight Support Harness (PUMA) | Active comparator | Children will play for 30 minutes with partial bodyweight support provided by the PUMA. Receives: Device: Portable Mobility Aid for Children (PUMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of space explored
The path of each child's movement during the play sessions will be tracked from video recordings and sensor data. The path will then be used to determine the percentage of the available play space that the child explored. Values will range from 0 - 100%, a higher value indicates more space explored.
Measured: At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)
Secondary outcomes (2)
Normalized Integrated Electromyography (EMG)
Children will wear electromyography (EMG) sensors while playing. We will measure the bilateral muscle activity of the tibialis anterior, gastrocnemius, quadriceps, hamstrings (biceps femoris), erector spinae, and cervical paraspinal using surface EMGs. EMG data will be high-pass filtered (40 Hz), rectified, and low-pass filtered (10 Hz) to create a linear envelope of muscle activity during play sessions. For each muscle group, we will calculate the integrated EMG signal, or area under the curve, for each session normalized by time in device. Values will range from 0 to 100%, higher values indicate more muscle activity.
Measured: At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.1: Children Version
The QUEST 2.1: Children Version is an extension of the original QUEST tool tailored specifically for children who use assistive technology. The primary aim of this test is to evaluate how well assistive technology devices meet the needs of children and enhance their overall satisfaction with these devices. The questionnaire is designed to gather information on various aspects of the assistive technology, including its functionality, ease of use, and impact on the life of the user.
Measured: At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start11 Feb 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Heather Feldner, University of Washington
- Investigators
- Heather A Feldner, PhD, PT, PCS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591559
- Sponsor's protocol ID
- STUDY00018915
- Other IDs
- 5TL1TR002318-07
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Up, Down, and All Around: Evaluating Mobility Devices for Young Children With Developmental Disabilities and Delays
- ClinicalTrials.gov ID
- NCT06591559
- Acronym / sponsor ID
- STUDY00018915
- Conditions
- Down Syndrome, Gross Motor Delay, Cerebral Palsy
- Keywords
- early intervention, mobility aid, powered mobility, partial bodyweight support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 19 Sep 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.
This research study will examine young children with Down syndrome's initial experiences with mobility devices. Children's biomechanics and exploration will be quantified while they are using both an overground partial bodyweight support system and powered mobility device.
Detailed description
Young children with Down syndrome experience delays in cognition, communication, and mobility. As a result of cerebellar hypoplasia, children with Down syndrome have altered balance and coordination, muscle hypotonia, decreased muscle strength, and ligament laxity. Low muscle tone and ligament laxity can lead to the adoption of unfavorable postures, putting children at risk for developing musculoskeletal disorders in the future.
While children with Down syndrome are expected to walk, they do so significantly later than their peers, creating a gap in mobility, exploration, and socialization in the first years of life. Mobility during the first years is crucial to facilitate cascades of reciprocal development in cognition, communication, and motor skills, as well as reduce developmental delays and participation disparities for children with Down syndrome compared to their peers. While early intervention is common during this time to facilitate movement, clinical practice patterns vary widely and there are few evidence-based interventions or assistive technologies to support children and their families.
Treadmill training is currently the only intervention that has demonstrated efficacy for young children with hypotonia, but only for improving walking speed among already ambulatory children. Traditional treadmill training is limited, however, in that it does not allow for the sensorimotor experiences and social interactions that occur with self-initiated mobility in enriched, and often unpredictable, natural environments. As such, treadmill training and other clinical interventions may not fully address the need for holistic and multi-modal mobility opportunities.
Augmented mobility - in the form of partial bodyweight support systems, gait trainers, and powered mobility - has been proposed as a promising and complementary intervention to support early development in Down syndrome. While these tools have the potential to bridge the gap in self-initiated mobility and accelerate the onset of independent walking, little is scientifically known about how children engage with these devices nor how these devices shape their interactions with their environment. Furthermore, there is a lack of knowledge concerning the impact of different mobility devices on a child's physical development and posture.
In this research, the investigators propose to quantify a child's exploration, posture, and motor control strategies while using two promising assistive technologies for pre-ambulatory young children with Down syndrome: a partial-bodyweight support system (PUMA, Enliten, LLC.) and a powered mobility device (Explorer Mini, Permobil) that can be used in both seated and standing postures.
Participants will attend a total of four play sessions where they will play with a) no devices, b) partial bodyweight support, c) in the Explorer Mini in a standing posture, and d) in the Explorer Mini in a seated posture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Device | No intervention | –Children will play for 30 minutes using no mobility device. |
| Explorer Mini in a Seated Posture | Active comparator | Device: Permobil Explorer MiniChildren will play for 30 minutes using the Explorer Mini a seated posture. |
| Explorer Mini in a Standing Posture | Active comparator | Device: Permobil Explorer MiniChildren will play for 30 minutes using the Explorer Mini a standing posture. |
| Portable Mobility Aid Partial Body Weight Support Harness (PUMA) | Active comparator | Device: Portable Mobility Aid for Children (PUMA)Children will play for 30 minutes with partial bodyweight support provided by the PUMA. |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- are able to sit upright independently
- are able to tolerate moving through space while upright for 30 minutes
- are under 35 pounds in weight
- are under 39 inches tall in height
- developmental delays and conditions that affect mobility and muscle tone
Key exclusion criteria (1 listed)
- are able to walk 10 ft independently
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 |
|---|---|---|
| Permobil Explorer MiniThe Explorer Mini (Permobil AB, Sweden) is a commercially available, FDA approved powered mobility device intended for young children between 12-36 months of age with mobility limitations (weight limit: 35 lbs; height limit: 39.4 inches). It is lightweight (52 lbs. including battery) and fits in most automobiles (length: 25 inches; width: 19 inches; adjustable height: 29-37 inches). The Explorer Mini runs on a 12-volt battery with a driving range of 3.5 miles and a maximum speed of 1.5 mph, is controlled via a joystick with a 360-degree turning radius, has proportional speed control with 5 speed options, and can be used in a seated or standing position. | Device | Explorer Mini in a Seated Posture, Explorer Mini in a Standing Posture |
| Portable Mobility Aid for Children (PUMA)The Portable Mobility Aid for Children (PUMA; Enliten LLC) is a portable canopy system that utilizes an overhead support rail structure and a counterweight. The rail structure consists of two rigid parallel beams that mount to the canopy structure and one perpendicular mobile beam that allows for freedom of movement in one direction. Freedom of movement in the opposite direction is achieved by a system of pulleys along the movable beam that connects the harness to a counterweight. The counterweight provides a passive vertical force, counteracting gravity. The PUMA provides 2-dimensional mobility support over 81 ft2 (9 ft x 9 ft). The overhead bar is connected at 4 points to a child-worn harness. Children are free to move through many postures including sitting, crawling, standing, and walking. | Device | Portable Mobility Aid Partial Body Weight Support Harness (PUMA) |
Primary outcome
Percentage of space explored
Time frame: At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)
The path of each child's movement during the play sessions will be tracked from video recordings and sensor data. The path will then be used to determine the percentage of the available play space that the child explored. Values will range from 0 - 100%, a higher value indicates more space explored.
2 secondary outcomes
Normalized Integrated Electromyography (EMG)
Time frame: At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.1: Children Version
Time frame: At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Heather A Feldner, PhD, PT, PCS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permobil Explorer Mini and Portable Mobility Aid for Children (PUMA) in people with Down Syndrome and Gross Motor Delay, run by University of Washington 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 1 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: finished, as of the sponsor's last update on 4 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of space explored (time frame: At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.