Spina BifidaNCT07290556
Establishing the Preliminary Utility of a Novel Pediatric Manual Mobile Standing Wheelchair
A study testing PedMMSWC Wheelchair User Testing and PedMMSWC Simulated Home, School, Community Environment in people with Spina Bifida, run by Optimal Mobility, Inc at 1 site in United States.
Trial summary
To establish the preliminary utility of a novel pediatric manual mobile standing wheelchair (PedMMSWC). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Spina Bifida
- What is being tested?
- PedMMSWC Wheelchair User Testing and PedMMSWC Simulated Home, School, Community Environment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2026to 25 Aug 2027
- Phase
- Interventional
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8 - 17 years old
- Primarily use a manual wheelchair for daily mobility
- Are actively enrolled in a standing program
- Fit the height and weight requirements of the PedMMSWC
- Can follow simple verbal instructions
- Are able to speak and read in English
Who cannot join
- Have insufficient trunk control to maneuver in seated and standing positions
- Have lower limb contracture which would preclude standing
- Have had orthopedic surgery within the last twelve months
- Have pressure injuries at the location where the PedMMSWC interfaces
- Have insufficient fine motor skills to independently initiate the sit-to-stand function
- Have a history of uncontrolled seizures or cardiovascular conditions that would make participation unsafe
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
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
Mark Jankowski, 651-229-1760, MarkDJankowski@gillettechildrens.com
Alyssa M Spomer, PhD
About this study
To establish the preliminary utility of a novel pediatric manual mobile standing wheelchair (PedMMSWC).
- Conditions
- Spina Bifida
- Being tested
- PedMMSWC Wheelchair User Testing, PedMMSWC Simulated Home, School, Community Environment
- Keywords
- Spinal Bifida, Wheelchair, Pediatric, Standing
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PedMMSWC Wheelchair User TestingDevice
The PedMMSWC standing wheelchair prototype will be tested and compared with a standing frame during Experiment 1: In-Lab Testing.
PedMMSWC Simulated Home, School, Community EnvironmentDevice
The PedMMSWC standing wheelchair will be tested in a simulated home, school, and community environment. Participants will be given assigned tasks and be scored on completion of activities.
| Study group | Role | What they receive |
|---|---|---|
| Experiment 1: In-Lab Testing | Experimental | Perform tasks in a laboratory environment designed to test the maneuverability and ease of use of the PedMMSWC as compared to commercial devices. Receives: Device: PedMMSWC Wheelchair User Testing |
| Experiment 2: Simulated Community and Home Testing | Experimental | Perform tasks in a simulated home, school, and community setting using the PedMedWC wheelchair. Receives: Device: PedMMSWC Simulated Home, School, Community Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of a modified Wheelchair Skills Test with Participants wheelchair to the PedMMSWC
The primary outcome measure for this aim is user performance on a modified Wheelchair Skills Test (mWST) under three test conditions: PedMMSWC in the seated position, PedMMSWC in the standing position, and the individuals' daily wheelchair.
The investigators hypothesize that performance on the mWST in the PedMMSWC will not be clinically inferior to performance in individuals' daily wheelchairs.
Measured: Day 1
Secondary outcomes (7)
100-Meter Roll Test (meters per second)
Participants will perform a 100-meter roll test in the PedMMSWC (in seated and standing) and their daily wheelchair (dWC). This test is originally described in the WST Version 4.1 and measures how quickly (meters per second) participants can cover 100 meters in their wheelchair over hard, flat, level ground. Participants will perform the test once in each device condition (PedMMSWC-Seated, PedMMSWC-Standing, dWC), rate their perceived exertion, and speed following each test.
Measured: Day 1
100-Meter Roll Test (perceived exertion)
Participants will perform a 100-meter roll test in the PedMMSWC (in seated and standing) and their daily wheelchair (dWC). This test measures how much effort (percieved exertion) participants use to cover 100 meters in their wheelchair over hard, flat, level ground. Participants will perform the test once in each device condition (PedMMSWC-Seated, PedMMSWC-Standing, dWC) and rate their perceived exertion.
Measured: Day 1
Pressure Mapping (peak pressure (mm/hg))
Participants will be measured with a pressure mapping device for peak pressure (mm/hg) in the PedMMSWC sitting, PedMMSWC standing, and the Easy Stand Device on interfacing surfaces.
Measured: Day 1
Pressure Mapping (coefficient of variation)
Participants will be measured with a pressure mapping device for coefficient of variation in the PedMMSWC sitting, PedMMSWC standing, and the Easy Stand Device on interfacing surfaces.
Measured: Day 1
Functional Mobility Assessment - Family Centered (FMA-FC)
To capture baseline satisfaction with individuals' primary wheelchair, each participant and their caregiver will collaboratively complete the FMA-FC outcome measure, which has been specifically designed and validated for pediatric use.
Measured: Day 1 or 2
Participant and Caregiver Perceptions of Device
Participants will complete a course in the PedMMSWC and their dWC designed to simulate typical activities in home, school, and community environments. In each of these environments, participants will engage in a series of structured activities tailored to their developmental level. While using the PedMMSWC, participants will also complete a 'free play' period during which they will be encouraged to explore and spontaneously interact with the space. Individuals will have free choice to move between seated and standing positions in the PedMMSWC for all tasks and play. Outcomes: qualitative and coded interview data, why and how often sit-to-stand transitions occur, the time spent standing, and therapist score task completion and safety on a 4-point scale.
Measured: Day 1 or Day 2
System Usability Scale
The SUS is a validated, 10-item quantitative scale used to measure the usability of an interactive system. Participants and their caregivers will complete the SUS in collaboration.
Measured: Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start18 Jun 2026
- Primary completion25 Aug 2027 (estimated)
- Study completion25 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optimal Mobility, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gillette Children's Specialty Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Minneapolis Veterans Affairs Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290556
- Sponsor's protocol ID
- Pro00086649
- Other IDs
- R44HD118822
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided