An interventional study of PedMMSWC Wheelchair User Testing and PedMMSWC Simulated Home, School, Community Environment in Spina Bifida, sponsored by Optimal Mobility, Inc. Recruiting at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Optimal Mobility, Inc · Not applicable, Interventional, and Basic science
To establish the preliminary utility of a novel pediatric manual mobile standing wheelchair (PedMMSWC).
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →This is the only study on the registry with Optimal Mobility, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Perform tasks in a laboratory environment designed to test the maneuverability and ease of use of the PedMMSWC as compared to commercial devices.
Device: PedMMSWC Wheelchair User Testing
Perform tasks in a simulated home, school, and community setting using the PedMedWC wheelchair.
Device: PedMMSWC Simulated Home, School, Community Environment
The PedMMSWC standing wheelchair prototype will be tested and compared with a standing frame during Experiment 1: In-Lab Testing.
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.
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.
Time frame: Day 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 1
User-Device Movement during Sit-to-Stand Transitions (degrees of motion)
Using body motion analysis, investigators will record and analyze sit-to-stand transitions in a standing frame and the PedMMSWC wheelchair. Measuring three dimensional rotation of the thigh, shank, torso segments relative to the wheelchair during sit to stand transitions. during sit-to-stand transitions.
Time frame: Day 1
User-Device Movement during Sit-to-Stand Transitions (mm)
Using body motion analysis, investigators will record and analyze sit-to-stand transitions in a standing frame and the PedMMSWC wheelchair. Measuring the offset and translation (mm) of the body segments (trunk and thigh) relative to the chair or standing frame during sit-to-stand transitions.
Time frame: Day 1
User-Device Movement during Sit-to-Stand Transitions (seconds)
Using body motion analysis, investigators will record and analyze sit-to-stand transitions in a standing frame and the PedMMSWC wheelchair. Measuring time-to-stand (seconds), time-to-sit (seconds) in the chair or standing frame during sit-to-stand transitions.
Time frame: Day 1
Plan to share: Undecided
Started Jun 2026 (actual). Primary completion is estimated for Aug 2027, 14 months after the start.
Of 62 interventional studies with no phase under Spinal Dysraphism, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's planned 14 months is below that.
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