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NCT Number: NCT07290556

Establishing the Preliminary Utility of a Novel Pediatric Manual Mobile Standing Wheelchair

To establish the preliminary utility of a novel pediatric manual mobile standing wheelchair (PedMMSWC).

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location status: Recruiting

Location contact

Alyssa M Spomer, PhD

PRINCIPAL_INVESTIGATOR

Linda Krach, MD

SUB_INVESTIGATOR

Mark Jankowski

CONTACT

[email protected]

651-229-1760

Mark Jankowski

SUB_INVESTIGATOR

Sara J Morgan, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PedMMSWC Wheelchair User Testing

Device

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 Environment

Device

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.

Primary outcomes

  1. Comparison of a modified Wheelchair Skills Test with Participants wheelchair to the PedMMSWC

    Time frame: Day 1

    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.

Secondary outcomes

  1. 100-Meter Roll Test (meters per second)

    Time frame: Day 1

    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.

  2. 100-Meter Roll Test (perceived exertion)

    Time frame: Day 1

    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.

  3. Pressure Mapping (peak pressure (mm/hg))

    Time frame: Day 1

    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.

  4. Pressure Mapping (coefficient of variation)

    Time frame: Day 1

    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.

  5. Functional Mobility Assessment - Family Centered (FMA-FC)

    Time frame: Day 1 or 2

    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.

  6. Participant and Caregiver Perceptions of Device

    Time frame: Day 1 or Day 2

    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.

  7. System Usability Scale

    Time frame: Visit 1

    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.

Other outcomes

  1. User-Device Movement during Sit-to-Stand Transitions (degrees of motion)

    Time frame: Day 1

    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.

  2. User-Device Movement during Sit-to-Stand Transitions (mm)

    Time frame: Day 1

    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.

  3. User-Device Movement during Sit-to-Stand Transitions (seconds)

    Time frame: Day 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia McCraken, DPT, MBA

CONTACT

[email protected]

320-247-2104

Sponsors and collaborators

Lead sponsor

Optimal Mobility, Inc

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Gillette Children's Specialty Healthcare
  • Minneapolis Veterans Affairs Medical Center

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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