Recruiting

Observational Study

Sponsor:

Optimal Mobility, Inc

Code:

NCT07290556

Conditions

Spina Bifida

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

PedMMSWC Wheelchair User Testing

PedMMSWC Simulated Home, School, Community Environment

Study Details

Brief summary:

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

Conditions

Spina Bifida

Study ID

NCT07290556

Start date

Jun 18, 2026

Status verified date

Jun, 2026

Completion date

Aug 25, 2027

Anticipated

Primary completion date

Aug 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Experiment 1: In-Lab Testing

Perform tasks in a laboratory environment designed to test the maneuverability and ease of use of the PedMMSWC as compared to commercial devices.

experimental: Experiment 2: Simulated Community and Home Testing

Perform tasks in a simulated home, school, and community setting using the PedMedWC wheelchair.

Interventions

PedMMSWC Wheelchair User Testing

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

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 outcome measure

  • Comparison of a modified Wheelchair Skills Test with Participants wheelchair to the PedMMSWC [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Patricia McCraken, DPT, MBA

320-247-2104pmccraken@optimal-mobility.com

Locations

Gillette Children's Specialty Healthcare

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Mark Jankowski

651-229-1760MarkDJankowski@gillettechildrens.com

Principal Investigator:

Alyssa M Spomer, PhD

More Information

Sponsor

Optimal Mobility, Inc

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Spinal Bifida
  • Wheelchair
  • Pediatric
  • Standing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Optimal Mobility, Inc on 2026-06-24.