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

NCT07290556 | Not Yet Recruiting FDA Device

• 2 other identifiers: Pro00086649R44HD118822
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spina Bifida

Keywords

Spinal Bifida; Wheelchair; Pediatric; Standing

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (6)

• 100-Meter Roll Test (meters per second)

  Day 1

• 100-Meter Roll Test (perceived exertion)

  Day 1

• Pressure Mapping (peak pressure (mm/hg))

  Day 1

• Pressure Mapping (coefficient of variation)

  Day 1

• Functional Mobility Assessment - Family Centered (FMA-FC)

  Day 1 or 2

Other Outcomes (3)

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

  Day 1

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

  Day 1

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

  Day 1

Study Arms (2)

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.

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.

Device: PedMMSWC Simulated Home, School, Community Environment

Interventions

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.

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.

Experiment 2: Simulated Community and Home Testing

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Optimal Mobility, Inc: lead
• Gillette Children's Specialty Healthcare: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (1)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

Related Links

• Company (sponsor) Website

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Patricia McCraken, DPT, MBA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 18, 2025
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 25, 2027
• Study Completion (Estimated): August 25, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)