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

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
Optimal Mobility, Inc
Study ID
NCT07290556
Status
Not Yet Recruiting

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Conditions

  • Spina Bifida

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
May 1, 2026
Status verified
Dec 2025
Primary completion
Aug 25, 2027
Completion
Aug 25, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Gillette Children's Specialty HealthcareSaint PaulMinnesota55101
Mark Jankowski
651-229-1760
Alyssa M Spomer, PhD (PRINCIPAL_INVESTIGATOR)
Linda Krach, MD (SUB_INVESTIGATOR)
Sara J Morgan, PhD (SUB_INVESTIGATOR)
Mark Jankowski (SUB_INVESTIGATOR)

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