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 — DEVICEThe 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 — DEVICEThe 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 TestingPerform 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 TestingPerform 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
- Patricia McCraken, DPT, MBA320-247-2104
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Gillette Children's Specialty Healthcare | Saint Paul | Minnesota | 55101 | 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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