Recruiting NCT07290556

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

No phase Interventional Spina Bifida

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: PedMMSWC Wheelchair User Testing, PedMMSWC Simulated Home, School, Community Environment.
Who it may be relevant to: Registry conditions: Spina Bifida. Basic parameters: 8 years — 17 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Device PedMMSWC Wheelchair User Testing
The PedMMSWC standing wheelchair prototype will be tested and compared with a standing frame during Experiment 1: In-Lab Testing.
Device 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.

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

Secondary outcome measures (7)

100-Meter Roll Test (meters per second) [Time frame: Day 1]
100-Meter Roll Test (perceived exertion) [Time frame: Day 1]
Pressure Mapping (peak pressure (mm/hg)) [Time frame: Day 1]
Pressure Mapping (coefficient of variation) [Time frame: Day 1]
Functional Mobility Assessment - Family Centered (FMA-FC) [Time frame: Day 1 or 2]
Participant and Caregiver Perceptions of Device [Time frame: Day 1 or Day 2]
System Usability Scale [Time frame: Visit 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT07290556 · Pro00086649 · R44HD118822