NCT07290556 · Optimal Mobility, Inc
Establishing the Preliminary Utility of a Novel Pediatric Manual Mobile Standing Wheelchair
What this study is about
To establish the preliminary utility of a novel pediatric manual mobile standing wheelchair (PedMMSWC).
View original scientific description
To establish the preliminary utility of a novel pediatric manual mobile standing wheelchair (PedMMSWC).
Interventions
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.
Primary outcome measures
Comparison of a modified Wheelchair Skills Test with Participants wheelchair to the PedMMSWC
Time frame: Day 1
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Saint Paul, Minnesota
Collaborators
Gillette Children's Specialty Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Minneapolis Veterans Affairs Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations