Spina Bifida
Conditions
Keywords
Spinal Bifida, Wheelchair, Pediatric, Standing
Brief summary
To establish the preliminary utility of a novel pediatric manual mobile standing wheelchair (PedMMSWC).
Interventions
DEVICEPedMMSWC Wheelchair User Testing
The PedMMSWC standing wheelchair prototype will be tested and compared with a standing frame during Experiment 1: In-Lab Testing.
DEVICEPedMMSWC 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.
Sponsors
Optimal Mobility, Inc
Gillette Children's Specialty Healthcare
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of a modified Wheelchair Skills Test with Participants wheelchair to the PedMMSWC | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 100-Meter Roll Test (meters per second) | Day 1 | Participants will perform a 100-meter roll test in the PedMMSWC (in seated and standing) and their daily wheelchair (dWC). This test is originally described in the WST Version 4.1 and measures how quickly (meters per second) participants can cover 100 meters in their wheelchair over hard, flat, level ground. Participants will perform the test once in each device condition (PedMMSWC-Seated, PedMMSWC-Standing, dWC), rate their perceived exertion, and speed following each test. |
| 100-Meter Roll Test (perceived exertion) | Day 1 | Participants will perform a 100-meter roll test in the PedMMSWC (in seated and standing) and their daily wheelchair (dWC). This test measures how much effort (percieved exertion) participants use to cover 100 meters in their wheelchair over hard, flat, level ground. Participants will perform the test once in each device condition (PedMMSWC-Seated, PedMMSWC-Standing, dWC) and rate their perceived exertion. |
| Pressure Mapping (peak pressure (mm/hg)) | Day 1 | Participants will be measured with a pressure mapping device for peak pressure (mm/hg) in the PedMMSWC sitting, PedMMSWC standing, and the Easy Stand Device on interfacing surfaces. |
| Pressure Mapping (coefficient of variation) | Day 1 | Participants will be measured with a pressure mapping device for coefficient of variation in the PedMMSWC sitting, PedMMSWC standing, and the Easy Stand Device on interfacing surfaces. |
| Functional Mobility Assessment - Family Centered (FMA-FC) | Day 1 or 2 | To capture baseline satisfaction with individuals' primary wheelchair, each participant and their caregiver will collaboratively complete the FMA-FC outcome measure, which has been specifically designed and validated for pediatric use. |
| Participant and Caregiver Perceptions of Device | Day 1 or Day 2 | Participants will complete a course in the PedMMSWC and their dWC designed to simulate typical activities in home, school, and community environments. In each of these environments, participants will engage in a series of structured activities tailored to their developmental level. While using the PedMMSWC, participants will also complete a 'free play' period during which they will be encouraged to explore and spontaneously interact with the space. Individuals will have free choice to move between seated and standing positions in the PedMMSWC for all tasks and play. Outcomes: qualitative and coded interview data, why and how often sit-to-stand transitions occur, the time spent standing, and therapist score task completion and safety on a 4-point scale. |
| System Usability Scale | Visit 1 | The SUS is a validated, 10-item quantitative scale used to measure the usability of an interactive system. Participants and their caregivers will complete the SUS in collaboration. |
Countries
United States
Contacts
CONTACTPatricia McCraken, DPT, MBA
Outcome results
None listed