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

ConditionSpina Bifida

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age8-17

SponsorOptimal Mobility, Inc

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Experiment 1: In-Lab TestingExperimental treatment 1 intervention

Group B: Experiment 2: Simulated Community and Home TestingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Comparison of a modified Wheelchair Skills Test with Participants wheelchair to the PedMMSWC

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.

Time frame

Day 1

Secondary outcomes

100-Meter Roll Test (meters per second)

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.

Time frame

Day 1

100-Meter Roll Test (perceived exertion)

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.

Time frame

Day 1

Pressure Mapping (peak pressure (mm/hg))

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.

Time frame

Day 1

Pressure Mapping (coefficient of variation)

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.

Time frame

Day 1

Other outcomes

User-Device Movement during Sit-to-Stand Transitions (degrees of motion)

Using body motion analysis, investigators will record and analyze sit-to-stand transitions in a standing frame and the PedMMSWC wheelchair. Measuring three dimensional rotation of the thigh, shank, torso segments relative to the wheelchair during sit to stand transitions. during sit-to-stand transitions.

Time frame

Day 1

User-Device Movement during Sit-to-Stand Transitions (mm)

Using body motion analysis, investigators will record and analyze sit-to-stand transitions in a standing frame and the PedMMSWC wheelchair. Measuring the offset and translation (mm) of the body segments (trunk and thigh) relative to the chair or standing frame during sit-to-stand transitions.

Time frame

Day 1

User-Device Movement during Sit-to-Stand Transitions (seconds)

Using body motion analysis, investigators will record and analyze sit-to-stand transitions in a standing frame and the PedMMSWC wheelchair. Measuring time-to-stand (seconds), time-to-sit (seconds) in the chair or standing frame during sit-to-stand transitions.

Time frame

Day 1