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

Optimal Mobility, Inc

Status: Begins enrollment in 4 months

Conditions: Spina Bifida

Treatments: Device: PedMMSWC Wheelchair User Testing; Device: PedMMSWC Simulated Home, School, Community Environment

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency; NIH

Identifiers

NCT07290556

R44HD118822 (U.S. NIH Grant/Contract)

Pro00086649

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experiment 1: In-Lab Testing

Experimental group

Description:

Perform tasks in a laboratory environment designed to test the maneuverability and ease of use of the PedMMSWC as compared to commercial devices.

Treatment:

Device: PedMMSWC Wheelchair User Testing

Experiment 2: Simulated Community and Home Testing

Experimental group

Description:

Perform tasks in a simulated home, school, and community setting using the PedMedWC wheelchair.

Treatment:

Device: PedMMSWC Simulated Home, School, Community Environment