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

Purpose

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

Condition

  • Spina Bifida

Eligibility

Eligible Ages
Between 8 Years and 17 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experiment 1: In-Lab Testing 		Perform tasks in a laboratory environment designed to test the maneuverability and ease of use of the PedMMSWC as compared to commercial devices.
  • 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.
Experimental
Experiment 2: Simulated Community and Home Testing 		Perform tasks in a simulated home, school, and community setting using the PedMedWC wheelchair.
  • 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.

Recruiting Locations

Gillette Children's Specialty Healthcare
Saint Paul, Minnesota 55101
Contact:
Mark Jankowski
651-229-1760
MarkDJankowski@gillettechildrens.com

More Details

Status
Recruiting
Sponsor
Optimal Mobility, Inc

Study Contact

Patricia McCraken, DPT, MBA
320-247-2104
pmccraken@optimal-mobility.com