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Purpose

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

Condition

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.