Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-007531
NCT ID: NCT03987243
Sponsor Protocol Number: 16-007531
About this study
The purpose of this study is to gather information on how a mobile pressure mapping system, when used at home on a daily basis, affects behaviors known to reduce risk of pressure ulcer development.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Participants will meet inclusion criteria if they live in the community.
- Aged 18 or older, male or female, have paraplegia or quadriplegia due to a spinal cord injury that includes sensory loss below their level of injury, and require full-time wheelchair use for mobility.
- Participants must demonstrate ability to independently access a smartphone and the required pressure mapping application on the smartphone.
- Participants must be able to tolerate sitting for a minimum of 6 hours per day, 7 days per week, and they must be able to perform weight shifts independently.
- Participants must be able and willing to attend in-person visits at start and end of the study, about 4 weeks apart.
Exclusion Criteria:
- Individuals will not be eligible for this study if there is an active stage 3, 4, or unstageable pressure ulcer as defined by the National Pressure Ulcer Advisory Panel definitions anywhere on their sitting surface.
- They are not able to independently access the pressure mapping application on a smartphone, or if they are not able to complete an adequate weight shift without help.
- Individual who use a specific custom-molded seat cushion (Ride Designs Custom Seat Cushion) will not be eligible due to challenges with conformability of the pressure sensing mat to the deep contours of this particular cushion.
- Individuals will also be excluded if they live in a long term care facility or group home and require 24 hours/day assistance.
- Participants will be screened by phone or in person when being considered for enrollment into the study for cognitive impairments relating to memory and new learning. If a cognitive impairment is identified by a score of 3 or less on the Six-item Screen for Cognitive Impairment (Callahan, Unverzagt, Hui, Perkins, & Hendrie, 2002), the participants will not be able to participate in this study because there is an expectation of ability to learn new information and be able to recall the information over the study period.
- Participants must be Mayo Clinic patients for access to the medical record.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available