This study will evaluate the effectiveness of newly developed self-powered, smart insoles that will be used for remote patient monitoring (RPM) for both military and civilian populations. The present study is part of a project funded by SEMI and the Air Force Research Laboratory (AFRL).
The present study, funded jointly by SEMI and the AFRL, is intended to evaluate the comfort, durability, and sensor accuracy of the smart insoles and associated mobile app. The study will evaluate both generation 1.0 and generation 2.0 of the smart insole. The primary difference between the two generations is the that gen 2.0 will use an improved energy harvester for power generation. The present study is structured in two phases. Phase 1 will evaluate gen 1.0 of the insole in a pilot study at the University of Utah (U of U) with 10 subjects. The subjects will be asked to wear the insole while walking at different speeds on an instrumented treadmill in the Motion Core Analysis Facility at the University of Utah and asked to walk over a ½ mile course on the U of U campus. This study will be overseen by Dr. Shad Roundy. Phase 2 will evaluate gen 2.0 of the insole. A pilot study will take place at the U of U and will mimic the phase 1 study with 10 subjects. Again, the study will be overseen by Dr. Shad Roundy. This will be followed up by a larger field study with 100 subjects who will be asked to take the insoles home and wear them over the course of 4 weeks. The field study will be overseen by Dr. Jeff Hiserman at Spectrum Ergonomics.
Study Type
OBSERVATIONAL
Enrollment
150
Observational with data collection from sensors in insole
Spectrum Ergonomics and Occupational Health Services
Williamsport, Pennsylvania, United States
RECRUITINGThe present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers.
The sensors will measure: Pulse Oxygen as the percentage saturation of oxygen carried in the red blood cells.
Time frame: "From enrollment to the end of observations at 4 weeks"
The present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers.
Description: The sensors will measure: Heart Rate and Heart Rate Variability in beats per minute.
Time frame: Time Frame: "From enrollment to the end of observations at 4 weeks"
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