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| ID | Type | Description | Link |
|---|---|---|---|
| SEMI NBMC, NB18-24-44 | Other Grant/Funding Number | USAFRL |
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| Name | Class |
|---|---|
| University of Utah | OTHER |
| United States Air Force Research Laboratory | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Males and female ages 18-100 years old and ambulatory |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational with data collected | Other | Observational with data collection from sensors in insole |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | "From enrollment to the end of observations at 4 weeks" |
| Measure | Description | Time Frame |
|---|---|---|
| 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: "From enrollment to the end of observations at 4 weeks" |
| Measure | Description | Time Frame |
|---|---|---|
| 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: Body temperature as measured in degrees Celsius. | Time Frame: "From enrollment to the end of observations at 4 weeks" |
Inclusion Criteria:
Participant is generally health and between 18 and 90 year of age at time of signing consent.
Participant must be available for 4 visits to Spectrum Ergonomics over a 4-week period, one visit per week.
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Exclusion Criteria:
Sample Size:
At Utah:
All Centers: 120
Inclusion Criteria:
Inclusion criteria for Phase 1 and Phase 2 pilot studies at UofU
1. Participant is generally healthy and between 18 and 90 years of age at time of signing consent 2. Participant must be able to walk comfortably for 1 mile. 3. Will seek 5 male and 5 female participants. Inclusion criteria for Phase 2 field studies conducted by Spectrum Ergonomics
Exclusion Criteria:
Exclusion Criteria for Phase 1 and Phase 2 pilot studies at UofU
Exclusion Criteria for Phase 2 field study at Spectrum Ergonomics
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Participants will be recruited from the clinic's patient population, their family and friends, and from the general public in the northcentral Pennsylvania region.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeff Hiserman, Bachelor's | Contact | 15704953298 | spectrumergonomics@gmail.com | |
| Ryane Sorenson, Bachelor's | Contact | 801-585-0302 | ryane.sorenson@hsc.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Andosca, PhD | Inviza Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Ergonomics and Occupational Health Services | Recruiting | Williamsport | Pennsylvania | 17701 | United States |
The data will be shared as group data, divided into various groups, i.e. age and gender.
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