Spectrum Ergonomics and Occupational Health Services
Phase
Observational
Started
2026-06
Last updated
2025-12-09
Condition(s) studied
No Applicable Condition; Study of Physiologic Monitor Alarms
Investigational drug(s) / intervention(s)
Observational with data collected
Observational with data collected: Observational with data collection from sensors in insole
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Participant is generally health and between 18 and 90 year of age at time of signing consent.
2. 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:
* Age of Participants: 18-90
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
1. Participant is generally health and between 18 and 90 year of age at time of signing consent.
2. Participant must be available for 4 visits to Spectrum Ergonomics over a 4-week period, one visit per week.
Exclusion Criteria:
Exclusion Criteria for Phase 1 and Phase 2 pilot studies at UofU
* Flat feet (Pes planus)
* Unilateral leg amputee
* Females who are pregnant, \< 3 months postpartum, or currently lactating.
* Major surgery \< 6 months or minor surgery \< 3 months before enrollment.
* Major infections such as sepsis or pneumonia \< 3 months before enrollment.
* Myocardial infarction or heart failure \< 5 years or less before enrollment.
* Ankle fusion or total replacement
* Morbid obesity BMI \> 40.
Exclusion Criteria for Phase 2 field study at Spectrum Ergonomics
* Flat feet (Pes planus) or high arches (Pes cavus)
* Unilateral leg amputee.
* Brittle Diabetes- hard-to-control diabetes (also called labile diabetes), which is characterized by wide variations in blood glucose in which blood glucose levels can quickly move from too high (hyperglycemia) to too low (hypoglycemia).
* Peripheral neuropathy.
* Loss of sensation in the sole of foot.
* Open wound on the foot.
* Females who are pregnant, \< 3 months postpartum, or currently lactating.
* Ankle fusion or total replacement
* Major surgery \< 6 months or minor surgery \< 3 months before enrollment.
* Major infections such as sepsis or pneumonia \< 3 months before enrollment.
* Myocardial infarction or heart failure \< 1 years before enrollment.
* Morbid obesity BMI \> 40.
Primary outcome measure(s)
The present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers. — "From enrollment to the end of observations at 4 weeks" The sensors will measure: Pulse Oxygen as the percentage saturation of oxygen carried in the red blood cells.
Trial sites (1)
Facility
City
Region
Status
Spectrum Ergonomics and Occupational Health Services
Williamsport
Pennsylvania
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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