Novel Self-charging, Medical-Grade Smart Insoles With AI/ML Edge Computing to Monitor Biometrics.
Recruiting
Observational Study
No Applicable Condition; Study of Physiologic Monitor Alarms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Any
Study type
Observational
Participants needed
150 (estimated)
Sponsor
Spectrum Ergonomics and Occupational Health Services · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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City
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Status
Eligibility Criteria
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:…
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.
\-
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.
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