Novel Self-charging, Medical-Grade Smart Insoles With AI/ML Edge Computing to Monitor Biometrics.

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

• 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

• 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

• 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.

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.