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

Spectrum Ergonomics and Occupational Health Services

Status: Enrolling

Conditions: No Applicable Condition; Study of Physiologic Monitor Alarms

Treatments: Other: Observational with data collected

Study type: Observational

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT07273422

SEMI NBMC, NB18-24-44 (Other Grant/Funding Number)

IRB_00176473

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Males and female ages 18-100 years old and ambulatory

Treatment:

Other: Observational with data collected