RecruitingNCT07273422
Novel Self-charging, Medical-Grade Smart Insoles With AI/ML Edge Computing to Monitor Biometrics.
Evaluation of Self-powered Smart Insoles
Sponsor
Spectrum Ergonomics and Occupational Health Services
Enrollment
150 participants
Start Date
Jun 1, 2026
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 YearsMax Age: 90 Years
Inclusion Criteria5
- 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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- 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 Criteria24
- Age of Participants: 18-90
- Sample Size:
- At Utah:
- All Centers: 120
- 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.
- 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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Interventions
OTHERObservational with data collected
Observational with data collection from sensors in insole
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07273422