Novel Self-charging, Medical-Grade Smart Insoles With AI/ML Edge Computing to Monitor Biometrics.
Recruiting now
Conditions studied: No Applicable Condition; Study of Physiologic Monitor Alarms
In brief
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).
Key facts
- Study ID
- NCT07273422
- Run by
- Spectrum Ergonomics and Occupational Health Services
- People needed
- 150
- Starts
- 2026-06-01
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2025-12-09
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Spectrum Ergonomics and Occupational Health Services — Williamsport, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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