Self-charging medical smart insoles that monitor biometrics

Evaluation of Self-powered Smart Insoles

This project will test self-powered smart insoles that collect walking biometrics in healthy adults 18–90 for military and civilian remote monitoring.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Spectrum Ergonomics and Occupational Health Services (industry)
• Locations: 1 site (Williamsport, Pennsylvania)
• Trial ID: NCT07273422 on ClinicalTrials.gov

What this trial studies

The project tests two generations of self-charging, medical-grade smart insoles and a companion mobile app to measure comfort, durability, and sensor accuracy. Phase 1 enrolls 10 subjects at the University of Utah for treadmill and campus walking tests using instrumented facilities; Phase 2 includes a 10-subject pilot at the University of Utah followed by a 100-subject, 4-week field study where participants wear insoles at home. The generation 2.0 device uses an improved energy harvester to increase on-device power for AI/ML edge computing. Data collection is observational: insoles record gait and physiologic signals while participants walk at different speeds and in daily life.

Who should consider this trial

Good fit: Ideal participants are generally healthy adults aged 18–90 who can walk about one mile comfortably and can attend weekly visits or wear the insoles at home for four weeks.

Not a fit: People who cannot walk a mile, are under 18 or over 90, have severe foot conditions preventing insole use, or are seeking therapeutic treatment rather than monitoring are unlikely to benefit.

Why it matters

Potential benefit: If successful, the insoles could provide continuous, self-powered remote monitoring of gait and physiologic signals without frequent recharging, enabling earlier detection of mobility or health changes.

How similar studies have performed: Wearable insoles and remote monitoring devices have shown promise for gait and physiologic tracking in prior work, but combining self-charging energy harvesting with on-device AI/ML for prolonged, charger-free monitoring is relatively novel.

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.

   \-

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.

Where this trial is running

Williamsport, Pennsylvania

• Spectrum Ergonomics and Occupational Health Services — Williamsport, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Robert Andosca, PhD — Inviza Health
• Study coordinator: Jeff Hiserman, Bachelor's

Conditions: No Applicable Condition, Study of Physiologic Monitor Alarms, remote patient monitoring, energy harvesting,