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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-02-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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No Applicable Condition; Study of Physiologic Monitor Alarms

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Males and female ages 18-100 years old and ambulatory

Observational with data collected

Intervention Type OTHER

Observational with data collection from sensors in insole

Interventions

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Observational with data collected

Observational with data collection from sensors in insole

Intervention Type OTHER

Eligibility Criteria

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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.

\-

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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes