Evaluation of Self-powered Smart Insoles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Age of Participants: 18-90
- •Sample Size:
- •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
- •Participant must be able to walk comfortably for 1 mile.
- •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 >
- •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.
结局指标
主要结局
The present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers.
时间窗: "From enrollment to the end of observations at 4 weeks"
The sensors will measure: Pulse Oxygen as the percentage saturation of oxygen carried in the red blood cells.
次要结局
- The present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers.(Time Frame: "From enrollment to the end of observations at 4 weeks")