Implementing Machine Learning Into Optical Pedography: Development and Validation of a Novel Instrument: a Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Criterion validity of foot area measurement
研究概览
简要总结
This study aims to evaluate the validity and reliability of a proposed plantar pressure assessment intrument based on an implementation of machine learning into optical pedography.
详细描述
This study aims to evaluate the validity and reliability of a proposed plantar pressure assessment intrument based on an implementation of machine learning into optical pedography. The whole process will be divided into distinct steps required for the targeted outcome, which includes:
- collecting visual data (podoscope foot pictures) and training a segmentation machine learning-based algorithm designed for recognizing only feet area, a total of atleast 30 participants performing 9 different standing positions - over 270 usable pictures for training and functionality validation
- collecting personal, visual and pressure data (participant weight, podoscope foot pictures, pedobarographic platform measurements) and training a machine/deep learning-based model designed for feet pressure distribution areas identification and quantification, a total of estimated 60 participants undergoing 5 alternating, as similar as possible, measurements on podoscope and pedobarographic platform
- evaluating the validity and reliability of a new plantar pressure measuring instrument following the same imaging procedure as described in step 2, a total of estimated 60 participants
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A healthy individual with no absence of lower extremity
- •Aged ≥18 years
- •Willingness to participate and ability to follow the assessors instructions.
排除标准
- •Presence of foot diseases alternating foot contact area
- •Cognitive or psychiatric disorders limiting cooperation
- •Lack of informed consent or non-compliance during imaging
结局指标
主要结局
Criterion validity of foot area measurement
时间窗: Day 1
The total contact area of the foot during a static stance will be measured by the machine learning based optical pedography Instrument and compared to the gold standard pedobarographic platform. The validity will be determined by the Pearson Correlation Coefficient (r) between the two devices. Unit of measure: Pearson Correlation Coefficient (r) ranging from -1 to 1.
Criterion validity of peak plantar pressure distribution
时间窗: Day 1
The distribution of pressure across the plantar surface (specifically mean peak pressure) will be measured. Validity will be assessed by calculating the Intraclass Correlation Coefficient (ICC) between the machine learning based optical pedography instrument and the gold standard pedobarographic platform. Unit of measure: Intraclass Correlation Coefficient (ICC) ranging from 0 to 1.
Intrasession reliability of foot area measurement
时间窗: Day 1
The consistency of the total contact area (cm 2) measured across 5 repeated trials within a single session. Reliability will be assessed using the Intraclass Correlation Coefficient (ICC 3,5) to determine the degree of agreement between the five captures of the same participant's feet. Units of measure: Intraclass Correlation Coefficient (ICC) ranging from 0 to 1
Intrasession reliability of mean peak pressure
时间窗: Day 1
The consistency of mean peak pressure measurements across 5 repeated trials within a single session. Reliability will be assessed by calculating the Intraclass Correlation Coefficient (ICC 3,5) for the five measurements taken on the machine learning based optical pedography instrument. Unit of measure: Intraclass Correlation Coefficient (ICC) ranging from 0 to 1
次要结局
未报告次要终点
研究者
Jonatan Dvoracek
PhD student
Palacky University