Reliability of 3D Foot Scanner for Use in Diabetes Fit Evaluation and Footwear Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Interrater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)
研究概览
简要总结
The investigators will carry out a proof-of-concept study in 20 adult healthy male and female volunteers in order to: assess a 3D foot scanner's reliability. Specifically, the investigators will assess its variability during repeated foot scans of the same subject's foot. Three repeated foot scans will be carried out by two different examiners to measure intrarater and interrater reliability (Intraclass Correlation Coefficient
详细描述
Evidence of reliability is essential for use of a 3D foot scanner in diabetes footwear fit evaluation and orthopaedic footwear design. The investigators will carry out a proof-of-concept study in 20 healthy adult male and female volunteers in order to: assess the 3D foot scanner's reliability. Specifically, the investigators will assess its variability during three repeated foot scans of the same subject's foot. Three half weightbearing foot scans will be carried out by two different examiners to measure intrarater and interrater reliability (Intraclass Correlation Coefficient).
The investigators will carry out a proof-of-concept study in 20 healthy adult male and female volunteers (10 each) in order to assess the Elinvision 3D foot scanner's (i) intra-rater reliability through repeated foot scans (3 times each) and (ii) inter-rater reliability of these scans as carried out by two independent examiners whilst participants are half weightbearing to establish adequate reliability (0.80+ ICC) for use in subsequent diabetes footwear fit assessment and orthopaedic footwear design and manufacture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Healthy men and women aged 18 years or over
- •Able to walk unaided
- •Able to walk up steps (the 3D scanner requires a small step on to the device to enter the correct position for measurement)
- •Willingness and capacity to participate in the study and to sign the informed consent form
排除标准
- •Diabetes mellitus diagnosis
- •Inability to ambulate independently without walking aids
- •No obvious foot deformities
- •No history of foot surgery
- •No pain, injuries or medical conditions affecting the legs or lower back
- •Any issues around balance (participants must remain standing in position for the approximately fifteen seconds required to obtain the 3D scan of their feet)
- •Health conditions that impact foot morphology
结局指标
主要结局
Interrater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)
时间窗: Repeated scans at baseline
(ii) Interrater reliability (Intraclass Correlation Coefficient) based on three scans of the same subject's foot first by one rater (as above) and then by a second rater
Intrarater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)
时间窗: Repeated scans at baseline
(i) Intrarater reliability (Intraclass Correlation Coefficient) based on three scans of the same subject's foot whilst half-weightbearing carried out by the same 'rater' i.e. person using the 3D foot scanner;
次要结局
未报告次要终点