School of Art and Design, Guangzhou Panyu Polytechnic, Guangzhou 511483, China.
Textile Engineering and Materials Research Group, School of Fashion and Textiles, De Montfort University, Leicester LE1 9BH, UK.
Int J Environ Res Public Health. 2022 Jul 26;19(15):9108. doi: 10.3390/ijerph19159108.
Hallux valgus (HV) is one of the most common forefoot deformities, and its prevalence increases with age. HV has been associated with poor foot function, difficulty in fitting footwear and poor health-related quality of life. The aims of this study were to design and develop an easy-to-use measurement device for measuring hallux valgus angle (HVA) in patients with HV and to assess the measurement reliability of the newly designed measurement device.
A manual measurement device for measuring HVA was designed and developed to test on patients with HV. Two measuring methods, i.e., test-retest and intra-observer measurements, were used to evaluate the repeatability and reliability of the newly designed measurement device. In the test-retest measurements, a total of 42 feet from 26 patients with HV were repeatedly measured by the same researcher using the manual measurement device every 3 weeks over a period of 12 months. The measurement reliability of the newly designed measurement device was analysed based on the collected HVA data. In the intra-observer measurements, a total of 22 feet from the same group of HV patients were measured by the same researcher using the manual measurement device and by a consultant using X-ray measurement for comparison. The intraclass correlation coefficient (ICC) was used to determine the correlation of measurements between the manual measurement device and X-ray measurement.
The mean of the difference between the two repeat measurements of HVA using the newly designed manual device was 0.62°, and the average of ICC was 0.995, which indicates excellent reliability. The ICC between X-ray and the average of twice-repeated manual measurements was 0.868, with 95% CI (0.649, 0.947) ( = 0.000). When the relationship in HVA between X-ray measurement and manual measurement using the new device was regressed as a linear relationship, the regression equation was y = 1.13x - 4.76 (R = 0.70).
The newly designed measurement device is easy to use, with low-cost and excellent reliability for HVA measurement, with the potential for use in clinical practice.
拇外翻（HV）是最常见的前足畸形之一，其患病率随着年龄的增长而增加。HV 与足部功能不佳、鞋类适配困难和健康相关生活质量差有关。本研究旨在设计和开发一种易于使用的测量装置，用于测量 HV 患者的拇外翻角（HVA），并评估新设计的测量装置的测量可靠性。
设计并开发了一种手动测量装置来测量 HV 患者的 HVA。使用两种测量方法，即复测和观察者内测量，来评估新设计的测量装置的可重复性和可靠性。在复测测量中，使用手动测量装置，由同一位研究者在 12 个月的时间内，每 3 周对 26 例 HV 患者的 42 只脚进行重复测量。基于收集的 HVA 数据，分析新设计的测量装置的测量可靠性。在观察者内测量中，由同一位研究者使用手动测量装置和顾问使用 X 射线测量对同一组 HV 患者的 22 只脚进行测量进行比较。使用组内相关系数（ICC）确定手动测量装置与 X 射线测量之间的测量相关性。
使用新设计的手动设备两次重复测量 HVA 的平均值差异为 0.62°，平均 ICC 为 0.995，表明可靠性极佳。X 射线和两次重复手动测量平均值之间的 ICC 为 0.868，95%CI（0.649，0.947）（ = 0.000）。当 X 射线测量和使用新设备的手动测量之间的 HVA 关系回归为线性关系时，回归方程为 y = 1.13x - 4.76（R = 0.70）。
新设计的测量装置易于使用，HVA 测量具有低成本和极佳的可靠性，有望在临床实践中应用。
