新型高频传感器设备在前负荷和无负荷条件下测量胫骨前向平移的重测信度和同时效度评估：一项探索性横断面研究。

Test-retest reliability and concurrent validity assessment of a novel high-frequency sensor device for anterior tibial translation measurement in loaded and unloaded condition: an exploratory cross-sectional study.

机构信息

Department of Health Professions, Physiotherapy, Bern University of Applied Sciences, Bern, Switzerland.

Institute for Human Centered Engineering, Bern University of Applied Sciences, Biel, Switzerland.

出版信息

BMC Musculoskelet Disord. 2024 Mar 16;25(1):218. doi: 10.1186/s12891-024-07343-y.

DOI:10.1186/s12891-024-07343-y

PMID:38491405

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10943913/

Abstract

BACKGROUND

Magnetic resonance imaging (MRI) and manual tests remain the standard for diagnosing anterior cruciate ligament (ACL) rupture. Furthermore, the passive knee displacement, also described as anterior tibial translation (ATT), is used in order to make decisions about surgery or to assess rehabilitation outcomes. Unfortunately, these manual tests are limited to passive situations, and their application to assess knee stability in loaded, weight-bearing positions are missing. Therefore, a new device with high-performance sensors and a new sensor setting was developed. The aim of this exploratory cross-sectional study was to assess the test-retest reliability of this new device in a first step and the concurrent validity in a second step.

METHODS

A total of 20 healthy volunteers were measured. Measurement consistency of the new device was assessed on the basis of reliability during Lachman test setting and in loaded position by artificial knee perturbation in a test-retest procedure. In a second step, the concurrent validity was evaluated with the Lachmeter® as a reference instrument. Intraclass correlation coefficient (ICC), standard error of measurement (SEM), the minimal detectable change (MDC) and Bland-Altman analysis were evaluated to assess the quality criteria.

RESULTS

The measurements with the new device during the Lachman test provided a mean ATT of 5.46±2.22mm. The SEM ranged from 0.60 to 0.69mm resulting in an MDC between 1.67 and 1.93mm for the new device. In the loaded test situation, the mean ATT was 2.11±1.20mm, with test-retest reliability also showing good correlation (r>0.83). The comparison of the two measurement methods with an ICC of (r>0.89) showed good correlation, which also underlines the reasonable agreement of the Bland-Altman analysis.

CONCLUSIONS

The evaluation of the test-retest reliability of the new device during the knee stability testing in passive situation as well as in a functional, loaded situation presented good reliability. In addition, the new device demonstrated good agreement with the reference device and therefore good validity. Furthermore, the quality criteria demonstrated the ability of the new device to detect the cut-off value (3-5mm) described in the literature for the diagnosis of ACL-deficient knees, which underlines the clinical relevance of this new device as a reliable and valid tool.

摘要

背景

磁共振成像（MRI）和手动测试仍然是诊断前交叉韧带（ACL）断裂的标准。此外，被动膝关节位移，也称为胫骨前移（ATT），用于做出手术决策或评估康复效果。不幸的是，这些手动测试仅限于被动情况，并且它们在负载、承重位置下评估膝关节稳定性的应用还不完善。因此，开发了一种具有高性能传感器和新传感器设置的新设备。本探索性横断面研究的目的是在第一步评估该新设备的测试-再测试可靠性，在第二步评估其同时效度。

方法

共测量了 20 名健康志愿者。在测试-再测试过程中，根据 Lachman 测试设置和人工膝关节扰动的负载位置，通过可靠性评估新设备的测量一致性。在第二步中，使用 Lachmeter®作为参考仪器评估同时效度。使用组内相关系数（ICC）、测量标准误差（SEM）、最小可检测变化（MDC）和 Bland-Altman 分析来评估质量标准。

结果

新设备在 Lachman 测试中的测量结果显示 ATT 平均值为 5.46±2.22mm。SEM 范围为 0.60 至 0.69mm，新设备的 MDC 为 1.67 至 1.93mm。在负载测试情况下，ATT 的平均值为 2.11±1.20mm，测试-再测试可靠性也显示出良好的相关性（r>0.83）。两种测量方法的 ICC（r>0.89）比较显示出良好的相关性，这也强调了 Bland-Altman 分析的合理一致性。

结论

在被动和功能性负载情况下评估新设备的膝关节稳定性测试的测试-再测试可靠性时，表现出良好的可靠性。此外，新设备与参考设备具有良好的一致性，因此具有良好的有效性。此外，质量标准表明，该新设备具有检测文献中描述的 ACL 缺失膝关节诊断的截断值（3-5mm）的能力，这强调了该新设备作为一种可靠有效的工具的临床相关性。