Abstract
Measurement errors play an important role in the development of goniometric equipment, devices used to measure range of motion. Reasonable validity and reliability are critical for both the device and examiner before and after to testing in human subjects. The objective is to evaluate the concurrent validity and reliability of five different clinical goniometric devices for the purpose of establishing an acceptable measurement error margin for a novel device. We explored the validity and inter- and intrarater reliability scores of five goniometric devices namely (i) the universal goniometer (UG), a two-armed hand-held goniometer, (ii) the inclinometer (IC), featuring a single base, fluid level, and gravity-weighted inclinometer, (iii) the digital inclinometer (DI), functioning as both a DI and dynamometer, (iv) the smartphone application (SA), employing gyroscope-based technology within a smartphone platform application and (v) the modified inclinometer (MI), a gravity pendulum-based inclinometer equipped with a specialized fixing apparatus. Measurements were obtained at 12 standard angles and 8 human shoulder flexion angles ranging from 0° to 180°. Over two testing sessions, 120 standardized angle measurements and 160 shoulder angle measurements from 20 shoulders were repetitively taken by three examiners for each device. The intraclass correlation coefficient (ICC), standard error of measurement (SEM), and minimal detectable change (MDC) were calculated to assess reliability and validity. Concurrent validity was also evaluated through the execution of the 95% limit of agreement (95% LOA) and Bland-Altman plots, with comparisons made to the UG. The concurrent validity for all device pairs was excellent in both study phases (ICC > 0.99, 95% LOA - 4.11° to 4.04° for standard angles, and - 10.98° to 11.36° for human joint angles). Inter- and intrarater reliability scores for standard angles were excellent across all devices (ICC > 0.98, SEM 0.59°-1.75°, MDC 1°-4°), with DI showing superior reliability. For human joint angles, device reliability ranged from moderate to excellent (ICC 0.697-0.975, SEM 1.93°-4.64°, MDC 5°-11° for inter-rater reliability; ICC 0.660-0.996, SEM 0.77°-4.06°, MDC 2°-9° for intra-rater reliability), with SA demonstrating superior reliability. Wider angle measurement however resulted in reduced device reliability. In conclusion, our study demonstrates that it is essential to assess measurement errors independently for standard and human joint angles. The DI is the preferred reference for standard angle testing, while the SA is recommended for human joint angle testing. Separate evaluations across the complete 0°-180° range offer valuable insights.