The use of inertial measurement units (IMUs) as an alternative to optical marker-based systems has the potential to make gait analysis part of the clinical standard of care. Previously, an IMU-based system leveraging Rauch-Tung-Striebel smoothing to estimate knee angles was assessed using a six-degrees-of-freedom joint simulator. In a clinical setting, however, accurately measuring abduction/adduction and external/internal rotation of the knee joint is particularly challenging, especially in the presence of soft tissue artefacts. In this study, the in vivo IMU-based joint angles of 40 asymptomatic knees were assessed during level walking, under two distinct sensor placement configurations: (1) IMUs fixed to a rigid harness, and (2) IMUs mounted on the skin using elastic hook-and-loop bands (from here on referred to as "skin-mounted IMUs"). Estimates were compared against values obtained from a harness-mounted optical marker-based system. The comparison of these three sets of kinematic signals (IMUs on harness, IMUs on skin, and optical markers on harness) was performed before and after implementation of a REference FRame Alignment MEthod (REFRAME) to account for the effects of differences in coordinate system orientations. Prior to the implementation of REFRAME, in comparison to optical estimates, skin-mounted IMU-based angles displayed mean root-mean-square errors (RMSEs) up to 6.5°, while mean RMSEs for angles based on harness-mounted IMUs peaked at 5.1°. After REFRAME implementation, peak mean RMSEs were reduced to 4.1°, and 1.5°, respectively. The negligible differences between harness-mounted IMUs and the optical system after REFRAME revealed that the IMU-based system was capable of capturing the same underlying motion pattern as the optical reference. In contrast, obvious differences between the skin-mounted IMUs and the optical reference indicated that the use of a harness led to fundamentally different joint motion being measured, even after accounting for reference frame misalignments. Fluctuations in the kinematic signals associated with harness use suggested the rigid device oscillated upon heel strike, likely due to inertial effects from its additional mass. Our study proposes that optical systems can be successfully replaced by more cost-effective IMUs with similar accuracy, but further investigation (especially in vivo and upon heel strike) against moving videofluoroscopy is recommended.
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