Mobility recorded by wearable devices and gold standards: the Mobilise-D procedure for data standardization

Wearable devices are used in movement analysis and physical activity research to extract clinically relevant information about an individual's mobility. Still, heterogeneity in protocols, sensor characteristics, data formats, and gold standards represent a barrier for data sharing, reproducibility, and external validation. In this study, we aim at providing an example of how movement data (from the real-world and the laboratory) recorded from different wearables and gold standard technologies can be organized, integrated, and stored. We leveraged on our experience from a large multi-centric study (Mobilise-D) to provide guidelines that can prove useful to access, understand, and re-use the data that will be made available from the study. These guidelines highlight the encountered challenges and the adopted solutions with the final aim of supporting standardization and integration of data in other studies and, in turn, to increase and facilitate comparison of data recorded in the scientific community. We also provide samples of standardized data, so that both the structure of the data and the procedure can be easily understood and reproduced

Technical validation of real-world monitoring of gait: a multicentric observational study

Introduction: Existing mobility endpoints based on functional performance, physical assessments and patient self-reporting are often affected by lack of sensitivity, limiting their utility in clinical practice. Wearable devices including inertial measurement units (IMUs) can overcome these limitations by quantifying digital mobility outcomes (DMOs) both during supervised structured assessments and in real-world conditions. The validity of IMU-based methods in the real- world, however, is still limited in patient populations. Rigorous validation procedures should cover the device metrological verification, the validation of the algorithms for the DMOs computation specifically for the population of interest and in daily life situations, and the users’ perspective on the device. Methods and analysis: This protocol was designed to establish the technical validity and patient acceptability of the approach used to quantify digital mobility in the real world by Mobilise-D, a consortium funded by the European Union (EU) as part of the Innovative Medicine Initiative, aiming at fostering regulatory approval and clinical adoption of DMOs. After defining the procedures for the metrological verification of an IMU-based device, the experimental procedures for the validation of algorithms used to calculate the DMOs are presented. These include laboratory and real-world assessment in 120 participants from five groups: healthy older adults; chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, proximal femoral fracture and congestive heart failure. DMOs extracted from the monitoring device will be compared with those from different reference systems, chosen according to the contexts of observation. Questionnaires and interviews will evaluate the users’ perspective on the deployed technology and relevance of the mobility assessment. Ethics and dissemination: The study has been granted ethics approval by the centre’s committees (London—Bloomsbury Research Ethics committee; Helsinki Committee, Tel Aviv Sourasky Medical Centre; Medical Faculties of The University of Tübingen and of the University of Kiel). Data and algorithms will be made publicly available

Increasing the Robustness of the automatic IMU calibration for lower Extremity Motion Analysis

With the advances of IMU-based human motion tracking, joint angle tracking in an home environment has become a realistic goal. Achieving it, could enable novel applications in rehabilitation and sports medicine. However, in existing systems the process of aligning the mounted sensors with the body coordinate system is either not robust enough or to complicated for fully unsupervised usage. In this publication the performance of a promising existing algorithm is evaluated with a range of different calibration motions. Further, an extension to this implementation is proposed, aiming to improve its stability when only non-ideal calibration data is available. It could be validated that the modification of the algorithm can increase the stability and reduce the dependency of the calibration on specific calibration motions. Based on these results, we recommend the proposed extension of the algorithm as a drop-in replacement for the existing implementation

Inertial sensor-based gait parameters reflect patient-reported fatigue in multiple sclerosis

Background!#!Multiple sclerosis (MS) is a disabling disease affecting the central nervous system and consequently the whole body's functional systems resulting in different gait disorders. Fatigue is the most common symptom in MS with a prevalence of 80%. Previous research studied the relation between fatigue and gait impairment using stationary gait analysis systems and short gait tests (e.g. timed 25 ft walk). However, wearable inertial sensors providing gait data from longer and continuous gait bouts have not been used to assess the relation between fatigue and gait parameters in MS. Therefore, the aim of this study was to evaluate the association between fatigue and spatio-temporal gait parameters extracted from wearable foot-worn sensors and to predict the degree of fatigue.!##!Methods!#!Forty-nine patients with MS (32 women; 17 men; aged 41.6 years, EDSS 1.0-6.5) were included where each participant was equipped with a small Inertial Measurement Unit (IMU) on each foot. Spatio-temporal gait parameters were obtained from the 6-min walking test, and the Borg scale of perceived exertion was used to represent fatigue. Gait parameters were normalized by taking the difference of averaged gait parameters between the beginning and end of the test to eliminate inter-individual differences. Afterwards, normalized parameters were transformed to principle components that were used as input to a Random Forest regression model to formulate the relationship between gait parameters and fatigue.!##!Results!#!Six principal components were used as input to our model explaining more than 90% of variance within our dataset. Random Forest regression was used to predict fatigue. The model was validated using 10-fold cross validation and the mean absolute error was 1.38 points. Principal components consisting mainly of stride time, maximum toe clearance, heel strike angle, and stride length had large contributions (67%) to the predictions made by the Random Forest.!##!Conclusions!#!The level of fatigue can be predicted based on spatio-temporal gait parameters obtained from an IMU based system. The results can help therapists to monitor fatigue before and after treatment and in rehabilitation programs to evaluate their efficacy. Furthermore, this can be used in home monitoring scenarios where therapists can monitor fatigue using IMUs reducing time and effort of patients and therapists

Does the Position of Foot-Mounted IMU Sensors Influence the Accuracy of Spatio-Temporal Parameters in Endurance Running?

Wearable sensor technology already has a great impact on the endurance running community. Smartwatches and heart rate monitors are heavily used to evaluate runners’ performance and monitor their training progress. Additionally, foot-mounted inertial measurement units (IMUs) have drawn the attention of sport scientists due to the possibility to monitor biomechanically relevant spatio-temporal parameters outside the lab in real-world environments. Researchers developed and investigated algorithms to extract various features using IMU data of different sensor positions on the foot. In this work, we evaluate whether the sensor position of IMUs mounted to running shoes has an impact on the accuracy of different spatio-temporal parameters. We compare both the raw data of the IMUs at different sensor positions as well as the accuracy of six endurance running-related parameters. We contribute a study with 29 subjects wearing running shoes equipped with four IMUs on both the left and the right shoes and a motion capture system as ground truth. The results show that the IMUs measure different raw data depending on their position on the foot and that the accuracy of the spatio-temporal parameters depends on the sensor position. We recommend to integrate IMU sensors in a cavity in the sole of a running shoe under the foot’s arch, because the raw data of this sensor position is best suitable for the reconstruction of the foot trajectory during a stride

Hidden Markov Model based stride segmentation on unsupervised free-living gait data in Parkinson’s disease patients

Background!#!To objectively assess a patient's gait, a robust identification of stride borders is one of the first steps in inertial sensor-based mobile gait analysis pipelines. While many different methods for stride segmentation have been presented in the literature, an out-of-lab evaluation of respective algorithms on free-living gait is still missing.!##!Method!#!To address this issue, we present a comprehensive free-living evaluation dataset, including 146.574 semi-automatic labeled strides of 28 Parkinson's Disease patients. This dataset was used to evaluate the segmentation performance of a new Hidden Markov Model (HMM) based stride segmentation approach compared to an available dynamic time warping (DTW) based method.!##!Results!#!The proposed HMM achieved a mean F1-score of 92.1% and outperformed the DTW approach significantly. Further analysis revealed a dependency of segmentation performance to the number of strides within respective walking bouts. Shorter bouts ([Formula: see text] strides) resulted in worse performance, which could be related to more heterogeneous gait and an increased diversity of different stride types in short free-living walking bouts. In contrast, the HMM reached F1-scores of more than 96.2% for longer bouts ([Formula: see text] strides). Furthermore, we showed that an HMM, which was trained on at-lab data only, could be transferred to a free-living context with a negligible decrease in performance.!##!Conclusion!#!The generalizability of the proposed HMM is a promising feature, as fully labeled free-living training data might not be available for many applications. To the best of our knowledge, this is the first evaluation of stride segmentation performance on a large scale free-living dataset. Our proposed HMM-based approach was able to address the increased complexity of free-living gait data, and thus will help to enable a robust assessment of stride parameters in future free-living gait analysis applications

Validation of a Sensor-Based Gait Analysis System with a Gold-Standard Motion Capture System in Patients with Parkinson’s Disease

Digital technologies provide the opportunity to analyze gait patterns in patients with Parkinson’s Disease using wearable sensors in clinical settings and a home environment. Confirming the technical validity of inertial sensors with a 3D motion capture system is a necessary step for the clinical application of sensor-based gait analysis. Therefore, the objective of this study was to compare gait parameters measured by a mobile sensor-based gait analysis system and a motion capture system as the gold standard. Gait parameters of 37 patients were compared between both systems after performing a standardized 5 × 10 m walking test by reliability analysis using intra-class correlation and Bland–Altman plots. Additionally, gait parameters of an age-matched healthy control group (n = 14) were compared to the Parkinson cohort. Gait parameters representing bradykinesia and short steps showed excellent reliability (ICC > 0.96). Shuffling gait parameters reached ICC > 0.82. In a stridewise synchronization, no differences were observed for gait speed, stride length, stride time, relative stance and swing time (p > 0.05). In contrast, heel strike, toe off and toe clearance significantly differed between both systems (p < 0.01). Both gait analysis systems distinguish Parkinson patients from controls. Our results indicate that wearable sensors generate valid gait parameters compared to the motion capture system and can consequently be used for clinically relevant gait recordings in flexible environments

Assessing real-world gait with digital technology? Validation, insights and recommendations from the Mobilise-D consortium.

Although digital mobility outcomes (DMOs) can be readily calculated from real-world data collected with wearable devices and ad-hoc algorithms, technical validation is still required. The aim of this paper is to comparatively assess and validate DMOs estimated using real-world gait data from six different cohorts, focusing on gait sequence detection, foot initial contact detection (ICD), cadence (CAD) and stride length (SL) estimates.Twenty healthy older adults, 20 people with Parkinson's disease, 20 with multiple sclerosis, 19 with proximal femoral fracture, 17 with chronic obstructive pulmonary disease and 12 with congestive heart failure were monitored for 2.5 h in the real-world, using a single wearable device worn on the lower back. A reference system combining inertial modules with distance sensors and pressure insoles was used for comparison of DMOs from the single wearable device. We assessed and validated three algorithms for gait sequence detection, four for ICD, three for CAD and four for SL by concurrently comparing their performances (e.g., accuracy, specificity, sensitivity, absolute and relative errors). Additionally, the effects of walking bout (WB) speed and duration on algorithm performance were investigated.We identified two cohort-specific top performing algorithms for gait sequence detection and CAD, and a single best for ICD and SL. Best gait sequence detection algorithms showed good performances (sensitivity > 0.73, positive predictive values > 0.75, specificity > 0.95, accuracy > 0.94). ICD and CAD algorithms presented excellent results, with sensitivity > 0.79, positive predictive values > 0.89 and relative errors < 11% for ICD and < 8.5% for CAD. The best identified SL algorithm showed lower performances than other DMOs (absolute error < 0.21 m). Lower performances across all DMOs were found for the cohort with most severe gait impairments (proximal femoral fracture). Algorithms' performances were lower for short walking bouts; slower gait speeds (< 0.5 m/s) resulted in reduced performance of the CAD and SL algorithms.Overall, the identified algorithms enabled a robust estimation of key DMOs. Our findings showed that the choice of algorithm for estimation of gait sequence detection and CAD should be cohort-specific (e.g., slow walkers and with gait impairments). Short walking bout length and slow walking speed worsened algorithms' performances. Trial registration ISRCTN - 12246987