IntroductionExisting 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 analysisThis 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 disseminationThe 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.Trial registration numberISRCTN (12246987).

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.

The use of machine learning (ML) with electronic health records (EHR) is growing in popularity as a means to extract knowledge that can improve the decision-making process in healthcare. Such methods require training of high-quality learning models based on diverse and comprehensive datasets, which are hard to obtain due to the sensitive nature of medical data from patients. In this context, federated learning (FL) is a methodology that enables the distributed training of machine learning models with remotely hosted datasets without the need to accumulate data and, therefore, compromise it. FL is a promising solution to improve ML-based systems, better aligning them to regulatory requirements, improving trustworthiness and data sovereignty. However, many open questions must be addressed before the use of FL becomes widespread. This article aims at presenting a systematic literature review on current research about FL in the context of EHR data for healthcare applications. Our analysis highlights the main research topics, proposed solutions, case studies, and respective ML methods. Furthermore, the article discusses a general architecture for FL applied to healthcare data based on the main insights obtained from the literature review. The collected literature corpus indicates that there is extensive research on the privacy and confidentiality aspects of training data and model sharing, which is expected given the sensitive nature of medical data. Studies also explore improvements to the aggregation mechanisms required to generate the learning model from distributed contributions and case studies with different types of medical data.

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.

Mobile gait analysis using wearable inertial measurement units (IMUs) provides valuable insights for the assessment of movement impairments in different neurological and musculoskeletal diseases, for example Parkinson's disease (PD). The increase in data volume due to arising long-term monitoring requires valid, robust and efficient analysis pipelines. In many studies an upstream detection of gait is therefore applied. However, current methods do not provide a robust way to successfully reject non-gait signals. Therefore, we developed a novel algorithm for the detection of gait from continuous inertial data of sensors worn at the feet. The algorithm is focused not only on a high sensitivity but also a high specificity for gait. Sliding windows of IMU signals recorded from the feet of PD patients were processed in the frequency domain. Gait was detected if the frequency spectrum contained specific patterns of harmonic frequencies. The approach was trained and evaluated on 150 clinical measurements containing standardized gait and cyclic movement tests. The detection reached a sensitivity of 0.98 and a specificity of 0.96 for the best sensor configuration (angular rate around the medio-lateral axis). On an independent validation data set including 203 unsupervised, semi-standardized gait tests, the algorithm achieved a sensitivity of 0.97. Our algorithm for the detection of gait from continuous IMU signals works reliably and showed promising results for the application in the context of free-living and non-standardized monitoring scenarios.

Digital mobility assessment using wearable sensor systems has the potential to capture walking performance in a patient’s natural environment. It enables monitoring of health status and disease progression and evaluation of interventions in real-world situations. In contrast to laboratory settings, real-world walking occurs in non-conventional environments and under unconstrained and uncontrolled conditions. Despite the general understanding, there is a lack of agreed definitions about what constitutes real-world walking, impeding the comparison and interpretation of the acquired data across systems and studies. The goal of this study was to obtain expert-based consensus on specific aspects of real-world walking and to provide respective definitions in a common terminological framework. An adapted Delphi method was used to obtain agreed definitions related to real-world walking. In an online survey, 162 participants from a panel of academic, clinical and industrial experts with experience in the field of gait analysis were asked for agreement on previously specified definitions. Descriptive statistics was used to evaluate whether consent (> 75% agreement as defined a priori) was reached. Of 162 experts invited to participate, 51 completed all rounds (31.5% response rate). We obtained consensus on all definitions (“Walking” > 90%, “Purposeful” > 75%, “Real-world” > 90%, “Walking bout” > 80%, “Walking speed” > 75%, “Turning” > 90% agreement) after two rounds. The identification of a consented set of real-world walking definitions has important implications for the development of assessment and analysis protocols, as well as for the reporting and comparison of digital mobility outcomes across studies and systems. The definitions will serve as a common framework for implementing digital and mobile technologies for gait assessment and are an important link for the transition from supervised to unsupervised gait assessment.

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.

Background 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. Methods 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. Results 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. Conclusions 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.