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. Trial registration number ISRCTN (12246987).

The orientation of a magneto and inertial measurement unit (MIMU) is estimated by means of sensor fusion algorithms (SFAs) thus enabling human motion tracking. However, despite several SFAs implementations proposed over the last decades, there is still a lack of consensus about the best performing SFAs and their accuracy. As suggested by recent literature, the filter parameters play a central role in determining the orientation errors. The aim of this work is to analyze the accuracy of ten SFAs while running under the best possible conditions (i.e., their parameter values are set using the orientation reference) in nine experimental scenarios including three rotation rates and three commercial products. The main finding is that parameter values must be specific for each SFA according to the experimental scenario to avoid errors comparable to those obtained when the default parameter values are used. Overall, when optimally tuned, no statistically significant differences are observed among the different SFAs in all tested experimental scenarios and the absolute errors are included between 3.8 deg and 7.1 deg. Increasing the rotation rate generally leads to a significant performance worsening. Errors are also influenced by the MIMU commercial model. SFA MATLAB implementations have been made available online.

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.

Magneto-Inertial Measurement Units (MIMUs) are a valid alternative tool to optical stereophotogrammetry in human motion analysis. The orientation of a MIMU may be estimated by using sensor fusion algorithms. Such algorithms require input parameters that are usually set using a trial-and-error (or grid-search) approach to find the optimal values. However, using trial-and-error requires a known reference orientation, a circumstance rarely occurring in real-life applications. In this paper, we present a way to suboptimally set input parameters, by exploiting the assumption that two MIMUs rigidly connected are expected to show no orientation difference during motion. This approach was validated by applying it to the popular complementary filter by Madgwick et al. and tested on 18 experimental conditions including three commercial products, three angular rates, and two dimensionality motion conditions. Two main findings were observed: i) the selection of the optimal parameter value strongly depends on the specific experimental conditions considered, ii) in 15 out of 18 conditions the errors obtained using the proposed approach and the trial-and-error were coincident, while in the other cases the maximum discrepancy amounted to 2.5 deg and less than 1.5 deg on average.

Inertial measurement units (IMUs) enable orientation, velocity, and position estimation in several application domains ranging from robotics and autonomous vehicles to human motion capture and rehabilitation engineering. Errors in orientation estimation greatly affect any of those motion parameters. The present work explains the main challenges in inertial orientation estimation (IOE) and presents an extensive benchmark dataset that includes 3D inertial and magnetic data with synchronized optical marker-based ground truth measurements, the Berlin Robust Orientation Estimation Assessment Dataset (BROAD). The BROAD dataset consists of 39 trials that are conducted at different speeds and include various types of movement. Thereof, 23 trials are performed in an undisturbed indoor environment, and 16 trials are recorded with deliberate magnetometer and accelerometer disturbances. We furthermore propose error metrics that allow for IOE accuracy evaluation while separating the heading and inclination portions of the error and introduce well-defined benchmark metrics. Based on the proposed benchmark, we perform an exemplary case study on two widely used openly available IOE algorithms. Due to the broad range of motion and disturbance scenarios, the proposed benchmark is expected to provide valuable insight and useful tools for the assessment, selection, and further development of inertial sensor fusion methods and IMU-based application systems.

Background: Measuring mobility in daily life entails dealing with confounding factors arising from multiple sources, including pathological characteristics, patient specific walking strategies, environment/context, and purpose of the task. The primary aim of this study is to propose and validate a protocol for simulating real-world gait accounting for all these factors within a single set of observations, while ensuring minimisation of participant burden and safety. Methods: The protocol included eight motor tasks at varying speed, incline/steps, surface, path shape, cognitive demand, and included postures that may abruptly alter the participants’ strategy of walking. It was deployed in a convenience sample of 108 participants recruited from six cohorts that included older healthy adults (HA) and participants with potentially altered mobility due to Parkinson’s disease (PD), multiple sclerosis (MS), proximal femoral fracture (PFF), chronic obstructive pulmonary disease (COPD) or congestive heart failure (CHF). A novelty introduced in the protocol was the tiered approach to increase difficulty both within the same task (e.g., by allowing use of aids or armrests) and across tasks. Results: The protocol proved to be safe and feasible (all participants could complete it and no adverse events were recorded) and the addition of the more complex tasks allowed a much greater spread in walking speeds to be achieved compared to standard straight walking trials. Furthermore, it allowed a representation of a variety of daily life relevant mobility aspects and can therefore be used for the validation of monitoring devices used in real life. Conclusions: The protocol allowed for measuring gait in a variety of pathological conditions suggests that it can also be used to detect changes in gait due to, for example, the onset or progression of a disease, or due to therapy. Trial registration: ISRCTN—12246987.