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.

Real-World Walking Speed Assessment Using a Mass-Market RTK-GNSS Receiver.

Walking speed is an important clinical parameter because it sums up the ability to move and predicts adverse outcomes. However, usually measured inside the clinics, it can suffer from poor ecological validity. Wearable devices such as global positioning systems (GPS) can be used to measure real-world walking speed. Still, the accuracy of GPS systems decreases in environments with poor sky visibility. This work tests a solution based on a mass-market, real-time kinematic receiver (RTK), overcoming such limitations. Seven participants walked a predefined path composed of tracts with different sky visibility. The walking speed was calculated by the RTK and compared with a reference value calculated using an odometer and a stopwatch. Despite tracts with totally obstructed visibility, the correlation between the receiver and the reference system was high (0.82 considering all tracts and 0.93 considering high-quality tracts). Similarly, a Bland Altman analysis showed a minimal detectable change of 0.12 m/s in the general case and 0.07 m/s considering only high-quality tracts. This work demonstrates the feasibility and validity of the presented device for the measurement of real-world walking speed, even in tracts with high interference. These findings pave the way for clinical use of the proposed device to measure walking speed in the real world, thus enabling digital remote monitoring of locomotor function. Several populations may benefit from similar devices, including older people at a high risk of fall, people with neurological diseases, and people following a rehabilitation intervention.

Machine learning-based distinction of left and right foot contacts in lower back inertial sensor gait data.

Digital gait measures derived from wearable inertial sensors have been shown to support the treatment of patients with motor impairments. From a technical perspective, the detection of left and right initial foot contacts (ICs) is essential for the computation of stride-by-stride outcome measures including gait asymmetry. However, in a majority of studies only one sensor close to the center of mass is used, complicating the assignment of detected ICs to the respective foot. Therefore, we developed an algorithm including supervised machine learning (ML) models for the robust classification of left and right ICs using multiple features from the gyroscope located at the lower back. The approach was tested on a data set including 40 participants (ten healthy controls, ten hemiparetic, ten Parkinson's disease, and ten Huntington's disease patients) and reached an accuracy of 96.3% for the overall data set and up to 100.0% for the Parkinson's sub data set. These results were compared to a state-of-the-art algorithm. The ML approaches outperformed this traditional algorithm in all subgroups. Our study contributes to an improved classification of left and right ICs in inertial sensor signals recorded at the lower back and thus enables a reliable computation of clinically relevant mobility measures.

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. TRIAL REGISTRATION NUMBER: ISRCTN (12246987).