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).

Accurate step detection is crucial for the estimation of gait spatio-temporal parameters. Although several step detection methods based on the use of inertial measurement units (IMUs) have been successfully proposed, they may not perform adequately when the foot is dragged while walking, when walking aids are used, or when walking at low speed. The aim of this study was to test an original step-detection method, the inter-foot distance step counter (IFOD), based on the direct measurement of the distance between feet. Gait data were recorded using a wearable prototype system (SWING 2DS), which integrates an IMU and two time-of-flight distance sensors (DSs). The system was attached to the medial side of the right foot with one DS positioned close to the forefoot (FOREDS) and the other close to the rearfoot (REARDS). Sixteen healthy adults were asked to walk over ground for two minutes along a loop, including both rectilinear and curvilinear portions, during two experimental sessions. The accuracy of the IFOD step counter was assessed using a stereophotogrammetric system as gold standard. The best performance was obtained for REARDS with an accuracy higher than 99.8% for the instrumented foot step and 88.8% for the noninstrumented foot step during both rectilinear and curvilinear walks. Key features of the IFOD step counter are that it is possible to detect both right and left steps by instrumenting one foot only and that it does not rely on foot impact dynamics. The IFOD step counter can be combined with existing IMU-based methods for increasing step-detection accuracy.

The accurate identification of initial and final foot contacts is a crucial prerequisite for obtaining a reliable estimation of spatio-temporal parameters of gait. Well-accepted gold standard techniques in this field are force platforms and instrumented walkways, which provide a direct measure of the foot-ground reaction forces. Nonetheless, these tools are expensive, non-portable and restrict the analysis to laboratory settings. Instrumented insoles with a reduced number of pressure sensing elements might overcome these limitations, but a suitable method for gait events identification has not been adopted yet. The aim of this paper was to present and validate a method aiming at filling such void, as applied to a system including two insoles with 16 pressure sensing elements (element area = 310 mm 2 ), sampling at 100Hz. Gait events were identified exploiting the sensor redundancy and a cluster-based strategy. The method was tested in the laboratory against force platforms on nine healthy subjects for a total of 801 initial and final contacts. Initial and final contacts were detected with low average errors of (about 20 ms and 10 ms, respectively). Similarly, the errors in estimating stance duration and step duration averaged 20 ms and less than 10 ms, respectively. By selecting appropriate thresholds, the method may be easily applied to other pressure insoles featuring similar requirements.

Magneto-inertial measurement units (MIMU) are a suitable solution to assess human motor performance both indoors and outdoors. However, relevant quantities such as step width and base of support, which play an important role in gait stability, cannot be directly measured using MIMU alone. To overcome this limitation, we developed a wearable platform specifically designed for human movement analysis applications, which integrates a MIMU and an Infrared Time-of-Flight proximity sensor (IR-ToF), allowing for the estimate of inter-object distance. We proposed a thorough testing protocol for evaluating the IR-ToF sensor performances under experimental conditions resembling those encountered during gait. In particular, we tested the sensor performance for different (i) target colors; (ii) sensor-target distances (up to 200 mm) and (iii) sensor-target angles of incidence (AoI) (up to 60∘). Both static and dynamic conditions were analyzed. A pendulum, simulating the oscillation of a human leg, was used to generate highly repeatable oscillations with a maximum angular velocity of 6 rad/s. Results showed that the IR-ToF proximity sensor was not sensitive to variations of both distance and target color (except for black). Conversely, a relationship between error magnitude and AoI values was found. For AoI equal to 0∘, the IR-ToF sensor performed equally well both in static and dynamic acquisitions with a distance mean absolute error <1.5 mm. Errors increased up to 3.6 mm (static) and 11.9 mm (dynamic) for AoI equal to ±30∘, and up to 7.8 mm (static) and 25.6 mm (dynamic) for AoI equal to ±60∘. In addition, the wearable platform was used during a preliminary experiment for the estimation of the inter-foot distance on a single healthy subject while walking. In conclusion, the combination of magneto-inertial unit and IR-ToF technology represents a valuable alternative solution in terms of accuracy, sampling frequency, dimension and power consumption, compared to existing technologies.