Digital health technologies that quantify mobility in unsupervised, daily-living environments are emerging as a complementary evaluation approach in neurology. Data collected in these ecologically valid, patient-relevant settings can overcome significant limitations of conventional clinical assessments. Unsupervised assessments can capture fluctuating and rare events and have the promise of supporting clinical decision-making and serving as outcomes in clinical trials. However, studies that directly compared assessments made in unsupervised and supervised (i.e. in the lab or clinical) settings point to large disparities, even in the same parameters of mobility (up to 180% difference). These differences appear to be influenced by psychological, physiological, cognitive, environmental, and technical factors and by the specific aspect of mobility and diagnosis. To facilitate the successful adaptation of the unsupervised assessment of mobility in the clinic and in clinical trials, clinicians and future work should take into account these disparities and the multiple factors that contribute to them.

Objective: Quantification of gait with wearable technology is promising; recent cross-sectional studies showed that gait characteristics are potential prodromal markers for Parkinson disease (PD). The aim of this longitudinal prospective observational study was to establish gait impairments and trajectories in the prodromal phase of PD, identifying which gait characteristics are potentially early diagnostic markers of PD. Methods: The 696 healthy controls (mean age = 63 AE 7 years) recruited in the Tubingen Evaluation of Risk Factors for Early Detection of Neurodegeneration study were included. Assessments were performed longitudinally 4 times at 2-year intervals, and people who converted to PD were identified. Participants were asked to walk at different speeds under single and dual tasking, with a wearable device placed on the lower back; 14 validated clinically relevant gait characteristics were quantified. Cox regression was used to examine whether gait at first visit could predict time to PD conversion after controlling for age and sex. Random effects linear mixed models (RELMs) were used to establish longitudinal trajectories of gait and model the latency between impaired gait and PD diagnosis. Results: Sixteen participants were diagnosed with PD on average 4.5 years after first visit (converters; PDC). Higher step time variability and asymmetry of all gait characteristics were associated with a shorter time to PD diagnosis. RELMs indicated that gait (lower pace) deviates from that of non-PDC approximately 4 years prior to diagnosis. Interpretation: Together with other prodromal markers, quantitative gait characteristics can play an important role in identifying prodromal PD and progression within this phase.

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).

Introduction: Impaired sit-to-stand and stand-to-sit movements (postural transitions, PTs) in patients with Parkinson's disease (PD) and older adults (OA) are associated with risk of falling and reduced quality of life. Inertial measurement units (IMUs, also called “wearables”) are powerful tools to monitor PT kinematics. The purpose of this study was to develop and validate an algorithm, based on a single IMU positioned at the lower back, for PT detection and description in the above-mentioned groups in a home-like environment.Methods: Four PD patients (two with dyskinesia) and one OA served as algorithm training group, and 21 PD patients (16 without and 5 with dyskinesia) and 11 OA served as test group. All wore an IMU on the lower back and were videotaped while performing everyday activities for 90–180 min in a non-standardized home-like environment. Accelerometer and gyroscope signals were analyzed using discrete wavelet transformation (DWT), a six degrees-of-freedom (DOF) fusion algorithm and vertical displacement estimation.Results: From the test group, 1,001 PTs, defined by video reference, were analyzed. The accuracy of the algorithm for the detection of PTs against video observation was 82% for PD patients without dyskinesia, 47% for PD patients with dyskinesia and 85% for OA. The overall accuracy of the PT direction detection was comparable across groups and yielded 98%. Mean PT duration values were 1.96 s for PD patients and 1.74 s for OA based on the algorithm (p < 0.001) and 1.77 s for PD patients and 1.51 s for OA based on clinical observation (p < 0.001).Conclusion: Validation of the PT detection algorithm in a home-like environment shows acceptable accuracy against the video reference in PD patients without dyskinesia and controls. Current limitations are the PT detection in PD patients with dyskinesia and the use of video observation as the video reference. Potential reasons are discussed.