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Digital health technology tools (DHTTs) have the potential to transform health care delivery by enabling new forms of participatory and personalized care that fit into patients’ daily lives. However, realizing this potential requires careful navigation of numerous challenges. This viewpoint presents the authors’ experiences and perspectives on the development and implementation of DHTTs, addressing both established practices and controversial topics. This article offers a practical guide organized into 10 recommendations derived from a multidisciplinary lecture series and associated workshop discussions on “Digital Health and Digital Biomarkers” held at the University of Luxembourg in 2023-2024. Key messages include the need to understand specific health care challenges, form interdisciplinary teams, incorporate patient feedback, select appropriate measurement technologies, ensure data integration and interoperability, apply advanced data science techniques, use scalable designs and open standards, comply with regulatory requirements, and maintain continuous evaluation and improvement. While the guide highlights essential practices, it also addresses contentious issues such as balancing innovation with regulatory compliance, addressing ethical concerns in artificial intelligence adoption, managing privacy versus the need for comprehensive data integration and open science, and managing the financial sustainability of DHTTs. The authors argue that digital health’s greatest potential lies in its ability to provide participatory and personalized care, but this requires a delicate balance between technological advances and ethical, legal, and social implications. Overall, this workshop-derived viewpoint aims to help health care professionals, engineers, developers, and researchers not only adopt best practices but also address and resolve the controversial aspects inherent in the development of DHTTs.

Relating continuously collected inertial data to the activities or postures performed by the sensor wearer requires pattern recognition or machine-learning-based algorithms, accounting for the temporal and scale variability present in human movements. The objective of this study was to develop a sensor-based framework for the detection and measurement of high-flexion postures frequently adopted in occupational settings. IMU-based joint angle estimates for the ankle, knee, and hip were time and scale normalized prior to being input to a multi-dimensional Dynamic Time Warping (mDTW) distance-based Nearest Neighbour algorithm for the identification of twelve postures. Data from 50 participants were divided to develop and evaluate the mDTW model. Overall accuracies of 82.3% and 55.6% were reached when classifying movements from the testing and validation datasets, respectively, which increased to 86% and 74.6% when adjusting for imbalances between classification groups. The highest misclassification rates occurred between flatfoot squatting, heels-up squatting, and stooping, while the model was incapable of identifying sequences of walking based on a single stride template. The developed mDTW model proved robust in identifying high-flexion postures performed by participants both included and precluded from algorithm development, indicating its strong potential for the quantitative measurement of postural adoption in real-world settings.

Climbing stairs is a fundamental part of daily life, adding additional demands on the postural control system compared to level walking. Although real-world gait analysis studies likely contain stair ambulation sequences, algorithms dedicated to the analysis of such activities are still missing. Therefore, we propose a new gait analysis pipeline for foot-worn inertial sensors, which can segment, parametrize, and classify strides from continuous gait sequences that include level walking, stair ascending, and stair descending. For segmentation, an existing approach based on the hidden Markov model and a feature-based gait event detection were extended, reaching an average segmentation F1 score of 98.5% and gait event timing errors below ±10ms for all conditions. Stride types were classified with an accuracy of 98.2% using spatial features derived from a Kalman filter-based trajectory reconstruction. The evaluation was performed on a dataset of 20 healthy participants walking on three different staircases at different speeds. The entire pipeline was additionally validated end-to-end on an independent dataset of 13 Parkinson’s disease patients. The presented work aims to extend real-world gait analysis by including stair ambulation parameters in order to gain new insights into mobility impairments that can be linked to clinically relevant conditions such as a patient’s fall risk and disease state or progression.

Developing machine learning algorithms for time-series data often requires manual annotation of the data. To do so, graphical user interfaces (GUIs) are an important component. Existing Python packages for annotation and analysis of time-series data have been developed without addressing adaptability, usability, and user experience. Therefore, we developed a generic open-source Python package focusing on adaptability, usability, and user experience. The developed package, Machine Learning and Data Analytics (MaD) GUI, enables developers to rapidly create a GUI for their specific use case. Furthermore, MaD GUI enables domain experts without programming knowledge to annotate time-series data and apply algorithms to it. We conducted a small-scale study with participants from three international universities to test the adaptability of MaD GUI by developers and to test the user interface by clinicians as representatives of domain experts. MaD GUI saves up to 75% of time in contrast to using a state-of-the-art package. In line with this, subjective ratings regarding usability and user experience show that MaD GUI is preferred over a state-of-the-art package by developers and clinicians. MaD GUI reduces the effort of developers in creating GUIs for time-series analysis and offers similar usability and user experience for clinicians as a state-of-the-art package.

Background/Objectives: Hearing loss, particularly in older adults, is associated with reduced physical functioning; increased fall risk; and altered gait patterns, including slower walking speed and shorter step length. While the underlying mechanisms are not fully understood, one possibility is that these gait changes result from an additional cognitive load due to hearing difficulties. Prior research suggests that hearing aids may improve balance; however, their impact on gait remains less well explored. Methods: This study investigated gait parameters in individuals with hearing loss as they walked with and without hearing aid amplification under different dual-task conditions. Additionally, we showed the potential of ear-worn sensors for detecting relevant gait changes. To achieve this, we used a hearing-aid-integrated accelerometer and our open-source EarGait framework comprising gait-related algorithms specifically developed for ear-worn sensors. Results: Our findings revealed no significant differences in gait velocity or step length between the unaided and aided conditions. For stride time, we observed a significant interaction effect; however, the effect size was negligible. The dual-task costs were lower than in previous reports, indicating that the applied dual-task paradigm did not induce the expected cognitive demand. The ear-worn gait analysis system showed strong performance compared to foot-worn sensors. Conclusions: Our findings indicate that in controlled, low-cognitive-demand settings, hearing aid amplification does not affect gait performance and, therefore, neither hinders nor improves walking performance. Additionally, the high accuracy of the ear-worn gait analysis system highlights the strong potential of ear-mounted wearable devices (“earables”) for real-world mobility assessments. Future research should explore more complex real-world conditions to better understand the impact of hearing aids on walking behavior. Our proposed earable-based system offers a promising tool for continuous, unobtrusive gait monitoring in everyday environments.

Gait analysis using foot-worn inertial measurement units has proven to be a reliable tool to diagnose and monitor many neurological and musculoskeletal indications. However, only few studies have investigated the robustness of such systems to changes in the sensor attachment and no consensus for suitable sensor positions exists in the research community. Specifically for unsupervised real-world measurements, understanding how the reliability of the monitoring system changes when the sensor is attached differently is from high importance. In these scenarios, placement variations are expected because of user error or personal preferences. In this manuscript, we present the largest study to date comparing different sensor positions and attachments. We recorded 9000 strides with motion-capture reference from 14 healthy participants with six synchronized sensors attached at each foot. Spatial gait parameters were calculated using a double-integration method and compared to the reference system. The results indicate that relevant differences in the accuracy of the stride length exists between the sensor positions. While the average error over multiple strides is comparable, single stride errors and variability parameters differ greatly. We further present a physics model and an analysis of the raw sensor data to understand the origin of the observed differences. This analysis indicates that a variety of attachment parameters can influence the systems’ performance. While this is only the starting point to understand and mitigate these types of errors, we conclude that sensor systems and algorithms must be reevaluated when the sensor position or attachment changes.

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.

Investigating acute stress responses is crucial to understanding the underlying mechanisms of stress. Current stress assessment methods include self-reports that can be biased and biomarkers that are often based on complex laboratory procedures. A promising additional modality for stress assessment might be the observation of body movements, which are affected by negative emotions and threatening situations. In this paper, we investigated the relationship between acute psychosocial stress induction and body posture and movements. We collected motion data from N = 59 individuals over two studies ( Pilot Study : N = 20, Main Study : N = 39) using inertial measurement unit (IMU)-based motion capture suits. In both studies, individuals underwent the Trier Social Stress Test (TSST) and a stress-free control condition (friendly-TSST; f-TSST) in randomized order. Our results show that acute stress induction leads to a reproducible freezing behavior, characterized by less overall motion as well as more and longer periods of no movement. Based on these data, we trained machine learning pipelines to detect acute stress solely from movement information, achieving an accuracy of 75.0 ± 17.7 % ( Pilot Study ) and 73.4 ± 7.7 % ( Main Study ). This, for the first time, suggests that body posture and movements can be used to detect whether individuals are exposed to acute psychosocial stress. While more studies are needed to further validate our approach, we are convinced that motion information can be a valuable extension to the existing biomarkers and can help to obtain a more holistic picture of the human stress response. Our work is the first to systematically explore the use of full-body body posture and movement to gain novel insights into the human stress response and its effects on the body and mind.

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.

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.