Mobile digital gait analysis captures effects of botulinum toxin in hereditary spastic paraplegia.

BACKGROUND AND PURPOSE: Hereditary spastic paraplegias (HSPs) comprise a group of inherited neurodegenerative disorders characterized by progressive spasticity and weakness. Botulinum toxin has been approved for lower limb spasticity following stroke and cerebral palsy, but its effects in HSPs remain underexplored. We aimed to characterize the effects of botulinum toxin on clinical, gait, and patient-reported outcomes in HSP patients and explore the potential of mobile digital gait analysis to monitor treatment effects and predict treatment response. METHODS: We conducted a prospective, observational, multicenter study involving ambulatory HSP patients treated with botulinum toxin tailored to individual goals. Comparing data at baseline, after 1 month, and after 3 months, treatment response was assessed using clinical parameters, goal attainment scaling, and mobile digital gait analysis. Machine learning algorithms were used for predicting individual goal attainment based on baseline parameters. RESULTS: A total of 56 patients were enrolled. Despite the heterogeneity of treatment goals and targeted muscles, botulinum toxin led to a significant improvement in specific clinical parameters and an improvement in specific gait characteristics, peaking at the 1-month and declining by the 3-month follow-up. Significant correlations were identified between gait parameters and clinical scores. With a mean balanced accuracy of 66%, machine learning algorithms identified important denominators to predict treatment response. CONCLUSIONS: Our study provides evidence supporting the beneficial effects of botulinum toxin in HSP when applied according to individual treatment goals. The use of mobile digital gait analysis and machine learning represents a novel approach for monitoring treatment effects and predicting treatment response.

Bridging the sim2real gap. Investigating deviations between experimental motion measurements and musculoskeletal simulation results-a systematic review.

Musculoskeletal simulations can be used to estimate biomechanical variables like muscle forces and joint torques from non-invasive experimental data using inverse and forward methods. Inverse kinematics followed by inverse dynamics (ID) uses body motion and external force measurements to compute joint movements and the corresponding joint loads, respectively. ID leads to residual forces and torques (residuals) that are not physically realistic, because of measurement noise and modeling assumptions. Forward dynamic simulations (FD) are found by tracking experimental data. They do not generate residuals but will move away from experimental data to achieve this. Therefore, there is a gap between reality (the experimental measurements) and simulations in both approaches, the sim2real gap. To answer (patho-) physiological research questions, simulation results have to be accurate and reliable; the sim2real gap needs to be handled. Therefore, we reviewed methods to handle the sim2real gap in such musculoskeletal simulations. The review identifies, classifies and analyses existing methods that bridge the sim2real gap, including their strengths and limitations. Using a systematic approach, we conducted an electronic search in the databases Scopus, PubMed and Web of Science. We selected and included 85 relevant papers that were sorted into eight different solution clusters based on three aspects: how the sim2real gap is handled, the mathematical method used, and the parameters/variables of the simulations which were adjusted. Each cluster has a distinctive way of handling the sim2real gap with accompanying strengths and limitations. Ultimately, the method choice largely depends on various factors: available model, input parameters/variables, investigated movement and of course the underlying research aim. Researchers should be aware that the sim2real gap remains for both ID and FD approaches. However, we conclude that multimodal approaches tracking kinematic and dynamic measurements may be one possible solution to handle the sim2real gap as methods tracking multimodal measurements (some combination of sensor position/orientation or EMG measurements), consistently lead to better tracking performances. Initial analyses show that motion analysis performance can be enhanced by using multimodal measurements as different sensor technologies can compensate each other's weaknesses.

Power-MF: robust fetal QRS detection from non-invasive fetal electrocardiogram recordings.

Objective.Perinatal asphyxia poses a significant risk to neonatal health, necessitating accurate fetal heart rate monitoring for effective detection and management. The current gold standard, cardiotocography, has inherent limitations, highlighting the need for alternative approaches. The emerging technology of non-invasive fetal electrocardiography shows promise as a new sensing technology for fetal cardiac activity, offering potential advancements in the detection and management of perinatal asphyxia. Although algorithms for fetal QRS detection have been developed in the past, only a few of them demonstrate accurate performance in the presence of noise and artifacts.Approach.In this work, we proposePower-MF, a new algorithm for fetal QRS detection combining power spectral density and matched filter techniques. We benchmarkPower-MFagainst three open-source algorithms on two recently published datasets (Abdominal and Direct Fetal ECG Database: ADFECG, subsets B1 Pregnancy and B2 Labour; Non-invasive Multimodal Foetal ECG-Doppler Dataset for Antenatal Cardiology Research: NInFEA).Main results.Our results show thatPower-MFoutperforms state-of-the-art algorithms on ADFECG (B1 Pregnancy: 99.5% ± 0.5% F1-score, B2 Labour: 98.0% ± 3.0% F1-score) and on NInFEA in three of six electrode configurations by being more robust against noise.Significance.Through this work, we contribute to improving the accuracy and reliability of fetal cardiac monitoring, an essential step toward early detection of perinatal asphyxia with the long-term goal of reducing costs and making prenatal care more accessible.

A sensorimotor enhanced neuromusculoskeletal model for simulating postural control of upright standing.

The human's upright standing is a complex control process that is not yet fully understood. Postural control models can provide insights into the body's internal control processes of balance behavior. Using physiologically plausible models can also help explaining pathophysiological motion behavior. In this paper, we introduce a neuromusculoskeletal postural control model using sensor feedback consisting of somatosensory, vestibular and visual information. The sagittal plane model was restricted to effectively six degrees of freedom and consisted of nine muscles per leg. Physiologically plausible neural delays were considered for balance control. We applied forward dynamic simulations and a single shooting approach to generate healthy reactive balance behavior during quiet and perturbed upright standing. Control parameters were optimized to minimize muscle effort. We showed that our model is capable of fulfilling the applied tasks successfully. We observed joint angles and ranges of motion in physiologically plausible ranges and comparable to experimental data. This model represents the starting point for subsequent simulations of pathophysiological postural control behavior.

Which Comprehensive Geriatric Assessment (CGA) instruments are currently used in Germany: a survey.

BACKGROUND: The Comprehensive Geriatric Assessment (CGA) records geriatric syndromes in a standardized manner, allowing individualized treatment tailored to the patient's needs and resources. Its use has shown a beneficial effect on the functional outcome and survival of geriatric patients. A recently published German S1 guideline for level 2 CGA provides recommendations for the use of a broad variety of different assessment instruments for each geriatric syndrome. However, the actual use of assessment instruments in routine geriatric clinical practice and its consistency with the guideline and the current state of literature has not been investigated to date. METHODS: An online survey was developed by an expert group of geriatricians and sent to all licenced geriatricians (n = 569) within Germany. The survey included the following geriatric syndromes: motor function and self-help capability, cognition, depression, pain, dysphagia and nutrition, social status and comorbidity, pressure ulcers, language and speech, delirium, and frailty. Respondents were asked to report which geriatric assessment instruments are used to assess the respective syndromes. RESULTS: A total of 122 clinicians participated in the survey (response rate: 21%); after data cleaning, 76 data sets remained for analysis. All participants regularly used assessment instruments in the following categories: motor function, self-help capability, cognition, depression, and pain. The most frequently used instruments in these categories were the Timed Up and Go (TUG), the Barthel Index (BI), the Mini Mental State Examination (MMSE), the Geriatric Depression Scale (GDS), and the Visual Analogue Scale (VAS). Limited or heterogenous assessments are used in the following categories: delirium, frailty and social status. CONCLUSIONS: Our results show that the assessment of motor function, self-help capability, cognition, depression, pain, and dysphagia and nutrition is consistent with the recommendations of the S1 guideline for level 2 CGA. Instruments recommended for more frequent use include the Short Physical Performance Battery (SPPB), the Montreal Cognitive Assessment (MoCA), and the WHO-5 (depression). There is a particular need for standardized assessment of delirium, frailty and social status. The harmonization of assessment instruments throughout geriatric departments shall enable more effective treatment and prevention of age-related diseases and syndromes.

Machine learning-based detection of acute psychosocial stress from body posture and movements.

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.

Estimating 3D kinematics and kinetics from virtual inertial sensor data through musculoskeletal movement simulations.

Portable measurement systems using inertial sensors enable motion capture outside the lab, facilitating longitudinal and large-scale studies in natural environments. However, estimating 3D kinematics and kinetics from inertial data for a comprehensive biomechanical movement analysis is still challenging. Machine learning models or stepwise approaches performing Kalman filtering, inverse kinematics, and inverse dynamics can lead to inconsistencies between kinematics and kinetics. We investigated the reconstruction of 3D kinematics and kinetics of arbitrary running motions from inertial sensor data using optimal control simulations of full-body musculoskeletal models. To evaluate the feasibility of the proposed method, we used marker tracking simulations created from optical motion capture data as a reference and for computing virtual inertial data such that the desired solution was known exactly. We generated the inertial tracking simulations by formulating optimal control problems that tracked virtual acceleration and angular velocity while minimizing effort without requiring a task constraint or an initial state. To evaluate the proposed approach, we reconstructed three trials each of straight running, curved running, and a v-cut of 10 participants. We compared the estimated inertial signals and biomechanical variables of the marker and inertial tracking simulations. The inertial data was tracked closely, resulting in low mean root mean squared deviations for pelvis translation (≤20.2 mm), angles (≤1.8 deg), ground reaction forces (≤1.1 BW%), joint moments (≤0.1 BWBH%), and muscle forces (≤5.4 BW%) and high mean coefficients of multiple correlation for all biomechanical variables (≥0.99). Accordingly, our results showed that optimal control simulations tracking 3D inertial data could reconstruct the kinematics and kinetics of individual trials of all running motions. The simulations led to mutually and dynamically consistent kinematics and kinetics, which allows researching causal chains, for example, to analyze anterior cruciate ligament injury prevention. Our work proved the feasibility of the approach using virtual inertial data. When using the approach in the future with measured data, the sensor location and alignment on the segment must be estimated, and soft-tissue artifacts are potential error sources. Nevertheless, we demonstrated that optimal control simulation tracking inertial data is highly promising for estimating 3D kinematics and kinetics for a comprehensive biomechanical analysis.

Gaitmap-An Open Ecosystem for IMU-Based Human Gait Analysis and Algorithm Benchmarking.

Goal: Gait analysis using inertial measurement units (IMUs) has emerged as a promising method for monitoring movement disorders. However, the lack of public data and easy-to-use open-source algorithms hinders method comparison and clinical application development. To address these challenges, this publication introduces the gaitmap ecosystem, a comprehensive set of open source Python packages for gait analysis using foot-worn IMUs. Methods: This initial release includes over 20 state-of-the-art algorithms, enables easy access to seven datasets, and provides eight benchmark challenges with reference implementations. Together with its extensive documentation and tooling, it enables rapid development and validation of new algorithm and provides a foundation for novel clinical applications. Conclusion: The published software projects represent a pioneering effort to establish an open-source ecosystem for IMU-based gait analysis. We believe that this work can democratize the access to high-quality algorithm and serve as a driver for open and reproducible research in the field of human gait analysis and beyond.

A content-based review of mobile health applications for breast cancer prevention and education: Characteristics, quality and functionality analysis.

Objective: Mobile Health apps could be a feasible and effective tool to raise awareness for breast cancer prevention and to support women to change their behaviour to a healthier lifestyle. The aim of this study was to analyse the characteristics and quality of apps designed for breast cancer prevention and education. Methods: We conducted a systematic search for apps covering breast cancer prevention topics in the Google Play and Apple App Store accessible from Germany using search terms either in German or in English. Only apps with a last update after June 2020 were included. The apps identified were downloaded and evaluated by two independent researchers. App quality was analysed using the Mobile Application Rating Scale (MARS). Associations of app characteristics and MARS rating were analysed. Results: We identified 19 apps available in the Google Play Store and seven apps available in the Apple App Store that met all inclusion criteria. The mean MARS score was 3.07 and 3.50, respectively. Functionality was the highest-scoring domain. Operating system, developer (healthcare), download rates and time since the last update were significantly associated with overall MARS score. In addition, the presence of the following app functions significantly influenced MARS rating: breast self-examination tutorial, reminder for self-examination, documentation feature and education about breast cancer risk factors. Conclusions: Although most of the apps offer important features for breast cancer prevention, none of the analysed apps combined all functions. The absence of healthcare professionals' expertise in developing apps negatively affects the overall quality.

Disgust-based approach-avoidance modification training for individuals suffering from elevated stress: A randomized controlled pilot study.

Perceived stress, a global health problem associated with various mental disorders, is assumed to be influenced by dysfunctional beliefs. It can be hypothesized that these beliefs can be modified with the help of approach-avoidance modification trainings (AAMTs). In the present study (conducted 2020-2022), we aimed to clarify whether the efficacy of AAMTs can be enhanced by utilizing the expression of emotions to move AAMT stimuli. For this purpose, we tested the feasibility and acceptability of a new AAMT paradigm in which the expression of disgust is used to move stress-increasing beliefs away from oneself and the expression of positive emotions is used to move stress-reducing beliefs towards oneself (AAMT-DP). Additionally, we explored the therapeutic potential of the AAMT-DP intervention by comparing it to an inactive control condition and to a conventional AAMT in which stimuli are moved by swipe movements (n = 10 in each condition). The primary outcome was perceived stress 1 week after the training as assessed with the Perceived Stress Scale. Findings indicate sufficient feasibility and acceptability of the intervention and that the decrease in perceived stress in the AAMT-DP condition was greater than in the inactive control condition (g = 0.72 [0.10, 1.72]) and than in the swipe control condition (g = 0.64 [0.01, 1.41]). In sum, findings provide preliminary evidence for the feasibility, acceptability, and the therapeutic potential of the AAMT-DP intervention.

Mobilise-D insights to estimate real-world walking speed in multiple conditions with a wearable device.

This study aimed to validate a wearable device's walking speed estimation pipeline, considering complexity, speed, and walking bout duration. The goal was to provide recommendations on the use of wearable devices for real-world mobility analysis. Participants with Parkinson's Disease, Multiple Sclerosis, Proximal Femoral Fracture, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, and healthy older adults (n = 97) were monitored in the laboratory and the real-world (2.5 h), using a lower back wearable device. Two walking speed estimation pipelines were validated across 4408/1298 (2.5 h/laboratory) detected walking bouts, compared to 4620/1365 bouts detected by a multi-sensor reference system. In the laboratory, the mean absolute error (MAE) and mean relative error (MRE) for walking speed estimation ranged from 0.06 to 0.12 m/s and - 2.1 to 14.4%, with ICCs (Intraclass correlation coefficients) between good (0.79) and excellent (0.91). Real-world MAE ranged from 0.09 to 0.13, MARE from 1.3 to 22.7%, with ICCs indicating moderate (0.57) to good (0.88) agreement. Lower errors were observed for cohorts without major gait impairments, less complex tasks, and longer walking bouts. The analytical pipelines demonstrated moderate to good accuracy in estimating walking speed. Accuracy depended on confounding factors, emphasizing the need for robust technical validation before clinical application.Trial registration: ISRCTN - 12246987.

Refinement and Usability Analysis of an eHealth App for Ankylosing Spondylitis as a Complementary Treatment to Physical Therapy: Development and Usability Study.

BACKGROUND: Mobile eHealth apps have been used as a complementary treatment to increase the quality of life of patients and provide new opportunities for the management of rheumatic diseases. Telemedicine, particularly in the areas of prevention, diagnostics, and therapy, has become an essential cornerstone in the care of patients with rheumatic diseases. OBJECTIVE: This study aims to improve the design and technology of YogiTherapy and evaluate its usability and quality. METHODS: We newly implemented the mobile eHealth app YogiTherapy with a modern design, the option to change language, and easy navigation to improve the app's usability and quality for patients. After refinement, we evaluated the app by conducting a study with 16 patients with AS (4 female and 12 male; mean age 48.1, SD 16.8 y). We assessed the usability of YogiTherapy with a task performance test (TPT) with a think-aloud protocol and the quality with the German version of the Mobile App Rating Scale (MARS). RESULTS: In the TPT, the participants had to solve 6 tasks that should be performed on the app. The overall task completion rate in the TPT was high (84/96, 88% completed tasks). Filtering for videos and navigating to perform an assessment test caused the largest issues during the TPT, while registering in the app and watching a yoga video were highly intuitive. Additionally, 12 (75%) of the 16 participants completed the German version of MARS. The quality of YogiTherapy was rated with an average MARS score of 3.79 (SD 0.51) from a maximum score of 5. Furthermore, results from the MARS questionnaire demonstrated a positive evaluation regarding functionality and aesthetics. CONCLUSIONS: The refined and tested YogiTherapy app showed promising results among most participants. In the future, the app could serve its function as a complementary treatment for patients with AS. For this purpose, surveys with a larger number of patients should still be conducted. As a substantial advancement, we made the app free and openly available on the iOS App and Google Play stores.

WebPPG: Feasibility and Usability of Self-Performed, Browser-Based Smartphone Photoplethysmography.

Smartphones enable and facilitate biomedical studies as they allow the recording of various biomedical signals, including photoplethysmograms (PPG). However, user engagement rates in mobile health studies are reduced when an application (app) needs to be installed. This could be alleviated by using installation-free web apps. We evaluate the feasibility of browser-based PPG recording, conducting the first usability study on smartphone-based PPG. We present an at-home study using a web app and library for PPG recording using the rear camera and flash. The underlying library is freely made available to researchers. 25 Android users participated, using their own smartphones. The study consisted of a demographic and anamnestic questionnaire, the signal recording itself (60 s), and a consecutive usability questionnaire. After filtering, heart rate was extracted (14/17 successful), signal-to-noise ratios assessed (0.64 ± 0.50 dB, mean ± standard deviation), and quality was visually inspected (12/17 usable for diagnosis). Recording was not supported in 9 cases. This was due to the browser's insufficient support for the flash light API. The app received a System Usability Scale score of 82 ± 9, which is above the 90th percentile. Overall, browser flash light support is the main limiting factor for broad device support. Thus, browser-based PPG is not yet widely applicable, although most participants feel comfortable with the recording itself. The utilization of the user-facing camera might represent a more promising approach. This study contributes to the development of low-barrier, user-friendly, installation-free smartphone signal acquisition. This enables profound, comprehensive data collection for research and clinical practice.Clinical relevance- WebPPG offers low-barrier remote diagnostic capabilities without the need for app installation.

Monitoring medication optimization in patients with Parkinson's disease.

Medication optimization is a common component of the treatment strategy in patients with Parkinson's disease. As the disease progresses, it is essential to compensate for the movement deterioration in patients. Conventionally, examining motor deterioration and prescribing medication requires the patient's onsite presence in hospitals or practices. Home-monitoring technologies can remotely deliver essential information to physicians and help them devise a treatment decision according to the patient's need. Additionally, they help to observe the patient's response to these changes. In this regard, we conducted a longitudinal study to collect gait data of patients with Parkinson's disease while they received medication changes. Using logistic regression classifier, we could detect the annotated motor deterioration during medication optimization with an accuracy of 92%. Moreover, an in-depth examination of the best features illustrated a decline in gait speed and swing phase duration in the deterioration phases due to suboptimal medication.Clinical relevance- Our proposed gait analysis method in this study provides objective, detailed, and punctual information to physicians. Revealing clinically relevant time points related to the patient's need for medical adaption alleviates therapy optimization for physicians and reduces the duration of suboptimal treatment for patients. As the home-monitoring system acts remotely, embedding it in the medical care pathways could improve patients' quality of life.

Fetal Re-Identification in Multiple Pregnancy Ultrasound Images Using Deep Learning.

Ultrasound examinations during pregnancy can detect abnormal fetal development, which is a leading cause of perinatal mortality. In multiple pregnancies, the position of the fetuses may change between examinations. The individual fetus cannot be clearly identified. Fetal re-identification may improve diagnostic capabilities by tracing individual fetal changes. This work evaluates the feasibility of fetal re-identification on FETAL_PLANES_DB, a publicly available dataset of singleton pregnancy ultrasound images. Five dataset subsets with 6,491 images from 1,088 pregnant women and two re-identification frameworks (Torchreid, FastReID) are evaluated. FastReID achieves a mean average precision of 68.77% (68.42%) and mean precision at rank 10 score of 89.60% (95.55%) when trained on images showing the fetal brain (abdomen). Visualization with gradient-weighted class activation mapping shows that the classifiers appear to rely on anatomical features. We conclude that fetal re-identification in ultrasound images may be feasible. However, more work on additional datasets, including images from multiple pregnancies and several subsequent examinations, is required to ensure and investigate performance stability and explainability.Clinical relevance- To date, fetuses in multiple pregnancies cannot be distinguished between ultrasound examinations. This work provides the first evidence for feasibility of fetal re-identification in pregnancy ultrasound images. This may improve diagnostic capabilities in clinical practice in the future, such as longitudinal analysis of fetal changes or abnormalities.

Usability and Perception of a Wearable-Integrated Digital Maternity Record App in Germany: User Study.

Background: Although digital maternity records (DMRs) have been evaluated in the past, no previous work investigated usability or acceptance through an observational usability study. Objective: The primary objective was to assess the usability and perception of a DMR smartphone app for pregnant women. The secondary objective was to assess personal preferences and habits related to online information searching, wearable data presentation and interpretation, at-home examination, and sharing data for research purposes during pregnancy. Methods: A DMR smartphone app was developed. Key features such as wearable device integration, study functionalities (eg, questionnaires), and common pregnancy app functionalities (eg, mood tracker) were included. Women who had previously given birth were invited to participate. Participants completed 10 tasks while asked to think aloud. Sessions were conducted via Zoom. Video, audio, and the shared screen were recorded for analysis. Task completion times, task success, errors, and self-reported (free text) feedback were evaluated. Usability was measured through the System Usability Scale (SUS) and User Experience Questionnaire (UEQ). Semistructured interviews were conducted to explore the secondary objective. Results: A total of 11 participants (mean age 34.6, SD 2.2 years) were included in the study. A mean SUS score of 79.09 (SD 18.38) was achieved. The app was rated "above average" in 4 of 6 UEQ categories. Sixteen unique features were requested. We found that 5 of 11 participants would only use wearables during pregnancy if requested to by their physician, while 10 of 11 stated they would share their data for research purposes. Conclusions: Pregnant women rely on their medical caregivers for advice, including on the use of mobile and ubiquitous health technology. Clear benefits must be communicated if issuing wearable devices to pregnant women. Participants that experienced pregnancy complications in the past were overall more open toward the use of wearable devices in pregnancy. Pregnant women have different opinions regarding access to, interpretation of, and reactions to alerts based on wearable data. Future work should investigate personalized concepts covering these aspects.

Prevalence and course of pregnancy symptoms using self-reported pregnancy app symptom tracker data.

During pregnancy, almost all women experience pregnancy-related symptoms. The relationship between symptoms and their association with pregnancy outcomes is not well understood. Many pregnancy apps allow pregnant women to track their symptoms. To date, the resulting data are primarily used from a commercial rather than a scientific perspective. In this work, we aim to examine symptom occurrence, course, and their correlation throughout pregnancy. Self-reported app data of a pregnancy symptom tracker is used. In this context, we present methods to handle noisy real-world app data from commercial applications to understand the trajectory of user and patient-reported data. We report real-world evidence from patient-reported outcomes that exceeds previous works: 1,549,186 tracked symptoms from 183,732 users of a smartphone pregnancy app symptom tracker are analyzed. The majority of users track symptoms on a single day. These data are generalizable to those users who use the tracker for at least 5 months. Week-by-week symptom report data are presented for each symptom. There are few or conflicting reports in the literature on the course of diarrhea, fatigue, headache, heartburn, and sleep problems. A peak in fatigue in the first trimester, a peak in headache reports around gestation week 15, and a steady increase in the reports of sleeping difficulty throughout pregnancy are found. Our work highlights the potential of secondary use of industry data. It reveals and clarifies several previously unknown or disputed symptom trajectories and relationships. Collaboration between academia and industry can help generate new scientific knowledge.

Evaluating the feasibility and exploring the efficacy of an emotion-based approach-avoidance modification training (eAAMT) in the context of perceived stress in an adult sample - protocol of a parallel randomized controlled pilot study.

BACKGROUND: Stress levels and thus the risk of developing related physical and mental health conditions are rising worldwide. Dysfunctional beliefs contribute to the development of stress. Potentially, such beliefs can be modified with approach-avoidance modification trainings (AAMT). As previous research indicates that effects of AAMTs are small, there is a need for innovative ways of increasing the efficacy of these interventions. For this purpose, we aim to evaluate the feasibility of the intervention and study design and explore the efficacy of an innovative emotion-based AAMT version (eAAMT) that uses the display of emotions to move stress-inducing beliefs away from and draw stress-reducing beliefs towards oneself. METHODS: We will conduct a parallel randomized controlled pilot study at the Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany. Individuals with elevated stress levels will be randomized to one of eight study conditions (n = 10 per condition) - one of six variants of the eAAMT, an active control intervention (swipe-based AAMT), or an inactive control condition. Participants in the intervention groups will engage in four sessions of 20-30 min (e)AAMT training on consecutive days. Participants in the inactive control condition will complete the assessments via an online tool. Non-blinded assessments will be taken directly before and after the training and 1 week after training completion. The primary outcome will be perceived stress. Secondary outcomes will be dysfunctional beliefs, symptoms of depression, emotion regulation skills, and physiological stress measures. We will compute effect sizes and conduct mixed ANOVAs to explore differences in change in outcomes between the eAAMT and control conditions. DISCUSSION: The study will provide valuable information to improve the intervention and study design. Moreover, if shown to be effective, the approach can be used as an automated smartphone-based intervention. Future research needs to identify target groups benefitting from this intervention utilized either as stand-alone treatment or an add-on intervention that is combined with other evidence-based treatments. TRIAL REGISTRATION: The trial has been registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS00023007 ; September 7, 2020).

Federated electronic health records for the European Health Data Space.

The European Commission's draft for the European Health Data Space (EHDS) aims to empower citizens to access their personal health data and share it with physicians and other health-care providers. It further defines procedures for the secondary use of electronic health data for research and development. Although this planned legislation is undoubtedly a step in the right direction, implementation approaches could potentially result in centralised data silos that pose data privacy and security risks for individuals. To address this concern, we propose federated personal health data spaces, a novel architecture for storing, managing, and sharing personal electronic health records that puts citizens at the centre-both conceptually and technologically. The proposed architecture puts citizens in control by storing personal health data on a combination of personal devices rather than in centralised data silos. We describe how this federated architecture fits within the EHDS and can enable the same features as centralised systems while protecting the privacy of citizens. We further argue that increased privacy and control do not contradict the use of electronic health data for research and development. Instead, data sovereignty and transparency encourage active participation in studies and data sharing. This combination of privacy-by-design and transparent, privacy-preserving data sharing can enable health-care leaders to break the privacy-exploitation barrier, which currently limits the secondary use of health data in many cases.

Automated assessment of foot elevation in adults with hereditary spastic paraplegia using inertial measurements and machine learning.

BACKGROUND: Hereditary spastic paraplegias (HSPs) cause characteristic gait impairment leading to an increased risk of stumbling or even falling. Biomechanically, gait deficits are characterized by reduced ranges of motion in lower body joints, limiting foot clearance and ankle range of motion. To date, there is no standardized approach to continuously and objectively track the degree of dysfunction in foot elevation since established clinical rating scales require an experienced investigator and are considered to be rather subjective. Therefore, digital disease-specific biomarkers for foot elevation are needed. METHODS: This study investigated the performance of machine learning classifiers for the automated detection and classification of reduced foot dorsiflexion and clearance using wearable sensors. Wearable inertial sensors were used to record gait patterns of 50 patients during standardized 4 [Formula: see text] 10 m walking tests at the hospital. Three movement disorder specialists independently annotated symptom severity. The majority vote of these annotations and the wearable sensor data were used to train and evaluate machine learning classifiers in a nested cross-validation scheme. RESULTS: The results showed that automated detection of reduced range of motion and foot clearance was possible with an accuracy of 87%. This accuracy is in the range of individual annotators, reaching an average accuracy of 88% compared to the ground truth majority vote. For classifying symptom severity, the algorithm reached an accuracy of 74%. CONCLUSION: Here, we show that the present wearable gait analysis system is able to objectively assess foot elevation patterns in HSP. Future studies will aim to improve the granularity for continuous tracking of disease severity and monitoring therapy response of HSP patients in a real-world environment.