Suchergebnisse

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. This work was supported by the Mobilise-D project that has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 820820. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation program and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Content in this publication reflects the authors' view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.

Abstract: Mobile gait analysis using wearable inertial measurement units (IMUs) provides valuable insights for the assessment of movement impairments in different neurological and musculoskeletal diseases, for example Parkinson's disease (PD). The increase in data volume due to arising long-term monitoring requires valid, robust and efficient analysis pipelines. In many studies an upstream detection of gait is therefore applied. However, current methods do not provide a robust way to successfully reject non-gait signals. Therefore, we developed a novel algorithm for the detection of gait from continuous inertial data of sensors worn at the feet. The algorithm is focused not only on a high sensitivity but also a high specificity for gait. Sliding windows of IMU signals recorded from the feet of PD patients were processed in the frequency domain. Gait was detected if the frequency spectrum contained specific patterns of harmonic frequencies. The approach was trained and evaluated on 150 clinical measurements containing standardized gait and cyclic movement tests. The detection reached a sensitivity of 0.98 and a specificity of 0.96 for the best sensor configuration (angular rate around the medio-lateral axis). On an independent validation data set including 203 unsupervised, semi-standardized gait tests, the algorithm achieved a sensitivity of 0.97. Our algorithm for the detection of gait from continuous IMU signals works reliably and showed promising results for the application in the context of free-living and non-standardized monitoring scenarios. This work was supported by the Mobilise-D project that has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 820820. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation program and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Content in this publication reflects the authors' view and neither IMI nor the European Union, EFPIA, or ...

Abstract 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 ...

Physical mobility is essential to health, and patients often rate it as a high-priority clinical outcome. Digital mobility outcomes (DMOs), such as real-world gait speed or step count, show promise as clinical measures in many medical conditions. However, current research is nascent and fragmented by discipline. This scoping review maps existing evidence on the clinical utility of DMOs, identifying commonalities across traditional disciplinary divides. In November 2019, 11 databases were searched for records investigating the validity and responsiveness of 34 DMOs in four diverse medical conditions (Parkinson's disease, multiple sclerosis, chronic obstructive pulmonary disease, hip fracture). Searches yielded 19,672 unique records. After screening, 855 records representing 775 studies were included and charted in systematic maps. Studies frequently investigated gait speed (70.4% of studies), step length (30.7%), cadence (21.4%), and daily step count (20.7%). They studied differences between healthy and pathological gait (36.4%), associations between DMOs and clinical measures (48.8%) or outcomes (4.3%), and responsiveness to interventions (26.8%). Gait speed, step length, cadence, step time and step count exhibited consistent evidence of validity and responsiveness in multiple conditions, although the evidence was inconsistent or lacking for other DMOs. If DMOs are to be adopted as mainstream tools, further work is needed to establish their predictive validity, responsiveness, and ecological validity. Cross-disciplinary efforts to align methodology and validate DMOs may facilitate their adoption into clinical practice. This work was supported by the Mobilise-D project that has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 820820. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation program and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Content in this publication ...

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 ...