Real-World Gait Detection Using a Wrist-Worn Inertial Sensor: Validation Study.

BACKGROUND: Wrist-worn inertial sensors are used in digital health for evaluating mobility in real-world environments. Preceding the estimation of spatiotemporal gait parameters within long-term recordings, gait detection is an important step to identify regions of interest where gait occurs, which requires robust algorithms due to the complexity of arm movements. While algorithms exist for other sensor positions, a comparative validation of algorithms applied to the wrist position on real-world data sets across different disease populations is missing. Furthermore, gait detection performance differences between the wrist and lower back position have not yet been explored but could yield valuable information regarding sensor position choice in clinical studies. OBJECTIVE: The aim of this study was to validate gait sequence (GS) detection algorithms developed for the wrist position against reference data acquired in a real-world context. In addition, this study aimed to compare the performance of algorithms applied to the wrist position to those applied to lower back-worn inertial sensors. METHODS: Participants with Parkinson disease, multiple sclerosis, proximal femoral fracture (hip fracture recovery), chronic obstructive pulmonary disease, and congestive heart failure and healthy older adults (N=83) were monitored for 2.5 hours in the real-world using inertial sensors on the wrist, lower back, and feet including pressure insoles and infrared distance sensors as reference. In total, 10 algorithms for wrist-based gait detection were validated against a multisensor reference system and compared to gait detection performance using lower back-worn inertial sensors. RESULTS: The best-performing GS detection algorithm for the wrist showed a mean (per disease group) sensitivity ranging between 0.55 (SD 0.29) and 0.81 (SD 0.09) and a mean (per disease group) specificity ranging between 0.95 (SD 0.06) and 0.98 (SD 0.02). The mean relative absolute error of estimated walking time ranged between 8.9% (SD 7.1%) and 32.7% (SD 19.2%) per disease group for this algorithm as compared to the reference system. Gait detection performance from the best algorithm applied to the wrist inertial sensors was lower than for the best algorithms applied to the lower back, which yielded mean sensitivity between 0.71 (SD 0.12) and 0.91 (SD 0.04), mean specificity between 0.96 (SD 0.03) and 0.99 (SD 0.01), and a mean relative absolute error of estimated walking time between 6.3% (SD 5.4%) and 23.5% (SD 13%). Performance was lower in disease groups with major gait impairments (eg, patients recovering from hip fracture) and for patients using bilateral walking aids. CONCLUSIONS: Algorithms applied to the wrist position can detect GSs with high performance in real-world environments. Those periods of interest in real-world recordings can facilitate gait parameter extraction and allow the quantification of gait duration distribution in everyday life. Our findings allow taking informed decisions on alternative positions for gait recording in clinical studies and public health. TRIAL REGISTRATION: ISRCTN Registry 12246987; https://www.isrctn.com/ISRCTN12246987. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-050785.

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.

Assessing real-world gait with digital technology? Validation, insights and recommendations from the Mobilise-D consortium.

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.

Mobility recorded by wearable devices and gold standards: the Mobilise-D procedure for data standardization.

Wearable devices are used in movement analysis and physical activity research to extract clinically relevant information about an individual's mobility. Still, heterogeneity in protocols, sensor characteristics, data formats, and gold standards represent a barrier for data sharing, reproducibility, and external validation. In this study, we aim at providing an example of how movement data (from the real-world and the laboratory) recorded from different wearables and gold standard technologies can be organized, integrated, and stored. We leveraged on our experience from a large multi-centric study (Mobilise-D) to provide guidelines that can prove useful to access, understand, and re-use the data that will be made available from the study. These guidelines highlight the encountered challenges and the adopted solutions with the final aim of supporting standardization and integration of data in other studies and, in turn, to increase and facilitate comparison of data recorded in the scientific community. We also provide samples of standardized data, so that both the structure of the data and the procedure can be easily understood and reproduced.

Technical validation of real-world monitoring of gait: a multicentric observational study.

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 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 NUMBER: ISRCTN (12246987).

Walking on common ground: a cross-disciplinary scoping review on the clinical utility of digital mobility outcomes.

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.

Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review.

INTRODUCTION: Advances in wearable sensor technology now enable frequent, objective monitoring of real-world walking. Walking-related digital mobility outcomes (DMOs), such as real-world walking speed, have the potential to be more sensitive to mobility changes than traditional clinical assessments. However, it is not yet clear which DMOs are most suitable for formal validation. In this review, we will explore the evidence on discriminant ability, construct validity, prognostic value and responsiveness of walking-related DMOs in four disease areas: Parkinson's disease, multiple sclerosis, chronic obstructive pulmonary disease and proximal femoral fracture. METHODS AND ANALYSIS: Arksey and O'Malley's methodological framework for scoping reviews will guide study conduct. We will search seven databases (Medline, CINAHL, Scopus, Web of Science, EMBASE, IEEE Digital Library and Cochrane Library) and grey literature for studies which (1) measure differences in DMOs between healthy and pathological walking, (2) assess relationships between DMOs and traditional clinical measures, (3) assess the prognostic value of DMOs and (4) use DMOs as endpoints in interventional clinical trials. Two reviewers will screen each abstract and full-text manuscript according to predefined eligibility criteria. We will then chart extracted data, map the literature, perform a narrative synthesis and identify gaps. ETHICS AND DISSEMINATION: As this review is limited to publicly available materials, it does not require ethical approval. This work is part of Mobilise-D, an Innovative Medicines Initiative Joint Undertaking which aims to deliver, validate and obtain regulatory approval for DMOs. Results will be shared with the scientific community and general public in cooperation with the Mobilise-D communication team. REGISTRATION: Study materials and updates will be made available through the Center for Open Science's OSFRegistry (https://osf.io/k7395).

Gait Asymmetry Post-Stroke: Determining Valid and Reliable Methods Using a Single Accelerometer Located on the Trunk.

Asymmetry is a cardinal symptom of gait post-stroke that is targeted during rehabilitation. Technological developments have allowed accelerometers to be a feasible tool to provide digital gait variables. Many acceleration-derived variables are proposed to measure gait asymmetry. Despite a need for accurate calculation, no consensus exists for what is the most valid and reliable variable. Using an instrumented walkway (GaitRite) as the reference standard, this study compared the validity and reliability of multiple acceleration-derived asymmetry variables. Twenty-five post-stroke participants performed repeated walks over GaitRite whilst wearing a tri-axial accelerometer (Axivity AX3) on their lower back, on two occasions, one week apart. Harmonic ratio, autocorrelation, gait symmetry index, phase plots, acceleration, and jerk root mean square were calculated from the acceleration signals. Test-retest reliability was calculated, and concurrent validity was estimated by comparison with GaitRite. The strongest concurrent validity was obtained from step regularity from the vertical signal, which also recorded excellent test-retest reliability (Spearman's rank correlation coefficients (rho) = 0.87 and Intraclass correlation coefficient (ICC21) = 0.98, respectively). Future research should test the responsiveness of this and other step asymmetry variables to quantify change during recovery and the effect of rehabilitative interventions for consideration as digital biomarkers to quantify gait asymmetry.

Dual vs. Single Tasking During Circular Walking: What Better Reflects Progression in Parkinson's Disease?

Background and Aim: Reliable, valid and sensitive measures of dual-task-associated impairments in patients with Parkinson's disease (PD) may reveal progressive deficits unnoticed under single-task walking. The aim of this study was to quantitatively identify markers of progressive gait deficits in idiopathic PD while walking over a circular trajectory condition in single-task walking and in different dual-task conditions: (1) circular walking while checking boxes on a paper sheet as fast as possible and (2) circular walking while performing subtraction of 7 as fast as possible. In addition, we aimed to study the added value of dual-tasking assessment over single (circular) walking task assessment in the study of PD progression. Methods: The assessments were performed every 6 months over a (up to) 5 years period for 22 patients in early-stage PD, 27 patients in middle-stage PD and 25 healthy controls (HC). Longitudinal changes of 27 gait features extracted from accelerometry were compared between PD groups and HCs using generalized estimating equations analysis, accounting for gait speed, age, and levodopa medication state confounders when required. In addition, dual-task-interference with gait and cognitive performance was assessed, as well as their combination. Results: The results support the validity and robustness of some of the gait features already identified in our previous work as progression markers of the disease in single-task circular walking. However, fewer gait features from dual-task than from single-task assessments were identified as markers of progression in PD. Moreover, we did not clearly identify progressive worsening of dual-task-interference in patients with PD, although some group differences between early and middle stages of PD vs. the control group were observed for dual-task interference with the gait task and with the concurrent tasks. Conclusions: Overall, the results showed that dual-tasking did not have added value in the study of PD progression from circular gait assessments. Our analyses suggest that, while single-task walking might be sensitive enough, dual-tasking may introduce additional (error) variance to the data and may represent complex composite measures of cognitive and motor performance.

Potential Markers of Progression in Idiopathic Parkinson's Disease Derived From Assessment of Circular Gait With a Single Body-Fixed-Sensor: A 5 Year Longitudinal Study.

Background and Aim: Development of objective, reliable and easy-to-use methods to obtain progression markers of Parkinson's disease (PD) is required to evaluate interventions and to advance research in PD. This study aimed to provide quantitative markers of progression in idiopathic PD from the assessment of circular gait (walking in circles) with a single body-fixed inertial sensor placed on the lower back. Methods: The assessments were performed every 6 months over a (up to) 5 years period for 22 patients in early-stage PD, 27 patients in middle-stage PD and 25 healthy controls (HC). Longitudinal changes of 24 gait features extracted from accelerometry were compared between PD groups and HCs with generalized estimating equations (GEE) analysis, accounting for gait speed, age and levodopa medication state confounders when required. Results: Five gait features indicated progressive worsening in early stages of PD: number of steps, total duration and harmonic ratios calculated from vertical (VT), medio-lateral (ML), and anterior-posterior (AP) accelerations. For middle stages of PD, three gait features were identified as potential progression markers: stride time variability, and stride regularity from VT and AP acceleration. Conclusion: Faster progressive worsening of gait features in early and middle stages of PD relative to healthy controls over 5 years confirmed the potential of accelerometry-based assessments as quantitative progression markers in early and middle stages of the disease. The difference in significant parameters between both PD groups suggests that distinct domains of gait deteriorate in these PD stages. We conclude that instrumented circular walking assessment is a practical and useful tool in the assessment of PD progression that may have relevant potential to be implemented in clinical trials and even clinical routine, particularly in a developing digital era.

A novel accelerometry-based algorithm for the detection of step durations over short episodes of gait in healthy elderly.

BACKGROUND: The assessment of short episodes of gait is clinically relevant and easily implemented, especially given limited space and time requirements. BFS (body-fixed-sensors) are small, lightweight and easy to wear sensors, which allow the assessment of gait at relative low cost and with low interference. Thus, the assessment with BFS of short episodes of gait, extracted from dailylife physical activity or measured in a standardised and supervised setting, may add value in the study of gait quality of the elderly. The aim of this study was to evaluate the accuracy of a novel algorithm based on acceleration signals recorded at different human locations (lower back and heels) for the detection of step durations over short episodes of gait in healthy elderly subjects. METHODS: Twenty healthy elderly subjects (73.7 ± 7.9 years old) walked twice a distance of 5 m, wearing a BFS on the lower back, and on the outside of each heel. Moreover, an optoelectronic three-dimensional (3D) motion tracking system was used to detect step durations. A novel algorithm is presented for the detection of step durations from low-back and heel acceleration signals separately. The accuracy of the algorithm was assessed by comparing absolute differences in step duration between the three methods: step detection from the optoelectronic 3D motion tracking system, step detection from the application of the novel algorithm to low-back accelerations, and step detection from the application of the novel algorithm to heel accelerations. RESULTS: The proposed algorithm successfully detected all the steps, without false positives and without false negatives. Absolute average differences in step duration within trials and across subjects were calculated for each comparison, between low-back accelerations and the optoelectronic system were on average 22.4 ± 7.6 ms (4.0 ± 1.3 % of average step duration), between heel accelerations and the optoelectronic system were on average 20.7 ± 11.8 ms (3.7 ± 1.9 %), and between low-back accelerations and heel accelerations were on average 27.8 ± 15.1 ms (4.9 ± 2.5 % of average step duration). CONCLUSIONS: This study showed that the presented novel algorithm detects step durations over short episodes of gait in healthy elderly subjects with acceptable accuracy from low-back and heel accelerations, which provides opportunities to extract a range of gait parameters from short episodes of gait.