Effects of physiotherapy and home-based training in parkinsonian syndromes: protocol for a randomised controlled trial (MobilityAPP).

INTRODUCTION: Gait and mobility impairment are pivotal signs of parkinsonism, and they are particularly severe in atypical parkinsonian disorders including multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). A pilot study demonstrated a significant improvement of gait in patients with MSA of parkinsonian type (MSA-P) after physiotherapy and matching home-based exercise, as reflected by sensor-based gait parameters. In this study, we aim to investigate whether a gait-focused physiotherapy (GPT) and matching home-based exercise lead to a greater improvement of gait performance compared with a standard physiotherapy/home-based exercise programme (standard physiotherapy, SPT). METHODS AND ANALYSIS: This protocol was deployed to evaluate the effects of a GPT versus an active control undergoing SPT and matching home-based exercise with regard to laboratory gait parameters, physical activity measures and clinical scales in patients with Parkinson's disease (PD), MSA-P and PSP. The primary outcomes of the trial are sensor-based laboratory gait parameters, while the secondary outcome measures comprise real-world derived parameters, clinical rating scales and patient questionnaires. We aim to enrol 48 patients per disease group into this double-blind, randomised-controlled trial. The study starts with a 1 week wearable sensor-based monitoring of physical activity. After randomisation, patients undergo a 2 week daily inpatient physiotherapy, followed by 5 week matching unsupervised home-based training. A 1 week physical activity monitoring is repeated during the last week of intervention. ETHICS AND DISSEMINATION: This study, registered as 'Mobility in Atypical Parkinsonism: a Trial of Physiotherapy (Mobility_APP)' at clinicaltrials.gov (NCT04608604), received ethics approval by local committees of the involved centres. The patient's recruitment takes place at the Movement Disorders Units of Innsbruck (Austria), Erlangen (Germany), Lausanne (Switzerland), Luxembourg (Luxembourg) and Bolzano (Italy). The data resulting from this project will be submitted to peer-reviewed journals, presented at international congresses and made publicly available at the end of the trial. TRIAL REGISTRATION NUMBER: NCT04608604.

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.

Automated Gait Detection in Older Adults during Daily-Living using Self-Supervised Learning of Wrist-Worn Accelerometer Data: Development and Validation of ElderNet.

Progressive gait impairment is common in aging adults. Remote phenotyping of gait during daily living has the potential to quantify gait alterations and evaluate the effects of interventions that may prevent disability in the aging population. Here, we developed ElderNet, a self-supervised learning model for gait detection from wrist-worn accelerometer data. Validation involved two diverse cohorts, including over 1,000 participants without gait labels, as well as 83 participants with labeled data: older adults with Parkinson's disease, proximal femoral fracture, chronic obstructive pulmonary disease, congestive heart failure, and healthy adults. ElderNet presented high accuracy (96.43 ± 2.27), specificity (98.87 ± 2.15), recall (82.32 ± 11.37), precision (86.69 ± 17.61), and F1 score (82.92 ± 13.39). The suggested method yielded superior performance compared to two state-of-the-art gait detection algorithms, with improved accuracy and F1 score (p < 0.05). In an initial evaluation of construct validity, ElderNet identified differences in estimated daily walking durations across cohorts with different clinical characteristics, such as mobility disability (p < 0.001) and parkinsonism (p < 0.001). The proposed self-supervised gait detection method has the potential to serve as a valuable tool for remote phenotyping of gait function during daily living in aging adults.

It needs more than a myocardial infarction to start exercising: the CoLaus|PsyCoLaus prospective study.

BACKGROUND: Increased physical activity (PA) is recommended after an acute coronary event to prevent recurrences. Whether patients with acute coronary event actually increase their PA has not been assessed using objective methods such as accelerometer. We aimed to assess the subjectively and objectively measured physical activity (PA) levels of patients before and after an acute coronary event. METHODS: Data from the three follow-up surveys of a prospective study conducted in Lausanne, Switzerland. Self-reported PA was assessed by questionnaire in the first (2009-2012) and second (2014-2017) follow-ups. Objective PA was assessed by a wrist-worn accelerometer in the second and third (2018-2021) follow-ups. Participants who developed an acute coronary event between each survey period were considered as eligible. PA levels were compared before and after the event, and changes in PA levels were also compared between participants who developed an acute event with three gender and age-matched healthy controls. RESULTS: For self-reported PA, data from 43 patients (12 women, 64 ± 9 years) were used. No differences were found for all PA levels expressed in minutes/day before and after the event: moderate PA, median and [interquartile range] 167 [104-250] vs. 153 [109-240]; light PA: 151 [77-259] vs. 166 [126-222], and sedentary behaviour: 513 [450-635] vs. 535 [465-642] minutes/day. Comparison with gender- and age-matched healthy controls showed no differences regarding trends in reported PA. For accelerometer-assessed PA, data from 32 patients (16 women, 66 ± 9 years) were used. No differences were found for all PA levels expressed in minutes/day before and after the event: moderate PA: 159 [113-189] vs. 141 [111-189]; light PA: 95.8 [79-113] vs. 95.9 [79-117], and sedentary behaviour: 610 [545-659] vs. 602 [540-624]. Regarding the comparison with gender- and age-matched healthy controls, controls had an increase in accelerometer-assessed sedentary behaviour as % of day: multivariable adjusted average standard error 2.7 ± 0.6, while no increase was found for cases: 0.1 ± 1.1; no differences were found for the other PA levels. CONCLUSION: Patients do not seem to change their PA levels after a first coronary event. Our results should be confirmed in larger samples.

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.

Ecological validity of a deep learning algorithm to detect gait events from real-life walking bouts in mobility-limiting diseases.

Introduction: The clinical assessment of mobility, and walking specifically, is still mainly based on functional tests that lack ecological validity. Thanks to inertial measurement units (IMUs), gait analysis is shifting to unsupervised monitoring in naturalistic and unconstrained settings. However, the extraction of clinically relevant gait parameters from IMU data often depends on heuristics-based algorithms that rely on empirically determined thresholds. These were mainly validated on small cohorts in supervised settings. Methods: Here, a deep learning (DL) algorithm was developed and validated for gait event detection in a heterogeneous population of different mobility-limiting disease cohorts and a cohort of healthy adults. Participants wore pressure insoles and IMUs on both feet for 2.5 h in their habitual environment. The raw accelerometer and gyroscope data from both feet were used as input to a deep convolutional neural network, while reference timings for gait events were based on the combined IMU and pressure insoles data. Results and discussion: The results showed a high-detection performance for initial contacts (ICs) (recall: 98%, precision: 96%) and final contacts (FCs) (recall: 99%, precision: 94%) and a maximum median time error of -0.02 s for ICs and 0.03 s for FCs. Subsequently derived temporal gait parameters were in good agreement with a pressure insoles-based reference with a maximum mean difference of 0.07, -0.07, and <0.01 s for stance, swing, and stride time, respectively. Thus, the DL algorithm is considered successful in detecting gait events in ecologically valid environments across different mobility-limiting diseases.

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.

A multi-sensor wearable system for the assessment of diseased gait in real-world conditions.

Introduction: Accurately assessing people's gait, especially in real-world conditions and in case of impaired mobility, is still a challenge due to intrinsic and extrinsic factors resulting in gait complexity. To improve the estimation of gait-related digital mobility outcomes (DMOs) in real-world scenarios, this study presents a wearable multi-sensor system (INDIP), integrating complementary sensing approaches (two plantar pressure insoles, three inertial units and two distance sensors). Methods: The INDIP technical validity was assessed against stereophotogrammetry during a laboratory experimental protocol comprising structured tests (including continuous curvilinear and rectilinear walking and steps) and a simulation of daily-life activities (including intermittent gait and short walking bouts). To evaluate its performance on various gait patterns, data were collected on 128 participants from seven cohorts: healthy young and older adults, patients with Parkinson's disease, multiple sclerosis, chronic obstructive pulmonary disease, congestive heart failure, and proximal femur fracture. Moreover, INDIP usability was evaluated by recording 2.5-h of real-world unsupervised activity. Results and discussion: Excellent absolute agreement (ICC >0.95) and very limited mean absolute errors were observed for all cohorts and digital mobility outcomes (cadence ≤0.61 steps/min, stride length ≤0.02 m, walking speed ≤0.02 m/s) in the structured tests. Larger, but limited, errors were observed during the daily-life simulation (cadence 2.72-4.87 steps/min, stride length 0.04-0.06 m, walking speed 0.03-0.05 m/s). Neither major technical nor usability issues were declared during the 2.5-h acquisitions. Therefore, the INDIP system can be considered a valid and feasible solution to collect reference data for analyzing gait in real-world conditions.

A robust walking detection algorithm using a single foot-worn inertial sensor: validation in real-life settings.

Walking activity and gait parameters are considered among the most relevant mobility-related parameters. Currently, gait assessments have been mainly analyzed in laboratory or hospital settings, which only partially reflect usual performance (i.e., real world behavior). In this study, we aim to validate a robust walking detection algorithm using a single foot-worn inertial measurement unit (IMU) in real-life settings. We used a challenging dataset including 18 individuals performing free-living activities. A multi-sensor wearable system including pressure insoles, multiple IMUs, and infrared distance sensors (INDIP) was used as reference. Accurate walking detection was obtained, with sensitivity and specificity of 98 and 91% respectively. As robust walking detection is needed for ambulatory monitoring to complete the processing pipeline from raw recorded data to walking/mobility outcomes, a validated algorithm would pave the way for assessing patient performance and gait quality in real-world conditions.

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.

Design and validation of a multi-task, multi-context protocol for real-world gait simulation.

BACKGROUND: Measuring mobility in daily life entails dealing with confounding factors arising from multiple sources, including pathological characteristics, patient specific walking strategies, environment/context, and purpose of the task. The primary aim of this study is to propose and validate a protocol for simulating real-world gait accounting for all these factors within a single set of observations, while ensuring minimisation of participant burden and safety. METHODS: The protocol included eight motor tasks at varying speed, incline/steps, surface, path shape, cognitive demand, and included postures that may abruptly alter the participants' strategy of walking. It was deployed in a convenience sample of 108 participants recruited from six cohorts that included older healthy adults (HA) and participants with potentially altered mobility due to Parkinson's disease (PD), multiple sclerosis (MS), proximal femoral fracture (PFF), chronic obstructive pulmonary disease (COPD) or congestive heart failure (CHF). A novelty introduced in the protocol was the tiered approach to increase difficulty both within the same task (e.g., by allowing use of aids or armrests) and across tasks. RESULTS: The protocol proved to be safe and feasible (all participants could complete it and no adverse events were recorded) and the addition of the more complex tasks allowed a much greater spread in walking speeds to be achieved compared to standard straight walking trials. Furthermore, it allowed a representation of a variety of daily life relevant mobility aspects and can therefore be used for the validation of monitoring devices used in real life. CONCLUSIONS: The protocol allowed for measuring gait in a variety of pathological conditions suggests that it can also be used to detect changes in gait due to, for example, the onset or progression of a disease, or due to therapy. TRIAL REGISTRATION: ISRCTN-12246987.

Impact of adherence to a lifestyle-integrated programme on physical function and behavioural complexity in young older adults at risk of functional decline: a multicentre RCT secondary analysis.

CONTEXT: Long-term adherence to physical activity (PA) interventions is challenging. The Lifestyle-integrated Functional Exercise programmes were adapted Lifestyle-integrated Functional Exercise (aLiFE) to include more challenging activities and a behavioural change framework, and then enhanced Lifestyle-integrated Functional Exercise (eLiFE) to be delivered using smartphones and smartwatches. OBJECTIVES: To (1) compare adherence measures, (2) identify determinants of adherence and (3) assess the impact on outcome measures of a lifestyle-integrated programme. DESIGN, SETTING AND PARTICIPANTS: A multicentre, feasibility randomised controlled trial including participants aged 61-70 years conducted in three European cities. INTERVENTIONS: Six-month trainer-supported aLiFE or eLiFE compared with a control group, which received written PA advice. OUTCOME MEASURES: Self-reporting adherence per month using a single question and after 6-month intervention using the Exercise Adherence Rating Scale (EARS, score range 6-24). Treatment outcomes included function and disability scores (measured using the Late-Life Function and Disability Index) and sensor-derived physical behaviour complexity measure. Determinants of adherence (EARS score) were identified using linear multivariate analysis. Linear regression estimated the association of adherence on treatment outcome. RESULTS: We included 120 participants randomised to the intervention groups (aLiFE/eLiFE) (66.3±2.3 years, 53% women). The 106 participants reassessed after 6 months had a mean EARS score of 16.0±5.1. Better adherence was associated with lower number of medications taken, lower depression and lower risk of functional decline. We estimated adherence to significantly increase basic lower extremity function by 1.3 points (p<0.0001), advanced lower extremity function by 1.0 point (p<0.0001) and behavioural complexity by 0.008 per 1.0 point higher EARS score (F(3,91)=3.55, p=0.017) regardless of group allocation. CONCLUSION: PA adherence was associated with better lower extremity function and physical behavioural complexity. Barriers to adherence should be addressed preintervention to enhance intervention efficacy. Further research is needed to unravel the impact of behaviour change techniques embedded into technology-delivered activity interventions on adherence. TRIAL REGISTRATION NUMBER: NCT03065088.

Concurrent Evolution of Biomechanical and Physiological Parameters With Running-Induced Acute Fatigue.

Understanding the influence of running-induced acute fatigue on the homeostasis of the body is essential to mitigate the adverse effects and optimize positive adaptations to training. Fatigue is a multifactorial phenomenon, which influences biomechanical, physiological, and psychological facets. This work aimed to assess the evolution of these three facets with acute fatigue during a half-marathon. 13 recreational runners were equipped with one inertial measurement unit (IMU) on each foot, one combined global navigation satellite system-IMU-electrocardiogram sensor on the chest, and an Android smartphone equipped with an audio recording application. Spatio-temporal parameters for the running gait, along with the heart rate, its variability and complexity were computed using validated algorithms. Perceived fatigability was assessed using the rating-of-fatigue (ROF) scale at every 10 min of the race. The data was split into eight equal segments, corresponding to at least one ROF value per segment, and only level running parts were retained for analysis. During the race, contact time, duty factor, and trunk anteroposterior acceleration increased, and the foot strike angle and vertical stiffness decreased significantly. Heart rate showed a progressive increase, while the metrics for heart rate variability and complexity decreased during the race. The biomechanical parameters showed a significant alteration even with a small change in perceived fatigue, whereas the heart rate dynamics altered at higher changes. When divided into two groups, the slower runners presented a higher change in heart rate dynamics throughout the race than the faster runners; they both showed similar trends for the gait parameters. When tested for linear and non-linear correlations, heart rate had the highest association with biomechanical parameters, while the trunk anteroposterior acceleration had the lowest association with heart rate dynamics. These results indicate the ability of faster runners to better judge their physiological limits and hint toward a higher sensitivity of perceived fatigue to neuromuscular changes in the running gait. This study highlights measurable influences of acute fatigue, which can be studied only through concurrent measurement of biomechanical, physiological, and psychological facets of running in real-world conditions.

Putting Temperature into the Equation: Development and Validation of Algorithms to Distinguish Non-Wearing from Inactivity and Sleep in Wearable Sensors.

Long-term monitoring of real-life physical activity (PA) using wearable devices is increasingly used in clinical and epidemiological studies. The quality of the recorded data is an important issue, as unreliable data may negatively affect the outcome measures. A potential source of bias in PA assessment is the non-wearing of a device during the expected monitoring period. Identification of non-wear time is usually performed as a pre-processing step using data recorded by the accelerometer, which is the most common sensor used for PA analysis algorithms. The main issue is the correct differentiation between non-wear time, sleep time, and sedentary wake time, especially in frail older adults or patient groups. Based on the current state of the art, the objectives of this study were to (1) develop robust non-wearing detection algorithms based on data recorded with a wearable device that integrates acceleration and temperature sensors; (2) validate the algorithms using real-world data recorded according to an appropriate measurement protocol. A comparative evaluation of the implemented algorithms indicated better performances (99%, 97%, 99%, and 98% for sensitivity, specificity, accuracy, and negative predictive value, respectively) for an event-based detection algorithm, where the temperature sensor signal was appropriately processed to identify the timing of device removal/non-wear.

Instrumented 5-Time Sit-To-Stand Test: Parameters Predicting Serious Falls beyond the Duration of the Test.

BACKGROUND: Falls are a major cause of injuries in older adults. To evaluate the risk of falls in older adults, clinical assessments such as the 5-time sit-to-stand (5xSTS) test can be performed. The development of inertial measurement units (IMUs) has provided the possibility of a more in-depth analysis of the movements' biomechanical characteristics during this test. The goal of the present study was to investigate whether an instrumented 5xSTS test provides additional information to predict multiple or serious falls compared to the conventional stopwatch-based method. METHODS: Data from 458 community-dwelling older adults were analyzed. The participants were equipped with an IMU on the trunk to extract temporal, kinematic, kinetic, and smoothness movement parameters in addition to the total duration of the test by the stopwatch. RESULTS: The total duration of the test obtained by the IMU and the stopwatch was in excellent agreement (Pearson's correlation coefficient: 0.99), while the total duration obtained by the IMU was systematically 0.52 s longer than the stopwatch. In multivariable analyses that adjusted for potential confounders, fallers had slower vertical velocity, reduced vertical acceleration, lower vertical power, and lower vertical jerk than nonfallers. In contrast, the total duration of the test measured by either the IMU or the stopwatch did not differ between the 2 groups. CONCLUSIONS: An instrumented 5xSTS test provides additional information that better discriminates among older adults those at risk of multiple or serious falls than the conventional stopwatch-based assessment.

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).

Real-world gait speed estimation, frailty and handgrip strength: a cohort-based study.

Gait speed is a reliable outcome measure across multiple diagnoses, recognized as the 6th vital sign. The focus of the present study was on assessment of gait speed in long-term real-life settings with the aim to: (1) demonstrate feasibility in large cohort studies, using data recorded with a wrist-worn accelerometer device; (2) investigate whether the walking speed assessed in the real-world is consistent with expected trends, and associated with clinical scores such as frailty/handgrip strength. This cross-sectional study included n = 2809 participants (1508 women, 1301 men, [45-75] years old), monitored with a wrist-worn device for 13 consecutive days. Validated algorithms were used to detect the gait bouts and estimate speed. A set of metrics were derived from the statistical distribution of speed of gait bouts categorized by duration (short, medium, long). The estimated usual gait speed (1-1.6 m/s) appears consistent with normative values and expected trends with age, gender, BMI and physical activity levels. Speed metrics significantly improved detection of frailty: AUC increase from 0.763 (no speed metrics) to 0.798, 0.800 and 0.793 for the 95th percentile of individual's gait speed for bout durations < 30, 30-120 and > 120 s, respectively (all p < 0.001). Similarly, speed metrics also improved the prediction of handgrip strength: AUC increase from 0.669 (no speed metrics) to 0.696, 0.696 and 0.691 for the 95th percentile of individual's gait speed for bout durations < 30, 30-120 and > 120 s, respectively (all p < 0.001). Forward stepwise regression showed that the 95th percentile speed of gait bouts with medium duration (30-120 s) to be the best predictor for both conditions. The study provides evidence that real-world gait speed can be estimated using a wrist-worn wearable system, and can be used as reliable indicator of age-related functional decline.

Indirect Estimation of Breathing Rate from Heart Rate Monitoring System during Running.

Recent advances in wearable technologies integrating multi-modal sensors have enabled the in-field monitoring of several physiological metrics. In sport applications, wearable devices have been widely used to improve performance while minimizing the risk of injuries and illness. The objective of this project is to estimate breathing rate (BR) from respiratory sinus arrhythmia (RSA) using heart rate (HR) recorded with a chest belt during physical activities, yielding additional physiological insight without the need of an additional sensor. Thirty-one healthy adults performed a run at increasing speed until exhaustion on an instrumented treadmill. RR intervals were measured using the Polar H10 HR monitoring system attached to a chest belt. A metabolic measurement system was used as a reference to evaluate the accuracy of the BR estimation. The evaluation of the algorithms consisted of exploring two pre-processing methods (band-pass filters and relative RR intervals transformation) with different instantaneous frequency tracking algorithms (short-term Fourier transform, single frequency tracking, harmonic frequency tracking and peak detection). The two most accurate BR estimations were achieved by combining band-pass filters with short-term Fourier transform, and relative RR intervals transformation with harmonic frequency tracking, showing 5.5% and 7.6% errors, respectively. These two methods were found to provide reasonably accurate BR estimation over a wide range of breathing frequency. Future challenges consist in applying/validating our approaches during in-field endurance running in the context of fatigue assessment.

Reliability of single-day walking performance and physical activity measures using inertial sensors in children with cerebral palsy.

BACKGROUND: There is a lack of objective and reliable tools to measure walking performance in children with cerebral palsy (CP). OBJECTIVE: To evaluate the reliability of inertial measurement units (IMUs) measuring daily life walking performance and physical activity (PA) in children with CP and healthy controls. METHODS: Algorithms were developed to analyse data collected with IMUs during 2 standard school days of the same week and 1 weekend day in 15 children with CP and 14 controls. Additionally, within a clinical trial, 10 children with CP were measured twice, on the same weekday 2 to 4 weeks apart. Relative and absolute reliabilities of PA (% time walking, standing, sitting/lying) and gait parameters (e.g., velocity, cadence) were evaluated by using the intraclass correlation coefficient (ICC) and minimal detectable change (MDC95), comparing 2 school days of the same week, a school day with a weekend day, and the same weekday 2 to 4 weeks apart. RESULTS: For the 15 children with CP (mean [SD] age 13.5 [3.4] years), ICCs were very high (0.70-0.98) when comparing gait parameters for 2 school days. ICCs were lower when comparing 2 school days for 14 control children (mean [SD] age 13.9 [3.0] years) and lowest when comparing a school day with a weekend day for both CP and control children. ICCs for PA were 0.90-0.91 when measuring the same weekday 2 to 4 weeks apart but were very low when comparing 2 school days of the same week or a school day with a weekend day. MDC95 values were high for both groups and all comparisons but comparable with findings of in-lab studies of similar parameters. CONCLUSIONS: Our IMU and algorithm setup appears to be a reliable tool to measure daily life gait parameters in children with CP when repeatedly measured on 2 school days. PA was also reliably assessed but when measuring the same school day some weeks apart. However, the high MDC95 values question whether the setup can be used as a responsive outcome measure of interventions.