The purpose of this study was to assess the concurrent validity and test-retest reliability of a sensor-based gait analysis system. Eleven healthy subjects and four Parkinson's disease (PD) patients ...were asked to complete gait tasks whilst wearing two inertial measurement units at their feet. The extracted spatio-temporal parameters of 1166 strides were compared to those extracted from a reference camera-based motion capture system concerning concurrent validity. Test-retest reliability was assessed for five healthy subjects at three different days in a two week period. The two systems were highly correlated for all gait parameters ( r > 0.93 ). The bias for stride time was 0 ± 16 ms and for stride length was 1.4 ± 6.7 cm. No systematic range dependent errors were observed and no significant changes existed between healthy subjects and PD patients. Test-retest reliability was excellent for all parameters (intraclass correlation (ICC) > 0.81) except for gait velocity (ICC > 0.55). The sensor-based system was able to accurately capture spatio-temporal gait parameters as compared to the reference camera-based system for normal and impaired gait. The system's high retest reliability renders the use in recurrent clinical measurements and in long-term applications feasible.
Multiple sclerosis (MS) is a disabling disease affecting the central nervous system and consequently the whole body's functional systems resulting in different gait disorders. Fatigue is the most ...common symptom in MS with a prevalence of 80%. Previous research studied the relation between fatigue and gait impairment using stationary gait analysis systems and short gait tests (e.g. timed 25 ft walk). However, wearable inertial sensors providing gait data from longer and continuous gait bouts have not been used to assess the relation between fatigue and gait parameters in MS. Therefore, the aim of this study was to evaluate the association between fatigue and spatio-temporal gait parameters extracted from wearable foot-worn sensors and to predict the degree of fatigue.
Forty-nine patients with MS (32 women; 17 men; aged 41.6 years, EDSS 1.0-6.5) were included where each participant was equipped with a small Inertial Measurement Unit (IMU) on each foot. Spatio-temporal gait parameters were obtained from the 6-min walking test, and the Borg scale of perceived exertion was used to represent fatigue. Gait parameters were normalized by taking the difference of averaged gait parameters between the beginning and end of the test to eliminate inter-individual differences. Afterwards, normalized parameters were transformed to principle components that were used as input to a Random Forest regression model to formulate the relationship between gait parameters and fatigue.
Six principal components were used as input to our model explaining more than 90% of variance within our dataset. Random Forest regression was used to predict fatigue. The model was validated using 10-fold cross validation and the mean absolute error was 1.38 points. Principal components consisting mainly of stride time, maximum toe clearance, heel strike angle, and stride length had large contributions (67%) to the predictions made by the Random Forest.
The level of fatigue can be predicted based on spatio-temporal gait parameters obtained from an IMU based system. The results can help therapists to monitor fatigue before and after treatment and in rehabilitation programs to evaluate their efficacy. Furthermore, this can be used in home monitoring scenarios where therapists can monitor fatigue using IMUs reducing time and effort of patients and therapists.
Digital mobility assessment using wearable sensor systems has the potential to capture walking performance in a patient's natural environment. It enables monitoring of health status and disease ...progression and evaluation of interventions in real-world situations. In contrast to laboratory settings, real-world walking occurs in non-conventional environments and under unconstrained and uncontrolled conditions. Despite the general understanding, there is a lack of agreed definitions about what constitutes real-world walking, impeding the comparison and interpretation of the acquired data across systems and studies. The goal of this study was to obtain expert-based consensus on specific aspects of real-world walking and to provide respective definitions in a common terminological framework. An adapted Delphi method was used to obtain agreed definitions related to real-world walking. In an online survey, 162 participants from a panel of academic, clinical and industrial experts with experience in the field of gait analysis were asked for agreement on previously specified definitions. Descriptive statistics was used to evaluate whether consent (> 75% agreement as defined a priori) was reached. Of 162 experts invited to participate, 51 completed all rounds (31.5% response rate). We obtained consensus on all definitions ("Walking" > 90%, "Purposeful" > 75%, "Real-world" > 90%, "Walking bout" > 80%, "Walking speed" > 75%, "Turning" > 90% agreement) after two rounds. The identification of a consented set of real-world walking definitions has important implications for the development of assessment and analysis protocols, as well as for the reporting and comparison of digital mobility outcomes across studies and systems. The definitions will serve as a common framework for implementing digital and mobile technologies for gait assessment and are an important link for the transition from supervised to unsupervised gait assessment.
Current challenges demand a profound restructuration of the global healthcare system. A more efficient system is required to cope with the growing world population and increased life expectancy, ...which is associated with a marked prevalence of chronic neurological disorders such as Parkinson's disease (PD). One possible approach to meet this demand is a laterally distributed platform such as the Internet of Things (IoT). Real-time motion metrics in PD could be obtained virtually in any scenario by placing lightweight wearable sensors in the patient's clothes and connecting them to a medical database through mobile devices such as cell phones or tablets. Technologies exist to collect huge amounts of patient data not only during regular medical visits but also at home during activities of daily life. These data could be fed into intelligent algorithms to first discriminate relevant threatening conditions, adjust medications based on online obtained physical deficits, and facilitate strategies to modify disease progression. A major impact of this approach lies in its efficiency, by maximizing resources and drastically improving the patient experience. The patient participates actively in disease management via combined objective device- and self-assessment and by sharing information within both medical and peer groups. Here, we review and discuss the existing wearable technologies and the Internet-of-Things concept applied to PD, with an emphasis on how this technological platform may lead to a shift in paradigm in terms of diagnostics and treatment.
Robust gait segmentation is the basis for mobile gait analysis. A range of methods have been applied and evaluated for gait segmentation of healthy and pathological gait bouts. However, a unified ...evaluation of gait segmentation methods in Parkinson's disease (PD) is missing. In this paper, we compare four prevalent gait segmentation methods in order to reveal their strengths and drawbacks in gait processing. We considered peak detection from event-based methods, two variations of dynamic time warping from template matching methods, and hierarchical hidden Markov models (hHMMs) from machine learning methods. To evaluate the methods, we included two supervised and instrumented gait tests that are widely used in the examination of Parkinsonian gait. In the first experiment, a sequence of strides from instructed straight walks was measured from 10 PD patients. In the second experiment, a more heterogeneous assessment paradigm was used from an additional 34 PD patients, including straight walks and turning strides as well as non-stride movements. The goal of the latter experiment was to evaluate the methods in challenging situations including turning strides and non-stride movements. Results showed no significant difference between the methods for the first scenario, in which all methods achieved an almost 100% accuracy in terms of F-score. Hence, we concluded that in the case of a predefined and homogeneous sequence of strides, all methods can be applied equally. However, in the second experiment the difference between methods became evident, with the hHMM obtaining a 96% F-score and significantly outperforming the other methods. The hHMM also proved promising in distinguishing between strides and non-stride movements, which is critical for clinical gait analysis. Our results indicate that both the instrumented test procedure and the required stride segmentation algorithm have to be selected adequately in order to support and complement classical clinical examination by sensor-based movement assessment.
Distinct gait characteristics like short steps and shuffling gait are prototypical signs commonly observed in Parkinson's disease. Routinely assessed by observation through clinicians, gait is rated ...as part of categorical clinical scores. There is an increasing need to provide quantitative measurements of gait, e.g. to provide detailed information about disease progression. Recently, we developed a wearable sensor-based gait analysis system as diagnostic tool that objectively assesses gait parameter in Parkinson's disease without the need of having a specialized gait laboratory. This system consists of inertial sensor units attached laterally to both shoes. The computed target of measures are spatiotemporal gait parameters including stride length and time, stance phase time, heel-strike and toe-off angle, toe clearance, and inter-stride variation from gait sequences. To translate this prototype into medical care, we conducted a cross-sectional study including 190 Parkinson's disease patients and 101 age-matched controls and measured gait characteristics during a 4x10 meter walk at the subjects' preferred speed. To determine intraindividual changes in gait, we monitored the gait characteristics of 63 patients longitudinally. Cross-sectional analysis revealed distinct spatiotemporal gait parameter differences reflecting typical Parkinson's disease gait characteristics including short steps, shuffling gait, and postural instability specific for different disease stages and levels of motor impairment. The longitudinal analysis revealed that gait parameters were sensitive to changes by mirroring the progressive nature of Parkinson's disease and corresponded to physician ratings. Taken together, we successfully show that wearable sensor-based gait analysis reaches clinical applicability providing a high biomechanical resolution for gait impairment in Parkinson's disease. These data demonstrate the feasibility and applicability of objective wearable sensor-based gait measurement in Parkinson's disease reaching high technological readiness levels for both, large scale clinical studies and individual patient care.
Background
Impaired gait plays an important role for quality of life in patients with Huntington’s disease (HD). Measuring objective gait parameters in HD might provide an unbiased assessment of ...motor deficits in order to determine potential beneficial effects of future treatments.
Objective
To objectively identify characteristic features of gait in HD patients using sensor-based gait analysis. Particularly, gait parameters were correlated to the Unified Huntington’s Disease Rating Scale, total motor score (TMS), and total functional capacity (TFC).
Methods
Patients with manifest HD at two German sites (
n
= 43) were included and clinically assessed during their annual ENROLL-HD visit. In addition, patients with HD and a cohort of age- and gender-matched controls performed a defined gait test (4 × 10 m walk). Gait patterns were recorded by inertial sensors attached to both shoes. Machine learning algorithms were applied to calculate spatio-temporal gait parameters and gait variability expressed as coefficient of variance (CV).
Results
Stride length (− 15%) and gait velocity (− 19%) were reduced, while stride (+ 7%) and stance time (+ 2%) were increased in patients with HD. However, parameters reflecting gait variability were substantially altered in HD patients (+ 17% stride length CV up to + 41% stride time CV with largest effect size) and showed strong correlations to TMS and TFC (0.416 ≤
r
Sp
≤ 0.690). Objective gait variability parameters correlated with disease stage based upon TFC.
Conclusions
Sensor-based gait variability parameters were identified as clinically most relevant digital biomarker for gait impairment in HD. Altered gait variability represents characteristic irregularity of gait in HD and reflects disease severity.
The development of optimal strategies to treat impaired mobility related to ageing and chronic disease requires better ways to detect and measure it. Digital health technology, including body worn ...sensors, has the potential to directly and accurately capture real-world mobility. Mobilise-D consists of 34 partners from 13 countries who are working together to jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes have the potential to provide a better, safer, and quicker way to assess, monitor, and predict the efficacy of new interventions on impaired mobility. The overarching objective of the study is to establish the clinical validity of digital outcomes in patient populations impacted by mobility challenges, and to support engagement with regulatory and health technology agencies towards acceptance of digital mobility assessment in regulatory and health technology assessment decisions. The Mobilise-D clinical validation study is a longitudinal observational cohort study that will recruit 2400 participants from four clinical cohorts. The populations of the Innovative Medicine Initiative-Joint Undertaking represent neurodegenerative conditions (Parkinson's Disease), respiratory disease (Chronic Obstructive Pulmonary Disease), neuro-inflammatory disorder (Multiple Sclerosis), fall-related injuries, osteoporosis, sarcopenia, and frailty (Proximal Femoral Fracture). In total, 17 clinical sites in ten countries will recruit participants who will be evaluated every six months over a period of two years. A wide range of core and cohort specific outcome measures will be collected, spanning patient-reported, observer-reported, and clinician-reported outcomes as well as performance-based outcomes (physical measures and cognitive/mental measures). Daily-living mobility and physical capacity will be assessed directly using a wearable device. These four clinical cohorts were chosen to obtain generalizable clinical findings, including diverse clinical, cultural, geographical, and age representation. The disease cohorts include a broad and heterogeneous range of subject characteristics with varying chronic care needs, and represent different trajectories of mobility disability. The results of Mobilise-D will provide longitudinal data on the use of digital mobility outcomes to identify, stratify, and monitor disability. This will support the development of widespread, cost-effective access to optimal clinical mobility management through personalised healthcare. Further, Mobilise-D will provide evidence-based, direct measures which can be endorsed by regulatory agencies and health technology assessment bodies to quantify the impact of disease-modifying interventions on mobility.
Developing machine learning algorithms for time-series data often requires manual annotation of the data. To do so, graphical user interfaces (GUIs) are an important component. Existing Python ...packages for annotation and analysis of time-series data have been developed without addressing adaptability, usability, and user experience. Therefore, we developed a generic open-source Python package focusing on adaptability, usability, and user experience. The developed package, Machine Learning and Data Analytics (MaD) GUI, enables developers to rapidly create a GUI for their specific use case. Furthermore, MaD GUI enables domain experts without programming knowledge to annotate time-series data and apply algorithms to it. We conducted a small-scale study with participants from three international universities to test the adaptability of MaD GUI by developers and to test the user interface by clinicians as representatives of domain experts. MaD GUI saves up to 75% of time in contrast to using a state-of-the-art package. In line with this, subjective ratings regarding usability and user experience show that MaD GUI is preferred over a state-of-the-art package by developers and clinicians. MaD GUI reduces the effort of developers in creating GUIs for time-series analysis and offers similar usability and user experience for clinicians as a state-of-the-art package.
Gait impairment is the cardinal motor symptom in hereditary spastic paraplegias (HSPs) possibly linked to increased fear of falling and reduced quality of life (QoL). Disease specific symptoms in HSP ...are rated using the Spastic Paraplegia Rating Scale (SPRS). However, limited studies evaluated more objectively easy-to-apply gait measures by comparing these standardized assessments with patients’ self-perceived impairment and clinically established scores. Therefore, the aim of this study was to correlate functional gait measures with self-rating questionnaires for fear of falling and QoL, and with the SPRS as clinical gold standard.
HSP patients (“pure” phenotype, n = 22) fulfilling the clinical diagnostic criteria for HSP and age-and gender-matched healthy subjects (n = 22) were included in this study. Motor impairment was evaluated using the SPRS, fear of falling by the Falls Efficacy Scale-International (FES-I), and QoL by SF-12. Functional gait measures included gait speed and step length (10-meter-walk-test), the Timed up and go test (TUG), and maximum walking distance (2-min-walking-test).
Functional gait measures correlated to fear of falling (gait speed: r = −0.726; step length: r = −0.689; TUG: r = 0.721; 2-min: r = −0.709) and the physical component of QoL (gait speed: r = 0.541; step length: r = 0.531; TUG: r = −0.512; 2-min: r = 0.548). Furthermore, FES-I (r = 0.767) and QoL (r = -0.728) correlated with the clinical gold standard (SPRS). Gait measures strongly correlated with SPRS (gait speed: r = −0.787; step length: r = −0.821; TUG: r = 0.756; 2-min: r = −0.791).
Functional gait measures reflect fear of falling, QoL, and mobility in HSP. The metric, semi-quantitative gait measures complement the clinician’s evaluation and support the clinical workup by more objective parameters.
•Easy-to-apply gait measures were used in patients with HSP.•Functional gait parameters reflect fear of falling in HSP.•Gait measures correlate to quality of life, and mobility in HSP.•More objective functional gait measures complement the clinician’s evaluation.
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