scholarly journals Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes

Sensors ◽  
2020 ◽  
Vol 20 (20) ◽  
pp. 5920
Author(s):  
Marco Viceconti ◽  
Sabina Hernandez Penna ◽  
Wilhelmus Dartee ◽  
Claudia Mazzà ◽  
Brian Caulfield ◽  
...  
Keyword(s):  
Real World ◽  
Inertial Sensors ◽  
Wearable Sensors ◽  
Human Movement ◽  
European Medicines Agency ◽  
Drug Trials ◽  
Mobility Performance ◽  
Mobility Assessment ◽  
Drug Regulatory Agencies ◽  
Wearable Inertial Sensors

Wearable inertial sensors can be used to monitor mobility in real-world settings over extended periods. Although these technologies are widely used in human movement research, they have not yet been qualified by drug regulatory agencies for their use in regulatory drug trials. This is because the first generation of these sensors was unreliable when used on slow-walking subjects. However, intense research in this area is now offering a new generation of algorithms to quantify Digital Mobility Outcomes so accurate they may be considered as biomarkers in regulatory drug trials. This perspective paper summarises the work in the Mobilise-D consortium around the regulatory qualification of the use of wearable sensors to quantify real-world mobility performance in patients affected by Parkinson’s Disease. The paper describes the qualification strategy and both the technical and clinical validation plans, which have recently received highly supportive qualification advice from the European Medicines Agency. The scope is to provide detailed guidance for the preparation of similar qualification submissions to broaden the use of real-world mobility assessment in regulatory drug trials.

scholarly journals An Expert System for Quantification of Bradykinesia Based on Wearable Inertial Sensors

Sensors ◽  
2019 ◽  
Vol 19 (11) ◽  
pp. 2644
Author(s):  
Vladislava Bobić ◽  
Milica Djurić-Jovičić ◽  
Nataša Dragašević ◽  
Mirjana B. Popović ◽  
Vladimir S. Kostić ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Decision Support ◽  
Expert System ◽  
Inertial Sensors ◽  
Wearable Sensors ◽  
Objective Evaluation ◽  
Finger Tapping ◽  
Symptom Evaluation ◽  
Wearable Inertial Sensors ◽  
Processing Techniques

Wearable sensors and advanced algorithms can provide significant decision support for clinical practice. Currently, the motor symptoms of patients with neurological disorders are often visually observed and evaluated, which may result in rough and subjective quantification. Using small inertial wearable sensors, fine repetitive and clinically important movements can be captured and objectively evaluated. In this paper, a new methodology is designed for objective evaluation and automatic scoring of bradykinesia in repetitive finger-tapping movements for patients with idiopathic Parkinson’s disease and atypical parkinsonism. The methodology comprises several simple and repeatable signal-processing techniques that are applied for the extraction of important movement features. The decision support system consists of simple rules designed to match universally defined criteria that are evaluated in clinical practice. The accuracy of the system is calculated based on the reference scores provided by two neurologists. The proposed expert system achieved an accuracy of 88.16% for files on which neurologists agreed with their scores. The introduced system is simple, repeatable, easy to implement, and can provide good assistance in clinical practice, providing a detailed analysis of finger-tapping performance and decision support for symptom evaluation.

scholarly journals The Use of Wearable Sensors in Human Movement Analysis in Non-Swimming Aquatic Activities: A Systematic Review

2019 ◽  
Vol 16 (24) ◽  
pp. 5067
Author(s):  
Daniel A. Marinho ◽  
Henrique P. Neiva ◽  
Jorge E. Morais
Keyword(s):  
Systematic Review ◽  
Aquatic Environment ◽  
Web Of Science ◽  
Inertial Sensors ◽  
State Of The Art ◽  
Wearable Sensors ◽  
Movement Analysis ◽  
Human Movement ◽  
Dry Land ◽  
Swimming Kinematics

The use of smart technology, specifically inertial sensors (accelerometers, gyroscopes, and magnetometers), to analyze swimming kinematics is being reported in the literature. However, little is known about the usage/application of such sensors in other human aquatic exercises. As the sensors are getting smaller, less expensive, and simple to deal with (regarding data acquisition), one might consider that its application to a broader range of exercises should be a reality. The aim of this systematic review was to update the state of the art about the framework related to the use of sensors assessing human movement in an aquatic environment, besides swimming. The following databases were used: IEEE Xplore, Pubmed, Science Direct, Scopus, and Web of Science. Five articles published in indexed journals, aiming to assess human exercises/movements in the aquatic environment were reviewed. The data from the five articles was categorized and summarized based on the aim, purpose, participants, sensor’s specifications, body area and variables analyzed, and data analysis and statistics. The analyzed studies aimed to compare the movement/exercise kinematics between environments (i.e., dry land versus aquatic), and in some cases compared healthy to pathological participants. The use of sensors in a rehabilitation/hydrotherapy perspective may provide major advantages for therapists.

scholarly journals Wearable Inertial Sensors to Assess Standing Balance: A Systematic Review

Sensors ◽  
2019 ◽  
Vol 19 (19) ◽  
pp. 4075 ◽  
Author(s):  
Marco Ghislieri ◽  
Laura Gastaldi ◽  
Stefano Pastorelli ◽  
Shigeru Tadano ◽  
Valentina Agostini
Keyword(s):  
Inertial Sensors ◽  
Postural Sway ◽  
Wearable Sensors ◽  
Critical Discussion ◽  
Standing Balance ◽  
Wearable Systems ◽  
The Subject ◽  
Wearable Inertial Sensors ◽  
Selection Of

Wearable sensors are de facto revolutionizing the assessment of standing balance. The aim of this work is to review the state-of-the-art literature that adopts this new posturographic paradigm, i.e., to analyse human postural sway through inertial sensors directly worn on the subject body. After a systematic search on PubMed and Scopus databases, two raters evaluated the quality of 73 full-text articles, selecting 47 high-quality contributions. A good inter-rater reliability was obtained (Cohen’s kappa = 0.79). This selection of papers was used to summarize the available knowledge on the types of sensors used and their positioning, the data acquisition protocols and the main applications in this field (e.g., “active aging”, biofeedback-based rehabilitation for fall prevention, and the management of Parkinson’s disease and other balance-related pathologies), as well as the most adopted outcome measures. A critical discussion on the validation of wearable systems against gold standards is also presented.

scholarly journals Automatic methods of hoof-on and -off detection in horses using wearable inertial sensors during walk and trot on asphalt, sand and grass

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254813
Author(s):  
Eloise V. Briggs ◽  
Claudia Mazzà
Keyword(s):  
Event Detection ◽  
Inertial Sensors ◽  
Inertial Sensor ◽  
Wearable Sensors ◽  
Force Plate ◽  
Field Conditions ◽  
Future Studies ◽  
Gait Classification ◽  
Automatic Methods ◽  
Wearable Inertial Sensors

Detection of hoof-on and -off events are essential to gait classification in horses. Wearable sensors have been endorsed as a convenient alternative to the traditional force plate-based method. The aim of this study was to propose and validate inertial sensor-based methods of gait event detection, reviewing different sensor locations and their performance on different gaits and exercise surfaces. Eleven horses of various breeds and ages were recruited to wear inertial sensors attached to the hooves, pasterns and cannons. Gait events detected by pastern and cannon methods were compared to the reference, hoof-detected events. Walk and trot strides were recorded on asphalt, grass and sand. Pastern-based methods were found to be the most accurate and precise for detecting gait events, incurring mean errors of between 1 and 6ms, depending on the limb and gait, on asphalt. These methods incurred consistent errors when used to measure stance durations on all surfaces, with mean errors of 0.1 to 1.16% of a stride cycle. In conclusion, the methods developed and validated here will enable future studies to reliably detect equine gait events using inertial sensors, under a wide variety of field conditions.

scholarly journals The Validity of a Mixed Reality-Based Automated Functional Mobility Assessment

Sensors ◽  
2019 ◽  
Vol 19 (9) ◽  
pp. 2183 ◽  
Author(s):  
Ruopeng Sun ◽  
Roberto G. Aldunate ◽  
Jacob J. Sosnoff
Keyword(s):  
Mixed Reality ◽  
Inertial Sensors ◽  
Inertial Sensor ◽  
Preliminary Investigation ◽  
Functional Mobility ◽  
Timed Up And Go ◽  
Perfect Agreement ◽  
Mobility Performance ◽  
Mobility Assessment ◽  
Clinical Tools

Functional mobility assessments (i.e., Timed Up and Go) are commonly used clinical tools for mobility and fall risk screening in older adults. In this work, we proposed a new Mixed Reality (MR)-based assessment that utilized a Microsoft HoloLensTM headset to automatically lead and track the performance of functional mobility tests, and subsequently evaluated its validity in comparison with reference inertial sensors. Twenty-two healthy adults (10 older and 12 young adults) participated in this study. An automated functional mobility assessment app was developed, based on the HoloLens platform. The mobility performance was recorded with the headset built-in sensor and reference inertial sensor (Opal, APDM) taped on the headset and lower back. The results indicate that the vertical kinematic measurements by HoloLens were in good agreement with the reference sensor (Normalized RMSE ~ 10%, except for cases where the inertial sensor drift correction was not viable). Additionally, the HoloLens-based test completion time was in perfect agreement with the clinical standard stopwatch measure. Overall, our preliminary investigation indicates that it is possible to use an MR headset to automatically guide users (without severe mobility deficit) to complete common mobility tests, and this approach has the potential to provide an objective and efficient sensor-based mobility assessment that does not require any direct research/clinical oversight.

Wearable inertial sensors for human movement analysis: a five-year update

2021 ◽  
pp. 1-16
Author(s):  
Pietro Picerno ◽  
Marco Iosa ◽  
Clive D’Souza ◽  
Maria Grazia Benedetti ◽  
Stefano Paolucci ◽  
...  
Keyword(s):  
Inertial Sensors ◽  
Movement Analysis ◽  
Human Movement ◽  
Human Movement Analysis ◽  
Wearable Inertial Sensors

scholarly journals The Validity of a Mixed Reality-Based Automated Functional Mobility Assessment

2019 ◽  
Author(s):  
Ruopeng Sun ◽  
Roberto G. Aldunate ◽  
Jacob J Sosnoff
Keyword(s):  
Mixed Reality ◽  
Inertial Sensors ◽  
Inertial Sensor ◽  
Preliminary Investigation ◽  
Functional Mobility ◽  
Timed Up And Go ◽  
Perfect Agreement ◽  
Mobility Performance ◽  
Mobility Assessment ◽  
Kinematic Measures

Functional mobility assessments (i.e., Timed Up and Go) are commonly used clinical tools for mobility and fall risk screening in the aging population. In this work, we proposed a new Mixed Reality (MR)-based assessment that utilized a Microsoft HoloLensTM headset to automatically lead and track the performance of functional mobility tests, and subsequently evaluated its validity in comparison with reference inertial sensors. Twenty-two healthy adults (10 older, 12 young) participated in this study. An automated functional mobility assessment app was developed based on the HoloLens platform. Mobility performance was recorded with the headset built-in sensor and validated with reference inertial sensor (Opal, APDM) taped on the headset and lower back. Results indicate vertical kinematic measures by HoloLens was in good agreement with the reference sensor (Normalized RMSE ~ 10%). Additionally, the HoloLens-based test completion time was in perfect agreement with clinical standard stopwatch measure. Overall, our preliminary investigation indicates that it is possible to use an MR headset to automatically guide users to complete common mobility tests with good measurement accuracy, thus it has great potential to provide objective and efficient sensor-based mobility assessment.

scholarly journals Wearable inertial sensors for human movement analysis

2016 ◽  
Vol 13 (7) ◽  
pp. 641-659 ◽  
Author(s):  
Marco Iosa ◽  
Pietro Picerno ◽  
Stefano Paolucci ◽  
Giovanni Morone
Keyword(s):  
Inertial Sensors ◽  
Movement Analysis ◽  
Human Movement ◽  
Human Movement Analysis ◽  
Wearable Inertial Sensors

scholarly journals Indirect Measurement of Ground Reaction Forces and Moments by Means of Wearable Inertial Sensors: A Systematic Review

Sensors ◽  
2018 ◽  
Vol 18 (8) ◽  
pp. 2564 ◽  
Author(s):  
Andrea Ancillao ◽  
Salvatore Tedesco ◽  
John Barton ◽  
Brendan O’Flynn
Keyword(s):  
Inertial Sensors ◽  
Wearable Sensors ◽  
Reaction Force ◽  
Performance Testing ◽  
Indirect Measurement ◽  
Sport Performance ◽  
Ground Reaction Forces ◽  
Kinematic Data ◽  
Reaction Forces ◽  
Wearable Inertial Sensors

In the last few years, estimating ground reaction forces by means of wearable sensors has come to be a challenging research topic paving the way to kinetic analysis and sport performance testing outside of labs. One possible approach involves estimating the ground reaction forces from kinematic data obtained by inertial measurement units (IMUs) worn by the subject. As estimating kinetic quantities from kinematic data is not an easy task, several models and protocols have been developed over the years. Non-wearable sensors, such as optoelectronic systems along with force platforms, remain the most accurate systems to record motion. In this review, we identified, selected and categorized the methodologies for estimating the ground reaction forces from IMUs as proposed across the years. Scopus, Google Scholar, IEEE Xplore, and PubMed databases were interrogated on the topic of Ground Reaction Forces estimation based on kinematic data obtained by IMUs. The identified papers were classified according to the methodology proposed: (i) methods based on direct modelling; (ii) methods based on machine learning. The methods based on direct modelling were further classified according to the task studied (walking, running, jumping, etc.). Finally, we comparatively examined the methods in order to identify the most reliable approaches for the implementation of a ground reaction force estimator based on IMU data.

PP469 From Theory To Practice: Which Value Framework Is Applied For Onco-Hematology Therapies In Italy? A 5-year Retrospective Analysis

2020 ◽  
Vol 36 (S1) ◽  
pp. 37-37
Author(s):  
Americo Cicchetti ◽  
Rossella Di Bidino ◽  
Entela Xoxi ◽  
Irene Luccarini ◽  
Alessia Brigido
Keyword(s):  
Real World ◽  
Ad Hoc ◽  
Grey Literature ◽  
National Level ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
The Real ◽  
R Process ◽  
The One ◽  
The Impact

IntroductionDifferent value frameworks (VFs) have been proposed in order to translate available evidence on risk-benefit profiles of new treatments into Pricing & Reimbursement (P&R) decisions. However limited evidence is available on the impact of their implementation. It's relevant to distinguish among VFs proposed by scientific societies and providers, which usually are applicable to all treatments, and VFs elaborated by regulatory agencies and health technology assessment (HTA), which focused on specific therapeutic areas. Such heterogeneity in VFs has significant implications in terms of value dimension considered and criteria adopted to define or support a price decision.MethodsA literature research was conducted to identify already proposed or adopted VF for onco-hematology treatments. Both scientific and grey literature were investigated. Then, an ad hoc data collection was conducted for multiple myeloma; breast, prostate and urothelial cancer; and Non Small Cell Lung Cancer (NSCLC) therapies. Pharmaceutical products authorized by European Medicines Agency from January 2014 till December 2019 were identified. Primary sources of data were European Public Assessment Reports and P&R decision taken by the Italian Medicines Agency (AIFA) till September 2019.ResultsThe analysis allowed to define a taxonomy to distinguish categories of VF relevant to onco-hematological treatments. We identified the “real-world” VF that emerged given past P&R decisions taken at the Italian level. Data was collected both for clinical and economical outcomes/indicators, as well as decisions taken on innovativeness of therapies. Relevant differences emerge between the real world value framework and the one that should be applied given the normative framework of the Italian Health System.ConclusionsThe value framework that emerged from the analysis addressed issues of specific aspects of onco-hematological treatments which emerged during an ad hoc analysis conducted on treatment authorized in the last 5 years. The perspective adopted to elaborate the VF was the one of an HTA agency responsible for P&R decisions at a national level. Furthermore, comparing a real-world value framework with the one based on the general criteria defined by the national legislation, our analysis allowed identification of the most critical point of the current national P&R process in terms ofsustainability of current and future therapies as advance therapies and agnostic-tumor therapies.

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