Projects
Name | Mobilise-D |
---|---|
Long Name | Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement |
Description | Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement. Mobilise-D will develop a comprehensive system to monitor and evaluate people’s gait based on digital technologies, including sensors worn on the body. The project focuses on conditions which often affect mobility, namely chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, hip fracture recovery, and congestive heart failure. The Mobilise-D results will help to improve the accurate assessment of daily life mobility in clinical trials and patient treatment, thereby contributing to improve and more personalised care. |
Objectives | 1. Define through consensus, literature review and technical development, optimal digital mobility outcomes for clinical validation. 2. Use our clinical networks to leverage existing and new cohorts to support clinical validation of digital mobility outcomes. 3. Determine the clinical validity of digital mobility outcomes. 4. Build a platform for robust digital-data management, defining standards for storage, analysis and sharing of digital mobility data. 5. Define and set the standards for technology-unbiased digital mobility assessment. 6. Create enduring impact by establishing the largest biobank of digital mobility data to support ongoing algorithm development, as well as technical and clinical validation. 7. Ensure dissemination of the project results and sustainability beyond the life of the project. |
Website | https://www.mobilise-d.eu/ |
Start date | 01-04-2019 |
End date | 31-03-2024 |
Logo |
Name | Projects | Type of institution | Country | |
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Amgen | EPAD EMIF Mobilise-D | EFPIA | Belgium | |
Astrazeneca AB | MOPEAD PHAGO Mobilise-D IDEA-FAST PD-MIND Pharma-Cog | EFPIA | Sweden | |
Bayer Aktiengesellschaft | Mobilise-D | EFPIA | Germany | |
Eresearch Technology Inc | Mobilise-D | EFPIA | United States | |
Grunenthal GMBH | Mobilise-D | EFPIA | Germany | |
Icon Clinical Research Limited | Mobilise-D | EFPIA | Ireland | |
Merck Kommanditgesellschaft Auf Aktien | EMIF Mobilise-D Pharma-Cog | EFPIA | Germany | |
Novartis Pharma AG | EPAD IMPRiND EQIPD AETIONOMY IM2PACT PRISM RADAR-AD ROADMAP Mobilise-D Pharma-Cog EPND | EFPIA | Switzerland | |
Pfizer Limited | EPAD EQIPD EMIF IM2PACT PRISM Mobilise-D IDEA-FAST | EFPIA | United Kingdom | |
Sanofi-Aventis Recherche & Developpement | EPAD EQIPD AETIONOMY IM2PACT PHAGO NEURONET Mobilise-D IDEA-FAST EPND | EFPIA | France | |
Teva Pharmaceutical Industries Limited | PD-MitoQUANT Mobilise-D EQIPD EPND | EFPIA | Israel | |
Alma Mater Studiorum - Universita Di Bologna | PRISM Mobilise-D PRISM2 | Academia | Italy | |
Centre Hospitalier Universitaire Montpellier | Mobilise-D | Academia | France | |
Christian-Albrechts-Universitaet Zu Kiel | Mobilise-D IDEA-FAST | Academia | Germany | |
Ecole Polytechnique Federale De Lausanne | Mobilise-D | Academia | Switzerland | |
Friedrich-Alexander-Universitaet Erlangen Nuernberg | Mobilise-D | Academia | Germany | |
Fundación Privada Instituto de Salud Global Barcelona | Mobilise-D | Academia | Spain | |
Imperial College Of Science Technology And Medicine | EQIPD Mobilise-D IDEA-FAST | Academia | United Kingdom | |
Katholieke Universiteit Leuven | RADAR-CNS Mobilise-D | Academia | Belgium | |
Norges teknisk-naturvitenskapelige universitet - NTNU | Mobilise-D | Academia | Norway | |
Robert Bosch Gesellschaft Fur Medizinische Forschung Mbh | Mobilise-D | Academia | Germany | |
The Foundation For Medical Research Infrastructural Development And Health Services Next To The Medical Center Tel Aviv | Mobilise-D | Academia | Israel | |
The University Of Sheffield | IM2PACT Mobilise-D | Academia | United Kingdom | |
Universita Vita-Salute San Raffaele | RADAR-CNS Mobilise-D | Academia | Italy | |
Universitat Zurich | Mobilise-D | Academia | Switzerland | |
Universitatsklinikum Erlangen | EMIF Mobilise-D | Academia | Germany | |
University College Dublin, National University Of Ireland, Dublin | Mobilise-D | Academia | Ireland | |
University Of Newcastle Upon Tyne | Mobilise-D IDEA-FAST | Academia | United Kingdom | |
University Of Northumbria At Newcastle | Mobilise-D | Academia | United Kingdom | |
Ixscient Limited, Uxbridge | Mobilise-D IDEA-FAST | SME | United Kingdom | |
McRoberts BV | Mobilise-D IDEA-FAST | SME | Netherlands | |
Penumologisches Forschungsinstitutan Der Lungenclinic Grosshansdorf GMBH | Mobilise-D | SME | Germany | |
Universita Degli Studi Di Sassari | Mobilise-D | Academia | Italy | |
Sheffield Teaching Hospitals NHS Foundation Trust | Mobilise-D | Other | United Kingdom | |
The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Mobilise-D | Other | United Kingdom | |
Takeda Pharmaceuticals International AG | EPND EPAD PRISM RADAR-AD ROADMAP IDEA-FAST Mobilise-D NEURONET | EFPIA | Switzerland |
WP number | Description | Project | |
---|---|---|---|
WP1 | Project management and oversight | Mobilise-D | |
WP2 | Algorithm development and technical validation | Mobilise-D | |
WP3 | Database development and data management | Mobilise-D | |
WP4 | Definition and validation of digital mobility outcomes against clinical endpoints | Mobilise-D | |
WP5 | Regulatory, HTA and payer consensus over operational definitions | Mobilise-D | |
WP6 | Statistical analysis, evaluation of results and data availability | Mobilise-D | |
WP7 | Stakeholder information and results dissemination and exploitation | Mobilise-D |
Deliverable number | Title | Project | Submission date | Link | Keywords | |
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D2.3 | First study subject approvals package | Mobilise-D | 30-06-2020 | https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d18132a8&appId=PPGMS | Validation study, outcomes, training, data, collection, analysis, study, recruitment | |
D1.2 | Risk Assessment Process and Management Procedure | Mobilise-D | 29-05-2019 | https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d1814266&appId=PPGMS | Risk Assessment Process, Management Procedure | |
D7.2 | Report on publications, presentations, and event organisation | Mobilise-D | 30-03-2020 | https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cda4b4af&appId=PPGMS | publications, presentations, event, dissemination, communication | |
D3.1 | System Requirements Specification (including definition of data acquisition, transmission, integration, processing, analysics and governance requirements) | Mobilise-D | 30-04-2020 | https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5cec0eeb3&appId=PPGMS | System Requirements Specification, data acquisition, transmission, integration, processing, analysics, governance | |
D1.3 | Mobilise-D Data Management Plan | Mobilise-D | 30-09-2019 | https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c7d5bbad&appId=PPGMS | Technical validation study, description of data, data collection, data organisation, metadata, data storage, data security, data generation, data sharing, data re-use | |
D2.2 | Gold standard solutions for technical validation | Mobilise-D | 31-03-2019 | https://www.mobilise-d.eu/wp-content/uploads/2020/12/Summary_D2.2.pdf | ||
D4.1 | Updated systematic review on primary and secondary clinical endpoints | Mobilise-D | 31-03-2020 | https://www.mobilise-d.eu/wp-content/uploads/2020/12/Symmary_D4.1-Updated-systematic-review-on-clinical-endpoints.pdf | ||
D7.1 | Communication plan and Dissemination strategy, including project identity | Mobilise-D | 30-09-2019 | https://www.mobilise-d.eu/wp-content/uploads/2020/12/Summary_D7.1-Communication-and-Dissemination-strategy-1.pdf | ||
D7.3 | Guidelines for open access and data sharing | Mobilise-D | 31-03-2020 | https://www.mobilise-d.eu/wp-content/uploads/2020/12/Summary_D7.3-Guidelines-for-open-access-and-data-sharing.pdf | ||
D4.2 | Ethical approval including all amendments | Mobilise-D | 08-01-2021 | https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d7d4ab55&appId=PPGMS | ||
D6.1 | Statistical description report on digital mobility outcomes, health outcomes and their relationships | Mobilise-D | 31-12-2020 | https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d797d306&appId=PPGMS | ||
D1.4 | Data Management Plan V2 | Mobilise-D | 30-09-2021 | https://www.mobilise-d.eu/wp-content/uploads/2022/01/Mobilise-D-Deliverable-D1.4-Data-Management-Plan-2-V1.0.pdf | ||
D2.1 | Digital mobility database of existing real-world and laboratory data and algorithms | Mobilise-D | 01-01-2020 | https://www.mobilise-d.eu/wp-content/uploads/2020/12/Summary_D2.1-Digital-mobility-database-of-existing-RW-and-lab-data-and-alg-confidential.pdf | ||
D2.4 | Midterm recruitment report | Mobilise-D | 01-11-2020 | https://www.mobilise-d.eu/wp-content/uploads/2022/01/Summary_D2.4-Midterm-recruitment-report.pdf | ||
D2.5 | Implemented algorithms for WB detection, step detection, RWS estimate, secondary outcomes and confounders | Mobilise-D | 01-11-2020 | https://www.mobilise-d.eu/wp-content/uploads/2022/01/Summary_D2.5-Implemented-algorithms.pdf | ||
D3.2 | Platform build, implementation and testing with relevant stakeholder groups | Mobilise-D | 01-12-2020 | https://www.mobilise-d.eu/wp-content/uploads/2022/01/Summary_D3.2-Platform-build-implementation-and-testing.pdf | ||
D3.3 | Suite of patient and investigator facing software tools for data capture | Mobilise-D | 01-12-2020 | https://www.mobilise-d.eu/wp-content/uploads/2022/01/Summary_D3.3-Suite-of-patient-and-investigator-facing-software-tools-for-data-capture.pdf | ||
D3.4 | Integrated end to end data collection, management and analytics platform | Mobilise-D | 01-03-2021 | https://www.mobilise-d.eu/wp-content/uploads/2022/01/Summary_D3.4-Integrated-end-to-end-data-collection-management-and-analytics-platform.pdf | ||
D4.3 | First study subject approvals package of the CVS | Mobilise-D | 01-12-2020 | https://www.mobilise-d.eu/wp-content/uploads/2022/01/Summary_D4.3-First-study-subject-approvals-package-of-the-CVS.pdf | ||
D5.1 | Regulatory Plan | Mobilise-D | 01-10-2020 | https://www.mobilise-d.eu/wp-content/uploads/2022/01/Summary_D5.1-Regulatory-Plan.pdf | ||
D5.2 | Regulatory Plan | Mobilise-D | 01-10-2020 | https://www.mobilise-d.eu/wp-content/uploads/2022/01/Summary_D5.2-Regulatory-Plan.pdf | ||
D7.4 | Initial Exploitation Strategy | Mobilise-D | 01-03-2021 | https://www.mobilise-d.eu/wp-content/uploads/2022/01/Summary_D7.4-Initial-Exploitation-Strategy.pdf |
Title | First author last name | Year | Project | Link | Keywords | |
---|---|---|---|---|---|---|
Wearable sensors can reliably quantify gait alterations associated with disability in people with progressive multiple sclerosis in a clinical setting | Angelini | 2020 | Mobilise-D | https://doi.org/10.1007/s00415-020-09928-8 | test-retest reliability, Gait analysis, Balance, Temporal parameters, Regularity, Six-minute walk, clinical, | |
A wearable sensor identifies alterations in community ambulation in multiple sclerosis: contributors to real-world gait quality and physical activity | Shema-Shiratzky | 2020 | Mobilise-D | https://doi.org/10.1007/s00415-020-09759-7 | Accelerometer, Activity, Daily living, Gait, Inertial measurement units, Multiple sclerosis, Wearables | |
Detection of Gait From Continuous Inertial Sensor Data Using Harmonic Frequencies | Ullrich | 2020 | Mobilise-D | https://doi.org/10.1109/JBHI.2020.2975361 | algorithm, gait, sensor, cyclic activities | |
Gait variability as digital biomarker of disease severity in Huntington’s disease | Gaßner | 2020 | Mobilise-D | https://doi.org/10.1007/s00415-020-09789-1 | Huntington’s disease, Gait analysis, Wearable sensors, Gait variability, Regularity of gait | |
Long-term unsupervised mobility assessment in movement disorders | Warmerdam | 2020 | Mobilise-D | https://doi.org/10.1016/S1474-4422(19)30397-7 | mobile, wearable, assessment | |
Accelerometry-based digital gait characteristics for classification of Parkinson’s disease: what counts? | Rehman | 2020 | Mobilise-D | https://doi.org/10.1109/OJEMB.2020.2966295 | Spatiotemporal phenomena , Tools , Accelerometers , Parkinson's disease , Data models , Complexity theory | |
Is a Wearable Sensor-Based Characterisation of Gait Robust Enough to Overcome Differences Between Measurement Protocols? A Multi-Centric Pragmatic Study in Patients with Multiple Sclerosis | Angelini | 2019 | Mobilise-D | https://doi.org/10.3390/s20010079 | Accelerometry, instrumentation, Accelerometry, Gait, Multiple Sclerosis, physiopathology, Retrospective Studies, Wearable Electronic Devices | |
Credibility of In Silico Trial Technologies—A Theoretical Framing | Viceconti | 2019 | Mobilise-D | http://dx.doi.org/10.1109/JBHI.2019.2949888 | In silico medicine , in silico trials , in silico-augmented clinical trials , credibility of predictive models , regulatory science , biomedical products | |
Orientation Estimation Through Magneto-Inertial Sensor Fusion: A Heuristic Approach for Suboptimal Parameters Tuning | Caruso | 2020 | Mobilise-D | https://ieeexplore.ieee.org/document/9201115/keywords#keywords | Magnetic separation, Sensor fusion, Optical filters, Magnetometers, Accelerometers, Filtering algorithms | |
Clinical Relevance of Standardized Mobile Gait Tests. Reliability Analysis Between Gait Recordings at Hospital and Home in Parkinson’s Disease: A Pilot Study | Gaßner | 2020 | Mobilise-D | https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd202129 | Parkinson’s disease, gait analysis, wearable sensors, telemedicine, home monitoring | |
Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review | Polhemus | 2020 | Mobilise-D | https://bmjopen.bmj.com/content/bmjopen/10/7/e038704.full.pdf | Parkinson-s disease; chronic airways disease; geriatric medicine; multiple sclerosis; orthopaedic & trauma surgery; telemedicine. | |
A roadmap to inform development, validation and approval of digital mobility outcomes: the Mobilise-D approach | Rochester | 2020 | Mobilise-D | https://doi.org/10.1159/000512513 | Remote Monitoring, Body-worn devices, Digital mobility outcomes | |
Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes | Viceconti | 2020 | Mobilise-D | https://doi.org/10.3390/s20205920 | Regulatory Qualification, Real-World Mobility, Performance Biomarkers, Parkinson, Digital Mobility, Outcome | |
An Objective Methodology for the Selection of a Device for Continuous Mobility Assessment | Bonci | 2020 | Mobilise-D | https://doi.org/10.3390/s20226509 | continuous monitoring, digital mobility outcomes, healthcare challenges, inertial measurement units, mobility assessment, real-world assessment, wearable technology. | |
Inertial sensor-based gait parameters reflect patient-reported fatigue in multiple sclerosis | Ibrahim | 2020 | Mobilise-D | https://doi.org/10.1186/s12984-020-00798-9 | MS, Gait, Fatigue, Accelerometer, IMU, Machine learning, Digital biomarker | |
Body-Worn Sensors for Remote Monitoring of Parkinson’s Disease Motor Symptoms: Vision, State of the Art, and Challenges Ahead | Del Din | 2021 | Mobilise-D | https://doi.org/10.3233/JPD-202471 | Parkinson’s disease, remote monitoring, real-world, wearables, motor symptoms, accelerometer, review article | |
Computational modelling of the scoliotic spine: A literature review | Gould | 2021 | Mobilise-D | https://doi.org/10.1002/cnm.3503 | finite element modelling, multibody modelling, musculoskeletal modelling, review, scoliosis, scoliotic spine | |
Consensus based framework for digital mobility monitoring | Kluge | 2021 | Mobilise-D | https://doi.org/10.1371/journal.pone.0256541 | Gait analysis, Walking, Feet, Consortia, Biological locomotion, Research assessment, Parkinson disease, Taxonomy, | |
A Proposal for a Linear Calculation of Gait Asymmetry | van Gelder | 2021 | Mobilise-D | https://doi.org/10.3390/sym13091560 | asymmetry; gait; accelerometer; IMU | |
Assessing the usability of wearable devices to measure gait and physical activity in chronic conditions: a systematic review | Keogh | 2021 | Mobilise-D | https://doi.org/10.1186/s12984-021-00931-2 | Usability, Wearable sensors, Gait, Physical activity, User experience | |
Extension of the Rigid-Constraint Method for the Heuristic Suboptimal Parameter Tuning to Ten Sensor Fusion Algorithms Using Inertial and Magnetic Sensing | Caruso | 2021 | Mobilise-D | https://doi.org/10.3390/s21186307 | AHSR; MARG; MIMU; complementary filter; filter parameter tuning; human motion analysis; kalman filter; optimal parameter; orientation estimation; sensor fusion; suboptimal parameter; wearable sensors. | |
Walking on common ground: a cross-disciplinary scoping review on the clinical utility of digital mobility outcomes | Polhemus | 2021 | Mobilise-D | https://doi.org/10.1038/s41746-021-00513-5 | Geriatrics, Movement disorders, Predictive markers, Respiratory tract diseases, | |
Algorithms for Walking Speed Estimation Using a Lower-Back-Worn Inertial Sensor: A Cross-Validation on Speed Ranges | Soltani | 2021 | Mobilise-D | https://doi.org/10.1109/TNSRE.2021.3111681 | Legged locomotion , Statistics , Sociology , Estimation , Instruments , Accelerometers , Walking speed , step length , cadence , inertial sensors , slow walkers , walking aids Three-dimensional displays | |
It’s not about the capture, it’s about what we can learn”: a qualitative study of experts’ opinions and experiences regarding the use of wearable sensors to measure gait and physical activity | Keogh | 2021 | Mobilise-D | https://doi.org/10.1186/s12984-021-00874-8 | Wearable devices, Acceptability, Remote monitoring, Qualitative, Accelerometry | |
Technical validation of real-world monitoring of gait: a multicentric observational study | Mazzà | 2021 | Mobilise-D | http://dx.doi.org/10.1136/bmjopen-2021-050785 | chronic airways disease; heart failure; hip; multiple sclerosis; parkinson's disease. | |
A Quality Control Check to Ensure Comparability of Stereophotogrammetric Data between Sessions and Systems | Scott | 2022 | Mobilise-D | https://doi.org/10.3390/s21248223 | optoelectronic stereophotogrammetry; 3D motion capture; quality control; spot check; accuracy; systematic errors; gait; human movement | |
Investigating the Impact of Environment and Data Aggregation by Walking Bout Duration on Parkinson’s Disease Classification Using Machine Learning | Zia Ur Rehman | 2022 | Mobilise-D | https://doi.org/10.3389/fnagi.2022.808518 | Gait, real-world data, Parkinson's disease, machine learning, real-world gait | |
An Algorithm for Accurate Marker-Based Gait Event Detection in Healthy and Pathological Populations During Complex Motor Tasks | Bonci | 2022 | Mobilise-D | http://dx.doi.org/10.3389/fbioe.2022.868928 | gait analysis, spatio-temporal gait parameters, gait cycle, stride length, stride duration, stride speed, stereophotogrammetry |
Title | Description | Type | Project | |
---|---|---|---|---|
Using musculoskeletal models to estimate in vivo TKR kinematics and loads: effect of differences between models | The dataset contains the results of the simulations performed to estimate in vivo total knee replacement (TKR) kinematics and loads presented in the paper “C. Curreli, F. Di Puccio, G. Davico, L. Modenese, and M. Viceconti, Using Musculoskeletal Models to Estimate in vivo Total Knee Replacement Kinematics and Loads: Effect of Differences Between Models, Frontiers in Bioengineering and Biotechnology, vol. 9, p. 611, 2021, doi: 10.3389/fbioe.2021.703508”. Specifically, the dataset contains a comparison of the kinematic and dynamic results obtained with three different musculoskeletal models developed using the OpenSim software. A comparison between the predicted joint reaction forces and the in vivo loads measured by the instrumented knee implant is also reported. Experimental data used for the simulations were obtained from the fifth edition of the “Grand Challenge Competitions to Predict in vivo Knee Loads” (https://simtk.org/projects/kneeloads). |
dataset-clinical-mobilise-d-14 | Mobilise-D | |
A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes | Because loss of mobility is an important feature of many health conditions, there is a need for regulatory accepted walking-related digital mobility outcomes (DMOs) as clinical trial endpoint measures in a variety of disease states. To achieve this, the consortium has elaborated a roadmap that is published (A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach). Part of the roadmap is the technical validation study. The consortium has started to recruit the 120 participants for this study (healthy older adults, Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease, congestive heart failure, proximal femoral fracture) across sites in 3 countries: Germany, United Kingdom and Israel. The conduct of study is challenging due to the COVID-19 pandemic and recruitment is slower than anticipated. This study will identify the best algorithms to quantify real-world walking speed and other relevant characteristics to describe the way we walk using a variety of advanced technology that will then be taken for further clinical validation. |
tools-clinical-mobilise-d-14 | Mobilise-D | |
Sensor fusion algorithm | The orientation of a magneto-inertial measurement unit can be estimated using a sensor fusion algorithm (SFA). However, orientation accuracy is greatly affected by the choice of the SFA parameter values which represents one of the most critical steps. A commonly adopted approach is to fine-tune parameter values to minimize the difference between estimated and true orientation. However, this can only be implemented within the laboratory setting by requiring the use of a concurrent gold-standard technology. To overcome this limitation, a Rigid-Constraint Method (RCM) was proposed to estimate suboptimal parameter values without relying on any orientation reference. The RCM method effectiveness was successfully tested on a single-parameter SFA, with an average error increase with respect to the optimal of 1.5 deg. In this work, the applicability of the RCM was evaluated on 10 popular SFAs with multiple parameters under different experimental scenarios. The average residual between the optimal and suboptimal errors amounted to 0.6 deg with a maximum of 3.7 deg. These encouraging results suggest the possibility to properly tune a generic SFA on different scenarios without using any reference. The synchronized dataset also including the optical data and the SFA codes are available online. |
tools-non-clinical-mobilise-d-29 | Mobilise-D |
Website: https://www.mobilise-d.eu/ |
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