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Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement


First study subject approvals

Final version of study protocol as approved by first ethics committee; registration number of clinical study in an approved registry that also allows later posting of study results; approvals required for enrolment of first subject in at least one clinical centre

Risk assessment process and management procedure

Description of the methodology for project risk assessment and categorisation, including a risk management process

Detailed system requirements specification, including definition of data acquisition, transmission, integration, processing, analytics and governance requirements

This report will incorporate detailed system requirements specification for the data management platform. This will include definition of data acquisition, transmission, integration, processing, analytics and governance requirements

Ethical approval including all amendments

Ethical approval will be prepared during the first year and will include the experience of the WP 2 technical validation. The process will be finalized based on the results of WP2. Each site will submit the ethical protocol including the national requirments.

Report on publications, presentations, and event organisation (M12, with annual updates)

This deliverable is based on work carried out in Tasks 7.3 and 7.4, and details the publications, presentations and event organisations throughout the first year of the project, with subsequent annual updates. The report will be based on a database containing all outreach activities carried out by the consortium members.

Statistical description report on digital mobility outcomes, health outcomes and their relationships

We will study the statistical distribution of digital mobility outcomes, clinical outcomes and the shape of their relationships, using standard and hypothesis-free statistical analyses and existing cohort data

Data Management Plan V1

Inititial version of the data management plan


Inertial sensor-based gait parameters reflect patient-reported fatigue in multiple sclerosis

Author(s): Alzhraa A. Ibrahim, Arne Küderle, Heiko Gaßner, Jochen Klucken, Bjoern M. Eskofier, Felix Kluge
Published in: Journal of NeuroEngineering and Rehabilitation, Issue 17/1, 2020, ISSN 1743-0003
DOI: 10.1186/s12984-020-00798-9

Technologische innovationen in der Pneumonologie - Facetten aus Diagnostik und Therapie

Author(s): Randerath W, Dreher M, Gompelmann D, Held M, Koczulla R, Köhnlein T, Rohde G, Wälscher J, Watz H, Steinkamp G.
Published in: Pneumologie, Issue 14.07.2020, 2020, ISSN 0934-8387
DOI: 10.5281/zenodo.4468658

Wearable sensors can reliably quantify gait alterations associated with disability in people with progressive multiple sclerosis in a clinical setting

Author(s): Lorenza Angelini, William Hodgkinson, Craig Smith, Jessie Moorman Dodd, Basil Sharrack, Claudia Mazzà, David Paling
Published in: Journal of Neurology, Issue 267/10, 2020, Page(s) 2897-2909, ISSN 0340-5354
DOI: 10.1007/s00415-020-09928-8

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

Author(s): Ashley Marie Polhemus, Ronny Bergquist, Magda Bosch de Basea, Gavin Brittain, Sara Catherine Buttery, Nikolaos Chynkiamis, Gloria dalla Costa, Laura Delgado Ortiz, Heleen Demeyer, Kirsten Emmert, Judith Garcia Aymerich, Heiko Gassner, Clint Hansen, Nicholas Hopkinson, Jochen Klucken, Felix Kluge, Sarah Koch, Letizia Leocani, Walter Maetzler, M Encarna Micó-Amigo, A Stefanie Mikolaizak, Paolo Pira
Published in: BMJ Open, Issue 10/7, 2020, Page(s) e038704, ISSN 2044-6055
DOI: 10.1136/bmjopen-2020-038704

Clinical Relevance of Standardized Mobile Gait Tests. Reliability Analysis Between Gait Recordings at Hospital and Home in Parkinson’s Disease: A Pilot Study

Author(s): Gaßner H, Sanders P, Dietrich A, Marxreiter F, Eskofier BM, Winkler J, Klucken J
Published in: Journal of Parkinson's Disease, Issue 8/17/2020, 2020, ISSN 1877-7171
DOI: 10.5281/zenodo.4468815

Classical Machine Learning Versus Deep Learning for the Older Adults Free-Living Activity Classification

Author(s): Muhammad Awais, Lorenzo Chiari, Espen A. F. Ihlen, Jorunn L. Helbostad, Luca Palmerini
Published in: Sensors, Issue 21/14, 2021, Page(s) 4669, ISSN 1424-8220
DOI: 10.3390/s21144669

Orientation Estimation Through Magneto-Inertial Sensor Fusion: A Heuristic Approach for Suboptimal Parameters Tuning

Author(s): Caruso M, Sabatini M, Knaflitz M, Gazzoni M, Della Croce U, Cereatti A
Published in: IEEE Sensors Journal, Issue 21.09.2020, 2020, ISSN 1530-437X
DOI: 10.5281/zenodo.4457500

A method for gait events detection based on low spatial resolution pressure insoles data

Author(s): F. Salis, S. Bertuletti, T. Bonci, U. Della Croce, C. Mazzà, A. Cereatti
Published in: Journal of Biomechanics, Issue 127, 2021, Page(s) 110687, ISSN 0021-9290
DOI: 10.1016/j.jbiomech.2021.110687

A Proposal for a Linear Calculation of Gait Asymmetry

Author(s): Linda Maria Adriana van Gelder, Lorenza Angelini, Ellen E. Buckley, Claudia Mazzà
Published in: Symmetry, Issue 13/9, 2021, Page(s) 1560, ISSN 2073-8994
DOI: 10.3390/sym13091560

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

Author(s): Lorenza Angelini, Ilaria Carpinella, Davide Cattaneo, Maurizio Ferrarin, Elisa Gervasoni, Basil Sharrack, David Paling, Krishnan Padmakumari Sivaraman Nair, Claudia Mazzà
Published in: Sensors, Issue 20/1, 2020, Page(s) 79, ISSN 1424-8220
DOI: 10.3390/s20010079

Accelerometry-Based Digital Gait Characteristics for Classification of Parkinson's Disease: What Counts?

Author(s): Rana Zia Ur Rehman, Christopher Buckley, Maria Encarna Mico-Amigo, Cameron Kirk, Michael Dunne-Willows, Claudia Mazza, Jian Qing Shi, Lisa Alcock, Lynn Rochester, Silvia Del Din
Published in: IEEE Open Journal of Engineering in Medicine and Biology, Issue 1, 2020, Page(s) 65-73, ISSN 2644-1276
DOI: 10.1109/ojemb.2020.2966295

Gait variability as digital biomarker of disease severity in Huntington’s disease

Author(s): Heiko Gaßner, Dennis Jensen, F. Marxreiter, Anja Kletsch, Stefan Bohlen, Robin Schubert, Lisa M. Muratori, Bjoern Eskofier, Jochen Klucken, Jürgen Winkler, Ralf Reilmann, Zacharias Kohl
Published in: Journal of Neurology, 2020, ISSN 0340-5354
DOI: 10.1007/s00415-020-09725-3

Detection of Gait From Continuous Inertial Sensor Data Using Harmonic Frequencies

Author(s): Martin Ullrich, Arne Kuderle, Julius Hannink, Silvia Del Din, Heiko Gassner, Franz Marxreiter, Jochen Klucken, Bjoern Michael Eskofier, Felix Kluge
Published in: IEEE Journal of Biomedical and Health Informatics, 2020, Page(s) 1-1, ISSN 2168-2194
DOI: 10.1109/jbhi.2020.2975361

A wearable sensor identifies alterations in community ambulation in multiple sclerosis: contributors to real-world gait quality and physical activity

Author(s): Shirley Shema-Shiratzky, Inbar Hillel, Anat Mirelman, Keren Regev, Katherine L. Hsieh, Arnon Karni, Hannes Devos, Jacob J. Sosnoff, Jeffrey M. Hausdorff
Published in: Journal of Neurology, 2020, ISSN 0340-5354
DOI: 10.1007/s00415-020-09759-7

Credibility of In Silico Trial Technologies—A Theoretical Framing

Author(s): Marco Viceconti, Miguel A. Juarez, Cristina Curreli, Marzio Pennisi, Giulia Russo, Francesco Pappalardo
Published in: IEEE Journal of Biomedical and Health Informatics, Issue 24/1, 2020, Page(s) 4-13, ISSN 2168-2194
DOI: 10.1109/JBHI.2019.2949888

Long-term unsupervised mobility assessment in movement disorders

Author(s): Elke Warmerdam, Jeffrey M Hausdorff, Arash Atrsaei, Yuhan Zhou, Anat Mirelman, Kamiar Aminian, Alberto J Espay, Clint Hansen, Luc J W Evers, Andreas Keller, Claudine Lamoth, Andrea Pilotto, Lynn Rochester, Gerhard Schmidt, Bastiaan R Bloem, Walter Maetzler
Published in: The Lancet Neurology, Issue 19/5, 2020, Page(s) 462-470, ISSN 1474-4422
DOI: 10.1016/s1474-4422(19)30397-7

A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach

Author(s): Lynn Rochester, Claudia Mazzà, Arne Mueller, Brian Caulfield, Marie McCarthy, Clemens Becker, Ram Miller, Paolo Piraino, Marco Viceconti, Wilhelmus P. Dartee, Judith Garcia-Aymerich, Aida A. Aydemir, Beatrix Vereijken, Valdo Arnera, Nadir Ammour, Michael Jackson, Tilo Hache, Ronenn Roubenoff
Published in: Digital Biomarkers, Issue 4/1, 2020, Page(s) 13-27, ISSN 2504-110X
DOI: 10.1159/000512513

Sensor-Based and Patient-Based Assessment of Daily-Living Physical Activity in People with Parkinson’s Disease: Do Motor Subtypes Play a Role?

Author(s): Irina Galperin, Talia Herman, Mira Assad, Natalie Ganz, Anat Mirelman, Nir Giladi, Jeffrey M. Hausdorff
Published in: Sensors, Issue 20/24, 2020, Page(s) 7015, ISSN 1424-8220
DOI: 10.3390/s20247015

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

Author(s): Marco Viceconti, Sabina Hernandez Penna, Wilhelmus Dartee, Claudia Mazzà, Brian Caulfield, Clemens Becker, Walter Maetzler, Judith Garcia-Aymerich, Giorgio Davico, Lynn Rochester
Published in: Sensors, Issue 20/20, 2020, Page(s) 5920, ISSN 1424-8220
DOI: 10.3390/s20205920

An Objective Methodology for the Selection of a Device for Continuous Mobility Assessment

Author(s): Tecla Bonci, Alison Keogh, Silvia Del Din, Kirsty Scott, Claudia Mazzà
Published in: Sensors, Issue 20/22, 2020, Page(s) 6509, ISSN 1424-8220
DOI: 10.3390/s20226509

Body-Worn Sensors for Remote Monitoring of Parkinson’s Disease Motor Symptoms: Vision, State of the Art, and Challenges Ahead

Author(s): Silvia Del Din, Cameron Kirk, Alison J. Yarnall, Lynn Rochester, Jeffrey M. Hausdorff
Published in: Journal of Parkinson's Disease, 2021, Page(s) 1-13, ISSN 1877-7171
DOI: 10.3233/jpd-202471

A Multifactorial Model of Multiple Sclerosis Gait and its Changes Across Different Disability Levels

Author(s): Lorenza Angelini, Ellen Buckley, Tecla Bonci, Alexandra Radford, Basil Sharrack, David Paling, Krishnan Padmakumari Sivaraman Nair, Claudia Mazza
Published in: IEEE Transactions on Biomedical Engineering, Issue 24.02.2021, 2021, Page(s) 1-1, ISSN 0018-9294
DOI: 10.1109/tbme.2021.3061998

Accuracy of the Orientation Estimate Obtained Using Four Sensor Fusion Filters Applied to Recordings of Magneto-Inertial Sensors Moving at Three Rotation Rates

Author(s): M. Caruso, A. M. Sabatini, M. Knaflitz, M. Gazzoni, U. Della Croce, A. Cereatti
Published in: 2019 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), 2019, Page(s) 2053-2058
DOI: 10.1109/embc.2019.8857655