Technical validation of real-world monitoring of gait: a multicentric observational study.

chronic airways disease heart failure hip multiple sclerosis parkinson-s disease

Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
02 12 2021
Historique:
entrez: 3 12 2021
pubmed: 4 12 2021
medline: 8 3 2022
Statut: epublish

Résumé

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. 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. 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. ISRCTN (12246987).

Identifiants

pubmed: 34857567
pii: bmjopen-2021-050785
doi: 10.1136/bmjopen-2021-050785
pmc: PMC8640671
doi:

Types de publication

Journal Article Observational Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e050785

Subventions

Organisme : Wellcome Trust
Pays : United Kingdom

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: FC is CEO and shareholder of Aeqora Ltd, of which VL is director and shareholder. HS is an employee of AstraZeneca. BE is co-founder and owns shares of Portabiles HealthCare Technologies GmbH. McRoberts is the manufacturer of the DynaPort. MN, JE, and LPl are employees of McRoberts. AM is an employee of Novartis and holds stock in Novartis. LS and CB are consultants of Philipps Healthcare, Bosch Healthcare, Eli Lilly, Gait-up. JMH reports having submitted a patent for assessment of mobility using wearable sensors in 400 Parkinson’s disease; the intellectual property rights 401 are held by the Tel Aviv Medical Center. LPa and LC are co-founders and own shares of mHealth Technologies.

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Auteurs

Claudia Mazzà (C)

INSIGNEO Institute for in silico Medicine, The University of Sheffield, Sheffield, UK c.mazza@sheffield.ac.uk.
Department of Mechanical Engineering, The University of Sheffield, Sheffield, UK.

Lisa Alcock (L)

Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.

Kamiar Aminian (K)

Laboratory of Movement Analysis and Measurement, Ecole Polytechnique Federale de Lausanne, Lausanne, Switzerland.

Clemens Becker (C)

Robert Bosch Gesellschaft für Medizinische Forschung, Stuttgart, Germany.

Stefano Bertuletti (S)

Department of Biomedical Sciences, University of Sassari, Sassari, Sardegna, Italy.

Tecla Bonci (T)

INSIGNEO Institute for in silico Medicine, The University of Sheffield, Sheffield, UK.
Department of Mechanical Engineering, The University of Sheffield, Sheffield, UK.

Philip Brown (P)

The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.

Marina Brozgol (M)

Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

Ellen Buckley (E)

INSIGNEO Institute for in silico Medicine, The University of Sheffield, Sheffield, UK.
Department of Mechanical Engineering, The University of Sheffield, Sheffield, UK.

Anne-Elie Carsin (AE)

ISGlobal, Barcelona, Spain.
Universitat Pompeu Fabra (UPF), Barcelona, Spain.
CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.
IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.

Marco Caruso (M)

Dipartimento di Elettronica e Telecomunicazioni, Politecnico di Torino, Torino, Italy.
PolitoBIOMed Lab - Biomedical Engineering Lab, Politecnico di Torino, Torino, Italy.

Brian Caulfield (B)

Insight Centre for Data Analytics, O'Brien Science Centre, University College Dublin, Dublin, Ireland.
UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.

Andrea Cereatti (A)

Dipartimento di Elettronica e Telecomunicazioni, Politecnico di Torino, Torino, Italy.

Lorenzo Chiari (L)

Department of Electrical, Electronic and Information Engineering «Guglielmo Marconi», University of Bologna, Bologna, Italy.
Health Sciences and Technologies-Interdepartmental Center for Industrial Research (CIRI-SDV), University of Bologna, Bologna, Italy.

Nikolaos Chynkiamis (N)

Department of Sport, Exercise and Rehabilitation, Northumbria University Newcastle, Newcastle upon Tyne, UK.

Fabio Ciravegna (F)

INSIGNEO Institute for in silico Medicine, The University of Sheffield, Sheffield, UK.
Department of Computer Science, The University of Sheffield, Sheffield, UK.

Silvia Del Din (S)

Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.

Björn Eskofier (B)

Machine Learning and Data Analytics Lab, Department of Artificial Intelligence in Biomedical Engineering, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.

Jordi Evers (J)

McRoberts BV, Den Haag, Zuid-Holland, Netherlands.

Judith Garcia Aymerich (J)

ISGlobal, Barcelona, Spain.
Universitat Pompeu Fabra (UPF), Barcelona, Spain.
CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.

Eran Gazit (E)

Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

Clint Hansen (C)

Department of Neurology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Germany.

Jeffrey M Hausdorff (JM)

Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Department of Physical Therapy, Sackler Faculty of Medicine & Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.

Jorunn L Helbostad (JL)

Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.

Hugo Hiden (H)

School of Computing, Newcastle University, Newcastle upon Tyne, UK.

Emily Hume (E)

Department of Sport, Exercise and Rehabilitation, Northumbria University Newcastle, Newcastle upon Tyne, UK.

Anisoara Paraschiv-Ionescu (A)

Laboratory of Movement Analysis and Measurement, Ecole Polytechnique Federale de Lausanne, Lausanne, Switzerland.

Neil Ireson (N)

INSIGNEO Institute for in silico Medicine, The University of Sheffield, Sheffield, UK.
Department of Computer Science, The University of Sheffield, Sheffield, UK.

Alison Keogh (A)

Insight Centre for Data Analytics, O'Brien Science Centre, University College Dublin, Dublin, Ireland.
UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.

Cameron Kirk (C)

Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.

Felix Kluge (F)

Machine Learning and Data Analytics Lab, Department of Artificial Intelligence in Biomedical Engineering, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.

Sarah Koch (S)

ISGlobal, Barcelona, Spain.
Universitat Pompeu Fabra (UPF), Barcelona, Spain.
CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.

Arne Küderle (A)

Machine Learning and Data Analytics Lab, Department of Artificial Intelligence in Biomedical Engineering, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.

Vitaveska Lanfranchi (V)

INSIGNEO Institute for in silico Medicine, The University of Sheffield, Sheffield, UK.
Department of Computer Science, The University of Sheffield, Sheffield, UK.

Walter Maetzler (W)

Department of Neurology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Germany.

M Encarna Micó-Amigo (ME)

Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.

Arne Mueller (A)

Novartis Institutes of Biomedical Research, Novartis Pharma AG, Basel, Switzerland.

Isabel Neatrour (I)

Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.

Martijn Niessen (M)

McRoberts BV, Den Haag, Zuid-Holland, Netherlands.

Luca Palmerini (L)

Department of Electrical, Electronic and Information Engineering «Guglielmo Marconi», University of Bologna, Bologna, Italy.
Health Sciences and Technologies-Interdepartmental Center for Industrial Research (CIRI-SDV), University of Bologna, Bologna, Italy.

Lucas Pluimgraaff (L)

McRoberts BV, Den Haag, Zuid-Holland, Netherlands.

Luca Reggi (L)

Health Sciences and Technologies-Interdepartmental Center for Industrial Research (CIRI-SDV), University of Bologna, Bologna, Italy.

Francesca Salis (F)

Department of Biomedical Sciences, University of Sassari, Sassari, Sardegna, Italy.

Lars Schwickert (L)

Robert Bosch Gesellschaft für Medizinische Forschung, Stuttgart, Germany.

Kirsty Scott (K)

INSIGNEO Institute for in silico Medicine, The University of Sheffield, Sheffield, UK.
Department of Mechanical Engineering, The University of Sheffield, Sheffield, UK.

Basil Sharrack (B)

Department of Neuroscience and Sheffield NIHR Translational Neuroscience BRC, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.

Henrik Sillen (H)

Digital Health R&D, AstraZeneca Sweden, Sodertalje, Sweden.

David Singleton (D)

Insight Centre for Data Analytics, O'Brien Science Centre, University College Dublin, Dublin, Ireland.
UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.

Abolfazi Soltani (A)

Laboratory of Movement Analysis and Measurement, Ecole Polytechnique Federale de Lausanne, Lausanne, Switzerland.

Kristin Taraldsen (K)

Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.

Martin Ullrich (M)

Machine Learning and Data Analytics Lab, Department of Artificial Intelligence in Biomedical Engineering, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.

Linda Van Gelder (L)

INSIGNEO Institute for in silico Medicine, The University of Sheffield, Sheffield, UK.
Department of Mechanical Engineering, The University of Sheffield, Sheffield, UK.

Beatrix Vereijken (B)

Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.

Ioannis Vogiatzis (I)

Department of Sport, Exercise and Rehabilitation, Northumbria University Newcastle, Newcastle upon Tyne, UK.

Elke Warmerdam (E)

Department of Neurology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Germany.

Alison Yarnall (A)

Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.

Lynn Rochester (L)

Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.

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