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

Autor: Martin Ullrich, Silvia Del Din, Lars Schwickert, Vitaveska Lanfranchi, Eran Gazit, Alison Keogh, Tecla Bonci, S. Bertuletti, Claudia Mazzà, Felix Kluge, David Singleton, Lynn Rochester, Lucas Pluimgraaff, Francesca Salis, Luca Palmerini, Basil Sharrack, Nikolaos Chynkiamis, Jordi Evers, Sarah Koch, Elke Warmerdam, Clemens Becker, Philip M. Brown, M. Encarna Micó-Amigo, Neil Ireson, Judith Garcia Aymerich, Arne Küderle, Jeffrey M Hausdorff, Emily Hume, Lorenzo Chiari, Fabio Ciravegna, Luca Reggi, Anne-Elie Carsin, Isabel Neatrour, Linda Van Gelder, Cameron Kirk, Walter Maetzler, Andrea Cereatti, Abolfazi Soltani, Beatrix Vereijken, Björn M. Eskofier, Martijn Niessen, Arne Mueller, Jorunn L. Helbostad, Alison J. Yarnall, Ioannis Vogiatzis, Marina Brozgol, Hugo Hiden, Kristin Taraldsen, Kirsty Scott, Henrik Sillen, Lisa Alcock, M. Caruso, Anisoara Paraschiv-Ionescu, Kamiar Aminian, Clint Hansen, Brian Caulfield, Ellen Buckley
Přispěvatelé: Mazza C., Alcock L., Aminian K., Becker C., Bertuletti S., Bonci T., Brown P., Brozgol M., Buckley E., Carsin A.-E., Caruso M., Caulfield B., Cereatti A., Chiari L., Chynkiamis N., Ciravegna F., Del Din S., Eskofier B., Evers J., Garcia Aymerich J., Gazit E., Hansen C., Hausdorff J.M., Helbostad J.L., Hiden H., Hume E., Paraschiv-Ionescu A., Ireson N., Keogh A., Kirk C., Kluge F., Koch S., Kuderle A., Lanfranchi V., Maetzler W., Mico-Amigo M.E., Mueller A., Neatrour I., Niessen M., Palmerini L., Pluimgraaff L., Reggi L., Salis F., Schwickert L., Scott K., Sharrack B., Sillen H., Singleton D., Soltani A., Taraldsen K., Ullrich M., Van Gelder L., Vereijken B., Vogiatzis I., Warmerdam E., Yarnall A., Rochester L.
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: BMJ Open
BMJ Open, Vol 11, Iss 12 (2021)
ISSN: 2044-6055
Popis: Introduction: 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. Methods and analysis: 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. Ethics and dissemination: 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. Trial registration number: ISRCTN (12246987). We acknowledge support from the Spanish Ministry of Science and Innovation through the “Centro de Excelencia Severo Ochoa 2019-2023” Program (CEX2018-000806-S), and support from the Generalitat de Catalunya through the CERCA Program. SDD, AY and LRo are also supported by the Newcastle Biomedical Research Centre (BRC) based at Newcastle upon Tyne and Newcastle University. CM, BS, LVG and EB are also supported by the Sheffield Biomedical Research Centre (BRC) based at the Sheffield Teaching Hospital and the University of Sheffield. The work was also supported by the NIHR/Wellcome Trust Clinical Research Facility (CRF) infrastructure at Newcastle upon Tyne Hospitals NHS Foundation Trust and the CRF at the Sheffield Teaching Hospital. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care or the funders.This study was co-funded by the European Union’s Horizon 2020 research and innovation programme and EFPIA via the Innovative Medicine Initiative 2 (Mobilise-D project, grant number IMI22017-13-7-820820). The views expressed are those of the authors and not necessarily those of the IMI, the European Union, the EFPIA, or any Associated Partners. We acknowledge the support of Grünenthal GmbH via the funding of a PhD scholarship directly dedicated to the technical validation protocol.
Databáze: OpenAIRE
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