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

Mazzà, Claudia, Alcock, Lisa, Aminian, Kamiar, Becker, Clemens, Bertuletti, Stefano, Bonci, Tecla, Brown, Philip, Brozgol, Marina, Buckley, Ellen, Carsin, Anne-Elie, Caruso, Marco, Caulfield, Brian, Cereatti, Andrea, Chiari, Lorenzo, Chynkiamis, Nikolaos, Ciravegna, Fabio, Del Din, Silvia, Eskofier, Björn, Evers, Jordi, Garcia-Aymerich, Judith, Gazit, Eran, Hansen, Clint, Hausdorff, Jeffrey M., Helbostad, Jorunn L., Hiden, Hugo, Hume, Emily, Paraschiv-Ionescu, Anisoara, Ireson, Neil, Keogh, Alison, Kirk, Cameron, Kluge, Felix, SKoch, Sarah, Küderle, Arne, Lanfranch, Vitaveska, Maetzler, Walter, Micó-Amigo, M. Encarna, Mueller, Arne, Neatrour, Isabel, Niessen, Martijn, Palmerini, Luca, Pluimgraaff, Lucas, Reggi, Luca, Salis, Francesca, Schwickert, Lars, Scott, Kirsty, Sharrack, Basil, Sillen, Henrik, Singleton, David, Soltani, Abolfazi, Taraldsen, Kristin, Ullrich, Martin, Van Gelder, Linda, Vereijken, Beatrix, Vogiatzis, Ioannis, Warmerdam, Elke, Yarnall, Alison and Rochester, Lynn (2021) Technical validation of real-world monitoring of gait: a multicentric observational study. BMJ Open, 11 (12). e050785. ISSN 2044-6055

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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.

Item Type: Article
Additional Information: Funding information: 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 a the funding of a PhD scholarship directly dedicated to the technical validation protocol.
Subjects: C600 Sports Science
Department: Faculties > Health and Life Sciences > Sport, Exercise and Rehabilitation
Depositing User: John Coen
Date Deposited: 07 Dec 2021 09:05
Last Modified: 07 Dec 2021 09:15

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