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

Claudia Mazzà*, Lisa Alcock, Kamiar Aminian, Clemens Becker, Stefano Bertuletti, Tecla Bonci, Philip Brown, Marina Brozgol, Ellen Buckley, Anne-Elie Carsin, Marco Caruso, Brian Caulfield, Andrea Cereatti, Lorenzo Chiari, Nikolaos Chynkiamis, Fabio Ciravegna, Silvia Del Din, Björn Eskofier, Jordi Evers, Judith Garcia-AymerichEran Gazit, Clint Hansen, Jeffrey M Hausdorff, Jorunn L. Helbostad, Hugo Hiden, Emily Hume, Anisoara Paraschiv-Ionescu, Neil Ireson, Alison Keogh, Cameron Kirk, Felix Kluge, Sarah Koch, Arne Küderle, Vitaveska Lanfranchi, Walter Maetzler, M. Encarna Micó-Amigo, Arne Mueller, Isabel Neatrour, Martijn Niessen, Luca Palmerini, Lucas Pluimgraaff, Luca Reggi, Francesca Salis, Lars Schwickert, Kirsty Scott, Basil Sharrack, Henrik Sillen, David Singleton, Abolfazi Soltani, Kristin Taraldsen, Martin Ullrich, Linda Van Gelder, Beatrix Vereijken, Ioannis Vogiatzis, Elke Warmerdam, Alison Yarnall, Lynn Rochester

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

45 Citations (Scopus)
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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.
Original languageEnglish
Article numbere050785
Pages (from-to)1-14
Number of pages14
JournalBMJ Open
Issue number12
Publication statusPublished - 2 Dec 2021


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