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

Mazza C, Alcock L, Aminian K, Becker C, Bertuletti S, Bonci T, Brown P, Brozgol M, Buckley E, Carsin AE, Caruso M, Caulfield B, Cereatti A, Chiari L, Chynkiamis N, Ciravegna F, Del Din S, Eskofier B, Evers J, Aymerich JG, Gazit E, Hansen C, Hausdorff JM, Helbostad JL, Hiden H, Hume E, Paraschiv-Ionescu A, Ireson N, Keogh A, Kirk C, Kluge F, Koch S, Küderle A, Lanfranchi V, Maetzler W, Mico-Amigo ME, 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 (2021)

Publication Type: Journal article

Publication year: 2021

Journal

Book Volume: 11

Journal Issue: 12

DOI: 10.1136/bmjopen-2021-050785

Abstract

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 Tubingen and of the University of Kiel). Data and algorithms will be made publicly available.

Authors with CRIS profile

Related research project(s)

Involved external institutions

McRoberts B.V. Netherlands (NL) Politecnico di Torino Italy (IT) Tel Aviv Sourasky Medical Center / Ichilov Hospital Israel (IL) University of Bologna / Università di Bologna Italy (IT) Northumbria University United Kingdom (GB) NTNU Trondheim - Norwegian University of Science and Technology Norway (NO) Università degli Studi di Sassari (UNISS) Italy (IT) University of Sheffield United Kingdom (GB) Robert Bosch Gesellschaft für medizinische Forschung mbH Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) Germany (DE) Newcastle upon Tyne Hospitals NHS Foundation Trust United Kingdom (GB) École Polytechnique Fédérale de Lausanne (EPFL) Switzerland (CH) Newcastle University United Kingdom (GB) University College Dublin (UCD) Ireland (IE) Instituto de Salud Global de Barcelona (ISGlobal) Spain (ES) Novartis AG Switzerland (CH) AstraZeneca Sweden Sweden (SE) Sheffield Teaching Hospitals NHS Foundation Trust United Kingdom (GB)

How to cite

APA:

Mazza, C., Alcock, L., Aminian, K., Becker, C., Bertuletti, S., Bonci, T.,... Rochester, L. (2021). Technical validation of real-world monitoring of gait: a multicentric observational study. BMJ Open, 11(12). https://dx.doi.org/10.1136/bmjopen-2021-050785

MLA:

Mazza, Claudia, et al. "Technical validation of real-world monitoring of gait: a multicentric observational study." BMJ Open 11.12 (2021).

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