Details

Autor(en) / Beteiligte

• 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
• Koch, Sarah
• Küderle, Arne
• Lanfranchi, 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
• Rochester, Lynn

Titel

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

Ist Teil von

• BMJ open, 2021-12, Vol.11 (12), p.e050785

Ort / Verlag

England: British Medical Journal Publishing Group

Erscheinungsjahr

2021

Link zum Volltext

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• IntroductionExisting 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 analysisThis 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 disseminationThe 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 numberISRCTN (12246987).