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Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement–the Mobilise-D study protocol

Lookup NU author(s): Professor Lynn RochesterORCiD, Professor Alison Yarnall, Dr Lisa AlcockORCiD, Isabel Neatrour



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


© 2022 Mikolaizak et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.Background The development of optimal strategies to treat impaired mobility related to ageing and chronic disease requires better ways to detect and measure it. Digital health technology, including body worn sensors, has the potential to directly and accurately capture real-world mobility. Mobilise-D consists of 34 partners from 13 countries who are working together to jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes have the potential to provide a better, safer, and quicker way to assess, monitor, and predict the efficacy of new interventions on impaired mobility. The overarching objective of the study is to establish the clinical validity of digital outcomes in patient populations impacted by mobility challenges, and to support engagement with regulatory and health technology agencies towards acceptance of digital mobility assessment in regulatory and health technology assessment decisions. Methods/design The Mobilise-D clinical validation study is a longitudinal observational cohort study that will recruit 2400 participants from four clinical cohorts. The populations of the Innovative Medicine Initiative-Joint Undertaking represent neurodegenerative conditions (Parkinson’s Disease), respiratory disease (Chronic Obstructive Pulmonary Disease), neuro-inflammatory disorder (Multiple Sclerosis), fall-related injuries, osteoporosis, sarcopenia, and frailty (Proximal Femoral Fracture). In total, 17 clinical sites in ten countries will recruit participants who will be evaluated every six months over a period of two years. A wide range of core and cohort specific outcome measures will be collected, spanning patient-reported, observer-reported, and clinician-reported outcomes as well as performance-based outcomes (physical measures and cognitive/mental measures). Daily-living mobility and physical capacity will be assessed directly using a wearable device. These four clinical cohorts were chosen to obtain generalizable clinical findings, including diverse clinical, cultural, geographical, and age representation. The disease cohorts include a broad and heterogeneous range of subject characteristics with varying chronic care needs, and represent different trajectories of mobility disability. Discussion The results of Mobilise-D will provide longitudinal data on the use of digital mobility outcomes to identify, stratify, and monitor disability. This will support the development of widespread, cost-effective access to optimal clinical mobility management through personalised healthcare. Further, Mobilise-D will provide evidence-based, direct measures which can be endorsed by regulatory agencies and health technology assessment bodies to quantify the impact of disease-modifying interventions on mobility.

Publication metadata

Author(s): Mikolaizak AS, Rochester L, Maetzler W, Sharrack B, Demeyer H, Mazza C, Caulfield B, Garcia-Aymerich J, Vereijken B, Arnera V, Miller R, Piraino P, Ammour N, Gordon MF, Troosters T, Yarnall AJ, Alcock L, Gassner H, Winkler J, Klucken J, Schlenstedt C, Watz H, Kirsten A-M, Vogiatzis I, Chynkiamis N, Hume E, Megaritis D, Nieuwboer A, Ginis P, Buckley E, Brittain G, Comi G, Leocani L, Helbostad JL, Johnsen LG, Taraldsen K, Blain H, Driss V, Frei A, Puhan MA, Polhemus A, de Basea MB, Gimeno E, Hopkinson NS, Buttery SC, Hausdorff JM, Mirelman A, Evers J, Neatrour I, Singleton D, Schwickert L, Becker C, Jansen C-P

Publication type: Article

Publication status: Published

Journal: PLoS ONE

Year: 2022

Volume: 17

Issue: 10

Print publication date: 01/10/2022

Online publication date: 06/10/2022

Acceptance date: 17/06/2022

Date deposited: 24/10/2022

ISSN (electronic): 1932-6203

Publisher: Public Library of Science


DOI: 10.1371/journal.pone.0269615

PubMed id: 36201476


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Funder referenceFunder name
Generalitat de Catalunya through the CERCA Program
ISGlobal acknowledges support from the Spanish Ministry of Science, Innovation and Universities through the “Centro de Excelencia Severo Ochoa 2019-2023” Program (CEX2018-000806-S)
Mobilise-D project that has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No. 820820
This JU receives support from the European Union's Horizon 2020 research and innovation program and the European Federation of Pharmaceutical Industries and Associations (EFPIA)