The future of clinical trials? Monitoring mobility as an outcome measure in Parkinson's disease: The mobilise-D study

BackgroundA key challenge in trials targeting disease modification in Parkinson's disease (PD) is the lack of sensitive, precise, and patient-relevant outcome measures. Digital mobility outcomes (DMOs), captured using body-worn devices, offer a novel, objective means to assess real-world gait and mobility-domains often impaired early in PD. The Mobilise-D consortium was established to develop and validate DMOs in PD and other conditions.ObjectiveTo describe DMOs in a large, representative international cohort of individuals with PD and compare to controls and across disease stage; and to determine compliance and feasibility.MethodsAs part of the Mobilise-D Clinical Validation and Extension Studies, real-world mobility of individuals with PD (n = 601) and matched controls (n = 232) was assessed using a single wearable device for seven days. Data were processed to yield 24 technically validated DMOs, representing different domains of real-world walking and mobility performance.ResultsDMO data were available for 531 PD and 221 controls. Significant differences between the groups were observed in 20 of 24 DMOs. Compared to controls, PD participants exhibited shorter daily walking duration and lower step counts, walking at a higher cadence and in fewer walking bouts per day. Findings also varied by disease severity, with differences observed particularly between controls <i>vs.</i> mild (Hoehn and Yahr stage I-II) and mild <i>vs.</i> moderate (Hoehn and Yahr stage III) disease. Compliance rates were high.ConclusionsDistinct DMO patterns across PD severity and between PD and controls support their utility as sensitive, scalable outcome measures for future clinical trials and therapeutic development.

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Publication Details

Journal
Journal of Parkinson s Disease
Published
2025-12-26
DOI
https://doi.org/10.1177/1877718x251407026
Citations
2
Primary Topic
Balance, Gait, and Falls Prevention
Type
article
Field-Weighted Citation Impact
9.52

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article

The future of clinical trials? Monitoring mobility as an outcome measure in Parkinson's disease: The mobilise-D study

Andrea Cereatti, Michael Long, W. Maetzler, B. Caulfield et al.
2 citations
Journal of Parkinson s Disease
Balance, Gait, and Falls Prevention
9.52
article

The future of clinical trials? Monitoring mobility as an outcome measure in Parkinson's disease: The mobilise-D study

Andrea Cereatti, Michael Long, W. Maetzler, B. Caulfield, Christian Schlenstedt, Isabel Neatrour, C. Jansen, Jürgen Winkler, Lou Sutcliffe, Hanna Hildesheim, Joren Buekers, Heather L. Hunter, Hugo Hiden, A. Nieuwboer, Silvia Del Din, Clint Hansen, Lynn Rochester, Jennifer Kudelka, Pieter Ginis, Alison Jane Yarnall, Heiko Gaßner, David Singleton, Anat Mirelman, Basil Sharrack, Claudia Armengol, Judith Garcia-Aymeriche, Thierry Troosters, Sarah Koch, Laura Cordova-Rivera, Clemens Becker, Laura Delgado-Ortiz, Philip Brown, Mark Forrest-Gordon, Jeffrey M Hausdorff, Pia Goerrissen, Lisa Alcock
article en
2 citations

Abstract

BackgroundA key challenge in trials targeting disease modification in Parkinson's disease (PD) is the lack of sensitive, precise, and patient-relevant outcome measures. Digital mobility outcomes (DMOs), captured using body-worn devices, offer a novel, objective means to assess real-world gait and mobility-domains often impaired early in PD. The Mobilise-D consortium was established to develop and validate DMOs in PD and other conditions.ObjectiveTo describe DMOs in a large, representative international cohort of individuals with PD and compare to controls and across disease stage; and to determine compliance and feasibility.MethodsAs part of the Mobilise-D Clinical Validation and Extension Studies, real-world mobility of individuals with PD (n = 601) and matched controls (n = 232) was assessed using a single wearable device for seven days. Data were processed to yield 24 technically validated DMOs, representing different domains of real-world walking and mobility performance.ResultsDMO data were available for 531 PD and 221 controls. Significant differences between the groups were observed in 20 of 24 DMOs. Compared to controls, PD participants exhibited shorter daily walking duration and lower step counts, walking at a higher cadence and in fewer walking bouts per day. Findings also varied by disease severity, with differences observed particularly between controls <i>vs.</i> mild (Hoehn and Yahr stage I-II) and mild <i>vs.</i> moderate (Hoehn and Yahr stage III) disease. Compliance rates were high.ConclusionsDistinct DMO patterns across PD severity and between PD and controls support their utility as sensitive, scalable outcome measures for future clinical trials and therapeutic development.

Journal of Parkinson s DiseaseVol. 16(1)
University College Dublin (IE), Rush University Medical Center (US), Universitat Pompeu Fabra (ES), Politecnico di Torino (IT), University of Basel (CH), Heidelberg University (DE), Tel Aviv Sourasky Medical Center (IL), Newcastle upon Tyne Hospitals NHS Foundation Trust (GB), Robert Bosch Stiftung (DE), University Hospital Heidelberg (DE), Christian-Albrechts-Universität zu Kiel (DE), Universitätsklinikum Erlangen (DE), MSH Medical School Hamburg – University of Applied Sciences and Medical University (DE), Sheffield Teaching Hospitals NHS Foundation Trust (GB), University Hospital Schleswig-Holstein (DE), Fraunhofer Institute for Integrated Circuits (DE), NIHR Newcastle Biomedical Research Centre (GB), Teva Pharmaceuticals (United States) (US), Neuroelectronics Research Flanders (BE), Barcelona Institute for Global Health (ES), Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (ES), Newcastle University (GB), University of Sheffield (GB), University of Lübeck (DE), KU Leuven (BE)
Michael J. Fox Foundation for Parkinson's Research, European Federation of Pharmaceutical Industries and Associations, National Institute for Health and Care Research, Newcastle University, European Commission, NIHR Newcastle Biomedical Research Centre
Openalex Percentile: Top 2%
Balance, Gait, and Falls Prevention
9.52
DOIOpen Access PDFOpenAlex
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