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

Background - A 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 gai...

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Main Authors: Yarnall, Alison (Author) , Alcock, Lisa (Author) , Schlenstedt, Christian (Author) , Armengol, Claudia (Author) , Becker, Clemens (Author) , Brown, Philip (Author) , Buekers, Joren (Author) , Caulfield, Brian (Author) , Cereatti, Andrea (Author) , Cordova-Rivera, Laura (Author) , Del Din, Silvia (Author) , Delgado-Ortiz, Laura (Author) , Forrest-Gordon, Mark (Author) , Garcia-Aymeriche, Judith (Author) , Goerrissen, Pia (Author) , Hansen, Clint (Author) , Hildesheim, Hanna (Author) , Hiden, Hugo (Author) , Hunter, Heather (Author) , Jansen, Carl-Philipp (Author) , Koch, Sarah (Author) , Kudelka, Jennifer (Author) , Long, Michael (Author) , Neatrour, Isabel (Author) , Sharrack, Basil (Author) , Singleton, David (Author) , Sutcliffe, Lou (Author) , Troosters, Thierry (Author) , Winkler, Juergen (Author) , Ginis, Pieter (Author) , Gassner, Heiko (Author) , Nieuwboer, Alice (Author) , Hausdorff, Jeffrey M. (Author) , Mirelman, Anat (Author) , Rochester, Lynn (Author) , Maetzler, Walter (Author)
Format: Article (Journal)
Language:English
Published: December 26, 2025
In: Journal of Parkinson's Disease
Year: 2026, Volume: 16, Issue: 1, Pages: 110-124
ISSN:1877-718X
DOI:10.1177/1877718X251407026
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1177/1877718X251407026
Verlag, kostenfrei, Volltext: https://journals.sagepub.com/doi/10.1177/1877718X251407026
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Author Notes:Alison J Yarnall, Lisa Alcock, Christian Schlenstedt, Claudia Armengol, Clemens Becker, Philip Brown, Joren Buekers, Brian Caulfield, Andrea Cereatti, Laura Cordova-Rivera, Silvia Del Din, Laura Delgado-Ortiz, Mark Forrest-Gordon, Judith Garcia-Aymeriche, Pia Goerrissen, Clint Hansen, Hanna Hildesheim, Hugo Hiden, Heather Hunter, Carl-Philipp Jansen, Sarah Koch, Jennifer Kudelka, Michael Long, Isabel Neatrour, Basil Sharrack, David Singleton, Lou Sutcliffe, Thierry Troosters, Juergen Winkler, Pieter Ginis, Heiko Gassner, Alice Nieuwboer, Jeffrey M Hausdorff, Anat Mirelman, Lynn Rochester and Walter Maetzler
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Summary:Background - A 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. - Objective - To 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. - Methods - As 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. - Results - DMO 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 vs. mild (Hoehn and Yahr stage I-II) and mild vs. moderate (Hoehn and Yahr stage III) disease. Compliance rates were high. - Conclusions - Distinct 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.
Item Description:Gesehen am 07.04.2026
Physical Description:Online Resource
ISSN:1877-718X
DOI:10.1177/1877718X251407026