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

Lookup NU author(s): Professor Alison YarnallORCiD, Dr Lisa AlcockORCiD, Philip Brown, Dr Laura Cordova RiveraORCiD, Dr Silvia Del DinORCiD, Dr Hugo Hiden, Heather Hunter, Isabel Neatrour, Dr Lou Sutcliffe, Professor Lynn RochesterORCiD

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


Abstract

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. Tracking walking to understand Parkinson’s: Insights from the Mobilise-D study Difficulty with walking is regularly highlighted by people with Parkinson's as one of their most troublesome symptoms. To identify treatments with the potential to slow or halt disease progression, researchers need to track changes to mobility in a way that is accurate and meaningful to people with Parkinson's. Currently, many measures used in clinical trials often provide only a snapshot on one day. This does not accurately reflect how fluctuations in mobility from day-to-day can affect people. One promising method instead is using wearable devices that monitor how people move during their daily lives. A large international research group, the Mobilise-D consortium, studied over 600 people with Parkinson's and more than 200 people without the condition across five sites in Europe. Participants wore a small device either on their lower back or on a belt around their waist for a week. This tracked their walking patterns and activity levels. The results showed clear differences in how people with Parkinson's moved compared to those without the disease. For example, people with PD walked less, took fewer steps, and had different walking rhythms throughout the day. These differences generally became more noticeable as the disease became more advanced. Importantly, participants were happy to wear the devices and followed the study instructions well, showing this method is practical for future use. Digital measures of mobility are therefore able to measure changes in mobility and walking in Parkinson's disease. This may be a useful tool for improving development and real-world testing of new treatments.


Publication metadata

Author(s): Yarnall AJ, Alcock L, Schlenstedt C, Armengol C, Becker C, Brown P, Buekers J, Caulfield B, Cereatti A, Cordova-Rivera L, Del Din S, Delgado-Ortiz L, Forrest-Gordon M, Garcia-Aymeriche J, Goerrissen P, Hansen C, Hildesheim H, Hiden H, Hunter H, Jansen C-P, Koch S, Kudelka J, Long M, Neatrour I, Sharrack B, Singleton D, Sutcliffe L, Troosters T, Winkler J, Ginis P, Gassner H, Nieuwboer A, Hausdorff JM, Mirelman A, Rochester L, Maetzler W

Publication type: Article

Publication status: Published

Journal: Journal of Parkinson's Disease

Year: 2026

Volume: 16

Issue: 1

Pages: 110-124

Print publication date: 01/02/2026

Online publication date: 26/12/2025

Acceptance date: 02/04/2018

Date deposited: 23/02/2026

ISSN (print): 1877-7171

ISSN (electronic): 1877-718X

Publisher: Sage Publications Ltd

URL: https://doi.org/10.1177/1877718X251407026

DOI: 10.1177/1877718X251407026

Data Access Statement: The data presented in this paper will be made available under a CC4.0 license in December 2025. Upon release, it can be accessed at: https://zenodo.org/communities/mobilise-d/

PubMed id: 41452018


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Funding

Funder referenceFunder name
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Union's Horizon 2020 research and innovation program
Innovative Medicines Initiative 2 Joint Undertaking under grant agreement no. 820820
Michael J Fox Foundation (MJFF-022735)

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