Mobilise-D has succeeded in its aim to develop and validate Digital Mobility Outcomes (DMOs) for real-world measurement of mobility performance in diverse health conditions. For a full list of results (open access deliverables), access to data, access to algorithm, publications and webinars, technical and clinical research implementation manuals and patient and public co-designed results please see the Mobilise-D website (www.mobilise-d.eu).
Key Results:
1. Development and validation of digital mobility assessment and outcomes:
The consortium has successfully completed a Technical Validation Study (TVS) in 112 participants from five health conditions Parkinson’s (PD), multiple sclerosis (MS), chronic obstructive pulmonary disease (COPD), hip fracture recovery (PFF), congestive heart failure (CHF), plus healthy adults (Mazza et al., 2021, DOI: 10.1136/bmjopen-2021-050785; Mico-Amigo et al., 2023, DOI: 10.1186/s12984-023-01198-5; Kirk et al., 2024, DOI: 10.1038/s41598-024-51766-5).
The validated DMOs can be implemented using any device meeting the technical requirements (making them ‘device agnostic’). The technology is applicable to many mobility-limiting conditions beyond those studied in this project. To drive improved standards in development and implement of valid digital mobility outcomes the consortium released the algorithm for research and commercial purposes (
https://github.com/mobilise-d(si apre in una nuova finestra)) together with an instructional webinar (
https://www.youtube.com/watch?v=sSLd1hwHR8M&t=84s(si apre in una nuova finestra)). This will increase the confidence of developers to implement the Mobilise-D methods, bring standardisation to the field and support future implementation of DMO’s. The consortium has also released the full date set from the technical validation study as a resource for developers (
https://mobilise-d.eu/data/(si apre in una nuova finestra)). A Technical Implementation manual for developers will be released on the website in the near future to complement learning and implementation.
2. Clinical Validation of digital mobility outcomes:
A clinical validation study (CVS) has been successfully completed in 2330 participants in four health conditions (PD, MS, COPD, PFF) (see Mikolaizak et al., 2022 for protocol, DOI: 10.1371/journal.pone.0269615). Participants showed a high level of compliance indicating its acceptability. Two devices were implemented, both were equally accepted by patients. Initial results demonstrate clinical validity with further analysis ongoing through SUSTAIN Mobilise-D. The results show that the methods are implementable and scalable. To drive improved standards in digital assessment a Clinical research Implementation Manual is planned and will be freely available on the website in the near future.
3. Patient Engagement: Extensive and diverse patient engagement was a focus of Mobilise-D and was embedded throughout the work of the consortium. The work led to multiple outputs (see Patient engagement resources on website for examples) and learnings (see Keogh et al., 2023, DOI: 10.2196/44206).
4. Regulatory Engagement: Mobilise-D has laid the foundations for the qualification of mobility DMOs as endpoints in clinical studies, drug development, clinical practice and in drug development by engaging with the EMA and FDA. Through two distinct requests for Qualification Advice to EMA (Viceconti et al., 2020, DOI: 10.3390/s20205920; 2022, DOI: 10.3389/fmed.2022.996903; European Medicines Agency, 2020, 2021, see
https://mobilise-d.eu/press-and-promotion/(si apre in una nuova finestra)) Mobilise-D obtained the endorsement of the Agency on the concept and design of the TVS and CVS, aimed at showing that DMOs can be used as monitoring biomarkers of disease status and progression in various clinical indications where mobility is impaired. EMA underlined that RCTs are needed to gather further evidence before regulatory qualification may be granted.
5. Capacity generation, dissemination & publication: The consortium adopted a multimedia approach to achieve the widest level of dissemination possible to all stakeholders including: industry (pharmaceutical, CRO and technical); regulatory authorities; clinicians; researchers; policy makers; patients and patient organisations; and the public. The approach has reached a wide audience with 77 webinar and project videos (>10,000 unique views), >99 publications, >1400 followers on social media (LinkedIn, X/Twitter and Facebook).
