Discover Mobilise-D's objectives and overview of our achievements so far. For a deeper dive into our work, explore the links to our publications and our deliverables below.

Objectives and Achievements

Define optimal Digital Mobility Outcomes for clinical validation through consensus, literature review and technical development.

Achievements:
  • Comprehensive analysis and selection of Digital Mobility Outcomes and associated algorithms for a Technical Validation Study, incorporating literature review, previous work, and testing against existing data. 
  • Development and definition of protocols and devices needed for algorithm validation. 
  • Sensor validation using a sensor-agnostic approach, including standardised lexicon for mobility outcomes to inform algorithm development and future work. 
  • Successful Digital Mobility Outcome validation in patients and healthy cohort via the Technical Validation Study. 
  • Submission of two Qualification Advice requests to the EMA, resulting in two letters of support, and a pre-Letter of Intent submitted to the FDA for regulatory advice. 

Use our clinical networks to leverage existing and new cohorts to support clinical validation of Digital Mobility Outcomes.

Achievements:
  • Engagement with the patient cohorts for the Clinical Validation Study, incorporated associated clinical expertise, set targets for recruitments. 
  • Seventeen sites across the EU have recruited and are assessing participants. 
  • All cohorts (MS, COPD, PD and PFF) have successfully met their recruitment targets, and some went beyond them. 

Determine the clinical validity of Digital Mobility Outcomes.

Achievements:

Publication of scoping reviews addressing evidence gaps in mobility endpoints, the use of DMOs in various cohorts, and real-world walking from a patient’s perspective. 

  • Ongoing Clinical Validation Study to determine construct validity, predictive capacity, thresholds, responsiveness, and minimal important difference. 
  • Collaboration with EFPIA partners to identify and contribute data from ongoing studies relevant to the project. 
  • Successful implementation of the Clinical Validation Study across different medical conditions (PD, MS, COPD, PFF), integrating Patient and Public Involvement and Engagement in all study design aspects. 

Build a platform for robust digital data management, defining standards for storage, analysis and sharing of digital mobility data.

Achievements:
  • Successful development and implementation of a comprehensive data management platform, including data transfer, ingestion, integration pipeline, and custom software tools, facilitating data sharing among partners. 
  • Collaboration with EFPIA partners to create eCOA forms, mobile applications, and eCRFs for the Mobilise-D studies. 
  • Advancing data standardization in wearable mobility devices through research publications and development of a data sharing agreement for Mobilise-D Technical and Clinical Validation study data. 

Define and set the standards for technology-unbiased Digital Mobility Assessment.

Achievements:
  • Establishment of standardized protocols for Technical and Clinical Validation studies, including a wearable Digital Mobility Assessment reference system and statistical analysis plans. 
  • Development of comprehensive standards regarding data format, type, capture, ingestion, integration, and device agnostic procedures. 
  • Creation of a standardized lexicon for mobility outcomes, sensor validation methodologies, and remote training approaches for clinical sites and study personnel. 
  • Integration of standards and approaches into EMA Qualification Advice applications. 
  • Definition of technical standards for devices for the use of Mobilise-D DMOs. 

Create enduring impact by establishing the largest biobank of digital mobility data to support ongoing algorithm development, as well as technical and clinical validation.

Achievements:
  • Participants’ data is centrally stored on a Data Management Platform and shared through the Mobilise-D data sharing policy. 
  • The Mobilise-D project provides access to data via its data sharing policy, with information and updates available on the project’s website. 
  • Committed to freely sharing data from the Technical Validation Study and Clinical Validation Study with the public. 

Ensure dissemination of the project results and sustainability beyond the life of Mobilise-D.

Achievements:
  • Mobilise-D has achieved significant impact through over 80 peer-reviewed publications and a comprehensive series of public webinars and tutorials. 
  • Development of manuals showcasing how to implement Mobilise-D tools and methods in future trials. 
  • Continuous dissemination of project results through the project’s website and social media outlets. 
  • Patient and Public Involvement and Engagement group and Patient and Public Advisory Group successfully implemented in all phases of Mobilise-D. 
  • Successfully securing follow-on funding grants to further amplify the project’s impact. 
Publications
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Deliverables
Promotion Resources