- 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.
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
- Objective 1 - Define DMOs
- Objective 2 - Cohorts
- Objective 3 - Clinical validity
- Objective 4 - Data
- Objective 5 - Standards
- Objective 6 - Impact
- Objective 7 - Dissemination
Define optimal Digital Mobility Outcomes for clinical validation through consensus, literature review and technical development.
Achievements:
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.