Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement-the Mobilise-D study protocol

Improved strategies to treat mobility impairment associated with ageing and chronic disease require better methods to detect and measure real-world mobility. Digital health technologies, including wearable sensors, enable direct and accurate assessment of mobility in daily life. Mobilise-D is a collaboration of 34 partners across 13 countries aiming to develop and implement a digital mobility assessment framework. The project seeks to demonstrate that digital mobility outcomes can offer a more efficient, safer, and sensitive approach to assessing, monitoring, and predicting the effects of interventions targeting impaired mobility. The overarching objective is to establish the clinical validity of these digital outcomes and support their acceptance by regulatory authorities and health technology assessment bodies.
Mobilise-D is a longitudinal observational cohort study recruiting 2,400 participants across four clinical cohorts: Parkinson’s disease, chronic obstructive pulmonary disease, multiple sclerosis, and proximal femoral fracture. Participants will be recruited from 17 clinical sites in ten countries and followed every six months over two years. Data collection includes patient-, observer-, and clinician-reported outcomes, alongside performance-based physical and cognitive measures. Daily-life mobility and physical capacity will be directly assessed using wearable devices. The cohorts were selected to ensure broad clinical, geographical, cultural, and age representation, capturing diverse trajectories of mobility impairment.
Mobilise-D will generate robust longitudinal evidence on digital mobility outcomes for identifying, stratifying, and monitoring disability. These findings will support personalised, cost-effective mobility management and provide validated measures suitable for regulatory and health technology assessment to quantify the impact of mobility-related interventions.