Study Rationale: Mobility, the ability to physically move around, is vitally important and key to an individual’s independence. Although loss of mobility is a key feature in Parkinson’s disease (PD), mobility is not routinely assessed — even in trials of new drugs. This lack of assessment may be due, in part, to the difficulty in measuring mobility continuously over time. Digital health technology, which includes devices that are worn on the body, can provide continuous tracking of mobility for weeks at a time, enabling remote monitoring and revealing how mobility in everyday life relates to an individual’s health.
Hypothesis: This extension of the Mobilise-D study will allow us to assess whether people with PD experience more real-world mobility changes than healthy individuals and whether digital mobility outcomes are valid, meaningful and can be useful in regulatory drug trials.
Study Design: The Mobilise-D study has recruited 600 participants with PD across five centers in Europe. In this study, participants are followed every six months for two years with an extensive clinical assessment and a seven-day digital mobility assessment. As part of the current project proposal extension, participants with PD from Mobilise-D will be offered one additional assessment at 36 months following their baseline visit. We will recruit 200 matched control participants at the five clinical sites and assess mobility in these individuals at baseline and after 12 months.
Impact on Diagnosis/Treatment of Parkinson’s disease: Although the future of sustainable healthcare is in digital measurement, the necessary tools require validation and approvals. Mobilise-D brings the key ingredients to achieve this. We hope this study will lead to measurable outcomes that can be used in trials of disease modification and other treatments in PD.
Next Steps for Development: The ultimate aim is that regulatory these digital mobility outcomes will be used to measure mobility in daily life in PD to transform clinical research and health.