One of the workstreams within PaLaDIn is exploring the collection and analysis of data from wearable devices for integration into the Interactium. To advance this work, a clinical research study has been set up at two PaLaDIn partner sites to collect gait data from wearable devices, including EMG-sensing shorts, inertial measurement units, heart-rate sensors, and plantar (bottom of the foot) pressure-sensing insoles, in a cohort of neuromuscular disease patients.
PalaGait (PaLaDIn gait analysis – Longitudinal observational study of gait features in patients with neuromuscular diseases) is now recruiting at the John Walton Muscular Dystrophy Research Centre at Newcastle University and Institut de Recerca Sant Pau at Hospital de la Santa Creu I Sant Pau in Barcelona. The study will use wearable sensors to collect gait data and analyse this with MRI data collected from the same patients. The Newcastle team are also testing activity monitoring sensors on a group of patients outside the clinic environment.
The study will identify gait features that show measurable change over a 12-month period and combine the most relevant of these into a composite score. This could potentially enable their use as biomarkers for patient monitoring in clinical practice and as surrogate markers for clinical trials. Data from the study will be integrated into the Interactium, serving as a test case for the platform.
The primary data collection tool is Ephion Mobility, a validated software platform that integrates data from multiple sensors, developed by PaLaDIn partner Ephion Health. Ephion Mobility is CE-marked as a medical device software and has been previously applied in neuromuscular diseases. In this project it is used on an investigational basis, including an additional subset of diseases and multimodal sensor data. The analysed study data will help us to understand how to standardise data from a gait study and resolve questions about data interoperability. PaLaDIn partners Amsterdam University Medical Center and Leiden University Medical Center will ensure the study data being integrated into the Interactium is Findable, Accessible, Interoperable, and Reusable (FAIR).
We will continue to provide updates as the study progresses!
