Longitudinal multi-centric study to assess the digital outcomes issued from wearable magneto-inertial devices in ambulant DMD

Duchenne muscular dystrophy is a muscle disease characterized by severe and rapidly progressive muscle weakness. One of the key challenges in treating this condition is identifying objective, reliable, and sensitive outcome measures to measure the effects of drug. For this purpose, the ActiMyo® (Sysnav, France), a magneto-inertial wearable device, was developed. Among the assessments with performed by this wearable device, the 95th centile stride velocity (SV95C) was qualified as the 2nd endpoint in 2019 by the European Medical Agency, representing the most rapid 5% of strides during real-life activities. The ActiLiège study is a multicentre clinical study with the aim of gathering data issued from a magneto-inertial wearable. Ambulant patients with DMD and healthy controls were included and will be followed up for three years. The patients wore the ActiMyo® on their ankle and wrist during the first 3 months after the inclusion and afterwards for one month every 3 months. Controls wear the device for a period of one month every 12 months. Digital outputs from the wearable sensors are compared to gold standard assessments. We enrolled seventy-six ambulant DMD patients aged between 4 and 20 years in 7 centres (Belgium, Poland, Hungary, Romania, Czech Republic, Slovenia, and Egypt). Thirty-five of them completed at least 1 year of follow-up. All ambulant patients were either on a 6-month stable course of steroids or started steroids at baseline. The baseline data of the patients and controls will be presented, along with longitudinal data that may provide an indication of sensitivity to change in comparison with other commonly performed outcomes.