The primary objective of this study is the preparation of the certification of the Clynx® Platform, a physiotherapy software, as a Class IIa medical device software in accordance with the regulatory framework outlined in Medical Device Regulation 2017/745 (MDR). The methodology involves a comprehensive analysis of European Union medical device regulations and guidelines, with a specific focus on the certificati...
Musculoskeletal conditions affect millions of people globally; however, conventional treatments pose challenges concerning price, accessibility, and convenience. Many telerehabilitation solutions offer an engaging alternative but rely on complex hardware for body tracking. This work explores the feasibility of a model for 3D Human Pose Estimation (HPE) from monocular 2D videos (MediaPipe Pose) in a physiotherap...
Bradykinetic, shuffling and shorter steps are prototypical signs of gait in Parkinson’s Disease (PD) and important indicators of Quality of Life (QoL). Advances in wearable technologies enabled their use to objectively evaluate these gait fluctuations complementing the subjective categorical clinical scales usually used by clinicians. This paper aims to study the ability of a wearable gait analysis lab, develop...