Gait & Activity Monitoring Solution For Patients With Orthopaedic Conditions

The medical unmet need - Patients with common orthopaedic conditions such as musculoskeletal injuries (e.g., bone fractures), arthrosis, and/or following surgical procedures (e.g., anterior cruciate ligament reconstructions, osteotomies or knee prosthesis) require long medical follow-up with regular medical visits and many rehabilitation sessions. These represent standardised examination in a controlled environment, and unfortunately, do not ensure the patient for a safe and normal return to daily activities without any complaints or functional impairment in the short, medium or long term. Indeed, patients may experience delayed, incomplete or failed healing, impairments, alterations of their gait pattern, changes in physical activity behaviour and inappropriate loading for their respective pathology during their daily life activities. This would put them at risk of suffering from long-term consequences (i.e., arthrosis, secondary injuries). The possibility to remotely monitor load bearing and gait patterns in patients would help clinicians in many ways such as detecting gait metrics that are out of normal range, avoiding load in the injured/operated limb, or controlling progressive load on it. Thus, monitoring the patient’s progress in daily living conditions is essential for proper adjustment of their treatment. The digital health solution consists of pressure-sensitive insoles combined with inertial measurement units and comprises both the hardware and digital environment for the analysis and management of a patient’s data. This new digital health solution will provide healthcare professionals with important and relevant information on the progress of their patients in their natural environment by detailing aspects of both movement quality (e.g., step cadence, contact time, maximal ground reaction force) and quantity (e.g., number of steps, stairs climbed per day).

The research project - The main purpose of this project is to develop and validate a new digital health solution, for remote monitoring of gait patterns during daily life activities in patients with orthopaedic conditions before, during and after their rehabilitation period. We will first collect end-user’s feedback to help identify the most critical gait parameters needed for healthcare professionals to evaluate the status and progress of the medical condition of their patients. Then, we will conduct a validation study to assess the safety and performance (i.e., validity, accuracy and reliability) of the system against gold standard measures in a controlled environment. Participants will also perform tasks such as standing, sitting, climbing stairs in a random order to assess the performance of the system in classifying these activities. In a third step, we will conduct a feasibility and acceptability study to test the device in the realworld in patients at risk for secondary knee arthrosis or treated for primary/secondary knee arthrosis. This study will provide valuable information on the possibility to recruit patients for future trials, the compliance of patients using such a digital health solution for daily living activities, comfort and ease-of-use of the system. In parallel to these studies, the software environment will be developed and permanently improved based on the feedback from the studies. The validation study will result in a set of improved gait metrics algorithms. We will use surveys to collect feedback from both patients and healthcare professionals, which will help develop the digital environment to meet the enduser’s expectations.

Impact - The proposed project will enable us to make important steps toward bringing the new digital health solution to the market by validating this innovative solution against the current gold standard for gait related applications, while following the regulatory path toward medical certification of the device.