Restoring complete sensory ability for natural walking of amputees
Lower limb amputees use prostheses that do not restore sensory feedback during walking. The lack of feedback increases the risk of falls of amputee, who lose confidence in the prosthesis, overusing the healthy leg, have increased fatigue, and reduced mobility. Finally, they do not feel the device as part of the body and experience phantom limb pain (pain from the missing limb). Because of these reasons, users abandon the prosthesis, with consequent low reinsertion into the working society. SensArs has developed the solution to these problems: a neuroprosthesis that allows amputees to feel sensory feedback from the prosthesis as from a real leg. So far, 3 amputees have tested its technology. The main goal of GoSafe is to improve the device and finalize a pilot trial proving safety and efficacy. The pilot trial will give insights on potential technology or clinical protocol modifications to go through a pivotal study to get CE mark for the neuroprosthesis. To reach this goal, SensArs will optimize the neuroprosthesis and integrate it with the commercial prosthetic leg of Össur, then will go through preclinical validation and clinical pilot study at UCSC and CHAR with leg amputees. With the clinical pilot study, SensArs will apply for a pivotal study for CE mark (class III device), which will allow commercialization after the project. To guarantee the product market uptake, the consortium will run during the project a study to define the strategy to get reimbursement right after the CE marking. There are no commercial devices similar to the one proposed in GoSafe. The prosthesis restoring sensory feedback will enable users to feel the prosthesis itself as part of the body, to avoid falls, and so to increase confidence in the device, which will reduce counterbalancing movements, and fatigue. The GoSafe neuroprosthesis would be a novel therapy for phantom pain and would enable the National Health Systems to save up to €330’000 per amputee, connected to a sedentary lifestyle following prosthesis abandonment. The sensory feedback system will represent a new product in the prosthetics market (valued €1.4 billion in 2016), allowing its further expansion.