Project

Discipline

prosthesis; electrical stimulation; sensory feedback; amputees; wearable sensors

Lead
MYLEG: un dispositivo di feedback sensoriale innovativo allo scopo do migliorare le capacità di camminare e la qualità della vita nelle persone con amputazione di gamba
Lay summary
Gli amputati degli arti inferiori utilizzano protesi che non ripristinano il feedback sensoriale durante la deambulazione. Per questo motivo, rischiano di cadere, perdendo così fiducia nella protesi e abusando della gamba sana, cio’ causa un aumento della fatica e una ridotta mobilità. Per questi motivi, gli utenti abbandonano la protesi, con conseguente difficile reinserimento nella società lavorativa. MYLEG è un dispositivo unico che ripristina il feedback sensoriale in pazienti amputati stimolando con impulsi di corrente la pelle. MYLEG è un componente aggiuntivo per qualsiasi tipo di protesi disponibile in commercio. Il sistema è costituito da una soletta sensorizzata che viene aggiunta alla protesi, un controller esterno che trasduce questa informazione ad un sistema di stimolazione costituito da stimolatore portatile ed elettrodi incorporati in una cintura. Il posizionamento ottimale degli elettrodi sulla pelle e gli algoritmi che controllano la stimolazione rendono le sensazioni suscitate molto intuitive per l'amputato, e quindi l'intero sistema facile da usare. La visione a lungo termine del progetto MYLEG è migliorare la mobilità e l'integrazione cognitiva della protesi, ripristinando il feedback sensoriale, nelle persone con amputazione di gamba, durante la loro vita quotidiana. Non ci sono dispositivi commerciali simili a quello proposto in MYLEG. La protesi che ripristina il feedback sensoriale consentirà agli utenti di evitare cadute, aumentare la fiducia nella protesi, riducendo i movimenti compensatori e affaticamento. La neuroprotesi MYLEG consentirebbe ai sistemi sanitari nazionali di risparmiare fino a 330.000 € per amputato, costo collegato ad uno stile di vita sedentario dopo l'abbandono della protesi. Il sistema di feedback sensoriale rappresenterà un nuovo prodotto nel mercato delle protesi (valutato 1,2 miliardi di euro nel 2019), consentendone l'ulteriore espansione.

Direct link to Lay Summary

Last update: 02.03.2020

Lead
MYLEG: an innovative sensory feedback device to improve walking abilities and quality of life in people with leg amputation
Lay summary
Lower limb amputees use prostheses that do not restore sensory feedback during walking. Because of this, they risk falls, thus losing confidence in the prosthesis and overusing the healthy leg, which causes increased fatigue, and reduced mobility. Because of these reasons, users abandon the prosthesis, with consequent low reinsertion into the working society. MYLEG is a unique device that restores sensory feedback to amputees by gently stimulating with pulses of current the skin of their remaining leg. MYLEG is an add-on to commercially available prostheses. The system is constituted by a sensorized insole that is added to the prosthesis, an external controller that transduces this information for a stimulating system constituted by portable stimulator and electrodes embedded in a portable belt. The optimal placement of the electrodes on the skin and the algorithms that control the stimulation make the elicited sensations very clear for the amputee, and thus the overall system easy to use. The long-term vision of the MYLEG project is to improve mobility and prosthesis cognitive integration, by restoring sensory feedback, in people with leg amputation where they matter the most to them, during their daily life. There are no commercial devices similar to the one proposed in MYLEG. The prosthesis restoring sensory feedback will enable users to avoid falls, to increase confidence in the device, which will reduce counterbalancing movements, and fatigue. The MYLEG neuroprosthesis 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 €1.2 billion in 2019), allowing its further expansion.

Direct link to Lay Summary

Last update: 02.03.2020

Leg amputees wear commercial prosthetic devices that do not give any sensory information about the interaction of the device with the ground or its movement. Amputees, relying on a very limited and uncomfortable haptic information from the stump-socket interaction, face grave impairments. The majority of amputees remain wheelchair bound, immobile, or only partially integrated in the activities of daily life. Costs wasted on an unused prosthetic limb along with a sedentary lifestyle are associated with long-term medical problems and lifetime medical expenses. In the US, these costs exceed €424k per person over his/her lifetime. For Europe, those costs will likely amount to at least 1/2 to 2/3 of the US costs (i.e. €250k - €330k). The mean 6-month direct medical costs of falls for hospitalized adults with transfemoral is about €23k. The mean costs for adults admitted to the emergency department is was about €16k. There are some startups that are developing devices that can restore sensory feedback from the prosthesis, but they require a surgery for the patients. Not all the patients are eligible or willing to go through a surgery to use a sensory feedback restoration device. We propose MYLEG, a unique device that restores sensory information about the prosthesis touch and movement through non-invasive electrical stimulation of the remaining skin of the patient. MYLEG does not need a surgery to be used and can be added to the currently available commercial prostheses. MYLEG is constituted by a sensorized insole that is added to the prosthesis, an external controller that transduces this information for a stimulating system constituted by portable stimulator and electrodes embedded in a portable belt. The optimal placement of the electrodes on the skin and the algorithms that control the stimulation make the elicited sensations very clear for the amputee, and thus the overall system easy to use. The long-term vision of the MYLEG project is to improve mobility and prosthesis cognitive integration, by restoring sensory feedback, in people with leg amputation where they matter the most to them, during their daily life. This will enable to blend the borders between everyday life and functional prosthetic use, with a threefold purpose:(I)Support independence in daily life through continuous sensory feedback.(II) Enhance prosthesis acceptance and integration by enabling meaningful use in multiple settings.(III)Reduce the economic burden on patients, healthcare systems and insurances caused by the disability (e.g. falls).MYLEG was developed by the applicant during his Ph.D. at Sant’Anna School of Advanced Studies (SSSA), EPFL and ETH and tested with an amputee, proving the ease of use and consequent improvement of cognitive and functional performance. MYLEG was used by the amputee also during a pilot of Cybathlon series 2019, ranking second. MYLEG project aims at providing a proof-of-concept that the technology: A)can be built as a stand-alone class II medical device product that will be sold either to prosthesis manufacturers which integrate it in their prosthetic products, or directly to patients, which can add it to their prosthesis -> Minimum Viable Product (MVP) B)can be protected (in terms of patentability and freedom to operate) for commercialization -> IP strategy C)has a clinical impact on the health and quality of life of patients, and consequently on the national healthcare systems -> Selling proposition and reimbursement pathD)can be further exploited for profit purposes -> Trial approval for CE/FDA application submission and fund raising These aims will be achieved through 3 WPs that will implement the following objectives:1.Upgrade of the sensory feedback restoration device (WP1)2.Testing of the functional and cognitive performance of the prosthesis and assessment of quality of life in transfemoral amputees with 10 amputees (WP2)3.Patent landscape assessment (WP3)4.Submission of the approval for a clinical trial to get clearance for commercialization (WP3)5.Fund raising (prices, awards, grants) (WP3)MYLEG project represents the first of three years roadmap to take this technology to the market. After the BRIDGE project, we will find a start-up, identify one or more clinical partners, submit the approvals for a clinical trial to get CE/FDA, recruit patients and start the clinical trial (year 2). During year 3 we will finalize the clinical trials, apply for CE/FDA and raise additional funds to start sales to patients or prosthesis manufacturers. Patients will be indicated about MYLEG by doctors at the clinical centers, having done the trials with us. During the project we will benefit of the supervision and network of ETH (hosting lab) and SensArs Neuroprosthetics which has given a letter of intent to give advices to promote the success of MYLEG, being interested in further exploitation of the technology.