prosthesis; electrical stimulation; sensory feedback; amputees; wearable sensors
Valle G., Petrini F. M., Mijovic P., Mijovic B., Raspopovic S. (2021), A Computer-Brain Interface that Restores Lost Extremities' Touch and Movement Sensations, in Gunduz Aysegul, Allison Brendan Z., Guger Christoph (ed.), Springer International Publishing, Springer International Publishing, 65-73.
Valle Giacomo, Preatoni Greta, Raspopovic Stanisa (2021), Chapter 9 - Connecting residual nervous system and prosthetic legs for sensorimotor and cognitive rehabilitation, in Güçlü Burak (ed.), Academic Press, Academic Press, 293-320.
Preatoni Greta, Valle Giacomo, Petrini Francesco M., Raspopovic Stanisa (2021), Lightening the Perceived Prosthesis Weight with Neural Embodiment Promoted by Sensory Feedback, in Current Biology
, 31(5), 1.
Valle Giacomo, Saliji Albulena, Fogle Ezra, Cimolato Andrea, Petrini Francesco M., Raspopovic Stanisa (2021), Mechanisms of neuro-robotic prosthesis operation in leg amputees, in Science Advances
, 7(17), 1.
Kljajic J., Valle G., Raspopovic S. (2021), Modeling sensory adaptation to peripheral nerve stimulation, in 2021 10th International IEEE/EMBS Conference on Neural Engineering (NER)
, 788-791, IEEE, IEEE788-791.
Raspopovic Stanisa, Valle Giacomo, Petrini Francesco Maria (2021), Sensory feedback for limb prostheses in amputees, in Nature Materials
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.