Project

Back to overview

MYLEG - A non-invasive sensory feedback to improve MobilitY and to promote cognitive prosthesis integration in people with LEG amputation

Applicant Valle Giacomo
Number 193724
Funding scheme Bridge - Proof of Concept
Research institution Institut für Robotik und Intelligente Systeme (IRIS) ETH Zürich
Institution of higher education ETH Zurich - ETHZ
Main discipline Biomedical Engineering
Start/End 01.04.2020 - 30.09.2021
Approved amount 183'951.00
Show all

All Disciplines (2)

Discipline
Biomedical Engineering
Neurology, Psychiatry

Keywords (5)

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

Lay Summary (Italian)

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 sfruttando in modo eccessivo la gamba sana, che provoca un aumento della fatica e una ridotta mobilità. Per questi motivi gli utenti abbandonano la protesi, con conseguente basso reinserimento nella società lavorativa. MYLEG è un dispositivo unico che ripristina il feedback sensoriale agli amputati stimolando delicatamente con impulsi di corrente la pelle della gamba rimanente. MYLEG è un add-on alle protesi disponibili in commercio e non esistono dispositivi commerciali simili a quello proposto in MYLEG.

Il sistema è costituito da un plantare sensorizzato che si aggiunge alla protesi, un controller esterno che trasduce queste informazioni per un sistema di stimolazione costituito da stimolatore portatile ed elettrodi annegati in una cintura portatile. Il posizionamento ottimale degli elettrodi sulla pelle e gli algoritmi che controllano la stimolazione rendono molto chiare le sensazioni suscitate per l'amputato, e quindi il sistema complessivo facile da usare.

MYLEG migliora la mobilità, l'integrazione cognitiva della protesi diminuendo il costo metabolico, ripristinando il feedback sensoriale, nelle persone con amputazione della gamba dove contano di più per loro, durante la loro vita quotidiana (vincentore anche della medaglia d'argento al CYBATHLON 2020). La protesi che ripristina il feedback sensoriale consente agli utenti di evitare cadute, aumentare la fiducia nel dispositivo, riducendo i movimenti di controbilanciamento e l'affaticamento.

La neuroprotesi MYLEG consentirebbe al Sistema Sanitario Nazionale di risparmiare fino a 330.000 euro per amputato, legato a uno stile di vita sedentario a seguito dell'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 un'ulteriore espansione.

 

Direct link to Lay Summary Last update: 25.10.2021

Lay Summary (English)

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 and there are no commercial devices similar to the one proposed in MYLEG. 

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.

MYLEG improves mobility, prosthesis cognitive integration while decreasing metabolic cost, by restoring sensory feedback, in people with leg amputation where they matter the most to them, during their daily life (winnig also the silver medal at CYBATHLON 2020). The prosthesis restoring sensory feedback enables users to avoid falls, to increase confidence in the device, which reduces 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: 25.10.2021

Responsible applicant and co-applicants

Employees

Publications

Publication
A Computer-Brain Interface that Restores Lost Extremities' Touch and Movement Sensations
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.
Chapter 9 - Connecting residual nervous system and prosthetic legs for sensorimotor and cognitive rehabilitation
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.
Lightening the Perceived Prosthesis Weight with Neural Embodiment Promoted by Sensory Feedback
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.
Mechanisms of neuro-robotic prosthesis operation in leg amputees
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.
Modeling sensory adaptation to peripheral nerve stimulation
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.
Sensory feedback for limb prostheses in amputees
Raspopovic Stanisa, Valle Giacomo, Petrini Francesco Maria (2021), Sensory feedback for limb prostheses in amputees, in Nature Materials, 1.

Collaboration

Group / person Country
Types of collaboration
SITEM School Bern Switzerland (Europe)
- Industry/business/other use-inspired collaboration
SensArs Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Industry/business/other use-inspired collaboration

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Frontiers in Medicine: New Technologies in Diagnostics and Therapy Individual talk Lecture 3: Neuroengineering and rehabilitation robotics 12.10.2021 Zurich, Switzerland Valle Giacomo;
Neuroprosthetics 2020: Summer school “A novel sensorimotor strategy with a leg neuroprosthesis” Talk given at a conference Connecting the brain to leg neuroprostheses 21.07.2021 Zurich, Switzerland Valle Giacomo;
10th International IEEE EMBS Conference on Neural Engineering (NER) 2021 Talk given at a conference Connecting humans and machines 16.04.2021 Zurich, Switzerland Valle Giacomo;
Data Blitz: Trainee Professional Development Award (TPDA) – Society for Neuroscience (USA) Talk given at a conference Connecting the brain to bionic limbs 22.02.2021 Bern, Switzerland Valle Giacomo;
Brain-Computer-Interface (BCI) Samara week 2020 Russia Talk given at a conference MYLEG 10.10.2020 Zurich, Switzerland Valle Giacomo;
5th Annual Virtual Research Symposium UCI PostDoctoral Association | University of California, Irvine USA Talk given at a conference Sensory feedback in neural prostheses 24.04.2020 Bern, Switzerland Valle Giacomo;


Knowledge transfer events

Active participation

Title Type of contribution Date Place Persons involved
Scientifica 2021: Synthetic naturally Talk 04.09.2021 Zurich, Switzerland Valle Giacomo;


Communication with the public

Communication Title Media Place Year
Media relations: print media, online media STAGE UP finalists - MYLEG Berner Zeitung Western Switzerland Italian-speaking Switzerland Rhaeto-Romanic Switzerland German-speaking Switzerland 2021
New media (web, blogs, podcasts, news feeds etc.) Cybathlon2020 Stefan and the NeuroLegs Team: Powered Leg Prosthesis Race Hello Zurich German-speaking Switzerland Italian-speaking Switzerland Western Switzerland Rhaeto-Romanic Switzerland 2020
Video/Film MYLEG video International 2020
New media (web, blogs, podcasts, news feeds etc.) NEUROLEGS TEAM PORTRAIT _ CYBATHLON2020 CYBATHLON International 2020
New media (web, blogs, podcasts, news feeds etc.) RAZOR Cybathlon The championship for robotics assisted athletes: MYLEG RAZOR BBC International 2020

Awards

Title Year
“Premio Eccellenza Italiana” 2021 2021
Deep Tech Pioneer 2021 2021
European Entrepreneurship Robotics Award 2021 2021
FENS EJN Young Investigator Prize 2022 2021
Finalists Swiss Innovation Challenge 2021 2021
First Place Lausanne startups for the IMAGINE IF! 2021
Forbes Under30 Italia in Science 2021 2021
Sir Henry Royce Medal 2021 - IET Achievement Award 2021
TOP 5 STAGE-UP THE BUSINESS CREATION COMPETITION 2021
Venture Kick I 2021
Winner startup 2021 We Make Future (WMF) 2021
1st place NeuroTech Cup 2020 International Projects Competition for Young Researchers and Engineers in the Field of Neurotechnology and Artificial Intelligence. 2020
2nd place at CYBATHLON Global Edition 2020 “Powered Leg Prosthesis Race” 2020
Best oral presentation award UCI Postdoctoral Association 2020
STARTUP CAMPUS Award - Best Business Concept 2020 - MYLEG 2020
TOP3 Medical Start-ups 2020 in Robotics category 9th MEDICA Start-up COMPETITION 2020

Abstract

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.
-