A Translational Alliance between Newcastle University and Ossur

Lead Research Organisation: Newcastle University
Department Name: Sch of Engineering

Abstract

Each year, over 5400 UK patients are referred to lower limb prosthesis clinics (2011), of whom over 90% are below- or above-knee amputees. The main causes of amputation are diabetes, limb dysvascularity (loss of blood supply), accidents and injury in the battlefield.

Prosthetic legs have the potential to dramatically improve the mobility, confidence and the quality of life of users. With an effective prosthetic solution, users can be independent in their daily living, e.g. walking, stair climbing and potentially running. In addition, advanced prosthetic legs enable amputees to improve their posture which in turn has a positive effect on reducing wear-and tear on their unaffected joints. However, individuals with lower-limb amputation lack the nervous structures associated with the foot and ankle from the prosthesis and, compared with able-bodied individuals, suffer from lack of stability. Technologies do not exist for targeted delivery of feedback information from the prosthesis to the nervous system.

As part of the EPSRC-funded SenseBack project, a highly-experienced team of UK researchers are developing a number of key technologies to restore sensation to the individuals using prosthetic hands. The proposed translational Alliance between Newcastle University and Össur (www.ossur.com) will facilitate translation of the the technologies developed in the SenseBack project to lower-limb prostheses. With Össur, within the next decade, we aim to create an artificial leg that can generate mechanical power, adapt autonomously to the user's changing needs and also provide feedback to the user regarding the state of the limb and the prosthesis.

Planned Impact

Society: One major missing element in current lower-limb prostheses is sensory feedback from the environment to the nervous system. Thus the most direct and immediate beneficiaries of this research will be amputees who will enjoy improved healthcare outcome, quality of life and higher levels of satisfaction with their prosthesis. There are over 10s of thousands of amputees in the UK who may benefit, with millions of others worldwide. Improving the quality of the lower limb prostheses will have a positive knock-on effect for healthcare providers. The challenge to provide effective prostheses is a recurrent feature of comments from users. It has been a key theme in national reports on prosthetic services in the UK [Chavasse report, 2014] particularly in relation to injured service personnel and survivors of major trauma. These issues are discussed regularly during meetings of the All-Party Parliamentary Limb Loss Group. Beyond prosthetics, loss of sensory integration is widely acknowledged as the major impairment in recovery from musculoskeletal and neurological conditions. In addition, sensory loss contributes to substantial secondary complications of disabling conditions and subsequent disability, such as pressure damage leading to ulcers. The cost to the health service of skin pressure damage is £2.1Bn per year. This is a direct result of people being unable to sense when their skin is at risk of breakdown and includes pressure sores from people inappropriately positioned in beds and chairs. Developing of assistive technologies that can provide sensory feedback to the user will enhance our ability to meet users' needs.

Economy: The results of this project will cement the EU's (and particularly the UK's) reputation as the leading location for prosthetic design and manufacture. The market for advanced prostheses and bionics is growing rapidly, e.g., Össur's prosthetics sales was $212M in 2014. This project will provide significant know-how and novel technologies thelp the UK's prosthetics research and EU industry in general stay competitive in a global market. In addition, the planned collaboration agreement between project partners means that any commercial potential can be rapidly exploited.

Knowledge: This project will inform the development of a wider range of assistive technology, in particular, understanding how sensory feedback is perceived in lower limb amputees is a totally under-studied topic. In the SenseBack project, we are testing the effect of feedback in rodents. This project will provide an avenue to translate knowledge from low level animal models directly to humans, bypassing the need for use of non-human primates.

People: The partnership not only will provide high-quality training in the general areas of signal analysis, stochastic learning and sensorimotor control for the research associate, but also provides an opportunity to learn from industry experts what steps should be taken until an idea is turned into a medical device. This is a very valuable experience for the Newcastle team. In addition, Össur's engineers will have the opportunity to join the Newcastle team and receive first hand training in top signal processing techniques and electrophysiology experiments. Furthermore, the research team in Newcastle (PDRA and a PhD student) will gain knowledge and expertise through the process of solving challenging problems and presenting their work. They will spend time at both Newcastle University's School of Electrical and Electronic Engineering and Institute of Neuroscience and benefit from a truly multi-disciplinary research environment. The Staff Development Unit at Newcastle University offers many training workshops, e.g. on maximising and measuring research impact. RA1 will be advised to attend all relevant workshops. At the completion of this project, the PDRA and the PhD student will be fully prepared to work in industry or to stay in academia to pursue an academic career.

Publications

10 25 50
publication icon
Brunton E (2018) Recovery of the Response of Sensory Fibers to the Second of a Pair of Peripheral Nerve Stimuli. in Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference

publication icon
Jones H (2018) Gaining NHS ethical approval from the perspective of a biomedical engineering team in British Journal of Healthcare Management

publication icon
Rapeaux A (2018) Preliminary Study of Time to Recovery of Rat Sciatic Nerve from High Frequency Alternating Current Nerve Block. in Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference

publication icon
Silveira C (2018) Positioning the Nerve Cuff Distally on the Sciatic Nerve Improves the Classification of Ankle-Movement Proprioceptive ENG Signals. in Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference

publication icon
Silveira C (2018) Evaluation of Time-Domain Features of Sensory ENG Signals. in Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference

 
Description 2019 We developed and tested a flexible and implantable electrode, which was the key aim of this project

2018 We have now understood the steps that need to be taken to work with NHS on implanting semi-invasive research devices in humans.
Exploitation Route 2019 The electrode has been tested in animals. We are taking it forward to the next level, in anticipation of human trials in 3-5 years

2018 We have developed a new nerve stimulation technique that can be used for providing sensory feedback. Similar methods could be used in electronic medicine.
Sectors Electronics,Healthcare

 
Description Healthcare Technology Challenge Award
Amount £1,028,683 (GBP)
Funding ID EP/R004242/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 02/2018 
End 01/2023
 
Title A novel surgical technique for implantation of multi-channel cuff electrodes in rats 
Description Understanding how the peripheral nervous systems responds to electro-mechanical stimulation of the limb can inform the design of advanced prostheses that can, for example, offer sensory feedback or accelerate recovery from stroke. However, due to differences in experimental protocols, it is difficult, if not impossible, to make meaningful comparisons between different neural interfaces. Therefore, standardised experimental protocols and inexpensive hardware to enable systematic comparison of various neural interfaces are necessary. Here, we develop a low-cost, computer-controlled electronic system to standardise the mechanical stimulation of a rat's hind-paw. 
Type Of Material Model of mechanisms or symptoms - mammalian in vivo 
Year Produced 2017 
Provided To Others? Yes  
Impact This experimental platform will enable the development of further complementary studies towards understanding the underlying mechanisms of sensorimotor control at the neural and behavioural levels. In addition, it is an in-vivo test platform upon which the efficiency of other neurotechnological developments can be evaluated; 
 
Title pyEMG 
Description Python package for offline and real-time myoelectric control by using sEMG and IMU signals 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2018 
Provided To Others? Yes  
Impact The impact is growing, as evidenced by new downloads 
URL https://github.com/agamemnonc/pyEMG
 
Title ENG recordings in response to mechanical stimulation 
Description Electroneurogram signals recorded from 16-channel cuff electrodes placed on the sciatic nerve of Sprague Dawley rats. The recordings were made in response to three types of mechanical stimulation, namely, proprioception, touch and nociception. The data files include synchronisation comments and signals that indicate when a stimulus was applied and what the stimulus was. Proprioceptive responses were recorded in response to a servo motor moving the foot to one of 6 different angles. Touch responses were recorded in response to heel of the foot being touched with one of two Von Frey fibres, corresponding to a force of either 100 or 300 grams. Finally, Nociception responses were recorded in response to the foot being pinched using a pair of forceps either on the heel, or the outer toe. 
Type Of Material Database/Collection of data 
Year Produced 2017 
Provided To Others? Yes  
Impact Experiments with animals create large amount valuable data on which various algorithms can be applied. This is a first database of its kind which made available online. We hope it will help with the reduction of number of animals used in research. 
URL https://rdm.ncl.ac.uk/landing/pages/10.17634/141353-2
 
Description Translational Partnership 
Organisation Ossur
Country Iceland 
Sector Private 
PI Contribution We develop techniques by which lower limb nerves can be stimulated to restore sensory feedback in prosthesis
Collaborator Contribution Ossur will provide a clinical platform for our techniques to translate.
Impact The work has not led to any outcome just yet
Start Year 2015
 
Title Prosthetcis Control 
Description We have received approval from NHS to start a small scale clinical trial. We are now in the patient recruiting phase. 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2017
Development Status Under active development/distribution
Impact We are now at an early stage. The ideal outcome of the clinical trial would be to be able to predict whether a user can benefit from using an advanced multi-fingered prosthesis or a conventional prosthesis would suffice. This could provide a very much required evidence to support funding for fitting advanced upper limb prosthetics under NHS. 
 
Description A talk or presentation - A talk or presentation - Presentation of the work at Trent International Prosthetics Symposium 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation of paper
A. Krasoulis, I. Kyranou, M. S. Erden, K. Nazarpour, and S. Vijayakumar, "Improved myoelectric classification via using inertial measurement units," In: ISPO Trent International Prosthetic Symposium (TIPS). 2016, Glasgow: International Society for Prosthetics and Orthotics.
Year(s) Of Engagement Activity 2016
URL http://www.ispo.org.uk/events_meetings-V.html
 
Description A talk or presentation - Presentation of the work at Trent International Prosthetics Symposium 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation of research work at Trent International Prosthetics Symposium (combined with the International Society for Prosthetics and Orthotics), a multidisciplinary conference attracting not just academics but industry, users and practitioners.

M. Dyson and K. Nazarpour "Pre-clinical application of abstract muscle synergies for myoelectric control," In: ISPO Trent International Prosthetic Symposium (TIPS). 2016, Glasgow: International Society for Prosthetics and Orthotics
Year(s) Of Engagement Activity 2016
URL http://www.ispo.org.uk/events_meetings-V.html
 
Description A talk or presentation - Imperial College Surgical Society 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Undergraduate students
Results and Impact A talk about body integrated prosthetic devices, surgical challenges and skills required

For the link, please refer to the tweets on Jan 15
Year(s) Of Engagement Activity 2017
URL https://twitter.com/ICSMSurgicalSoc
 
Description A talk presented at Sheffiled University 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact The CATCH Network learned about machine learning in the control of prosthetic hands and Patient and Public Involvement. We were delighted to be joined by not one, not two, but three exciting speakers at the June 2016 CATCH Networking Lunch.
Year(s) Of Engagement Activity 2017
URL http://www.catch.org.uk/news-articles/6th-networking-lunch/
 
Description Future prosthetic: towards the bionic human 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Kia Nazarpour gave an interview to The Engineer Magazine about the science-fiction vision of robotic prosthetic limbs that can be controlled by the brain and provide sensory feedback, which in his opinion is coming closer to reality.
Year(s) Of Engagement Activity 2018
URL https://www.theengineer.co.uk/future-prosthetic/
 
Description International Press Release 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Press release about the UNESCO award received by the hand that sees project
Year(s) Of Engagement Activity 2018
URL http://www.ncl.ac.uk/press/articles/latest/2018/02/handthatseesunesco/
 
Description Interview 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Gave an interview to The Engineer on the science-fiction vision of robotic prosthetic limbs that can be controlled by the brain and provide sensory feedback is coming closer.
Year(s) Of Engagement Activity 2018
URL https://www.theengineer.co.uk/future-prosthetic/
 
Description Interview with Dazed 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Interview about "How AI could increase art world accessibility for disabled artists"
Year(s) Of Engagement Activity 2018
URL https://www.dazeddigital.com/art-photography/article/41334/1/how-ai-could-increase-art-world-accessi...
 
Description Interview with Verdict 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact This was an interview about how AI is exploding into healthcare
Year(s) Of Engagement Activity 2018
URL https://www.verdict.co.uk/ai-healthcare-growth-apps/
 
Description School Visit 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact Presenting control of myoelectric hands in a local girls only school
Year(s) Of Engagement Activity 2017
URL http://www.intellsensing.com/outreach-we-love-stem/
 
Description Speaking at IET Annual Lecture 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Presented challenges of myoelectric control in a public event
Year(s) Of Engagement Activity 2017
URL http://www.theiet.org/events/local/250075.cfm
 
Description The Future of Surgery 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Kia Nazarpour has given evidence to the Commission on the Future of Surgery, formed by Royal College of Surgeons. The purpose of the hearing was to set out a compelling and credible vision of the future advances in medicine and technology, including prosthetics, and how those developments will affect the delivery of surgical care in the United Kingdom. In particular, the Commission considers what the future of surgery is likely to look like for patients in five years, could look like in ten years, and might be in 15 to 20 years.
Year(s) Of Engagement Activity 2018
URL https://futureofsurgery.rcseng.ac.uk/report
 
Description Transhumanism 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact This was an interview by The Guardian about the future of Humans and how AI and bionics can create transhumans.
Year(s) Of Engagement Activity 2018
URL https://www.theguardian.com/technology/2018/may/06/no-death-and-an-enhanced-life-is-the-future-trans...