A Translational Alliance between Newcastle University and Ossur

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.

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 to help 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.