Development of a high-performance, durable, low-cost, modular recycled Carbon fibre composite prosthetic foot system for Low/Middle income countries

BACKGROUND/NEED
The WHO estimates that amongst the disabled people living in LMIC's the need for prostheses will have risen to 30 million by 2011. To address rehabilitation issues a plethora of legislation has been produced. Despite this, varied levels of service provision exist in LMIC's. Entitlement of access to rehabilitation services is emphasised in legislation. However, in countries where the gross national income is low; rehabilitation services are rarely prioritised as primary health care understandably takes precedence. Conversely, as primary health care initiatives achieve success, greater demand is created for rehabilitation services as more disabled people survive infancy. Therefore, more research is required to ; a) assess current models of service provision in LMIC's. and b) to develop high performance and low cost engineering solutions that enable adequate prosthetic intervention.
RESEARCH OBJECTIVES
The aim of the project is to develop recycled carbon fibre based biomimetic prosthetic ankle-foot system which exhibits high-performance, durability, comfort as well as energy storage and release which is low cost and could potentially be fabricated in LMICs. This will involve a concerted effort in the key scientific areas of advanced composites, compliant active structures and components, full prosthetic system design and computational modelling, simulation, testing and validation, manufacturing to scale, as well as sustainable social enterprise development, functional outcome quantification, need assessment and prosthetic service provision in LMICs. All fundamental research components will be driven by the ultimate clinical and social needs and user centred design as identified, evaluated and quantified previously by a clinical team in collaboration with established partners in LMICs. These will address the needs of the core user groups who require rehabilitation and assistance to maintain independence of prosthetic users.
To realise a set of objectives are defined:
Determine the specific needs and perceptions of the target user groups for prosthetic feet systems.
Establish engineering specifications for the specific behaviour required for demanding environments to meet the identified needs of the target user group.
Design and develop targeted functional compliant materials to enable dynamic capability of high-performance prosthetic feet.
Develop product design specifications for the prosthetic foot, based on user engagement and feedback.
Design, fabricate and test a set of NFC components. This includes feet and adapters to connect the feet to the other prosthetic components i.e. the knee for trans femoral prosthesis and socket for below the knee prosthesis.
Evaluate prototype feet in the real world. i.e. UK, India, Rwanda and Malawi.
PROGRAMME AND METHODOLOGY
The work programme consists of eight interlinked work packages (P1-P6) which address, from the bottom up, the developmental pipeline from composite research and computational modelling to complete prototype prosthetic ankle-foot system and clinical validation.
P1.Need assessment and perceptions of the target user groups
P2.Mechanical characterisation of the identified natural fibre composites.
P3. Design and optimisation of the high-performance components.
P4. Mechanical testing
P5. Field trials
P6.Recommended pathways for production at scale.

Impact:
The direct beneficiaries of this work's outcomes are persons with a below the knee amputation.
In addition, a knowledge base in relation to advanced composites and computational modelling data base will be created benefiting, academia and industry.

The CDT students will help create solutions for amputees and people with debilitating conditions such as stroke and diabetes, reducing mortality and enabling them to live more satisfying, productive and fulfilling lives. These solutions, co-created with industry and people living with disabilities, will have direct economic and societal benefits. The principal beneficiaries are industry, P&O service delivery, people who need P&O devices, and society in general.
Industry
The novel methods, devices and processes co-created with users and industry will have a direct economic value to our industry partners (by the creation of IP, new products, and improved industry and academic links). Our CDT graduates will be the natural potential employees of our industry partners and for companies in the wider healthcare technology sector. This will help address the identified critical skills need and shortage leading to improvement in the UK's competitiveness in this rapidly developing and growing global market. The CDT outcomes will help UK businesses spread risk (because new developments are well founded) and more confidently enter new markets with highly skilled employees (CDT graduates).

P&O service delivery
Doctoral engineering graduates with clinical knowledge are needed to improve the deployment of advanced technologies in practice. Our main UK industry partner, Blatchford, stated: "As technology develops it will become easier for the end-user (the patient), but the providers (the clinicians) are going to need to have a higher level of engineering training, ideally to PhD level". The British Association of Prosthetists and Orthotists estimates that no more than ten practising P&O clinicians have a PhD in the UK. Long-term P&O clinical academic leadership will be substantially improved by the CDT supporting a select number of clinically qualified P&O professionals to gain doctorates.

Users
The innovation of devices, use of device and patient monitoring, and innovation approaches in LMIC should not only lead to improved care but also lower healthcare costs. Diabetes UK estimates that the total healthcare expenditure related to foot ulceration and amputation in diabetes was £1billion (2014-15), with 2/3 of this related to foot ulceration. Small innovations could lead to large cost savings if targeted at the right aspects of care (e.g. earlier adoption, and reducing device abandonment).
An ability to work is fundamental to a person's place in society and their sense of purpose and has a significant societal impact in all territories. This is perhaps greatest in LMIC where attitudes towards disability may still be maturing, and appropriate social care infrastructure is not always in place. In these cases, an ability to work is essential for survival.
Improved design approaches will impact on all users regardless of context, since the device solutions will better match local and individual user needs. Addressing issues related to prosthetic/orthotic device abandonment (e.g. cosmesis) and improved adherence should also lead to greater social participation. Improved device solutions will shift focus from what users "cannot do" to what they now "can do", and help progress attitudes towards acceptance of disability.
Societal
The majority of the global P&O users are of working age, and a key economic impact will be keeping users in work. The average age at amputation due to diabetes is just 52 in the USA but much younger in countries with less well-developed health care and trauma services (e.g. 38 in Iran). Diabetes UK reports that 35-50% of people are of working age at diagnosis and that there are around 70,000 foot ulcers in the UK, precursors to amputation. There is a similar concern for stroke survivors around a quarter of whom are of working age and are 2-3 times more likely to be out of work after eight years.