Optimal alignment of ankle foot orthoses in cerebral palsy

Cerebral Palsy (CP) is the most common serious physical disability in childhood. It is caused by neurological insult to a developing brain, affecting 2-3 per 1000 live births, making it 20 times more common than childhood arthritis, and 500 times more common than childhood leukaemia. According to the Department of Health National Service Framework for Long Term Conditions (2005) the prevalence of CP is 186 per 100,000 cases of population, higher than the prevalence of multiple sclerosis (120/100,000) and spinal cord injury (50/100,000), and like that of Parkinson's (200/100,000). Incidence rates of CP have remained stable over several decades in the western world. Although the initial brain lesion is permanent and unchanging, progressive musculoskeletal deformity develops during growth. This deformity causes progressive severe disability, with a profound impact at a societal level and high economic burden. In the US the direct annual lifetime cost per child in 2003 was $921,000 and the indirect costs 2-5 times higher in Europe with a direct cost exceeding 800,00 euros in 2009. Children affected with CP frequently receive orthopaedic surgery with the intent to improve functional outcomes and minimise functional decline. Diplegia is the form of CP that involves predominantly the legs and restricts the ability to walk. In the most severe cases a child would be unable to walk, and in less severe cases their ability would be significantly restricted and often require the use of orthotics and walking aids to achieve any reasonable function. Ankle Foot Orthoses (AFO's) are common orthotic treatments in a variety of neurological disorders (e.g., cerebral palsy, stroke and multiple sclerosis) and are generally fitted to restrict or allow specific motion to occur at joints. The usual care pathways for the prescription of these orthoses would be an evaluation by an orthotist (majority with no technological input) to prescribe the most relevant angle (90 degrees, plantarflexed, dorsiflexed) for the individual. Previously, literature has shown that ankle foot orthoses have beneficial effects on the child in several ways (clinically, biomechanically, physiologically). However, there is an opinion that children should have optimal alignment of their AFO's to encourage typical walking and to challenge the musculoskeletal system. This may allow a stretch of a muscle to occur which would aid the range of motion at a particular joint and reduce the risk of contractures which are a major issue in cerebral palsy. There are anecdotal information in the grey literature which give some evidence but rigorous peer-reviewed evidence is needed. This piece of research would link directly with the Alignment clinic that is running out of the University alongside London Orthotic Consultancy and with Elaine Owen in particular. As part of this clinic, a proposed KTP is being developed which would aim to alter the clinical practices and audit trail within the company and this PhD would further benefit the whole project going forward.

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.