A Step Change in LMIC Prosthetics Provision through Computer Aided Design, Actimetry and Database Technologies

Lead Research Organisation: University of Southampton
Department Name: Faculty of Engineering & the Environment

Abstract

Approximately 100M people worldwide need prosthetic and orthotic (P&O) devices [1]. Low-cost, robust devices are only half the story; an estimated 80-90% do not have access to P&O services "due to a shortage of personnel, service units and health rehabilitation infrastructures" [2]. All three barriers could be addressed by data, so we propose research into novel tools to enhance P&O data.

Access is particularly poor for people in Lower and Middle Income Countries (LMICs) such as Cambodia with its landmine legacy, who are typically young and live longer lives of more physical work than in the developed world, for whom most prosthetics technology has been developed. LMICs have higher levels traumatic amputation from accidents, conflict and landmine injuries, and humanitarian crises present particular access challenges [3]. Services are set up primarily for trauma injuries but by 2035 it is estimate diabetes may affect over 500M people, and is growing fastest in LMICs [4].

Through the International Society for Prosthetics and Orthotics (ISPO), substantial improvements have been made in P&O design and training for LMICs [2,5]. An overwhelming patient:clinician ratio remains and "the development of the sector is too slow ... to meet existing needs or keep pace with the growing populations of people with disabilities" [2]. Even with ISPO accredited training, in South East Asian LMICs it is estimated that three times the current number of clinician is required for the current amputee population [6].

We will conduct two data-technology research studies, to develop tools to improve P&O service access, train clinicians and improve efficiency of service funding use. With a team of expert clinicians, academics and policy makers in Cambodia, we will investigate:
1) digital measurement tools to assess a user's residual limb anatomy, biomechanics of gait, typical daily prosthetic limb use, and health status; and
2) the architecture for a portable digital patient casenote system: a robust and secure IT network for travelling prosthetists to visit provincial areas to provide evidence-based treatment for those in remote communities who cannot afford to travel.

Beside these scientific challenges, the context makes this work highly ambitious. Experience shows that care must be taken in applying P&O from Western countries directly in LMICs. As well as users' different needs, their relationship with clinicians and prosthetics are different for complex cultural, social and environmental reasons. We frame our scientific research using a first-of-kind ethnographic study of P&O service providers and users to ensure the developed technologies are practical. We will also conduct business modelling research, producing tools to ensure the technologies are cost effective and can be implemented sustainably.

These technologies have the potential to transform the quality of life of prosthetic limb users worldwide and are required today. A more portable P&O service would enable people to access provision, fitting, adjustment and repair of their prosthetics with reduced time off work - essential where an agricultural worker spends their day's earnings on the same day's food. Prosthetists would access and update casenotes for their patients, provide a repository for clinician training, and enable users to access information regarding their progress and report problems to obtain critical treatment.

Longer term the project results will enable a valuable database to become established. The data will enable selection of technology that delivers greatest quality of life benefit, making best use of limited budgets [7]. It will support academics and trainee healthcare providers in research and education. We have a network of Asia's most influential clinicians, educators and policymakers to help achieve these ambitious benefits. Finally, the research will return benefits to the UK - we do not yet have a unified P&O digital record system and database.

Planned Impact

Direct beneficiaries during the project will include Cambodian healthcare providers in P&O services in 3 of the 11 national clinics, and their service users. Following project completion, our partners propose trialling the application of the research results, initially in their clinics' new lower limb amputee clients, which typically number 500-600/yr. In the project's implementation plan we will also engage the other 3 NGOs which manage the other 8 Cambodian clinics and make the technologies available nationwide. We will hold stakeholder engagement events in Asia and the UK to encourage the community to take up the results of the project. Our partners from Exceed and CSPO, and our network including people of influence at the International Society for Prosthetics and Orthotics (ISPO) the World Health Organisation (WHO), the Commonweath Medical Association and the Asian e-Health Information Network have the influence to drive adoption across South-East Asia, Africa and the Pacific.

For these service users, we envisage that the cost of service access will be reduced, and quality of life should thus be improved, as long waiting times for prosthesis repair or replacement will reduce, limiting time away from work. This will enable individuals retain the ability to support their families and contribute to society.

Secondary benefits will be substantial service improvements, enabled by databases built on our research's foundations. The data will enable selection of appropriate technologies, to make the best use of limited service budgets. It will support national service managers in making the case for sustained funding by showing the quality of life improvement they deliver. It will support capacity building by representing a valuable research resource for academics and trainee healthcare providers, raising their international profile and enabling a formalised analytical approach to pursuing their own service improvement. We have built the relationships for this translation into our work plan, through supporting student projects at CSPO and NISA.

As well as providing a data infrastructure for healthcare providers to access and collect clinical data in communities, the project's deliverables would be able to disseminate educational material to the communities. Within the project this will include information regarding care of the residual limb (stump) tissues and prosthesis maintenance, for clients and their carers. Longer term, this would enable other healthcare advice (e.g. diabetic foot care) and Exceed's community service information (e.g. small business management courses) to be disseminated to a broader audience.

Finally, as a computer-based foundation, this will enable the effective uptake of further new technologies. One key example is a full CAD/CAM approach to prosthetic limb provision. Once the CAM prosthesis and orthosis fabrication technologies (CNC machining or additive manufacturing / 3D printing) become appropriate, the project's deliverables present the data infrastructure for them to be implemented. Patient records would be prepared for storage of paired .stl limb and prosthesis design data files, so that there is minimal disruption to the prosthesis fabrication workflow. This would show particular benefits for the described Travelling Prosthetist Service, as with full CAD/CAM processes, once established and trained in prosthetic use, some clients would need never leave their community.
 
Description This project is now underway, and we have made progress on foundation research into the needs and use-cases for data technologies to enhance access to prosthetics & orthotics (P&O) services in lower & middle income countries (LMICs).
We have developed a flexible toolbox of qualitative research methods and approaches to train colleagues in Cambodia to assess user needs of these healthcare technologies, tailored to specific social and cultural issues of clinicians, P&O users and their families, in Cambodia.
We have undertaken benchmarking research for one particular set of data technologies (3D scanners) in Cambodian clinic environments, and mapped the architecture for a synchronisation process for electronic healthcare records (EHCR) whereby such data might be collected offline, in remote community settings.

Leveraging our research and partnerships with the Cambodian School of Prosthetics & Orthotics and Imperial College, we have also addressed capacity building in-country. We have provided workshops to trainee clinicians from LMICs around the world in research methodologies, introduction to biomechanical modelling, and how to publish their student projects at conferences. This included twenty one delegates from ODA countries including Cambodia, Vietnam, Lao, and from Africa and Oceania.
Exploitation Route This project is still a work-in-progress. However, we have embedded plans for sharing our results for others' use. Currently:
- we are making as much of our technical development work as possible available Open Access and Open Source, including first of all our 'AmpScan' computer code, which allows P&O clinicians and researchers to extract high resolution measurements of prosthetics users' residual limbs, from 3D scans.
- we are developing a process for providing access to these tools to allow others to co-design research with their LMIC partners, and ensure that it is fit for purpose.
Sectors Digital/Communication/Information Technologies (including Software),Education,Healthcare

 
Description People Powered Prosthetics: prosthetic innovation driven by user needs (HEFCE Higher Education Innovation Fund, University of Southampton Institute for Life Sciences)
Amount £7,908 (GBP)
Organisation Higher Education Innovation Funding (HEIF) 
Sector Public
Country United Kingdom
Start 03/2019 
End 07/2019
 
Description University of Salford 
Organisation University of Salford
Department School of Health Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution We run a key Work Package on this project together, investigating " Biomechanical, Anatomic and Prosthesis Analysis Metrics for LMIC Environments (Biomedical Engineering Fundamentals)". With colleagues at Salford, we are co-supervising a postdoctoral researcher who is developing data collection protocols for physical activity assessment of people using prosthetic limbs in community-based settings, and has conducted proof-of-principle tests with candidate technologies (actimeters and accelerometers) in Cambodia with our ODA partners at CSPO.
Collaborator Contribution We run a key Work Package on this project together, investigating " Biomechanical, Anatomic and Prosthesis Analysis Metrics for LMIC Environments (Biomedical Engineering Fundamentals)". Our partners bring in particular expertise in physical activity assessment using actimeter devices, and have hosted and cosupervised the researcher for the first 9 months of their project work. Whilst the present project focuses on lower limb devices, we are working towards a joint publication including correspondence with partner project EP/R013985/1 (Fit-for-purpose, affordable body-powered prostheses) where the same technologies will be applied to upper limb devices.
Impact Draft literature review and candidate actimeter technology review documents. Work in progress.
Start Year 2018
 
Title AmpScan: Open-source 3D scan shape analysis for prosthetics and orthotics 
Description AmpScan is an open-source Python package for analysis and visualisation of digitised surface scan data, specifically for applications within Prosthetics and Orthotics (P&O), with an aim to improve evidence-based clinical practice towards improved patient outcomes. The P&O industry is increasingly using surface scanners as part of clinical practice to capture patients' individual anatomic geometry, and design personalised devices. AmpScan gives clinicians access to powerful tools to enhance their records and the evidence-base behind their practice. It gives researchers the capability to analyse data in a robust manner, and the project's open-source distribution enables the community to contribute to the tool's development, for example towards a mutually agreed standards of metrics and results presentation. 
Type Of Technology Software 
Year Produced 2018 
Open Source License? Yes  
Impact Released recently; shared with research students at three universities, and shortly to be publicised more widely at the International Society of Prosthetics and Orthotics (ISPO) World Congress 2019, Kobe, Japan. Used by one developing researcher (J Steer) to support his doctoral studies, completed in February 2019. 
URL https://readthedocs.org/projects/ampscan/
 
Description #handson: Prosthetics and People (New Forest Show 2018) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact >150 people visited our tent at the New Forest Show, hosted by Wessex Medical Research / Institute for Life Sciences, where we held the interactive 'Prosthetics and People' activity. This set out to communicate the issues involved in designing prosthetics which are fit for particular users, capturing what they really want, and the different kinds of people involved in providing prosthetic limbs from engineers and health scientists to clinicians. We pitched this in particular at school students, as part of a wider activity to address the engineering skills gap. We brought this to life with case studies from our Cambodian collaborators, and displayed their prosthetic devices. Activities included:
- 'Show and tell' (of existing devices)
- 'The kitchen challenge' (opening food containers and preparing plastic food against the clock - first with two, and then with one hand - and comparing times, to assess adaptive mechanisms and which containers are most accessible for people with hand impairments)
- 'The Wire Buzzer Challenge' (wire buzzer game, again against the clock - first playing the game as normal, and then using a thick glove as a 'constraint therapy' and then holding the handle using a prosthetic hand - and comparing times).
- 'Design your own hand' (drawing and describing key features of a prosthesis to fit the most important activity you do with your hands)
- 'Build your own hand' (a kit we produced, where visitors could make a working mechanical hand using a corrugated cardboard outline, string, straws and rubber bands).
Year(s) Of Engagement Activity 2017,2018
 
Description IMechE Portsmouth & Isle of Wight Area invited talk: 'Next Generation Prosthetics' 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact 24 practicing engineers, academics and interested members of the public attended this evening lecture held at University of Portsmouth for the Portsmouth & Isle of Wight area membership. This ended up as more of a two-way discussion than a presentation, and the audience from a variety of backgrounds reported particular interest in the multidisciplinary issues that drive this research area and the clinical challenges we are addressing.
Year(s) Of Engagement Activity 2018
 
Description Interview for regional news: BBC Radio Solent 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Interview on the Julian Clegg Breakfast Show of BBC Radio Solent, on Wednesday 2nd May, providing 'The Weather Report', where someone travelling to an interesting place tells Julian and his audience about the weather there, and about the purpose of their visit. I used this to report from our project launch visit to Cambodia, and to describe the aims of our project and team of collaborators.

- The presenter invited us back to report on the continued work we will be doing.
- The intended outcomes included stimulating the interest of the general public in our research, and changing attitudes to healthcare provision and research in Lower/Middle Income Countries.
- Level of coverage received: this station has estimated 266,000 listeners per week on all platforms (https://media.info/radio/stations/bbc-radio-solent/listening-figures).
Year(s) Of Engagement Activity 2018
 
Description Interview in StepForwards magazine: Ask the Expert. 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Patients, carers and/or patient groups
Results and Impact Ask the expert Interview in StepForwards magazine. Here we detailed the advances in prosthetic fitting and the aims and objectives of the global challenge research project. This was aimed at individuals with amputation and clinicians working in the sector.
Year(s) Of Engagement Activity 2019
 
Description Pint of Science 2018: "Engineering Replacement Limbs: a Global Challenge" 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact 60 peopole attended this evening talk in the popular 'Pint of Science' public engagement series, under the 'Tech Me Out' theme.
This included live demonstrations of 3D scanning and a discussion of the multidisciplinary interface between biomechanical engineering and social science which is so relevant to LMIC research, with our Cambodian collaborative partnership providing case studies.
Year(s) Of Engagement Activity 2015,2018
URL https://twitter.com/antodg16/status/996470302640082944
 
Description Reflections on GCRF Project Conception and Building Partnerships 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact My colleagues and I have presented our experience, process and ethos for developing meaningful ODA country partnerships for GCRF projects, to our peers and to early career researchers (ECRs).

Our talk was entitled "Where do you start? Reflections on GCRF Project Conception and Building Partnerships" presented by Dr Alex Dickinson, Dr Maggie Donovan-Hall, Dr Peter Worsley and Dr Cheryl Metcalf

This has been presented at the University of Southampton 'GCRF Showcase' 2019, and to an Institute for Life Sciences (IfLS) research networking audience in 2018.

In the 2019 iteration, we spoke to 116 attendees, including ECR delegates from ODA countries:
- 4 from Ghana
- 6 from Malawi
- 4 from Kenya
- 1 from Botswana
Year(s) Of Engagement Activity 2018,2019