Evaluating the use of a novel low-cost measurement insole to characterise plantar foot strain during gait loading regimes

Introduction: Under plantar loading regimes, it is accepted that both pressure and shear strain biomechanically contribute to formation and deterioration of diabetic foot ulceration (DFU). Plantar foot strain characteristics in the at-risk diabetic foot are little researched due to lack of measurement devices. Plantar pressure comparatively, is widely quantified and used in the characterisation of diabetic foot ulceration risk, with a range of clinically implemented pressure measurement devices on the market. With the development of novel strain quantification methods in its infancy, feasibility testing and validation of these measurement devices for use is required. Initial studies centre on normal walking speed, reflecting common activities of daily living, but evaluating response to differing gait loading regimes is needed to support the use of such technologies for potential clinical translation. This study evaluates the effects of speed and inclination on stance time, strain location and strain response using a low-cost novel strain measurement insole.Methods: The STrain Analysis and Mapping of the Plantar Aspect (STAMPS) insole has been developed, and feasibility tested under self-selected normal walking speeds to characterise plantar foot strain, with testing beyond this limited regime required. A treadmill was implemented to standardise speed and inclination for a range of daily plantar loading conditions. A small cohort, comprising of five non-diabetic participants, were examined at slow (0.75 m/s), normal (1.25 m/s) and brisk (2 m/s) walking speeds and normal speed at inclination (10% gradient).Results: Plantar strain active regions were seen to increase with increasing speed across all participants. With inclination, it was seen that strain active regions reduce in the hindfoot and show a tendency to forefoot with discretionary changes to strain seen. Stance time decreases with increasing speed, as expected, with reduced stance time with inclination.Discussion: Comparison of the strain response and stance time should be considered when evaluating foot biomechanics in diabetic populations to assess strain time interval effects. This study supports the evaluation of the STAMPS insole to successfully track strain changes under differing plantar loading conditions and warrants further investigation of healthy and diabetic cohorts to assess the implications for use as a risk assessment tool for DFU

Child-led, Creative Exploration of Paediatric Incontinence

This paper describes a novel collaboration between a health science initiative, a MedTech Co-operative and a university design research department alongside a group of children with incontinence, their parents and siblings. This collaboration hoped to inform the development of technological interventions specifically aimed at supporting paediatric incontinence. Together, we used a range of bespoke tools to creatively and collaboratively explore questions of ‘What are your main challenges? How do you currently address them? And how would you like to address them in the future?’ These tools aimed to place the children as the experts in the rooms, reflecting on their wider life (i.e. their hobbies, friends, family) and took an asset-based approach to highlight the skills and resources they already leverage to address their personal challenges. Later, ideation activities were used to empower the families as inventors to highlight and address any unmet health needs. Central to each of the activities was the aim to reframe a traditionally ‘taboo’ topic as something that is safe, and even fun, to explore through creative means. This study concludes that by using context-specific, sensitive and creative tools, children from a range of ages can (and should) be included in setting the agenda for future healthcare technology development, even in topics that are traditionally difficult to discuss

Drawing on new ideas (and paper) to better understand kids’ toileting needs

This talk presented the findings of 'Toilet Talk' - a collaboration between IMPRESS (Incontinence Management & PRevention through Engineering and ScienceS) and Devices for Dignity (both National Institute for Health Research Healthcare Technology Co-operatives), alongside a group of children with incontinence, their parents and siblings. This collaboration hoped to inform the development of technological interventions specifically aimed at supporting paediatric incontinence. Together, we used a range of bespoke tools to creatively and collaboratively explore questions of ‘What are your main challenges? How do you currently address them? And how would you like to address them in the future?’ These tools aimed to place the children as the experts in the rooms, reflecting on their wider life (i.e. their hobbies, friends, family) and took an asset-based approach to highlight the skills and resources they already leverage to address their personal challenges. Later, ideation activities were used to empower the families as inventors to highlight and address any unmet health needs. Central to each of the activities was the aim to reframe a traditionally ‘taboo’ topic as something that is safe, and even fun, to explore through creative means. This study concludes that by using context-specific, sensitive and creative tools, children from a range of ages can (and should) be included in setting the agenda for future healthcare technology development, even in topics that are traditionally difficult to discuss

Mechanical characteristics of diabetic and non-diabetic plantar skin

Diabetic foot ulceration is linked to high amputation and mortality rates, with the substantial associated annual spend on the at-risk diabetic foot reflecting the intensive time and labour involved in treatment. Assessing plantar interactions and developing improved understanding of the formation pathways of diabetic ulceration is important to orthotic interventions and patient outcomes. Plantar skin surrogates which emulate the mechanical and tribological characteristics can help improve physical models of ulceration, reduce reliance on cadaveric use and inform more complex computational modelling approaches. The information available from existing studies to characterise plantar skin is limited, typically featuring ex-vivo representations of skin and subcutaneous tissue combined and given focus to shear studies with time dependency. The aim of this study is to improve understanding of plantar tissue mechanics by assessing the mechanical characteristics of plantar skin in two groups; (1) non-diabetic and (2) diabetic donors without the subcutaneous tissue attachment of previous work in this field. Digital image correlation was used to assess inherent skin pre-tension of the plantar rearfoot prior to dissection. Young’s modulus, storage and loss moduli were tested for using tensile stress–strain failure analysis and tensile and compressive dynamic mechanical analysis, which was conducted on excised plantar rearfoot donor specimens for both disease state cohorts at frequencies reflecting those achieved in activities of daily living. Plantar skin thickness for donor specimens were comparable to values obtained using ultrasound acquired in vivo values. Median tensile storage and loss moduli, along with Young’s modulus, was higher in the diabetic cohort. With a mean Young’s modulus of 0.83 ± 0.49 MPa and 1.33 ± 0.43 MPa for non-diabetic and diabetic specimens respectively. Compressive studies showed consistency between cohorts for median storage and loss moduli. The outcomes from this study show mechanical characteristics of plantar skin without the involvement of subcuteanous tissues under reflective daily achieved loading regimes, showing differences in the non-diabetic and diabetic specimens trialled to support improved understanding of plantar tissue response under tribological interactions

Translating healthcare innovation from academia to industry

Innovation lies at the heart of academia, and universities generate high-quality, intellectual property on a large scale. However, commercial translation of this intellectual property has traditionally been poor, particularly in the critical healthcare sector. It is critical that this situation is addressed to ensure that innovation from research institutes can fulfil its potential and progress to have a genuine impact on the outside world. In this article, we consider the nature of healthcare innovation in academia and ways in which commercial translation of intellectual property can be successfully realised. This is first analysed from an academic perspective, with a particular focus on how academic motivations and work practices can shape successful translation. We then switch perspective to examine the same process from an industry perspective, looking at the characteristics and expectations involved in the innovation life cycle. To place these analyses in context, we present a case study examining a project being undertaken to commercialise a novel surgical instrument, the intra-abdominal platform, from identification of clinical need, through the development life cycle, to commercialisation of the system. We reflect on the successes and challenges encountered during the intra-abdominal platform project, the broader lessons learned and in conclusion use these to emphasise how academia can adopt practices to better translate intellectual property in the future

A cross sectional pilot study utilising STrain Analysis and Mapping of the Plantar Surface (STAMPS) to measure plantar load characteristics within a healthy population

BackgroundNo in-shoe systems, measuring both components of plantar load (plantar pressure and shear stress) are available for use in patients with diabetes. The STAMPS (STrain Analysis and Mapping of the Plantar Surface) system utilises digital image correlation (DIC) to determine the strain sustained by a deformable insole, providing a more complete understanding of plantar shear load at the foot-surface interface.Research questionsWhat is the normal range and pattern of strain at the foot-surface interface within a healthy population as measured by the STAMPS system? Is STAMPS a valid tool to measure the effects of plantar load?MethodsA cross-sectional study of healthy participants was undertaken. Healthy adults without foot pathology or diabetes were included. Participants walked 20 steps with the STAMPS insole in a standardised shoe. Participants also walked 10 m with the Novel Pedar® plantar pressure measurement insole within the standardised shoe. Both measurements were repeated three times. Outcomes of interest were global and regional values for peak resultant strain (SMAG) and peak plantar pressure (PPP).ResultsIn 18 participants, median peak SMAG and PPP were 35.01 % and 410.6kPa respectively. The regions of the hallux and heel sustained the highest SMAG (29.31 % (IQR 24.56–31.39) and 20.50 % (IQR 15.59–24.12) respectively) and PPP (344.8kPa (IQR 268.3 – 452.5) and 279.3kPa (IQR 231.3–302.1) respectively). SMAG was moderately correlated with PPP (r= 0.65, p < 0.001). Peak SMAG was located at the hallux in 55.6 % of participants, at the 1st metatarsal head (MTH) in 16.7 %, the heel in 16.7 %, toes 3–5 in 11.1 % and the MTH2 in 5.6 %.SignificanceThe results demonstrate the STAMPS system is a valid tool to measure plantar strain. Further studies are required to investigate the effects of elevated strain and the relationship with diabetic foot ulcer formation

Laparoscopic motor learning and workspace exploration

Background: Laparoscopic surgery requires operators to learn novel complex movement patterns. However, our understanding of how best to train surgeons’ motor skills is inadequate and research is needed to determine optimal laparoscopic training regimes. This difficulty is confounded by variables inherent in surgical practice – e.g. the increasing prevalence of morbidly obese patients presents additional challenges related to restriction of movement due to abdominal wall resistance and reduced intra-abdominal space. The aim of this study was to assess learning of a surgery related task in constrained and unconstrained conditions using a novel system linking a commercially available robotic arm with specialised software creating the novel kinematic assessment tool (Omni-KAT). Methods: We created an experimental tool that records motor performance by linking a commercially available robotic arm with specialised software that presents visual stimuli and objectively measures movement outcome (kinematics). Participants were given the task of generating aiming movements along a horizontal plane to move a visual cursor on a vertical screen. One group received training that constrained movements to the correct plane whilst the other group was unconstrained and could explore the entire ‘action space’. Results: The tool successfully generated the requisite force fields and precisely recorded the aiming movements. Consistent with predictions from structural learning theory, the unconstrained group produced better performance after training as indexed by movement duration (p < .05). Conclusion: The data showed improved performance for participants who explored the entire action space, highlighting the importance of learning the full dynamics of laparoscopic instruments. These findings, alongside the development of the Omni-KAT, open up exciting prospects for better understanding of the learning processes behind surgical training and investigating ways in which learning can be optimised

Design Methodology for Magnetic Field-Based Soft Tri-Axis Tactile Sensors

Tactile sensors are essential if robots are to safely interact with the external world and to dexterously manipulate objects. Current tactile sensors have limitations restricting their use, notably being too fragile or having limited performance. Magnetic field-based soft tactile sensors offer a potential improvement, being durable, low cost, accurate and high bandwidth, but they are relatively undeveloped because of the complexities involved in design and calibration. This paper presents a general design methodology for magnetic field-based three-axis soft tactile sensors, enabling researchers to easily develop specific tactile sensors for a variety of applications. All aspects (design, fabrication, calibration and evaluation) of the development of tri-axis soft tactile sensors are presented and discussed. A moving least square approach is used to decouple and convert the magnetic field signal to force output to eliminate non-linearity and cross-talk effects. A case study of a tactile sensor prototype, MagOne, was developed. This achieved a resolution of 1.42 mN in normal force measurement (0.71 mN in shear force), good output repeatability and has a maximum hysteresis error of 3.4%. These results outperform comparable sensors reported previously, highlighting the efficacy of our methodology for sensor design

No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework

Objective: The Global IDEAL Sub-Framework Study aimed to combine the intended effects of the 2009/2019 IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework recommendations on evaluating surgical innovation with the vision outlined by the 2015 Lancet Commission on Global Surgery to provide recommendations for evaluating surgical innovation in low-resource environments. Design: A mixture of methods including an online global survey and semistructured interviews (SSIs). Quantitative data were summarized with descriptive statistics and qualitative data were analyzed using the Framework Method. Participants: Surgeons and surgical researchers from any country. Main outcome measures: Findings were used to suggest the nature of adaptations to the IDEAL Framework to address the particular problems of evaluation in low-resource settings. Results: The online survey yielded 66 responses representing experience from 40 countries, and nine individual SSIs were conducted. Most respondents (n=49; 74.2%) had experience evaluating surgical technologies across a range of life cycle stages. Innovation was most frequently adopted based on colleague recommendation or clinical evaluation in other countries. Four themes emerged, centered around: frugal innovation in technological development; evaluating the same technology/innovation in different contexts; additional methodologies important in evaluation of surgical innovation in low/middle-income countries; and support for low-income country researchers along the evaluation pathway. Conclusions: The Global IDEAL Sub-Framework provides suggestions for modified IDEAL recommendations aimed at dealing with the special problems found in this setting. These will require validation in a stakeholder consensus forum, and qualitative assessment in pilot studies. From assisting researchers with identification of the correct evaluation stage, to providing context-specific recommendations relevant to the whole evaluation pathway, this process will aim to develop a comprehensive and applicable set of guidance that will benefit surgical innovation and patients globally

Variational Exploration Module VEM: A Cloud-Native Optimization and Validation Tool for Geospatial Modeling and AI Workflows

Geospatial observations combined with computational models have become key to understanding the physical systems of our environment and enable the design of best practices to reduce societal harm. Cloud-based deployments help to scale up these modeling and AI workflows. Yet, for practitioners to make robust conclusions, model tuning and testing is crucial, a resource intensive process which involves the variation of model input variables. We have developed the Variational Exploration Module which facilitates the optimization and validation of modeling workflows deployed in the cloud by orchestrating workflow executions and using Bayesian and machine learning-based methods to analyze model behavior. User configurations allow the combination of diverse sampling strategies in multi-agent environments. The flexibility and robustness of the model-agnostic module is demonstrated using real-world applications.Comment: Submitted to IAAI 2024: Deployed Innovative Tools for Enabling AI Application