Christopher James Nester

Introduction: Traditionally, orthosis manufacturing is time and labor-intensive. Digitalization of some of the fabrication process is already ubiquitous, yet extension across device types could reduce the burden of manual labor and advance automation to help unblock access to assistive technologies globally. It seems, however, that appropriately strong evidence is holding this back. This review looks to thoroughly examine the current state of evidence to make this clear. Objectives: To identify gaps in the literature that create barriers to decision-making on either appropriate uptake by clinical teams or setting research directions, by identifying what forms of evidence the current research literature provides to the orthotics community. Study design: Scoping literature review. Methods: A comprehensive search was completed in the following databases: AMED, MEDLINE, EMBASE, Global Health Archive, CINAHL Plus, Cochrane Library, Web of Science, ACM, IEEE, and Engineering Village, resulting in 3487 articles to be screened. Results: After screening, 121 lower limb orthosis, 104 upper limb orthosis, and 30 spinal orthosis articles were included in this review. For some areas such as CAD/CAM-produced insoles and spinal orthoses, the evidence base is strong. For most additive manufacture articles, long-term, larger-scale studies as well as research into training requirements are lacking. Conclusion: The advantages of digital fabrication technology that could streamline orthotic device production in many cases are still blocked by a lack of strong formal evidence, ie large longitudinal studies with a range of evaluation measures. Increased collaboration between clinicians, patient/service users, academia, and industry could be a route to addressing these gaps and creating a better pathway to market for new technologies.

Pressure coupled with shear stresses are the critical external factors for diabetic foot ulceration assessment and prevention. To date, a wearable system capable of measuring in-shoe multi-directional stresses for out-of-lab analysis has been elusive. The lack of an insole system capable of measuring plantar pressure and shear hinders the development of an effective foot ulcer prevention solution that could be potentially used in a daily living environment. This study reports the development of a first-of-its-kind sensorised insole system and its evaluation in laboratory settings and on human participants, indicating its potential as a wearable technology to be used in real-world applications. Laboratory evaluation revealed that the linearity error and accuracy error of the sensorised insole system were up to 3% and 5%, respectively. When evaluated on a healthy participant, change in footwear resulted in approximately 20%, 75% and 82% change in pressure, medial–lateral and anterior–posterior shear stress, respectively. When evaluated on diabetic participants, no notable difference in peak plantar pressure, as a result of wearing the sensorised insole, was measured. The preliminary results showed that the performance of the sensorised insole system is comparable to previously reported research devices. The system has adequate sensitivity to assist footwear assessment relevant to foot ulcer prevention and is safe to use for people with diabetes. The reported insole system presents the potential to help assess diabetic foot ulceration risk in a daily living environment underpinned by wearable pressure and shear sensing technologies.

Altering plantar load using foot orthoses (FOs) may alter the mechanical work required of internal structures and change the size of muscle and connective tissues. Skin sensitivity might also change as a result of altering mechanoreceptor stimulation. This study investigated the effects of FOs on foot soft tissue morphology and skin sensitivity over three months of use. Forty-one healthy participants wore prefabricated FOs (n = 23) or no insert (n = 18) for three months. The FOs were prescribed specific to each participant, using criteria of a change in peak pressure of 8% in the medial arch (pressure increase) and medial heel (pressure decrease). Ultrasound images were recorded pre- and post-FOs use to derive cross-sectional area and thickness of: abductor hallucis, flexor hallucis brevis, flexor digitorum brevis and the Achilles tendon at the insertion and mid-portion. Plantar fascia thickness was measured at the insertion and midfoot. The minimal detectable difference was established in piloting (n = 7). Skin sensitivity was measured with monofilaments at the dorsum (between the hallux and second toe), medial and lateral heel, medial and lateral arch and the 1st metatarsal head. The FOs increased peak pressure by 15% in the medial arch and reduced it by 21% in the medial heel. None of the changes in soft tissue measurements was greater than the minimal detectable difference and there were no effects of group and time. Skin sensitivity decreased over time at the 1st metatarsal head for both groups, but there was no group effect. Using FOs over three months did not change the foot tissues nor skin sensitivity. This study challenges the notion that FOs make muscles smaller.

Postural control impairments following a stroke have an impact on mobility, reduce independence, and increase the risk of falls. Assessing these impairments during tasks representative of real-life...

Background: A small minority of countries around the globe have podiatry as a recognized profession, hence, there are considerable differences among these countries when it comes to the curricula, the duration of training and legislation regulating the profession. The growth in research led evidence based practice, and the emerging digital landscape of health care practice, occur alongside trends in disease and health behaviours that strongly impact on foot health. As such, the changing complex role of the podiatrist requires critical reflection on current frameworks of practice and whether they are fit for purpose. This commentary presents a conceptual framework which sets the scene for further development of concepts in a podiatry context, reflecting contemporary health care beliefs and the changing expectations of health care and society.The proposed conceptual framework for podiatry practice utilizes the metaphor of an electronic circuit to reflect the vast and complex interconnections between factors that affect practice and professional behaviours. The framework helps in portraying and defining drivers of practice, actual practice as well potential barriers for current and future practice.The circuit emphasis the interconnectedness/interaction of three clusters: 1) internal factors, 2) interaction factors, 3) external factors.Conclusion: Whatever promise this new framework holds, it will only be realised through conscious development of community consensus, respectful dialogue, constructive critical appraisal, and maintaining passion and focus on improving the health of people with foot related problems.

Background and Objective: Ninety percent of patients with rheumatoid arthritis (RA) feel foot pain during the disease process. Pharmacological treatment of RA has a systematic effect on the body and includes: Nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs (DMARDs) and biologics. The objective of our review was to examine the impact of biologics on patients with RA ‘foot. Methods and Material: A systematic review of randomized control trials and observational studies that evaluated the efficacy of biologics against other pharmacological treatment, and included a foot outcome measure. The search covered MEDLINE Ovid, Pubmed, CINAHL, Cochrane Library, Evidence Search, and Web of Science. Risk of bias was evaluated using Cochrane guidance and the Newcastle Ottawa Scale adapted version. Results: A total of eight studies fully met the inclusion criteria: Three randomized control trials, and five observational studies were the basis of our review. A total sample of 1856 RA patients with RA treatment participated. The use of biologics was not associated as a risk factor for post-operative surgical site infection or delayed wound healing. The benefits of biologics, in terms of the disease evolution, were assessed using X-ray. Conclusion: Evidence suggests that the use of biologics is not a risk factor for post-operative surgical site infection or delayed wound healing. The use of biologics presents benefits in terms of the disease evolution assessed through X-ray.

The aim was to identify conservative treatments available for acute ankle sprain and to evaluate their effectiveness with respect to pain relief and short-term recovery of functional capacity. A systematic review of the relevant literature was conducted via a data search of the PROSPERO, PubMed, Scopus, CINAHL, PyscINFO and SPORTDiscus databases, from inception until December 2019, focusing on randomised control trial studies. Two of the authors independently assessed the quality of each study located and extracted the relevant data. The quality of each paper was assessed using the Cochrane risk of bias tool included in RevMan 5. In all, 20 studies met the inclusion criteria. In terms of absence of bias, only nine papers were classed as “high quality”. Studies (75%) were of low quality in terms of the blinding of participants and personnel and uncertainty in blinding of outcome assessment and all presented one or more other forms of bias. Despite the generally low quality of the studies considered, it can be concluded that conservative treatment for acute ankle sprain normally achieves pain relief and rapidly improved functionality. Research based on higher-quality study designs and procedures would enable more definitive conclusions to be drawn.

Background: Appropriate footwear is important for those who stand for prolonged periods of time at work, enabling them to remain comfortable, healthy and safe. Preferences for different footwear cushioning or hardness are often person specific and one shoe or insole will not be the choice for all. The aim of this study was to develop a range of insole options to maintain comfort during long periods of standing at work and test insole material preferences in the workplace.Methods: The study consisted of two parts. Part one evaluated 9 insoles of the same geometry that varied in hardness under 2 different plantar regions (n = 34). Insole preference, plantar pressure and selected anthropometric foot measures were taken. Three insole designs based on the most preferred options were identified from this part.In part two, these three insoles were evaluated with 22 workers immediately after trying them on (1 min) and after a working day. Foot anthropometric measures and subjective questions concerning material hardness preferences and self‐reported foot characteristics were used to investigate whether either had a relationship with insole preference.Results: Part one found insole preference predominantly varied according to material hardness under the medial arch rather than the heel/forefoot. Softer material under the heel and forefoot was associated with a reduction in peak pressures in these regions (p < 0.05). The most preferred insole had lower pressures under the hallux and first metatarsal phalangeal joint, and greater pressures and contact area under the medial midfoot (p < 0.05) compared to the least preferred insole. Height and foot anthropometrics were related to insole preference.In part two, under real world conditions, insole preference changed for 65% of participants between the immediate assessment (1 min) and after a whole workday, with dorsum height related to the latter (p < 0.05). Subjective questions for self‐assessed arch height and footwear feel identified 66.7% of the insole preferences after 1 day at work, compared to 36% using immediate assessment of insole preference.Conclusion: Preference for material hardness varies underneath the medial arch of the foot and is time dependent. Simple foot measures and questions about comfort can guide selection of preferred insoles.

Background: Diabetic foot ulceration is a considerable cost to the NHS and foot orthotic provision is a core strategy for the management of the people with diabetes and a moderate to high risk of foot ulceration. The traditional process to produce a custom‐made foot orthotic device is to use manual casting of foot shape and physical moulding of orthoses materials. Parts of this process can be undertaken using digital tools rather than manual processes with potential advantages. The aim of this trial was to provide the first comparison of a traditional orthoses supply chain to a digital supply chain over a 6 month period. The trial used plantar pressure, health status, and health service time and cost data to compare the two supply chains.Methods: Fifty‐seven participants with diabetes were randomly allocated to each supply chain. Plantar pressure data and health status (EQ5D, ICECAP) was assessed at point of supply and at six‐months. The costs for orthoses and clinical services accessed by participants were assessed over the 6 months of the trial. Primary outcomes were: reduction in peak plantar pressure at the site of highest pressure, assessed for non‐inferiority to current care. Secondary outcomes were: reduction in plantar pressure at foot regions identified as at risk (> 200 kPa), cost‐consequence analysis (supply chain, clinician time, service use) and health status.Results: At point of supply pressure reduction for the digital supply chain was non‐inferior to a predefined margin and superior (p < 0.1) to the traditional supply chain, but both supply chains were inferior to the margin after 6 months. Custom‐made orthoses significantly reduced pressure for at risk regions compared to a flat control (traditional − 13.85%, digital − 20.52%). The digital supply chain was more expensive (+£13.17) and required more clinician time (+ 35 min). There were no significant differences in health status or service use between supply chains.Conclusions: Custom made foot orthoses reduce pressure as expected. Given some assumptions about the cost models we used, the supply chain process adopted to produce the orthoses seems to have marginal impact on overall costs and health status.Trial registration: Retrospectively registered on ISRCTN registry (ISRCTN10978940, 04/11/2015).

Objective: This study focussed on pressure relieving orthotic insoles designed for retail footwear and people with diabetes and at risk of first forefoot ulceration. The aim was to investigate whether the pressure relieving effects of a customised metatarsal bar and forefoot cushioning are sensitive to bar location and shape, and material choice.Research design and methods: Patient‐specific foot shape was used to design an orthotic insole, with metatarsal bar location and shape customised according to plantar pressure data. Changes in forefoot plantar pressure were investigated when 60 people with diabetes and neuropathy walked in nine variants of the orthotic insole. These comprised three variations in proximal/distal location of the customised metatarsal bar and three different metatarsal head offloading materials.Results & conclusions: The most frequent reductions in pressure occurred when the anterior edge of the metatarsal bar was placed at 77% of the peak pressure values, and its effects were independent of the choice of EVA or Poron offloading material. In the flat insole, 61% of participants had one or more metatarsal head areas with pressure above the 200 KPa, reducing to 58% when adopting generic orthotic design rules and 51% when using the best orthotic insole of the nine tested. Our results confirm that plantar pressure relief is sensitive to orthotic insole design decisions and individual patient feet.