A Review of Wearable Sensor Systems to Monitor Plantar Loading in the Assessment of Diabetic Foot Ulcers

Diabetes is highly prevalent throughout the world and imposes a high economic cost on countries at all income levels. Foot ulceration is one devastating consequence of diabetes, which can lead to amputation and mortality. Clinical assessment of diabetic foot ulcer (DFU) is currently subjective and limited, impeding effective diagnosis, treatment and prevention. Studies have shown that pressure and shear stress at the plantar surface of the foot plays an important role in the development of DFUs. Quantification of these could provide an improved means of assessment of the risk of developing DFUs. However, commercially-available sensing technology can only measure plantar pressures, neglecting shear stresses and thus limiting their clinical utility. Research into new sensor systems which can measure both plantar pressure and shear stresses are thus critical. Our aim in this paper is to provide the reader with an overview of recent advances in plantar pressure and stress sensing and offer insights into future needs in this critical area of healthcare. Firstly, we use current clinical understanding as the basis to define requirements for wearable sensor systems capable of assessing DFU. Secondly, we review the fundamental sensing technologies employed in this field and investigate the capabilities of the resultant wearable systems, including both commercial and research-grade equipment. Finally, we discuss research trends, ongoing challenges and future opportunities for improved sensing technologies to monitor plantar loading in the diabetic foot

Commercially available pressure sensors for sport and health applications: A comparative review

Pressure measurement systems have numerous applications in healthcare and sport. The purpose of this review is to: (a) describe the brief history of the development of pressure sensors for clinical and sport applications, (b) discuss the design requirements for pressure measurement systems for different applications, (c) critique the suitability, reliability, and validity of commercial pressure measurement systems, and (d) suggest future directions for the development of pressure measurements systems in this area. Commercial pressure measurement systems generally use capacitive or resistive sensors, and typically capacitive sensors have been reported to be more valid and reliable than resistive sensors for prolonged use. It is important to acknowledge, however, that the selection of sensors is contingent upon the specific application requirements. Recent improvements in sensor and wireless technology and computational power have resulted in systems that have higher sensor density and sampling frequency with improved usability – thinner, lighter platforms, some of which are wireless, and reduced the obtrusiveness of in-shoe systems due to wireless data transmission and smaller data-logger and control units. Future developments of pressure sensors should focus on the design of systems that can measure or accurately predict shear stresses in conjunction with pressure, as it is thought the combination of both contributes to the development of pressure ulcers and diabetic plantar ulcers. The focus for the development of in-shoe pressure measurement systems is to minimise any potential interference to the patient or athlete, and to reduce power consumption of the wireless systems to improve the battery life, so these systems can be used to monitor daily activity. A potential solution to reduce the obtrusiveness of in-shoe systems include thin flexible pressure sensors which can be incorporated into socks. Although some experimental systems are available further work is needed to improve their validity and reliability

Fiber Bragg Gratings as e-Health Enablers: An Overview for Gait Analysis Applications

Nowadays, the fast advances in sensing technologies and ubiquitous wireless networking are reflected in medical practice. It provides new healthcare advantages under the scope of e-Health applications, enhancing life quality of citizens. The increase of life expectancy of current population comes with its challenges and growing health risks, which include locomotive problems. Such impairments and its rehabilitation require a close monitoring and continuous evaluation, which add financial burdens on an already overloaded healthcare system. Analysis of body movements and gait pattern can help in the rehabilitation of such problems. These monitoring systems should be noninvasive and comfortable, in order to not jeopardize the mobility and the day-to-day activities of citizens. The use of fiber Bragg gratings (FBGs) as e-Health enablers has presented itself as a new topic to be investigated, exploiting the FBGs’ advantages over its electronic counterparts. Although gait analysis has been widely assessed, the use of FBGs in biomechanics and rehabilitation is recent, with a wide field of applications. This chapter provides a review of the application of FBGs for gait analysis monitoring, namely its use in topics such as the monitoring of plantar pressure, angle, and torsion and its integration in rehabilitation exoskeletons and for prosthetic control

Sensores de fibra ótica para arquiteturas e-Health

In this work, optical fiber sensors were developed and optimized for biomedical applications in wearable and non-intrusive and/or invisible solutions. As it was intended that the developed devices would not interfere with the user's movements and their daily life, the fibre optic sensors presented several advantages when compared to conventional electronic sensors, among others, the following stand out: size and reduced weight, biocompatibility, safety, immunity to electromagnetic interference and high sensitivity. In a first step, wearable devices with fibre optic sensors based in Fiber Bragg gratings (FBG) were developed to be incorporated into insoles to monitor different walking parameters based on the analysis of the pressure exerted on several areas of the insole. Still within this theme, other sensors were developed using the same sensing technology, but capable of monitoring pressure and shear forces simultaneously. This work was pioneering and allowed monitoring one of the main causes of foot ulceration in people with diabetes: shear. At a later stage, the study focused on the issue related with the appearance of ulcers in people with reduced mobility and wheelchair users. In order to contribute to the mitigation of this scourge, a system was developed composed of a network of fibre optic sensors capable of monitoring the pressure at various points of the wheelchair. It not only measures the pressure at each point, but also monitors the posture of the wheelchair user and advises him/her to change posture regularly to reduce the probability of this pathology occurring. Still within this application, another work was developed where the sensor not only monitored the pressure but also the temperature in each of the analysis points, thus indirectly measuring shear. In another phase, plastic fibre optic sensors were studied and developed to monitor the body posture of an office chair user. Simultaneously, software was developed capable of monitoring and showing the user all the acquired data in real time and warning for incorrect postures, as well as advising for work breaks. In a fourth phase, the study focused on the development of highly sensitive sensors embedded in materials printed by a 3D printer. The sensor was composed of an optical fibre with a FBG and the sensor body of a flexible polymeric material called "Flexible". This material was printed on a 3D printer and during its printing the optical fibre was incorporated. The sensor proved to be highly sensitive and was able to monitor respiratory and cardiac rate, both in wearable solutions (chest and wrist) and in "invisible" solutions (office chair).Neste trabalho foram desenvolvidos e otimizados sensores em fibra ótica para aplicações biomédicas em soluções vestíveis e não intrusivas/ou invisíveis. Tendo em conta que se pretende que os dispositivos desenvolvidos não interfiram com os movimentos e o dia-a-dia do utilizador, os sensores de fibra ótica apresentam inúmeras vantagens quando comparados com os sensores eletrónicos convencionais, de entre várias, destacam-se: tamanho e peso reduzido, biocompatibilidade, segurança, imunidade a interferências eletromagnéticas e elevada sensibilidade. Numa primeira etapa, foram desenvolvidos dispositivos vestíveis com sensores de fibra ótica baseados em redes de Bragg (FBG) para incorporar em palmilhas de modo a monitorizar diferentes parâmetros da marcha com base na análise da pressão exercida em várias zonas da palmilha. Ainda no âmbito deste tema, adicionalmente, foram desenvolvidos sensores utilizando a mesma tecnologia de sensoriamento, mas capazes de monitorizar simultaneamente pressão e forças de cisalhamento. Este trabalho foi pioneiro e permitiu monitorizar um dos principais responsáveis pela ulceração dos pés em pessoas com diabetes: o cisalhamento. Numa fase posterior, o estudo centrou-se na temática relacionada com o aparecimento de úlceras em pessoas com mobilidade reduzida e utilizadores de cadeiras de rodas. De modo a contribuir para a mitigação deste flagelo, procurou-se desenvolver um sistema composto por uma rede de sensores de fibra ótica capaz de monitorizar a pressão em vários pontos de uma cadeira de rodas e não só aferir a pressão em cada ponto, mas monitorizar a postura do cadeirante e aconselhá-lo a mudar de postura com regularidade, de modo a diminuir a probabilidade de ocorrência desta patologia. Ainda dentro desta aplicação, foi publicado um outro trabalho onde o sensor não só monitoriza a pressão como também a temperatura em cada um dos pontos de análise, conseguindo aferir assim indiretamente o cisalhamento. Numa outra fase, foi realizado o estudo e desenvolvimento de sensores de fibra ótica de plástico para monitorizar a postura corporal de um utilizador de uma cadeira de escritório. Simultaneamente, foi desenvolvido um software capaz de monitorizar e mostrar ao utilizador todos os dados adquiridos em tempo real e advertir o utilizador de posturas incorretas, bem como aconselhar para pausas no trabalho. Numa quarta fase, o estudo centrou-se no desenvolvimento de sensores altamente sensíveis embebidos em materiais impressos 3D. O sensor é composto por uma fibra ótica com uma FBG e o corpo do sensor por um material polimérico flexível, denominado “Flexible”. O sensor foi impresso numa impressora 3D e durante a sua impressão foi incorporada a fibra ótica. O sensor demonstrou ser altamente sensível e foi capaz de monitorizar frequência respiratória e cardíaca, tanto em soluções vestíveis (peito e pulso) como em soluções “invisíveis” (cadeira de escritório).Programa Doutoral em Engenharia Físic

Low Cost Shear and Pressure Sensor

Elevated pressure and shearing stresses at the foot-shoe interface are believed to play a role in diabetic foot ulceration. The main goal of this project was to design a simple insole that could distinguish between sites of high pressure and sites of excessive shearing stresses at the foot-shoe interface. Wear patterns that relate specifically to shear and pressure acting on the plantar surface of a patient’s foot also needed to be exhibited. The team used reflective tape that was applied to the surface to various types of insoles to look for visible wear patterns. These wear patterns were identified by the use of a MATLAB code. Pressure sensitive Fujifilm Prescale was used to detect sites of excessive shear stresses at the skin-shoe interface, by being inserted into slits in an insole. Based on the color and color-density of the Fujifilm sites, high and low shear stresses can be identified. Areas of excessive wear from the reflective tape and the Fujifilm results can be correlated to the control sample step we obtained from Dr. Davis’s shear detection machine

Soluções em fibra ótica para sistemas de reabilitação física e aplicações e-Health

In this dissertation a biaxial optical fiber sensor, based on Bragg gratings, is proposed for simultaneous monitoring of plantar and shear pressures. This work begins with the definition of the problem: the consequences of pathologies associated with diabetic foot and lower limbs disorders. It was analysed several previously published studies on plantar pressure sensors, the several methodologies and applications that already exist. A biomechanical research was carried out, with particular focus on gait pattern and human foot anatomy, in order to understand the different gait phases and points of greatest interest for foot pressure monitoring. Thus, the response of sensors based on Bragg gratings was studied in several configurations of sensing cells, then integrated in insoles. The sensitivities obtained for normal pressure were between 0.56 and 2.16 pm/kPa and, for shear pressure, between 0.51 and 3.98 pm/kPa. Those prove to be a non-invasive solution with potential to be included in e-health systems for real-time gait monitoring. They can be prepared for daily medical use, serving as important tools in aiding prevention and diagnosis, especially of foot diseases.Nesta dissertação é proposto um sensor biaxial em fibra ótica, baseado em redes de Bragg, para monitorização simultânea de pressões plantar e de cisalhamento. Este trabalho começa com a definição do problema: as consequências de patologias associadas ao pé diabético e distúrbios na sincronização dos membros inferiores. Foram analisados vários estudos publicados anteriormente sobre sensores de pressão plantar, as diversas metodologias e aplicações já existentes. Foi realizada uma pesquisa na área da biomecânica, com particular foco no padrão de marcha e na anatomia do pé humano, de forma a compreender as diferentes fases da marcha e os pontos de maior interesse para monitorização da pressão do pé. Assim, foi desenvolvido um estudo sobre a resposta de sensores baseados em redes de Bragg à pressão, em várias configurações de células sensoriais, culminando na integração desses sensores em palmilhas. Foram obtidas sensibilidades para pressão normal entre 0,56 e 2,16 pm/kPa e, para pressão de cisalhamento, entre 0,51 e 3,98 pm/kPa. Estas demonstram ser uma solução não invasiva, com potencial de ser incluída em sistemas e-Health, para monitorização da marcha em tempo real. Podem ser preparadas para uso médico diário, servindo como importantes ferramentas no auxílio para a prevenção e diagnóstico, em especial de doenças do pé.Mestrado em Engenharia Físic

A Portable Insole System to Simultaneously Measure Plantar Pressure and Shear Stress

Objective: This work aims to develop an integrated in-shoe measurement system to fully record plantar loading, including both pressure and shear stresses, across the full contact surface. These data are vital to help understand and prevent the development of complex conditions such as Diabetic Foot Ulcers (DFUs), a worldwide healthcare challenge. Currently no systems exist to reliably record these data. Methods: In this paper we report development of the SLIPS ('Shear Load Inductive Plantar Sensing') system which integrates 64 tri-axial force sensors into a flexible insole to measure plantar loading. SLIPS translates our multi-axis inductive load sensing technology into a full sensory array embedded within an insole and complete with communication and power bus. A pilot study evaluates the system in three healthy participants during walking. Results: Testing shows that the SLIPS system is well tolerated by participants and can operate under dynamic gait loading regimes. The pilot study reveals the complex nature of plantar loading. Regions of peak pressure loading align with anatomical landmarks and shear loading forms a significant component of the overall load. Notably, regions of peak shear and pressure are not necessarily collocated or present in unison. Conclusion: This work highlights the need for in-shoe plantar measurement systems like SLIPS capable of mapping both pressure and shear load, and their use to improve understanding of how these factors relate to clinical conditions like DFU. Significance: SLIPS represents the first in-shoe measurement system capable of measuring both pressure and shear across the whole plantar surface in unison

An Inductive Sensor for Real Time Measurement of Plantar Normal and Shear Forces Distribution

Goal: The objective of this article is to demonstrate a multiplexed inductive force sensor for simultaneously measuring normal force and shear forces on a foot. Methods: The sensor measures the normal force and shear forces by monitoring the inductance changes of three planar sensing coils. Resonance frequency division multiplexing was applied to signals from the multiple sensing coils, making it feasible to simultaneously measure the three forces (normal force, shear forces in x and y axis) on a foot using only one set of measurement electronics with high sensitivity and resolution. Results: The testing results of the prototype sensor have shown that the sensor is capable of measuring normal force ranging from 0 to 800 N and shear forces ranging from 0 to 130 N in real time. Conclusion: With its high resolution, high sensitivity and the capability of monitoring forces at different positions of a foot simultaneously, this sensor can be potentially used for real time measurement of plantar normal force and shear forces distribution on diabetes patient’s foot. Significance: Real time monitoring of the normal force and shear forces on diabetes patient’s foot can provide useful information for physicians and diabetes patients to take actions in preventing foot ulceration

Evaluation of in-shoe plantar pressure and shear during walking for diabetic foot ulcer prevention.

To investigate reliability and changes of in-shoe plantar pressure and shear during walking at three cadences with two insole designs. This was a precursor to the investigation of plantar loading in people with diabetes for potential foot ulcer prevention. A sensorised insole system, capable of measuring plantar pressure and shear at the heel, fifth metatarsal head (5MH), first metatarsal head (1MH) and hallux, was tested with ten healthy participants during level walking. Reliability was evaluated, using intra-class correlation coefficient (ICC), while varying the cadences and insole types. Percentage changes in pressure and shear relative to values obtained at self-selected cadence with a flat insole design were investigated. Mean±standard deviation of maximum pressure, medial-lateral and anterior-posterior shear of up to 380±24kPa, 46±2kPa and -71±4kPa, respectively, were measured. The ICC in ranges of 0.762-0.973, 0.758-0.987 and 0.800-0.980 were obtained for pressure, anterior-posterior and medial-lateral shear, respectively. Opposite anterior-posterior shear directions between 5MH and 1MH (stretching), and between 1MH and hallux (pinching) were observed for some participants. Increasing cadence increased pressure and anterior-posterior shear (by up to +77%) but reduced medial-lateral shear at the heel and hallux (by up to -34%). Slower cadence increased anterior-posterior shear (+114%) but decreased medial-lateral shear (-46%) at the hallux. The use of a flexible contoured insole resulted in pressure reduction at the heel and 5MH but an increase in anterior-posterior shear at the heel (+69%) and hallux (+75%). The insole system demonstrated good reliability and is comparable to reported pressure-only systems. Pressure measurements were sensitive to changes in cadence and insole designs in ways that were consistent with the literature. However, our plantar shear showed localised shear changes with cadences and insoles for the first time, as well as stretching and pinching effects on plantar tissue. This opens new possibilities to investigate plantar tissue viability, loading characteristics and orthotic designs aimed towards foot ulcer prevention

An In-Shoe Laser Doppler Sensor for Assessing Plantar Blood Flow in the Diabetic Foot

An in-shoe laser Doppler sensor for assessing plantar blood flow in the diabetic foot. Jonathan Edwin Cobb Plantar ulceration is a complication of the diabetic foot prevalent in adults with type 11 diabetes mellitus. Although neuropathy, microvascular disease and biornechanical factors are all implicated, the mechanism by which the tissue becomes pre-disposed to damage remains unclear. Recent theories suggest that the nutritional supply to the tissue is compromised, either by increased flow through the arteriovenous anastomoses ('capillary steal' theory) or through changes in the micro vascu I ature (haemodynamic hypothesis). Clinical data to support these ideas has been limited to assessment of the unclad foot under rest conditions. A limitation of previous studies has been the exclusion of static and dynamic tissue loading, despite extensive evidence that these biornechanical factors are essential in the development of plantar ulceration. The present study has overcome these problems by allowing assessment of plantar blood flow, in-shoe, during standing and walking. The system comprises a laser Doppler blood flux sensor operating at 780nm, load sensor, measurement shoe, instrumentation, and analysis software. In-vitro calibration was performed using standard techniques. An in-vivo study of a small group of diabetic subjects indicated differences in the blood flux response between diabetic neuropaths, diabetics with vascular complications and a control group. For example, following a loading period of 120s, relative increases in response from rest to peak were: Control (150% to 259%), Vascular (-70% to 242%), Neuropathic (109%-174%) and recovery times to 50% of the peak response were: Control (33s to 45s), Vascular (43s to >120s), Neuropathic (>120s). Dynamic re-perfusion rates (arbitrary units per millisecond) obtained for the swing phase of gait were: Control (6.1 a. u/ms to 7.9 a. u/ms), Vascular (4 a. u/ms to 6.2 a. u/ms), Neuropathic (2.3 a. u/ms to 4.5 a. u/ms)