Smart Diabetic Socks: Embedded device for diabetic foot prevention

ObjectivesMost foot ulcers are the consequence of a trauma (repetitive high stress, ill-fitting footwear, or an object inside the shoe) associated to diabetes. They are often followed by amputation and shorten life expectancy. This paper describes the prototype of the Smart Diabetic Socks that has been developed in the context of the French ANR TecSan project. The objective is to prevent pressure foot ulcers for diabetic persons.Material and methodsA fully wireless, customizable and washable “smart sock” has been designed. It is made of a textile which fibers are knitted in a way they provide measurements of the pressure exerted under and all around the foot in real-life conditions. This device is coupled with a subject-specific Finite Element foot model that simulates the internal strains within the soft tissues of the foot.ResultsA number of derived stress indicators can be computed based on that analysis, such as the accumulated stress dose, high internal strains or peak pressures near bony prominences during gait. In case of risks for pressure ulcer, an alert is sent to the person and/or to the clinician. A watch, a smart-phone or a distant laptop can be used for providing such alert.     

Parametric study of orthopedic insole of valgus foot on partial foot amputation

Orthopedic insole was important for partial foot amputation (PFA) to achieve foot balance and avoid foot deformity. The inapposite insole orthosis was thought to be one of the risk factors of reamputation for foot valgus patient, but biomechanical effects of internal tissues on valgus foot had not been clearly addressed. In this study, plantar pressure on heel and metatarsal regions of PFA was measured using F-Scan. The three-dimensional finite element (FE) model of partial foot evaluated different medial wedge angles (MWAs) (0.0°–10.0°) of orthopedic insole on valgus foot. The effect of orthopedic insole on the internal bone stress, the medial ligament tension of ankle, plantar fascia tension, and plantar pressure was investigated. Plantar pressure on medial heel region was about 2.5 times higher than that of lateral region based on the F-Scan measurements. FE-predicted results showed that the tension of medial ankle ligaments was the lowest, and the plantar pressure was redistributed around the heel, the first metatarsal, and the lateral longitudinal arch regions when MWA of orthopedic insole ranged from 7.5° to 8.0°. The plantar fascias maintained about 3.5% of the total load bearing on foot. However, the internal stresses from foot bones increased. The simulation in this study would provide the suggestion of guiding optimal design of orthopedic insole and therapeutic planning to pedorthist.     

A study of the viability of obtaining a generic animation of the foot while walking for the virtual testing of footwear using dorsal pressures

Establishing the appropriate pressure exerted by the shoe upper over the foot surface is fundamental for the design of specific footwear, although measuring the dorsal pressures can also provide important additional information. In previous works, a virtual simulator to perform studies of comfort and functionality in CAD footwear design was presented. This paper describes the procedure carried out to obtain the foot animations used in this simulator. The virtual feet used in the simulator are feet without a standard form scanned in a static way. Their movements are rebuilt from the register of movements of several foot anatomical points during a complete step. The dorsal pressures exerted by some shoe uppers on these anatomical points were measured for several subjects and used to establish the viability of the use of these animations in a virtual simulator for footwear.     

First Direct Evidence of Chalcolithic Footwear from the Near Eastern Highlands

In 2008, a well preserved and complete shoe was recovered at the base of a Chalcolithic pit in the cave of Areni-1, Armenia. Here, we discuss the chronology of this find, its archaeological context and its relevance to the study of the evolution of footwear. Two leather samples and one grass sample from the shoe were dated at the Oxford Radiocarbon Accelerator Unit (ORAU). A third leather sample was dated at the University of California-Irvine Accelerator Mass Spectrometry Facility (UCIAMS). The R_Combine function for the three leather samples provides a date range of 3627–3377 Cal BC (95.4% confidence interval) and the calibrated range for the straw is contemporaneous (3627–3377 Cal BC). The shoe was stuffed with loose, unfastened grass (Poaceae) without clear orientation which was more than likely used to maintain the shape of the shoe and/or prepare it for storage. The shoe is 24.5 cm long (European size 37), 7.6 to 10 cm wide, and was made from a single piece of leather that wrapped around the foot. It was worn and shaped to the wearer''s right foot, particularly around the heel and hallux where the highest pressure is exerted in normal gait. The Chalcolithic shoe provides solid evidence for the use of footwear among Old World populations at least since the Chalcolithic. Other 4^th millennium discoveries of shoes (Italian and Swiss Alps), and sandals (Southern Israel) indicate that more than one type of footwear existed during the 4^th millennium BC, and that we should expect to discover more regional variations in the manufacturing and style of shoes where preservation conditions permit.     

The Principal Components of Adult Female Insole Shape Align Closely with Two of Its Classic Indicators

The plantar surface of the human foot transmits the weight and dynamic force of the owner’s lower limbs to the ground and the reaction forces back to the musculoskeletal system. Its anatomical variation is intensely studied in such fields as sports medicine and orthopedic dysmorphology. Yet, strangely, the shape of the insole that accommodates this surface and elastically buffers these forces is neither an aspect of the conventional anthropometrics of feet nor an informative label on the packet that markets supplementary insoles. In this paper we pursue an earlier suggestion that insole form in vertical view be quantified in terms of the shape of the foot not at the plane of support (the “footprint”) but some two millimeters above that level. Using such sections extracted from laser scans of 158 feet of adult women from the University of Zagreb, in conjunction with an appropriate modification of today’s standard geometric morphometrics (GMM), we find that the sectioned form can be described by its size together with two meaningful relative warps of shape. The pattern of this shape variation is not novel. It is closely aligned with two of the standard footprint measurements, the Chippaux-Šmiřák arch index and the Clarke arch angle, whose geometrical foci (the former in the ball of the foot, the latter in the arch) it apparently combines. Thus a strong contemporary analysis complements but does not supplant the simpler anthropometric analyses of half a century ago, with implications for applied anthropology.     

Validation of a smart shoe for estimating foot progression angle during walking gait

The foot progression angle is an important measurement related to knee loading, pain, and function for individuals with knee osteoarthritis, however current measurement methods require camera-based motion capture or floor-embedded force plates confining foot progression angle assessment to facilities with specialized equipment. This paper presents the validation of a customized smart shoe for estimating foot progression angle during walking. The smart shoe is composed of an electronic module with inertial and magnetometer sensing inserted into the sole of a standard walking shoe. The smart shoe charges wirelessly, and up to 160 h of continuous data (sampled at 100 Hz) can be stored locally on the shoe. For validation testing, fourteen healthy subjects were recruited and performed treadmill walking trials with small, medium, and large toe-in (internal foot rotation), small, medium, and large toe-out (external foot rotation) and normal foot progression angle at self-selected walking speeds. Foot progression angle calculations from the smart shoe were compared with measurements from a standard motion capture system. In general, foot progression angle values from the smart shoe closely followed motion capture values for all walking conditions with an overall average error of 0.1 ± 1.9 deg and an overall average absolute error of 1.7 ± 1.0 deg. There were no significant differences in foot progression angle accuracy across the seven different walking gait patterns. The presented smart shoe could potentially be used for knee osteoarthritis or other clinical applications requiring foot progression angle assessment in community settings or in clinics without specialized motion capture equipment.     

Computational techniques for using insole pressure sensors to analyse three-dimensional joint kinetics

This study evaluated the feasibility of using insole pressure sensors together with whole body dynamics to analyse joint kinetics while running. Local affine transformations of shoe kinematics were first used to track the position of insole sensors during locomotion. Centre of pressure estimates derived from the insoles were within 10 mm of forceplate measures through much of stance, while vertical force estimates were within 15% of peak forceplate recordings. Insole data were then coupled with a least squares whole body dynamic model to obtain shear force estimates that were comparable to forceplate records during running. We demonstrated that these techniques provide a viable approach for analysing joint kinetics when running on uninstrumented surfaces.     

Effects of insoles and additional shock absorption foam on the cushioning properties of sport shoes

The purpose of this study was to investigate the effects of insoles and additional shock absorption foam on the cushioning properties of various sport shoes with an impact testing method. Three commercial sport shoes were used in this study, and shock absorption foam (TPE5020; Vers Tech Science Co. Ltd., Taiwan) with 2-mm thickness was placed below the insole in the heel region for each shoe. Eight total impacts with potential energy ranged from 1.82 to 6.08 J were performed onto the heel region of the shoe. The order of testing conditions was first without insole, then with insole, and finally interposing the shock absorption foam for each shoe. Peak deceleration of the striker was measured with an accelerometer attached to the striker during impact. The results of this study seemed to show that the insole or additional shock absorption foam could perform its shock absorption effect well for the shoes with limited midsole cushioning. Further, our findings showed that insoles absorbed more, even up to 24-32% of impact energy under low impact energy. It seemed to indicate that insoles play a more important role in cushioning properties of sport shoes under a low impact energy condition.     

Response of able-bodied persons to changes in shoe rocker radius during walking: Changes in ankle kinematics to maintain a consistent roll-over shape

Recent studies have determined a seemingly consistent feature of able-bodied level ground walking, termed the roll-over shape, which is the effective rocker (cam) shape that the lower limb system conforms to between heel contact and contralateral heel contact during walking (first half of the gait cycle). The roll-over shape has been found to be largely unaffected by changes in walking speed, load carriage, and shoe heel height. However, it is unclear from previous studies whether persons are controlling their lower limb systems to maintain a consistent roll-over shape or whether this finding is a byproduct of their attempt to keep ankle kinematic patterns similar during the first half of the gait cycle. We measured the ankle–foot roll-over shapes and ankle kinematics of eleven able-bodied subjects while walking on rocker shoes of different radii. We hypothesized that the ankle flexion patterns during single support would change to maintain a similar roll-over shape. We also hypothesized that with decrease in rocker shoe radii, the difference in ankle flexion between the end and beginning of single support would decrease. Our results supported these hypotheses. Ankle kinematics were changed significantly during walking with the different rocker shoe radii (p<0.001), while ankle–foot roll-over shape radii (p=0.146) and fore–aft position (p=0.132) were not significantly affected. The results of this study have direct implications for designers of ankle–foot prostheses, orthoses, walking casts/boots, and rocker shoes. The results may also be relevant to researchers studying control of human movements.     

Locomotion pattern and foot pressure adjustments during gentle turns in healthy subjects

People suffering from locomotor impairment find turning manoeuvres more challenging than straight-ahead walking. Turning manoeuvres are estimated to comprise a substantial proportion of steps taken daily, yet research has predominantly focused on straight-line walking, meaning that the basic kinetic, kinematic and foot pressure adaptations required for turning are not as well understood. We investigated how healthy subjects adapt their locomotion patterns to accommodate walking along a gently curved trajectory (radius 2.75 m). Twenty healthy adult participants performed walking tasks at self-selected speeds along straight and curved pathways. For the first time for this mode of turning, plantar pressures were recorded using insole foot pressure sensors while participants’ movements were simultaneously tracked using marker-based 3D motion capture. During the steady-state strides at the apex of the turn, the mean operating point of the inside ankle shifted by 1 degree towards dorsiflexion and that for the outside ankle shifted towards plantarflexion. The largest change in relative joint angle range was an increase in hip rotation in the inside leg (>60%). In addition, the inside foot was subject to a prolonged stance phase and a 10% increase in vertical force in the posteromedial section of the foot compared to straight-line walking. Most of the mechanical change required was therefore generated by the inside leg with hip rotation being a major driver of the gentle turn. This study provides new insight into healthy gait during gentle turns and may help us to understand the mechanics behind some forms of impairment.     

Reduction of plantar heel pressures: Insole design using finite element analysis

Plantar heel pain is a common condition that is often exacerbated by the repetitive stresses of walking. Treatment usually includes an in-shoe intervention designed to reduce plantar pressure under the heel by using insoles and a variety of off-the-shelf products. The design process for these products is often intuitive in nature and does not always rely on scientifically derived guidelines. Finite element analysis provides an efficient computational framework to investigate the performance of a large number of designs for optimal plantar pressure reduction. In this study, we used two-dimensional plane strain finite element modeling to investigate 27 insole designs. Combinations of three insole conformity levels (flat, half conforming, full conforming), three insole thickness values (6.3, 9.5 and 12.7 mm) and three insole materials (Poron Cushioning, Microcel Puff Lite and Microcel Puff) were simulated during the early support phase of gait. Plantar pressures predicted by the model were validated by experimental trials conducted in the same subject whose heel was modeled by loading the bare foot on a rigid surface and on foam mats. Conformity of the insole was the most important design variable, whereas peak pressures were relatively insensitive to insole material selection. The model predicted a 24% relief in pressure compared to barefoot conditions when using flat insoles; the reduction increased up to 44% for full conforming insoles.     

Finite element analysis of heel pad with insoles

To design optimal insoles for reduction of pedal tissue trauma, experimental measurements and computational analyses were performed. To characterize the mechanical properties of the tissues, indentation tests were performed. Pedal tissue geometry and morphology were obtained from magnetic resonance scan of the subject's foot. Axisymmetrical finite element models of the heel of the foot were created with 1/4 of body weight load applied. The stress, strain and strain energy density (SED) fields produced in the pedal tissues were computed. The effects of various insole designs and materials on the resulting stress, strain, and SED in the soft pedal tissues were analyzed. The results showed: (a) Flat insoles made of soft material provide some reductions in the maximum stress, strain and SED produced in the pedal tissues. These maximum values were computed near the calcaneus. (b) Flat insoles, with conical/cylindrical reliefs, provided more reductions in these maximum values than without reliefs. (c) Custom insoles, contoured to match the pedal geometry provide most reductions in the maximum stress, strain and SED. Also note, the maximum stress, strain and SED computed near the calcaneus were found to be about 10 times the corresponding peak values computed on the skin surface. Based on the FEA analysis, it can be concluded that changing insole design and using different material can significantly redistribute the stress/strain inside the heel pad as well as on the skin surface.     

Greater toe grip and gentler heel strike are the strategies to adapt to slippery surface

This study investigated the plantar pressure distribution during gait on wooden surface with different slipperiness in the presence of contaminants. Fifteen Chinese males performed 10 walking trials on a 5-m wooden walkway wearing cloth shoe in four contaminated conditions (dry, sand, water, oil). A pressure insole system was employed to record the plantar pressure data at 50Hz. Peak pressure and time-normalized pressure-time integral were evaluated in nine regions. In comparing walking on slippery to non-slippery surfaces, results showed a 30% increase of peak pressure beneath the hallux (from 195.6 to 254.1kPa), with a dramatic 79% increase in the pressure time integral beneath the hallux (from 63.8 to 114.3kPa) and a 34% increase beneath the lateral toes (from 35.1 to 47.2kPa). In addition, the peak pressure beneath the medial and lateral heel showed significant 20-24% reductions, respectively (from 233.6-253.5 to 204.0-219.0kPa). These findings suggested that greater toe grip and gentler heel strike are the strategies to adapt to slippery surface. Such strategies plantarflexed the ankle and the metatarsals to achieve a flat foot contact with the ground, especially at heel strike, in order to shift the ground reaction force to a more vertical direction. As the vertical ground reaction force component increased, the available ground friction increased and the floor became less slippery. Therefore, human could walk without slip on slippery surfaces with greater toe grip and gentler heel strike as adaptation strategies.     

Method for in-shoe shear stress measurement

A methodology is described for use of a shear transducer, based on a magneto-resistive principle, to measure stresses under the plantar surface of the foot in-shoe during walking. Particular attention is paid to a projected application for study of diabetic plantar ulceration and its management by footwear. The transducer has a disc construction, approximately 4 mm thick by 16 mm diameter, and measures two orthogonal axes of shear simultaneously; this disc is mounted into an inlay that can be inserted into any stock orthopaedic shoe of the type commonly prescribed for diabetic foot problems. The transducer is located in the metatarsal head region of the inlay; exact placement of the transducer is determined by reference to the direct pressure distribution, the common method of palpation shown to be imprecise. Pilot trials on normal subjects are presented to evaluate the method.     

Estimation of sex from the dimensions of foot, footprints, and shoe

This study intends to determine if the sex of an individual can be identified by foot lengths, shoe lengths, and/or footprints. For this purpose, foot length, foot breadth, and foot heel breadth of 506 subjects, comprising 253 females and 253 males ranging from 17.56 to 82.92 years of age, were taken. In addition, the footprints (length, breadth, and heel breadth) and footwear (length and breadth) of the same subjects were measured. Finally, the shoe size of the subjects was recorded. Univariate and multivariate discriminant function models were developed for sex allocations. Statistical analyses indicated that univariate models correctly assign approximately 67-94% of individuals to their correct sex groups. Among univariate models the most reliable measurement was shoe length. The results of multivariate models were better than those of univariate ones, with an approximately 82-96% correct assignment. The best multivariate model was comprised of four variables: foot length, shoe length, shoe breadth and shoe size. It could be suggested that these discriminant functions can provide useful clues to establish personal identity whenever complete or partial feet, footprints, or footwear are recovered.     

An instrumented shoe—A portable force measuring device

Effective protection from fracture for diseased or partially healed bones can be quantitatively developed only with a knowledge of the external forces applied to the bone. While force studies using force plates have documented the forces for certain activities, a more portable force measuring device is required to determine forces during most daily activities. The authors have developed an instrumented shoe with load cells attached directly to the shoe which measured orthogonal components of foot-to-ground forces and moments. Goniometers simultaneously monitor the position of the lower leg. The signals are transported to a system of loads acting at the lower leg. Typical load curves are presented.     

The structure of body measurements for the determination of shoe sizing for young Croatian men

The determination and promotion of the system of shoe sizing requires accurate knowledge of morphological properties of the foot and lower leg of the tested population. Similarly it is necessary to establish the occurrence and regional distribution of definite sizes in the tested population. Possible regional differences in morphological properties must not be ignored because it has been established by means of anthropological measuring that both foot dimensions and foot shapes differ between populations and within the same population. This has been proven by the investigation of body measures, carried out for the purpose of establishing a system of footwear sizes, which was executed on a randomly selected sample of 4,268 healthy and normally developed males aged 18-22. The investigation was carried out in 1993 on five locations each of which representing a definite region of the Republic of Croatia: Jastrebarsko (central), Koprivnica (northwestern), Pula (southwestern), Sinj (southern) and Pozega (northeastern). The measuring instrument was 31 foot and lower-leg sizes according to the existing ISO standards for footwear. Interregional differences are significant in all body measures. The role and the contribution of individual measures to these differences has been established by means of discriminatory analysis with regions as a priori defined samples. In order to constitute a convenient and purposeful standard for the footwear size system it is necessary to work out a database with referent values for the same system.     

A new method to measure foot contact

A new method to measure foot contact is described. It consists of a pressure sensitive transducer attached to one end of a flexible silicone rubber tube. A reliable indicator of foot contact is obtained with the tube glued to the outer perimeter of the sole of a shoe.     

Effect of heel height on in-shoe localized triaxial stresses

Abnormal and excessive plantar pressure and shear are potential risk factors for high-heeled related foot problems, such as forefoot pain, hallux valgus deformity and calluses. Plantar shear stresses could be of particular importance with an inclined supporting surface of high-heeled shoe. This study aimed to investigate the contact pressures and shear stresses simultaneously between plantar foot and high-heeled shoe over five major weightbearing regions: hallux, heel, first, second and fourth metatarsal heads, using in-shoe triaxial force transducers. During both standing and walking, peak pressure and shear stress shifted from the lateral to the medial forefoot as the heel height increased from 30 to 70mm. Heel height elevation had a greater influence on peak shear than peak pressure. The increase in peak shear was up to 119% during walking, which was about five times that of peak pressure. With increasing heel height, peak posterolateral shear over the hallux at midstance increased, whereas peak pressure at push-off decreased. The increased posterolateral shear could be a contributing factor to hallux deformity. It was found that there were differences in the location and time of occurrence between in-shoe peak pressure and peak shear. In addition, there were significant differences in time of occurrence for the double-peak loading pattern between the resultant horizontal ground reaction force peaks and in-shoe localized peak shears. The abnormal and drastic increase of in-shoe shear stresses might be a critical risk factor for shoe-related foot disorders. In-shoe triaxial stresses should therefore be considered to help in designing proper footwear.     

Mechanism of reducing knee adduction moment by shortening of the knee lever arm via medio-lateral manipulation of foot center of pressure: A pilot study

Prominent conservative treatment options for medial-compartment knee osteoarthritis include footwear that reduces knee adduction moment (KAM) correlated with detrimental loads in the medial compartment of the knee, thus providing clinical benefit. The proposed mechanism by which they reduce KAM is a lateral shift in foot center of pressure (COP) and a consequent shortening of the knee lever arm (KLA), thereby reducing KAM, which can be simply calculated as KLA multiplied by the frontal plane ground reaction force (FP-GRF). The present study investigated this mechanism for a unique biomechanical device capable of shifting COP by means of moveable convex elements attached to the shoe. Fourteen healthy young male subjects underwent gait analysis in two COP configurations of the device for comparison: (1) laterally and (2) medially deviated. Average midstance KLA and KAM were decreased by 8.2% and 8.7%, respectively, in the lateral COP compared to medial. Ground reaction force parameters, frontal plane knee angle (FP-KA), and spine lateral flexion angle (SLF) did not differ between COP configurations. No study parameters differed for terminal stance. Linear mixed effects models showed that COP and FP-GRF components, but not FP-KA and SLF, were significant predictors of KLA. In addition, KLA and FP-GRF were significant predictors of KAM; although, FP-GRF did not change significantly with medio-lateral COP shift, while KLA did. This suggests that the mechanism by which the study device reduces KAM is primarily through shortening of KLA brought on by a lateral shift in COP.