Reliability and Validity of Shore Hardness in Plantar Soft Tissue Biomechanics.

Shore hardness (SH) is a cost-effective and easy-to-use method to assess soft tissue biomechanics. Its use for the plantar soft tissue could enhance the clinical management of conditions such as diabetic foot complications, but its validity and reliability remain unclear. Twenty healthy adults were recruited for this study. Validity and reliability were assessed across six different plantar sites. The validity was assessed against shear wave (SW) elastography (the gold standard). SH was measured by two examiners to assess inter-rater reliability. Testing was repeated following a test/retest study design to assess intra-rater reliability. SH was significantly correlated with SW speed measured in the skin or in the microchamber layer of the first metatarsal head (MetHead), third MetHead and rearfoot. Intraclass correlation coefficients and Bland-Altman plots of limits of agreement indicated satisfactory levels of reliability for these sites. No significant correlation between SH and SW elastography was found for the hallux, 5th MetHead or midfoot. Reliability for these sites was also compromised. SH is a valid and reliable measurement for plantar soft tissue biomechanics in the first MetHead, the third MetHead and the rearfoot. Our results do not support the use of SH for the hallux, 5th MetHead or midfoot.

The enhanced paper grip test can substantially improve community screening for the risk of falling.

BACKGROUND: Lower-limb strength measures can enhance falls risk assessment but due to the lack of clinically applicable methods, such measures are not included in current screening. The enhanced paper grip test (EPGT) is a simple-to-use and cost-effective test that could fill this gap. However, its outcome measure (EPGT force) has not yet been directly linked to the risk of falling. RESEARCH QUESTION: Is the EPGT a good candidate for falls risk screening in older people in the community? METHODS: Seventy-one older people living independently in the community were recruited for this prospective observational study (median age 69 y, range 65y-79y). Lower-limb and whole-body strength were assessed at baseline using the EPGT and a standardised hand-grip method respectively. Incident falls were recorded monthly for a year through follow-up telephone conversations. The capacity of individual strength measures to predict falls and to enhance an established falls risk assessment tool (FRAT) commonly used by UK's national health service (NHS) was assessed using binomial logistic regression. The analysis was repeated for the subset of participants without history of falling at baseline (prediction of first-ever falls). RESULTS: Increased EPGT force and increased symmetry in strength between limbs were significantly associated with reduced risk of falling. Compared to the NHS-FRAT, the EPGT correctly classified more people (73% vs 69%), it achieved higher sensitivity (56% vs 26%) and higher negative predictive value (76% vs 68%). Complementing the NHS-FRAT with the EPGT produced a more comprehensive model that correctly classified 91% of participants and achieved 98% specificity, 81% sensitivity, 89% negative and 96% positive predictive value. Replacing the EPGT with hand-grip strength consistently undermined prediction accuracy. The EPGT remained highly accurate when focused on the prediction of first-ever falls. SIGNIFICANCE: The EPGT can substantially enhance falls screening in the community. These results can also inform effective personalised strength exercise interventions.

An exploration of the mechanistic link between the enhanced paper grip test and the risk of falling.

The enhanced paper grip test (EPGT) offers an easy-to-use measure of hallux plantar-flexion strength that does not need expensive specialised equipment. Literature suggests that it could be a useful screening tool to assess the risk of falling in older people. However, research on a specific mechanistic link to the risk of falling is lacking. It is hypothesised here that muscle weakening (assessed by the EPGT) is indicative of impaired ability to recover balance after a slip or a trip. To get an initial assessment of validity of the above hypothesis, the EPGT is compared against an established lab-based measure of lower-limb strength that is capable of assessing a person's ability to recover balance after a slip or a trip: maximum isometric leg press push-off force (leg press force). A gender-balanced sample of twenty people (median age=34 y) was recruited. Two different but equaly valid techniques of administering the EPGT were included regarding whether the participants' ankle was supported by the examiner or not. Results for the two EPGT techniques differed susbtantialy but they were both significantly associated with leg press force and therefore linked to better ability to maintain balance after a slip or a trip. The "ankle not held" EPGT technique was more strongly correlated to leg press force (r(18) = 0.652, p = 0.002) than the "ankle held" (r(18) = 0.623, p = 0.003) and appears to be the more favourable technique to administer the EPGT. These findings offer new insight on a potential mechanistic link between the EPGT and the risk of falling and support its optimal use in future research involving older people.

Effective and clinically relevant optimisation of cushioning stiffness to maximise the offloading capacity of diabetic footwear.

INTRODUCTION: Optimising the cushioning stiffness of diabetic footwear/orthoses can significantly enhance their offloading capacity. This study explores whether optimum cushioning stiffness can be predicted using simple demographic and anthropometric parameters. METHODS: Sixty-nine adults with diabetes and loss of protective sensation in their feet were recruited for this cross-sectional observational study. In-shoe plantar pressure was measured using Pedar® for a neutral diabetic shoe (baseline) and after adding cushioning footbeds of varying stiffness. The cushioning stiffness that achieved maximum offloading was identified for each participant. The link between optimum cushioning stiffness and plantar loading or demographic/anthropometric parameters was assessed using multinomial regression. RESULTS: People with higher baseline plantar loading required stiffer cushioning materials for maximum offloading. Using sex, age, weight, height, and shoe-size as covariates correctly predicted the cushioning stiffness that minimised peak pressure across the entire foot, or specifically in the metatarsal heads, midfoot and heel regions in 70%, 72%, 83% and 66% of participants respectively. CONCLUSIONS: Increased plantar loading is associated with the need for stiffer cushioning materials for maximum offloading. Patient-specific optimum cushioning stiffness can be predicted using five simple demographic/anthropometric parameters. These results open the way for methods to optimise cushioning stiffness as part of clinical practice.

A quantitative analysis of optimum design for rigid ankle foot orthoses: The effect of thickness and reinforcement design on stiffness.

BACKGROUND: An ankle foot orthosis (AFO) which is prescribed to be rigid should only deform a small amount to achieve its clinical goals. Material thickness and the design of reinforcing features can significantly affect AFO rigidity, but their selection remains based on anecdotal evidence. OBJECTIVES: To quantify the effect of these parameters on AFO stiffness and to set the basis for quantitative guidelines for the design optimisation of rigid AFOs. STUDY DESIGN: Experimental and computational study. METHODS: A polypropylene AFO was produced according to UK standard practice and its stiffness was experimentally measured for 30Nm of dorsiflexion. Its geometry and mechanical characteristics were utilised to create a finite element (FE) model of a typical AFO prescribed to be rigid. Following validation, the model was used to quantify the effect of material thickness and reinforcement design (i.e., reinforcement placement, length) on stiffness. A final set of AFO samples was produced to experimentally confirm key findings. RESULTS AND CONCLUSIONS: For a specific AFO geometry and loading magnitude, there is a thickness threshold below which the AFO cannot effectively resist flexion and buckles. FE modelling showed that stiffness is maximised when reinforcements are placed at the anterior-most position possible. This key finding was also experimentally confirmed. The stiffness of an AFO reinforced according to standard practice with lateral and medial ribbing was 4.4 ± 0.1 Nm/degree. Instructing the orthotic technician to move the ribbings anteriorly increased stiffness by 22%. Further stiffening is achieved by ensuring the reinforcements extend from the footplate to at least two-thirds of the AFO's total height.

Shore hardness is a more representative measurement of bulk tissue biomechanics than of skin biomechanics.

To support the effective use of Shore hardness (SH) in research and clinical practice this study investigates whether SH should be interpreted as a measurement of skin or of bulk tissue biomechanics. A 3D finite element model of the heel and a validated model of a Shore-00 durometer were used to simulate testing for different combinations of stiffness and thickness in the skin and subcutaneous tissue. The results of this numerical analysis showed that SH is significantly more sensitive to changes in skin thickness, relatively to subcutaneous tissue, but equally sensitive to changes in the stiffness of either tissue. Indicatively, 25% reduction in skin thickness (0.3 mm thickness change) or in subcutaneous tissue thickness (5.9 mm thickness change), reduced SH by 7% or increased SH by 2% respectively. At the same time, 25% reduction in skin stiffness (10.1 MPa change in initial shear modulus) or of subcutaneous tissue (4.1 MPa change in initial shear modulus) led to 11% or 8% reduction in SH respectively. In the literature, SH is commonly used to study skin biomechanics. However, this analysis indicates that SH quantifies the deformability of bulk tissue, not of skin. Measurements of skin thickness are also necessary for the correct interpretation of SH.

An in vivo model for overloading-induced soft tissue injury.

This proof-of-concept study demonstrates that repetitive loading to the pain threshold can safely recreate overloading-induced soft tissue damage and that localised tissue stiffening can be a potential marker for injury. This concept was demonstrated here for the soft tissue of the sole of the foot where it was found that repeated loading to the pain threshold led to long-lasting statistically significant stiffening in the overloaded areas. Loading at lower magnitudes did not have the same effect. This method can shed new light on the aetiology of overloading injury in the foot to improve the management of conditions such as diabetic foot ulceration and heel pain syndrome. Moreover, the link between overloading and tissue stiffening, which was demonstrated here for the first time for the plantar soft tissue, opens the way for an assessment of overloading thresholds that is not based on the subjective measurement of pain thresholds.

A novel concept for low-cost non-electronic detection of overloading in the foot during activities of daily living.

Identifying areas in the sole of the foot which are routinely overloaded during daily living is extremely important for the management of the diabetic foot. This work showcases the feasibility of reliably detecting overloading using a low-cost non-electronic technique. This technique uses thin-wall structures that change their properties differently when they are repeatedly loaded above or below a tuneable threshold. Flexible hexagonal thin-wall structures were produced using three-dimensional printing, and their mechanical behaviour was assessed before and after repetitive loading at different magnitudes. These structures had an elastic mechanical behaviour until a critical pressure (P crit = 252 kPa ± 17 kPa) beyond which they buckled. Assessing changes in stiffness after simulated use enabled the accurate detection of whether a sample was loaded above or below P crit (sensitivity = 100%, specificity = 100%), with the overloaded samples becoming significantly softer. No specific P crit value was targeted in this study. However, finite-element modelling showed that P crit can be easily raised or lowered, through simple geometrical modifications, to become aligned with established thresholds for overloading (e.g. 200 kPa) or to assess overloading thresholds on a patient-specific basis. Although further research is needed, the results of this study indicate that clinically relevant overloading could indeed be reliably detected without the use of complex electronic in-shoe sensors.

Reliability and validity of an enhanced paper grip test; A simple clinical test for assessing lower limb strength.

BACKGROUND: The paper-grip-test (PGT) involves pulling a small card from underneath the participant's foot while asking them to grip with their hallux. The PGT is shown to be effective in detecting foot muscle-weakening but its outcome is operator-dependent. To overcome this limitation, an enhanced PGT (EPGT) is proposed that replaces the pass/fail outcome of the PGT with a continuous measurement of the pulling force that is needed to remove the card (EPGT-force). RESEARCH QUESTION: Is the EPGT-force an accurate, reliable and clinically applicable measurement of strength? METHODS: Reliability and clinical applicability were examined in two ways. Firstly, two examiners measured EPGT-force for twenty healthy volunteers in a test/retest set-up. EPGT force was measured using a dynamometer, the hallux grip force was measured using a pressure mat. The clinical applicability of the EPGT was tested in ten people with diabetes. Postural sway was also measured. RESULTS: Interclass correlation coefficients (ICC) revealed excellent inter-rater reliability (ICC > 0.75). Intra-rater reliability was excellent for the first examiner (ICC = 0.795) and good for the second (ICC = 0.703). Linear regression analysis indicated that hallux grip force accounted (on average) for 83 %±4 % of the variability in EPGT force. This strong relationship between EPGT force and hallux grip force remained when the test was performed in a clinical setting with the latter accounting for 88 % in EPGT force variability. Spearman rank order correlation showed that people with diabetes with a higher difference in EPGT force between limbs swayed more. SIGNIFICANCE: EPGT force is a reliable and accurate measurement of hallux grip force. Hallux grip force was previously found to be strongly correlated to the strength of all muscle groups of the foot and ankle and to the ability to maintain balance. The proposed EPGT could be used to monitor muscle weakness in clinics for better falls-risk assessment.

Comparative study of the strength characteristics of a novel wood-plastic composite and commonly used synthetic casting materials.

BACKGROUND: Woodcast® is a wood-plastic composite casting material that becomes pliable and self-adhesive when heated to 65 °C and returns to being weightbearing as it cools down. The present study aims to test whether this novel non-toxic casting material is strong enough for clinical use by comparing its strength against materials that are already used in weightbearing casting applications such as total contact casts. METHODS: The strength of Woodcast® samples was compared against the strength of two commonly used synthetic casting materials (Delta-Cast®, OrthoTape). The effect of environmental factors such as cooling, prolonged heating and exposure to water was also assessed. FINDINGS: The results of this study indicated that Woodcast® is stronger than the synthetic casting materials in compression but weaker in tension. The flexural strength of Woodcast® was 14.24 MPa (±1.25 MPa) while the respective strength of Delta-Cast® and OrthoTape was 18.96 MPa (±7.46 MPa) and 12.93 MPa (±1.93 MPa). Independent samples t-test indicated that the difference between Woodcast® and the other two materials was not statistically significant (P > .05). Woodcast® recovered 90% and 78% of its tensile or flexural strength respectively after 15 min of cooling at ambient temperature and its strength was not reduced by prolonged heating. On average, exposure to water reduced the flexural strength of Delta-Cast® by 6% and of OrthoTape by 44%. The strength of Woodcast® was not affected by exposure to water. INTERPRETATION: The comparison between Woodcast® and commonly used synthetic casting materials indicated that Woodcast® is indeed strong enough to be safely used in weightbearing casting applications.

Optimised cushioning in diabetic footwear can significantly enhance their capacity to reduce plantar pressure.

BACKGROUND: Plantar pressure reduction with the use of cushioning materials play an important role in the clinical management of the diabetic foot. Previous studies in people without diabetes have shown that appropriate selection of the stiffness of such materials can significantly enhance their capacity to reduce pressure. However the significance of optimised cushioning has not been yet assessed for people with diabetic foot syndrome. RESEARCH QUESTION: What is the potential benefit of using footwear with optimised cushioning, with regards to plantar pressure reduction, in people with diabetes and peripheral neuropathy? METHODS: Plantar pressure distribution was measured during walking for fifteen people with diabetic foot syndrome in a cohort observational study. The participants were asked to walk in the same type of footwear that was fitted with 3D-printed footbeds. These footbeds were used to change the stiffness of the entire sole-complex of the shoe; from very soft to very stiff. The stiffness that achieved the highest pressure reduction relative to a no-footbed condition was identified as the patient-specific optimum one. RESULTS: The use of the patient-specific optimum stiffness reduced, on average, peak pressure by 46% (±14%). Using the same stiffness across all participants lowered the footwears' capacity for pressure reduction by at least nine percentile points (37% ±â€¯17%); a statistically significant difference (paired samples t-test, t(13) = -3.733, p = 0.003, d = 0.997). Pearson correlation analysis indicated that patient-specific optimum stiffness was significantly correlated with the participants' body mass index (BMI), with stiffer materials needed for people with higher BMI (rs(14) = 0.609, p = 0.021). SIGNIFICANCE: This study offers the first quantitative evidence in support of optimising cushioning in diabetic footwear as part of standard clinical practice. Further research is needed to develop a clinically applicable method to help professionals working with diabetic feet identify the optimum cushioning stiffness on a patient-specific basis.

The relationship between hallux grip force and balance in people with diabetes.

BACKGROUND: Diabetes accelerates the decline in muscle strength in older people and substantially increases the risk for fall and injury. Weakening of lower extremity muscles, in particular, is a strong predictor for falls, but currently there is no established method for its assessment in clinics. The paper grip test (PGT) offers a qualitative assessment of hallux plantar flexor strength and its usefulness for predicting falls has been demonstrated in non-diabetic populations. RESEARCH QUESTION: The aim of this study is to test whether the PGT can be used for a quantitative assessment of lower-extremity strength and to investigate its relationship with isometric muscle strength and balance in people with diabetes and peripheral neuropathy. METHODS: Isometric muscle strength of all muscle groups of the foot-ankle was assessed using a dynamometer in sixty-nine people with diabetes and neuropathy. Postural sway and the gripping force exerted by the participants during the PGT was measured for the same participants using a plantar pressure assessment system. These measurements were repeated in regular intervals for 18 months in a longitudinal observational cohort study. RESULTS: Cross-sectional analysis of baseline data showed that people who failed the PGT swayed more. Analysis of longitudinal data showed that increasing hallux grip force is significantly associated with reduced postural sway. No significant association was found between dynamometry-based measurements of strength and postural sway. Hallux grip force was significantly correlated to the strength of all muscle groups of the foot-ankle complex. SIGNIFICANCE: These results indicate that hallux grip force can assess the strength of the foot-ankle muscles and could potentially be used to identify people at risk of falling. This sets the basis for the development of new screening protocols to assess weakening of the muscles of the foot-ankle and to enhance risk assessment for falls in people with diabetes and peripheral neuropathy.

Localized pressure stimulation using turf-like structures can improve skin perfusion in the foot.

OBJECTIVE: Improving perfusion under the skin can potentially reduce ulceration and amputation risk in people with diabetic foot. Localized pressure stimulation has been proven capable of improving skin perfusion in the scalp but its effectiveness for the foot has not been tested. In this study, localized pressure stimulation was realized using flexible turf-like structures (TLS) with dense vertical fibers and their ability to increase perfusion was assessed. METHODS: The skin in the rearfoot, midfoot, and forefoot of nine healthy volunteers was stimulated using two TLS with different stiffness and one wound filler material that generated a uniform compression. Changes in perfusion were assessed using laser speckle. RESULTS: Mechanical stimulation significantly increased perfusion in the forefoot and midfoot areas with the TLS achieving higher and more long-lasting increase compared to the wound filler. The stiffer of the two TLS appeared to be the most effective for the forefoot achieving a significant increase in perfusion that lasted for 25.5 seconds immediately after stimulation. CONCLUSION: The results of this study indicate that localized pressure stimulation is more effective compared to uniform compression for improving skin perfusion in the healthy foot. Further research in people with diabetic foot disease is needed to verify the clinical value of the observed effect.

Shear wave elastography can assess the in-vivo nonlinear mechanical behavior of heel-pad.

This study combines non-invasive mechanical testing with finite element (FE) modelling to assess for the first time the reliability of shear wave (SW) elastography for the quantitative assessment of the in-vivo nonlinear mechanical behavior of heel-pad. The heel-pads of five volunteers were compressed using a custom-made ultrasound indentation device. Tissue deformation was assessed from B-mode ultrasound and force was measured using a load cell to calculate the force - deformation graph of the indentation test. These results were used to design subject specific FE models and to inverse engineer the tissue's hyperelastic material coefficients and its stress - strain behavior. SW speed was measured for different levels of compression (from 0% to 50% compression). SW speed for 0% compression was used to assess the initial stiffness of heel-pad (i.e. initial shear modulus, initial Young's modulus). Changes in SW speed with increasing compressive loading were used to quantify the tissue's nonlinear mechanical behavior based on the theory of acoustoelasticity. Statistical analysis of results showed significant correlation between SW-based and FE-based estimations of initial stiffness, but SW underestimated initial shear modulus by 64%(±16). A linear relationship was found between the SW-based and FE-based estimations of nonlinear behavior. The results of this study indicate that SW elastography is capable of reliably assessing differences in stiffness, but the absolute values of stiffness should be used with caution. Measuring changes in SW speed for different magnitudes of compression enables the quantification of the tissue's nonlinear behavior which can significantly enhance the diagnostic value of SW elastography.

A Simulation of the Viscoelastic Behaviour of Heel Pad During Weight-Bearing Activities of Daily Living.

Internal strain is known to be one of the contributors to plantar soft tissue damage. However, due to challenges related to measurement techniques, there is a paucity of research investigating the strain within the plantar soft tissue during daily weight-bearing activities. Therefore, the main aim of this study was to develop a non-invasive method for predicting heel pad strain during loading. An ultrasound indentation technique along with a mathematical model was employed to calculate visco-hyperelastic structural coefficients from the results of cyclic-dynamic indentation and stress-relaxation tests. Subject-specific structural coefficients of heel pads were calculated from twenty participants along with the assessment of plantar pressure. The average difference between the predicted and the measured force during the cyclic-dynamic indentation test was only 5.8%. Moreover, the average difference between the predicted and the in vivo strain during walking was 14%. No statistically significant correlation was observed between maximum strain and peak plantar pressure during walking; indicating that the measurement of strain along with plantar pressure can improve our understanding of the mechanical behaviour of the plantar soft tissue.

Supplementary medial locking plate fixation of Ludloff osteotomy versus sole lag screw fixation: A biomechanical evaluation.

BACKGROUND: The Ludloff oblique osteotomy is inherently unstable, which might lead to delayed union and loss of correction. Supplementary fixation to two lag screw fixation has been proposed. The hypothesis is that the osteotomy fixation constructs supplemented by a mini locking plate provide greater resistance to osteotomy gaping and loss of angular correction in response to cyclic loading. METHODS: Twenty fourth generation composite 1st metatarsals were used and underwent a Ludloff osteotomy. They were divided in two fixation groups: two lag screws (Group A), and with a supplementary mini locking plate (Group B). Specimens were subjected to either monotonic loading up to failure or to fatigue (cyclic) tests and tracked using an optical system for 3D Digital Image Correlation. FINDINGS: The osteotomy gap increased in size under maximum loading and was significantly greater in Group A throughout the test. This increase was observed very early in the loading process (within the first 1000cycles). The most important finding though, was that with the specimens completely unloaded the residual gap increase was significantly greater in Group A after only 5000cycles of loading up to the completion of the test. The lateral angle change under maximum loading was also significantly greater in Group A throughout the test, with that increase observed early in the loading process (5000cycles). With the specimens completely unloaded the residual lateral angle change was also significantly greater in Group A at the completion of the test. INTERPRETATION: Supplementary fixation with a mini locking plate of the Ludloff osteotomy provided greater resistance to osteotomy gaping and loss of angular correction compared to sole lag screws, in response to cyclic loading.

Subject Specific Optimisation of the Stiffness of Footwear Material for Maximum Plantar Pressure Reduction.

Current selection of cushioning materials for therapeutic footwear and orthoses is based on empirical and anecdotal evidence. The aim of this investigation is to assess the biomechanical properties of carefully selected cushioning materials and to establish the basis for patient-specific material optimisation. For this purpose, bespoke cushioning materials with qualitatively similar mechanical behaviour but different stiffness were produced. Healthy volunteers were asked to stand and walk on materials with varying stiffness and their capacity for pressure reduction was assessed. Mechanical testing using a surrogate heel model was employed to investigate the effect of loading on optimum stiffness. Results indicated that optimising the stiffness of cushioning materials improved pressure reduction during standing and walking by at least 16 and 19% respectively. Moreover, the optimum stiffness was strongly correlated to body mass (BM) and body mass index (BMI), with stiffer materials needed in the case of people with higher BM or BMI. Mechanical testing confirmed that optimum stiffness increases with the magnitude of compressive loading. For the first time, this study provides quantitative data to support the importance of stiffness optimisation in cushioning materials and sets the basis for methods to inform optimum material selection in the clinic.

A clinically applicable non-invasive method to quantitatively assess the visco-hyperelastic properties of human heel pad, implications for assessing the risk of mechanical trauma.

INTRODUCTION: Pathological conditions such as diabetic foot and plantar heel pain are associated with changes in the mechanical properties of plantar soft tissue. However, the causes and implications of these changes are not yet fully understood. This is mainly because accurate assessment of the mechanical properties of plantar soft tissue in the clinic remains extremely challenging. PURPOSE: To develop a clinically viable non-invasive method of assessing the mechanical properties of the heel pad. Furthermore the effect of non-linear mechanical behaviour of the heel pad on its ability to uniformly distribute foot-ground contact loads in light of the effect of overloading is also investigated. METHODS: An automated custom device for ultrasound indentation was developed along with custom algorithms for the automated subject-specific modeling of heel pad. Non-time-dependent and time-dependent material properties were inverse engineered from results from quasi-static indentation and stress relaxation test respectively. The validity of the calculated coefficients was assessed for five healthy participants. The implications of altered mechanical properties on the heel pad's ability to uniformly distribute plantar loading were also investigated in a parametric analysis. RESULTS: The subject-specific heel pad models with coefficients calculated based on quasi-static indentation and stress relaxation were able to accurately simulate dynamic indentation. Average error in the predicted forces for maximum deformation was only 6.6±4.0%. When the inverse engineered coefficients were used to simulate the first instance of heel strike the error in terms of peak plantar pressure was 27%. The parametric analysis indicated that the heel pad's ability to uniformly distribute plantar loads is influenced both by its overall deformability and by its stress-strain behaviour. When overall deformability stays constant, changes in stress/strain behaviour leading to a more "linear" mechanical behaviour appear to improve the heel pad's ability to uniformly distribute plantar loading. CONCLUSIONS: The developed technique can accurately assess the visco-hyperelastic behaviour of heel pad. It was observed that specific change in stress-strain behaviour can enhance/weaken the heel pad's ability to uniformly distribute plantar loading that will increase/decrease the risk for overloading and trauma.

A mathematical method for quantifying in vivo mechanical behaviour of heel pad under dynamic load.

Mechanical behaviour of the heel pad, as a shock attenuating interface during a foot strike, determines the loading on the musculoskeletal system during walking. The mathematical models that describe the force deformation relationship of the heel pad structure can determine the mechanical behaviour of heel pad under load. Hence, the purpose of this study was to propose a method of quantifying the heel pad stress-strain relationship using force-deformation data from an indentation test. The energy input and energy returned densities were calculated by numerically integrating the area below the stress-strain curve during loading and unloading, respectively. Elastic energy and energy absorbed densities were calculated as the sum of and the difference between energy input and energy returned densities, respectively. By fitting the energy function, derived from a nonlinear viscoelastic model, to the energy density-strain data, the elastic and viscous model parameters were quantified. The viscous and elastic exponent model parameters were significantly correlated with maximum strain, indicating the need to perform indentation tests at realistic maximum strains relevant to walking. The proposed method showed to be able to differentiate between the elastic and viscous components of the heel pad response to loading and to allow quantifying the corresponding stress-strain model parameters.

A method for subject-specific modelling and optimisation of the cushioning properties of insole materials used in diabetic footwear.

This study aims to develop a numerical method that can be used to investigate the cushioning properties of different insole materials on a subject-specific basis. Diabetic footwear and orthotic insoles play an important role for the reduction of plantar pressure in people with diabetes (type-2). Despite that, little information exists about their optimum cushioning properties. A new in-vivo measurement based computational procedure was developed which entails the generation of 2D subject-specific finite element models of the heel pad based on ultrasound indentation. These models are used to inverse engineer the material properties of the heel pad and simulate the contact between plantar soft tissue and a flat insole. After its validation this modelling procedure was utilised to investigate the importance of plantar soft tissue stiffness, thickness and loading for the correct selection of insole material. The results indicated that heel pad stiffness and thickness influence plantar pressure but not the optimum insole properties. On the other hand loading appears to significantly influence the optimum insole material properties. These results indicate that parameters that affect the loading of the plantar soft tissues such as body mass or a person's level of physical activity should be carefully considered during insole material selection.