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Background: there is a high risk of falls in older adults. One of the factors contributing to fall episodes is advancing age due to deterioration of the proprioceptive system. Certain clinical procedures improve balance and posture, such as the use of insoles. Objective: the objective of this study was to evaluate the impact of hard and soft insoles on static foot balance in healthy older adults compared to barefoot people. Methods: a clinical trial was conducted with a sample size of 150 healthy adults (69 male and 81 women) with a mean age of 69.03 ± 3.82 years. Postural control was evaluated in different conditions of barefoot balance with hard and soft insoles. Results: All tests were statistically significant (p < 0.001). The test with soft insoles presented higher stabilometric values and presented worse postural control compared to the barefoot and hard insoles in all eyes-open and eyes-closed conditions. Conclusions: Hard and soft insoles show no improvement in postural control compared to barefoot standing. The findings suggest that soft insoles may result in impaired balance during standing. The density of the materials in the insoles emerges as a significant factor influencing postural control. [ABSTRACT FROM AUTHOR]

Background: Flatfoot deformity is a common condition in children and teenagers that may increase the risk of knee, hip, and back pain. Most of the insoles suggested to treat flatfoot symptoms are not designed to adapt to foot temperature during walking, and they are either too soft to provide support or hard enough to be uncomfortable. Purpose: This study aims to develop an advanced solution to diagnose and treat flexible flatfoot (FFT) using infrared thermography measurements and a hybrid insole reinforced by nitinol (NiTiCu) smart-memory-alloy wires (SMAWs), this super-elastic alloy can return back to its pre-deformed shape when heated, which helps to reduce the local high-temperature points caused by the uneven pressure of FFT. This approach achieves a more uniform thermal distribution across the foot, which makes the hybrid insole more comfortable. Methods: The study involved 16 subjects, divided into two groups of eight flat-footed and eight normal. The procedure includes two parts, namely, designing a prototype insole with SMAW properties based on thermography measurement by using SolidWorks, and evaluating this design using Ansys. Second, a hybrid insole reinforced with SMAWs is customized for flatfoot subjects. The thermography measurement differences between the medial and lateral sides of the metatarsophalangeal line are compared for the normal and flatfoot groups before and after wearing the suggested design. Results: The results show that our approach safely diagnosed FFT and significantly improved the thermal distribution in FFT subjects by more than 80% after wearing the suggested design. A paired t-test reported significant (p-value > 0.001) thermal decreases in the high-temperature points after using the SMAW insole, which was closely approximated to the normal subjects. Conclusions: the SMAW-reinforced insole is comfortable and suitable for treating FFT deformity, and infrared thermography is an effective tool to evaluate FFT deformity. [ABSTRACT FROM AUTHOR]

Abstract Background Running is a widely practiced sport worldwide associated with a host of benefits on cardiovascular, metabolic, musculoskeletal, and mental health, but often leads to musculoskeletal overuse injuries. The prescription of a foot orthosis (FO) is common to manage musculoskeletal impairments during physical activity or functional tasks. Although FOs are frequently prescribed by clinicians for symptomatic populations of runners, the existing literature supporting the prescription of FOs in runners has predominantly focused on either uninjured individuals or a mix of uninjured and symptomatic populations. Thus, the effects of FOs on the treatment and/or prevention of overuse running injuries need to be investigated to guide future research and assist clinicians in their decision-making process. Main body This scoping review aimed to evaluate the immediate and long-term effects of FOs on lower limb biomechanics, neuromuscular parameters, and pain and disability in symptomatic runners, and to identify factors that may influence the effects of FOs. Five databases (CINAHL, SPORTDiscus, MEDLINE, Embase, and Web of Science) were searched, resulting in 2536 studies. A total of 30 studies, published between 1992 and 2023 (730 symptomatic runners), were included following the removal of duplicates and the screening process. Wearing FOs while running is related to an immediate and a long-term decrease in pain and symptoms of overuse running injuries. Also, wearing FOs while running decreases eversion at the foot/ankle complex, leads to a more lateral plantar pressure at the heel and forefoot, and may change running motor control strategies. Finally, the effectiveness of FOs is influenced by its added features. Conclusions This study provides recommendations for future research such as the need for standardized methods in describing FOs, considering participant characteristics such as foot morphology, and comparing different types of FOs. Also, this scoping review provides valuable insights for guiding the prescription and design of FOs, and suggests that integrating FOs into a comprehensive treatment plan may yield better results than standalone first-line treatments. Nonetheless, this scoping review highlights the need for future research to explore the optimal integration of FOs into injury-specific treatment plans.

Background: Running is a widely practiced sport worldwide associated with a host of benefits on cardiovascular, metabolic, musculoskeletal, and mental health, but often leads to musculoskeletal overuse injuries. The prescription of a foot orthosis (FO) is common to manage musculoskeletal impairments during physical activity or functional tasks. Although FOs are frequently prescribed by clinicians for symptomatic populations of runners, the existing literature supporting the prescription of FOs in runners has predominantly focused on either uninjured individuals or a mix of uninjured and symptomatic populations. Thus, the effects of FOs on the treatment and/or prevention of overuse running injuries need to be investigated to guide future research and assist clinicians in their decision-making process. Main body: This scoping review aimed to evaluate the immediate and long-term effects of FOs on lower limb biomechanics, neuromuscular parameters, and pain and disability in symptomatic runners, and to identify factors that may influence the effects of FOs. Five databases (CINAHL, SPORTDiscus, MEDLINE, Embase, and Web of Science) were searched, resulting in 2536 studies. A total of 30 studies, published between 1992 and 2023 (730 symptomatic runners), were included following the removal of duplicates and the screening process. Wearing FOs while running is related to an immediate and a long-term decrease in pain and symptoms of overuse running injuries. Also, wearing FOs while running decreases eversion at the foot/ankle complex, leads to a more lateral plantar pressure at the heel and forefoot, and may change running motor control strategies. Finally, the effectiveness of FOs is influenced by its added features. Conclusions: This study provides recommendations for future research such as the need for standardized methods in describing FOs, considering participant characteristics such as foot morphology, and comparing different types of FOs. Also, this scoping review provides valuable insights for guiding the prescription and design of FOs, and suggests that integrating FOs into a comprehensive treatment plan may yield better results than standalone first-line treatments. Nonetheless, this scoping review highlights the need for future research to explore the optimal integration of FOs into injury-specific treatment plans. Key Points: Foot orthoses may redistribute loads onto non-injured structures, thereby resulting in an immediate decrease in pain and potentially contributing to the treatment of injuries. A rearfoot medial wedge decreases rearfoot and/or calcaneal eversion motion and moments in injured runners. A foot orthosis integrated into a comprehensive treatment plan may yield better results compared to standalone first-line treatments. The use of sham/flat insoles as a control/blinding condition is crucial in evaluating the effect of a foot orthosis. [ABSTRACT FROM AUTHOR]

Diabetic foot syndrome is a syndrome of specific conditions affecting the foot. It is a complication of diabetes. It occurs in 12–25% of patients with diabetes. Untreated, it leads to irreversible deformities and necrosis of the foot, often resulting in amputation. In this study the statistics and consequences of diabetic foot syndrome are described. Patients with diabetes need to take care of their lower limbs. Proper footwear can prevent foot wounds. Available solutions for the prevention and treatment of diabetic foot syndrome are presented herein: footwear, insoles and requirements for footwear materials. Appropriate equipment for a person with diabetes, especially one who has been diagnosed with diabetic foot syndrome or is at risk of such a condition, includes footwear and replaceable insoles. The parameters of footwear, insoles and footwear materials that are most optimal for patients with diabetes and diabetic foot syndrome were defined. The effect of a pulsed electromagnetic field and pulsed ultrasound on diabetic foot problems was evaluated. [ABSTRACT FROM AUTHOR]

Background: Three-dimensional motion analysis using optoelectronic cameras and force platforms is typically used to quantify gait disorders. However, these systems have various limitations, particularly when assessing patients in an ecological environment. To address these limitations, several wearable devices have been developed. However, few studies have reported metrological information regarding their repeatability and sensitivity to change. Methods: A healthy adult performed 6 min walking tests with FeetMe® system insoles under different walking conditions overground and on a treadmill. The standard error of measurement (SEM), the minimum detectable differences (MDDs), and the effect size (ES) were calculated for spatio-temporal parameters, and the ground reaction force was calculated from the 16,000 steps recorded. Results: SEM values were below 3.9% for the ground reaction force and below 6.8% for spatio-temporal parameters. ES values were predominantly high, with 72.9% of cases between overground and treadmill conditions with induced asymmetry, and 64.5% of cases between treadmill conditions with and without induced asymmetry exhibiting an ES greater than 1.2. The minimum detectable differences ranged from 4.5% to 10.7% for ground reaction forces and 2.1% to 18.9% for spatio-temporal parameters. Conclusion: Our study demonstrated that the FeetMe® system is a reliable solution. The sensitivity to change showed that these instrumented insoles can effectively reflect patient asymmetry and progress. [ABSTRACT FROM AUTHOR]

Comfort is among the priorities of wearers, this creates a requirement to understand and measure footwear comfort within the real-world where footwear is being used. Comfort is subjective however associations have been drawn to biomechanical parameters. Prediction of real-world footwear or insole comfort based upon biomechanical parameters is appealing due to the reduction of potential participant biases. This study aims to develop an equation to predict insole comfort from real-world biomechanics data. Five conditions were evaluated, a control (participant shoe only) and four commercially available insole conditions (Insole A, B, C, D). The RunScribe IMU was worn for one day per condition for the participants normal daily activity, measuring previously validated variables: vertical ground reaction force (GRF), vertical GRF loading rate (GRFr), impact shock (IS), braking shock, total shock, pronation excursion (PE), and maximum pronation velocity (PV). Comfort was measured using a 100 mm visual analogue scale (VAS). A mixed model with fixed effects was used to develop the comfort equation, pseudo r2 statistics were assessed to identify the best equation. All combinations of conditions were tested from single conditions to all 5 together. The following equation was defined using data from insole A and insole B: Comfort = 96.557 + (−0.456*GRFr) + (−11.757*IS) + (−2.869*PE) + (0.142*PV). Marginal pseudo r2 = 0.175 and conditional pseudo r2 = 0.675, meaning that 17.5% of the variance in comfort was explained by the biomechanics variables. Previous footwear comfort equations focused on different biomechanics variables including EMG, plantar pressure, loading rates and lower limb kinematics and reported larger explained variance (34.9%–71.4%). Additional variables would be required to improve the current equation; however, it provides insight into how comfort could be improved for usage within product development, as well as measuring comfort during testing. [ABSTRACT FROM AUTHOR]

Abstract Introduction Therapeutic offloading devices, including insoles, shoes, and other orthoses, are some of the most commonly used interventions to treat or prevent diabetic foot ulceration. Custom-made offloading devices are increasingly used to offset the development of foot ulcers. However, whether these devices are more effective than prefabricated standard offloading devices is uncertain. Therefore, this systematic review collates and examines evidence on the efficacy of custom-made offloading devices in preventing foot ulcer incidence and recurrence in people diagnosed with diabetes. Methods Five scientific databases were searched, covering 2011–2023. Initial searches and screening were carried out independently by two researchers. Studies meeting the inclusion criteria were further examined through additional screenings, and critical appraisal. Data relevant to the review aims were extracted and analysed within a narrative synthesis. Results Of the 1,715 articles found in the initial searches, nine papers were found to meet inclusion criteria and were included in the review. The evidence shows that custom-made offloading devices are likely to be more effective for reducing or preventing diabetic foot ulcers than standard offloading devices. However, due to a lack of data it remains uncertain whether custom-made offloading devices are more cost-effective for preventing ulceration compared to standard insoles. Likewise, due to measurement heterogeneity between studies and lack of data, it is unclear whether adherence is higher in users of custom-made offloading devices, and whether such devices deliver significantly greater reductions in peak pressure as compared to standard offloading devices. Conclusion Custom-made offloading devices are more effective than standard devices for preventing diabetic foot ulceration, and we recommended their use when feasible; however, there remains uncertainty regarding their cost-effectiveness compared to standard insoles and offloading devices.

Background: Footwear, orthoses, and insoles have been shown to influence balance in older adults; however, it remains unclear which features, singular or in combination, are considered optimal. The aim of this scoping review was to identify and synthesise the current evidence regarding how footwear, orthoses, and insoles influence balance in older adults. Four electronic databases (MEDLINE, CINAHL, Embase, and AMED) were searched from inception to October 2023. Key terms such as "shoe*," "orthoses," "postural balance" and "older people" were employed in the search strategy. Studies meeting the following criteria were included: (i) participants had a minimum age ≥60 years, and were free of any neurological, musculoskeletal, and cardiovascular diseases; (ii) an active intervention consisting of footwear, foot orthoses, or insoles was evaluated; and (iii) at least one objective outcome measure of balance was reported. Summary: A total of 56 studies from 17 different countries were included. Three study designs were utilised (cross-sectional study, n = 44; randomised parallel group, n = 6; cohort study n = 6). The duration of studies varied considerably, with 41 studies evaluating immediate effects, 14 evaluating effects from 3 days to 12 weeks, and 1 study having a duration of 6 months. Seventeen different interventions were evaluated, including/consisting of textured insoles (n = 12), heel elevation (n = 8), non-specific standardised footwear and changes in sole thickness or hardness (n = 7 each), sole geometry or rocker soles, contoured or custom insoles and high collar height (n = 6 each), insole thickness or hardness and vibrating insoles (n = 5 each), outsole tread (n = 4), minimalist footwear and slippers (n = 3 each), balance-enhancing shoes, footwear fit, socks, and ankle-foot orthoses (n = 2 each), and eversion insoles, heel cups, and unstable footwear (n = 1 each). Twenty-three different outcomes were assessed, and postural sway was the most common (n = 20), followed by temporo-spatial gait parameters (n = 17). There was uncertainty regarding intervention effectiveness. Overall, features such as secure fixation, a textured insole, a medium-to-hard density midsole and a higher ankle collar, in isolation, were able to positively impact balance. Conversely, footwear with an elevated heel height and the use of socks and slippers impaired balance. Key Messages: There is a substantial body of literature exploring the effects of footwear, orthoses, and insoles on balance in older adults. However, considerable uncertainty exists regarding the efficacy of these interventions due to variability in methodological approaches. Further high-quality research is necessary to determine whether a singular intervention or a combination of interventions is most effective for enhancing balance in older adults. [ABSTRACT FROM AUTHOR]

Introduction: Therapeutic offloading devices, including insoles, shoes, and other orthoses, are some of the most commonly used interventions to treat or prevent diabetic foot ulceration. Custom-made offloading devices are increasingly used to offset the development of foot ulcers. However, whether these devices are more effective than prefabricated standard offloading devices is uncertain. Therefore, this systematic review collates and examines evidence on the efficacy of custom-made offloading devices in preventing foot ulcer incidence and recurrence in people diagnosed with diabetes. Methods: Five scientific databases were searched, covering 2011–2023. Initial searches and screening were carried out independently by two researchers. Studies meeting the inclusion criteria were further examined through additional screenings, and critical appraisal. Data relevant to the review aims were extracted and analysed within a narrative synthesis. Results: Of the 1,715 articles found in the initial searches, nine papers were found to meet inclusion criteria and were included in the review. The evidence shows that custom-made offloading devices are likely to be more effective for reducing or preventing diabetic foot ulcers than standard offloading devices. However, due to a lack of data it remains uncertain whether custom-made offloading devices are more cost-effective for preventing ulceration compared to standard insoles. Likewise, due to measurement heterogeneity between studies and lack of data, it is unclear whether adherence is higher in users of custom-made offloading devices, and whether such devices deliver significantly greater reductions in peak pressure as compared to standard offloading devices. Conclusion: Custom-made offloading devices are more effective than standard devices for preventing diabetic foot ulceration, and we recommended their use when feasible; however, there remains uncertainty regarding their cost-effectiveness compared to standard insoles and offloading devices. [ABSTRACT FROM AUTHOR]

Background: For children with Osteogenesis Imperfecta (OI), a rare genetic bone disease, walking can be difficult to carry out due to a combination of bone fragility and deformity, muscle weakness, joint hypermobility, and pain. Bisphosphonate treatment has facilitated more children being able to walk, but for many, foot and ankle hypermobility is a limiting factor. Current evidence on foot orthoses in children with OI is sparse. This study aimed to evaluate gait characteristics in children with OI walking barefoot as compared to walking with foot orthoses. Methods: Twenty-three children with OI and hypermobility (mean age 8.3 ± 3.0 years) were included in this cross-sectional study. Children conducted three-dimensional gait analysis barefoot, and with foot orthoses and appropriate foot wear (stable yet light-weight), respectively. Walking speed, step length, lower limb kinematics and kinetics were collected. Differences in gait characteristics between test conditions were evaluated using paired sample t-tests. Results: When walking with foot orthoses, the external foot progression angle was reduced, peak ankle dorsiflexion angle increased, and peak plantarflexion moment increased as compared to barefoot. No difference was found in walking speed between test conditions, however, children with OI walked with longer steps with foot orthoses as compared to barefoot. Conclusion: The observed gait alterations suggest that foot orthoses, aiming to support the foot and ankle joint, contributed to reduced overall foot rotation as measured by external foot progression, increased peak plantarflexion moment, and increased step length. In a wider perspective, the ability to walk provides the opportunity to be physically active, and thereby increase skeletal loading and prevent fractures, thus, foot orthoses may be an important treatment option to consider in children with OI. Level of evidence: III. [ABSTRACT FROM AUTHOR]

The use of custom-made foot orthoses has been associated with numerous benefits, such as decreased impact accelerations. However, it is not known whether this effect could be due to better customisation. The present study analysed the effects of the first generation of a microwavable prefabricated self-customised foot orthosis vs. a prefabricated standard one on impact accelerations throughout a prolonged run. Thirty runners performed two tests of 30-min running on a treadmill, each one with an orthosis condition. Impact acceleration variables of tibia and head were recorded every 5 min. Microwavable self-customised foot orthosis increased the following variables in the first instants compared to the prefabricated standard one: tibial peak (min1: 6.5 (1.8) vs. 6.0 (1.7) g, P =.009, min5: 6.6 (1.7) vs. 6.2 (1.7) g, P =.035), tibial magnitude (min1: 8.3 (2.6) vs. 7.7 (2.4) g, P =.030, min5: 8.5 (2.6) vs. 7.9 (2.5) g, P =.026) and shock attenuation (min1: 61.4 (16.8) vs. 56.3 (16.3)%, P =.014, min5: 62.0 (15.5) vs. 57.2 (15.3)%, P =.040), and tibial rate throughout the entire run (504.3 (229.7) vs. 422.7 (212.9) g/s, P =.006). However, it was more stable throughout 30-min running (P <.05). These results show that the shape customisation entailed by the thermoformable material does not provide impact acceleration improvements. [ABSTRACT FROM AUTHOR]

Introduction: The choice of materials for covering plantar orthoses or wearable insoles is often based on their hardness, breathability, and moisture absorption capacity, although more due to professional preference than clear scientific criteria. An analysis of the thermal response to the use of these materials would provide information about their behavior; hence, the objective of this study was to assess the temperature of three lining materials with different characteristics. Materials and Methods: The temperature of three materials for covering plantar orthoses was analyzed in a sample of 36 subjects (15 men and 21 women, aged 24.6 ± 8.2 years, mass 67.1 ± 13.6 kg, and height 1.7 ± 0.09 m). Temperature was measured before and after 3 h of use in clinical activities, using a polyethylene foam copolymer (PE), ethylene vinyl acetate (EVA), and PE-EVA copolymer foam insole with the use of a FLIR E60BX thermal camera. Results: In the PE copolymer (material 1), temperature increases between 1.07 and 1.85 °C were found after activity, with these differences being statistically significant in all regions of interest (p < 0.001), except for the first toe (0.36 °C, p = 0.170). In the EVA foam (material 2) and the expansive foam of the PE-EVA copolymer (material 3), the temperatures were also significantly higher in all analyzed areas (p < 0.001), ranging between 1.49 and 2.73 °C for EVA and 0.58 and 2.16 °C for PE-EVA. The PE copolymer experienced lower overall overheating, and the area of the fifth metatarsal head underwent the greatest temperature increase, regardless of the material analyzed. Conclusions: PE foam lining materials, with lower density or an open-cell structure, would be preferred for controlling temperature rise in the lining/footbed interface and providing better thermal comfort for users. The area of the first toe was found to be the least overheated, while the fifth metatarsal head increased the most in temperature. This should be considered in the design of new wearables to avoid excessive temperatures due to the lining materials. [ABSTRACT FROM AUTHOR]

The primary objective of this study was to investigate the compressive behavior of 3D-printed specimens made of a thermoplastic polyurethane filament, specifically colorFabb varioShore TPU, which incorporates a foaming agent. The foaming technology makes it possible to manipulate 3D prints' properties by adjusting process parameters that affect the level of expansion, such as printing temperature, printing speed or flow ratio. This capability opens new possibilities for 3D-printed personalized foot orthotics or for static comfort-oriented applications by tailoring the stiffness of the print based on the application requirements. Since infill density and infill pattern also affect the compressive characteristics of 3D prints, this research took these two parameters into account as independent variables, alongside the printing temperature. Thus, the specimens with printing temperatures set at 190 °C, 220 °C, and 240 °C, gyroid and honeycomb patterns, and infill variations from 10 % to 35 % in 5 % increments were experimentally investigated in compression testing. The evaluation was conducted to determine the influence of these factors on the stiffness of prints at 10 % and 20 % strains, in accordance with established standard. The findings had an important practical value as they provide data for adjusting the variable stiffness based on peak plantar pressure measurement data when developing tailored foot orthoses (insoles), which was the second objective of the research. The most influential factor affecting the compressive strength was the printing temperature, followed by infill density and pattern type. The difference in compression modulus between 10 % and 20 % strains did not exhibit statistical significance. Moreover, the main effects plots indicated minimal variations in compression modulus effects at 220 °C and 240 °C, whereas an important difference was observed at 190 °C printing temperature, which was confirmed by scanning electron microscopy investigations showing foamed layers at 220 °C and unfoamed layers at 190 °C. Furthermore, interaction plots revealed no significant interaction effect among the studied variables. Additionally, a comparison of samples’ sizes and densities before and two months after testing indicated no observable modifications When applied to custom orthotics (five pairs of insoles were customized and tested), the experimental findings documented variations in the reduction and distribution of peak plantar pressure based on the infill variability.

Abstract Background The six-minute walk test (6MWT) is widely used to assess functional capacity in patients with various diseases. Use of wearable devices can make this test more accurate and easier to administer, and may even enhance it by providing additional information. The purpose of this study was to evaluate the validity of FeetMe® insoles for assessing the total six-minute walking distance (6MWD) by comparing the FeetMe® estimates and those obtained by a rater to the ground truth measured with a surveyor’s wheel. Results Data were analyzed from healthy volunteers who performed the 6MWT on 10-m and 30-m tracks while wearing FeetMe® insoles (n = 32), and being simultaneously assessed by a rater (n = 33) and followed by an investigator with a surveyor’s wheel. The mean average error (MAE) of the estimates was below 13 m on both tracks for FeetMe®, whereas it ranged from 16.24 m to 38.88 m on the 30-m and 10-m tracks for the rater. Conclusion The FeetMe® insoles provided a more accurate estimate and showed greater agreement with the ground truth than the rater, and the accuracy of the FeetMe® estimates did not vary according to the track length. We conclude that the FeetMe insoles are a valid solution for measuring the 6MWD.

This study examined the effect of foot orthoses used on ground reaction forces, ankle, and knee kinematics when running at preferred and nonpreferred speeds. Sixteen runners ran on instrumented treadmills at various speeds (90%, 100%, and 110% of preferred speed) when wearing arch-support and flat-control orthoses. Two-way repeated analysis of variance (ANOVA) was performed on the mean and coefficient of variation of all variables. Results indicated that arch-support orthoses experienced larger maximum loading rates than flat-control orthoses (P =.017, 95% CI, 2.22 to 19.53). Slower speed was related to smaller loading rates (preferred: P =.002, 95% CI, −17.02 to −4.20; faster: P =.003, 95% CI, −29.78 to −6.17), shorter stride length (preferred: P <.001, 95% CI, −0.204 to −0.090; faster: P <.001, 95% CI, −0.382 to −0.237), and longer contact time (preferred: P <.001, 95% CI, 0.006–0.021; faster: 95% CI, 0.012–0.042). In arch-support condition, preferred speed induced higher stride length coefficient of variation (P =.046, 95% CI, 0.035–1.117) than faster speed, while displaying no differences in flat-control condition. These findings suggest that the use of arch-support orthoses would influence impact loading, but not spatial-temporal and joint kinematics in recreational runners. [ABSTRACT FROM AUTHOR]

Diabetic foot ulcer non-reimbursed treatment depends on multiple factors, including the patient's buying behaviors. Factors affecting buying behaviors for the removable off-loading devices are not completely understood. The aim of this study was to investigate the patients' buying behaviors of the removable off-loading devices and their influence on the DFU treatment outcomes remotely monitored during the COVID-19 pandemic. In this prospective observational study, 45 patients affected by diabetic peripheral neuropathy, with/without peripheral arterial disease, with foot ulcers treated with removable devices were remotely monitored. Prefabricated removable cast walkers, insoles, and therapeutic footwear were the proposed off-loading methods. Patients affected by high blood pressure (p = 0.018), peripheral arterial disease (p = 0.029), past amputations (p = 0.018), and ulcer on the left foot (p = 0.007) bought removable cast walkers. Rural provenience (p = 0.011) and male (p = 0.034) did not buy a removable walker. The healing rate was 69.4%, while the median healing time was 20 weeks. High blood pressure negatively influenced healing time (p = 0.020). Patients who bought the most efficient treatment method for DFUs were females from urban provenience, with amputation in the past, with peripheral arterial disease, and with high blood pressure. [ABSTRACT FROM AUTHOR]

Background: The six-minute walk test (6MWT) is widely used to assess functional capacity in patients with various diseases. Use of wearable devices can make this test more accurate and easier to administer, and may even enhance it by providing additional information. The purpose of this study was to evaluate the validity of FeetMe® insoles for assessing the total six-minute walking distance (6MWD) by comparing the FeetMe® estimates and those obtained by a rater to the ground truth measured with a surveyor's wheel. Results: Data were analyzed from healthy volunteers who performed the 6MWT on 10-m and 30-m tracks while wearing FeetMe® insoles (n = 32), and being simultaneously assessed by a rater (n = 33) and followed by an investigator with a surveyor's wheel. The mean average error (MAE) of the estimates was below 13 m on both tracks for FeetMe®, whereas it ranged from 16.24 m to 38.88 m on the 30-m and 10-m tracks for the rater. Conclusion: The FeetMe® insoles provided a more accurate estimate and showed greater agreement with the ground truth than the rater, and the accuracy of the FeetMe® estimates did not vary according to the track length. We conclude that the FeetMe insoles are a valid solution for measuring the 6MWD. [ABSTRACT FROM AUTHOR]

Chronic ankle instability (CAI) is a prevalent condition characterized by recurring instances of the ankle giving way and persistent symptoms, including pain and diminished function. Foot and ankle external supports are commonly used in clinical practice and research for treating CAI. This systematic review aimed to assess the effects of foot and ankle external supports on the postural stability of individuals with CAI to guide clinical practice and inform future research. A comprehensive search was conducted in PubMed, Web of Science, Scopus, and Google Scholar databases from 1 January 2012 to 1 November 2022. Eighteen studies involving individuals with CAI were chosen in this systematic review. The quality of the included studies and risk of bias were assessed using Cochrane Collaboration's tool for randomized controlled trials, the Newcastle–Ottawa Scale for case–control studies, and the DELPHl-list for crossover trial studies. The external supports included in this review were ankle orthoses (elastic, semi-rigid, and active orthoses), taping (kinesiotaping and fibular reposition taping), and insoles (textured and supportive insoles). The outcome measures included static and dynamic postural stability tests, such as the single-leg stance test, star excursion balance test, Y-balance test, single-leg landing test, lateral jump test, walking test, and running test. The results showed that elastic orthoses, Kinesiotaping, and textured insoles demonstrated potential benefits in improving postural stability in individuals with CAI. Elastic orthoses decreased ankle joint motion variability, kinesiotaping facilitated cutaneous receptors and proprioceptive feedback, while textured insoles increased tactile stimulation and foot position awareness. However, the effects of semi-rigid orthoses, fibular reposition taping, and arch support insoles were inconsistent across studies. Future research should explore the long-term effects of these external supports, analyze the effects of different characteristics and combinations of supports, and employ standardized outcome measures and testing protocols for assessing postural stability. [ABSTRACT FROM AUTHOR]

Purpose : Although flatfoot is a widespread human condition, historical medical texts and ancient illustrations on this deformity are extremely rare. Nowadays, doubts regarding its management remain unsolved. This historical review aims to identify the presence of pes planus since the prehistoric era and examine the treatments proposed over the centuries up to the present. Method: For this propose, we performed an extensive electronic search of the relevant literature, complemented by a manual search of additional sources from archaeological to artistic, literary, historical, and scientific accounts, describing flatfoot and its treatment in different eras. Results: Flatfoot accompanied the evolutionary timeline of human species: from Lucy Australopithecus to Homo Sapiens. It was described among various diseases suffered by Tutankhamun (1343–1324 B.C.), while the first anatomical description dates to Emperor Trajan (53–117 A.D.) and the medical studies of Galen (129–201 A.D.). It was also represented in the anatomical drawings of Leonardo da Vinci (1452–1519) and Girolamo Fabrici d'Acquapendente (1533–1619). Historically, the conservative treatment by insoles was the only one proposed until the nineteenth century. Since then, the most popular surgical procedures performed for correction have been osteotomies, arthrodesis, arthrorisis, and tendon lengthening and transfer. Conclusion: During the centuries, conservative therapeutic strategies have not radically changed in their substance, while operative ones have become the protagonists during the twentieth century up to the present. Nevertheless, after more than 2000 years of history, there is no consensus regarding the best indication for the flatfoot and if it really needs to be treated. [ABSTRACT FROM AUTHOR]

Abstract Background Foot complications occur in conjunction with poorly controlled diabetes. Plantar forefoot ulceration contributes to partial amputation in unstable diabetics, and the risk increases with concomitant neuropathy. Reducing peak plantar forefoot pressure reduces ulcer occurrence and recurrence. Footwear and insoles are used to offload the neuropathic foot, but the success of offloading is dependent on patient adherence. This study aims to determine which design and modification features of footwear and insoles improve forefoot plantar pressure offloading and adherence in people with diabetes and neuropathy. Methods This study, involving a series of N-of-1 trials, included 21 participants who had a history of neuropathic plantar forefoot ulcers. Participants were recruited from two public hospitals and one private podiatry clinic in Sydney, New South Wales, Australia. This trial is non-randomised and unblinded. Participants will be recruited from three sites, including two high-risk foot services and a private podiatry clinic in Sydney, Australia. Mobilemat™ and F-Scan® plantar pressure mapping systems by TekScan® (Boston, USA) will be used to measure barefoot and in-shoe plantar pressures. Participants’ self-reports will be used to quantify the wearing period over a certain period of between 2 and 4 weeks during the trial. Participant preference toward footwear, insole design and quality-of-life-related information will be collected and analysed. The descriptive and inferential statistical analyses will be performed using IBM SPSS Statistics (version 27). And the software NVivo (version 12) will be utilised for the qualitative data analysis. Discussion This is the first trial assessing footwear and insole interventions in people with diabetes by using a series of N-of-1 trials. Reporting self-declared wearing periods and participants’ preferences on footwear style and aesthetics are the important approaches for this trial. Patient-centric device designs are the key to therapeutic outcomes, and this study is designed with that strategy in mind. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000699965p. Registered on June 23, 2020

The lining materials of plantar orthoses are chosen for their hardness, breathability, and moisture absorption, but without there being any clear scientific criterion. Thermographic analysis would provide information about the thermal response of the sole of the foot, and would thereby allow the choice to be adapted in accordance with this criterion. The objective of this study was to evaluate plantar temperatures after the use of three materials with different characteristics. Plantar temperatures were analyzed by using a FLIR E60BX thermographic camera on 36 participants (15 men and 21 women, 24.6 ± 8.2 years old, 67.1 ± 13.6 kg, and 1.7 ± 0.09 m). Measurements were made before and after (3 h) the use of three lining materials for plantar orthoses (Material 1: PE copolymer; Material 2: EVA; Material 3: PE–EVA copolymer) on different days. For Material 1 (PE), the temperature under the heel was significantly higher after exercise, increasing from 30.8 ± 2.9 °C to 31.9 ± 2.8 °C (p = 0.008), and negative correlations were found between room temperature and the pre/post temperature difference for the big toe (r = −0.342, p = 0.041) and the 1st metatarsal head (r = −0.334, p = 0.046). No significant pre/post temperature differences were found with the other materials. The three materials thermoregulated the plantar surface efficiently by maintaining the skin temperature at levels similar to those evaluated before exercise. If PE is used as a lining material, it should be avoided for the heel area in patients with hyperhidrosis or those with a tendency to suffer from skin pathologies due to excess moisture. [ABSTRACT FROM AUTHOR]

Background: The treatment of lymphoedema requires a multi-professional and interdisciplinary approach. Despite being prescribed in the management of lymphatic disorders, the effectiveness of the phlebological insoles is still under investigation. Aim: This scoping review aims to identify and analyse evidence regarding the efficacy of phlebological insoles as a conservative intervention for lower limb lymphoedema. Method: The following databases were searched up to November 2022: PubMed, Cochrane Library, CINAHL Complete, PEDro and Scopus. Preventive and conservative interventions were considered. Studies considering people with lower limb oedema, of any age and type of oedema, were eligible for inclusion. No restrictions in terms of language, year of publication, study design and type of publication were applied. Additional studies were sought through grey literature. Results: From 117 initial records, 3 studies met the inclusion criteria. Two quasi-experimental studies and one randomised cross-over study were included. The results of the examined studies confirmed the positive effects of insoles usage and foot and ankle mobility on the venous return. Conclusion: This scoping review provided an overview of the topic. The studies analysed in this scoping review have shown that insoles seem to be beneficial in reducing the lower limb oedema in healthy individuals. However, there are still no comprehensive trials confirming this evidence on people with lymphoedema. The small number of identified articles, the selection of participants not affected by lymphoedema, the use of heterogeneous devices in terms of modifications and materials highlight the need of further investigations. Future trails should include people affected by lymphoedema, address the choice of materials in manufacturing the insoles and take in consideration the patients' adherence to the device and concordance to the treatment. [ABSTRACT FROM AUTHOR]

The prevalence of individuals with flat feet and high arches is very high (between 15% to 37%), which can often lead to other orthopedic complications. Three-dimensional-printed insoles are being studied and validated for their effects in correcting these highly prevalent foot disorders. Highly customizable parameters while printing the insole allows for precise correction of foot biomechanics. In this study, 200 patients suffering from various foot-related problems and joint pain were given 3d-printed insoles (designed using plantar pressure systems and clinical practitioner's assessment) to use in their footwear. Tested activities included standing, walking, running, sports, and gym workout. Customization of insoles included custom density, heel cup, heel rise, medial arch height, and lateral wedge. Based on the patient history, additional podiatry elements were provided for patients with diabetes. Each insole was designed as per the insole profile of the shoe with a comfortable fit. These insoles were found to be effective in alleviating pain for more than 90% of the patients and provided a longer life cycle with effective orthotic correction (for >16 months of daily use). This paper presents the post-use effects (6–18 months) of custom 3D-printed insoles. [ABSTRACT FROM AUTHOR]

Background: Enhancing knee protection for individuals who are overweight and obese is crucial. Cushioning insoles may improve knee biomechanics and play a significant protective role. However, the impact of insoles with varying cushioning properties on knee joints in individuals with different body mass index (BMI) categories remains unknown. Our aim was to investigate the biomechanical effects of insoles with different cushioning properties on knee joints across different BMI grades.Methods: Gravity-driven impact tests were used to characterize the cushioning properties of three types of Artificial Cartilage Foam (ACF18, 28, and 38) and ethylene-vinyl acetate (EVA) insoles. Knee joint sagittal, coronal, and vertical axis angles and moments were collected from healthy-weight (BMI 18.5–23.9 kg/m2, n = 15), overweight (BMI 24.0–27.9 kg/m2, n = 16), and obese (BMI ≥28.0 kg/m2, n = 15) individuals randomly assigned four different insoles during a drop jump. The Kruskal–Wallis test and mixed model repeated measures analysis of variance were used to compare differences among cushioning and biomechanical data across various insoles, respectively.Results: ACF showed higher cushioning than EVA, and ACF38 was the highest among the three types of ACF (all p < 0.001). During the drop jump, the knee flexion angles and moments of the ACF insoles were lower than those of the EVA insoles, the knee adduction angles of the ACF18 and ACF28 insoles were lower than those of the EVA insoles, and ACF18 insoles increased the first cushion time (all p < 0.05) for all participants in whom biomechanical variables demonstrated no interactions between insoles and BMI. Regarding the BMI-dependent biomechanical variables, compared with the EVA insoles, ACF28 insoles decreased the knee flexion angle and ACF38 insoles decreased the knee adduction and rotation moment in the healthy-weight group; ACF18 insoles decreased the knee flexion angle and ACF38 insoles decreased the knee moment in the overweight group; ACF28 insoles decreased the knee flexion and adduction moment, and ACF38 insoles decreased the knee flexion angle and rotation moment in the obese group (all p < 0.05).Conclusion: Insoles with higher cushioning properties could improve knee biomechanics and provide better knee joint protection in people across different BMI ranges.

Introduction: We investigated the isolated and combined (HYB) effects of ethylene-vinyl acetate (EVA) and expanded thermoplastic polyurethane (TPU) custom foot orthoses (CFOs), compared to a control condition (CON; shoes only), on constant speed, treadmill running kinematics.Methods: Twenty (10 male and 10 female subjects) well-trained runners performed four 6-min bouts at the same individualized speed for each bout on a treadmill under four footwear conditions (EVA, TPU, HYB, and CON). Twenty markers and four clusters (four markers each) were placed on lower limbs and the pelvis. Lower limb and pelvis movements were tracked using a three-dimensional motion capture system with 11 cameras (Vicon MX System, Oxford, United Kingdom). Lower limb joint angles and angular velocity were normalized to 100% of the stance phase.Results: Peak ankle eversion (p < 0.001, η2 = 0.72), peak ankle eversion angular velocity (AV) (p < 0.001, η2 = 0.64), peak ankle inversion AV (p < 0.001, η2 = 0.60), and peak ankle internal rotation AV (p < 0.001, η2 = 0.49) demonstrated the largest differences between conditions. Statistical non-parametric mapping analysis revealed that HYB exhibited the largest proportions of change during the total stance phase compared to the CON.Discussion: All CFO materials caused significant reductions in peak angles and peak AVs at the ankle in the frontal plane, with more pronounced effects for harder (EVA) than softer (TPU) materials. These significant reductions occurred during large portions of the total stance phase for the angles and for the AVs. Although some effects could be found in more proximal joints such as the knee and hip, most significant effects were found at the ankle joint. Overall, combining hard EVA material in the heel and soft TPU in the forefoot (HYB) resulted in significant, more favorable changes compared to the CON that lasted for the largest proportion of stance phase when compared to wearing shoes only.

Knowledge of ergonomics/human factors plays an important role in the creation and design of safety shoes and insoles, contributing to worker protection, comfort, and stability. The purpose of this study is to compare previous insole designs and analyze the plantar pressure and gait pattern kinematics using the Oxford foot model protocol. The tests were performed comparing the environments on the three rockers of the gait, represented by the heel, midfoot, and forefoot, according to the classification of foot type. The analysis of plantar pressure, regarding its total and maximum distribution, showed that the innovative insole presents a better load distribution in terms of the maximum plantar pressure exerted in the hindfoot and forefoot regions. In the biomechanical analysis of gait, the five variables studied did not show variation in the normal mechanics of the foot in any of the three environments considered. The hallux joint was the one that presented the greatest divergences with the barefoot in terms of amplitude and variability, as expected. [ABSTRACT FROM AUTHOR]

Background and purpose: Stroke and small vessel disease cause gait disturbances and falls. The naturally occurring loss‐of‐function mutation in the C‐C chemokine receptor 5 gene (CCR5‐Δ32) has recently been reported as a protective factor in post‐stroke motor and cognitive recovery. We sought to examine whether it also influences gait and balance measures up to 2 years after stroke. Method: Participants were 575 survivors of first‐ever, mild–moderate ischaemic stroke or transient ischaemic attack from the TABASCO prospective study, who underwent a 3 T magnetic resonance imaging at baseline and were examined by a multi‐professional team 6, 12 and 24 months after the event, using neurological, neuropsychological and mobility examinations. Gait rhythm and the timing of the gait cycle were measured by force‐sensitive insoles. CCR5‐Δ32 status and gait measures were available for 335 patients. Results: CCR5‐Δ32 carriers (16.4%) had higher gait speed and decreased (better) stride and swing time variability 6 and 12 months after the index event compared to non‐carriers (p < 0.01 for all). The association remained significant after adjustment for age, gender, education, ethnicity and stroke severity. Conclusions: Significant associations were found between gait measurements and CCR5‐Δ32 loss‐of‐function mutation amongst stroke survivors. This is the first study showing that genetic predisposition may predict long‐term gait function after ischaemic stroke. [ABSTRACT FROM AUTHOR]

This study examined the impact of custom foot orthoses made of ethyl-vinyl acetate (EVA) and expanded thermoplastic polyurethane (TPU) materials, both compared to a control condition (CON; shoes only), on mechanical asymmetries during repeated treadmill sprints. Eighteen well-trained male runners executed eight, 5-s sprints (rest: 25 s) on an instrumented motorized treadmill in three footwear conditions (EVA, TPU, and CON). We evaluated the group mean asymmetry scores using the 'symmetry angle' (SA) formula, which assigns a score of 0% for perfect symmetry and a score of 100% for perfect asymmetry. There was no condition (all p ≥ 0.053) or time (p ≥ 0.074) main effects, nor were there any significant time × condition interactions on SA scores for any variables (p ≥ 0.640). Mean vertical, horizontal, and total forces presented mean SA values (pooled values for the three conditions) of 2.6 ± 1.9%, 2.9 ± 1.6%, and 2.4 ± 1.8%, respectively. Mean SA scores were ~1–3% for contact time (1.5 ± 0.5%), flight time (3.0 ± 0.3%), step frequency (1.1 ± 0.5%), step length (1.9 ± 0.7%), vertical stiffness (2.1 ± 0.9%), and leg stiffness (2.4 ± 1.1%). Mean SA scores were ~2–6.5% for duration of braking (4.1 ± 1.6%) and propulsive (2.4 ± 1.0%) phases, and peak braking (6.2 ± 2.9%) and propulsive (2.1 ± 1.4%) forces. In well-trained runners facing intense fatigue, wearing custom foot orthoses did not modify the observed low-to-moderate natural stride mechanical asymmetries. [ABSTRACT FROM AUTHOR]

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Abstract Backround Calcaneal spurs are described as bony outgrowths arising on medial calcaneal, where inappropriate footwear can promote disease progression. Objective Investigate the effectiveness of mechanical treatment with customized insole and minimalist flexible footwear during gait training program in women with calcaneal spur. Methods Design: A single-blinded, randomized and controlled trial. Setting: Biomechanics laboratory. Participants: Forty-three women, 29 with calcaneal spur and 14 control. Intervention Gait training program with use of the minimalist flexible footwear (MFG n = 15, age: 48.9 ± 9.4, height: 1.61 ± 0.1, BMI: 32.1 ± 7.0) and customized insole on footwear (COIG n = 14, age: 50.3 ± 5.8, height: 1.62 ± 0.1, BMI: 32.2 ± 4.3) and control (CG n = 14, age: 47.8 ± 8.6, height: 1.63 ± 0.1, BMI: 27.5 ± 4.5), followed of the evaluations: baseline (T0) and after three (T3) and six (T6) months. Duration of the intervention was of the six months consecutive for at least 42 h per week (six hours a day, seven days a week). Outcome primary were calcaneus pain (visual analogue scale), Foot Function Index (FFI), Foot Health Status Questionnaire (FHSQ-Br) and 6-min walk test (6MWT). Secondary was plantar pressure distribution by a pressure platform system during gait and static index foot posture (FPI). Statistical analysis: analysis of variance for repeated measure and between groups were used to detect treatment-time interactions (α = 5%). Effect size with D Cohen’s also was used between T0 and after six (T6) months of intervention. Results The MFG and COIG were effective at reducing pain after six months (MFG: 2.5–4.5 CI, p = 0.001; COIG: 1.5–3.5 CI, p = 0.011). The FFI and FHSQ-Br showed improvements with MFG and COIG after T6 (MFG: 13.7–15.4 CI, p = 0.010; COIG: 11.3–15.0 CI, p = 0.001). The 6MWT increased with MFG (589.3–622.7 CI) and COIG (401.3–644.7 CI) and foot pronation was decreased after T3 and T6 MFG (FPI Right: 4.2–5.4 CI; Left: 3.6–5.4 CI) COIG (FPI Right: 3.4–6.8 CI; Left: 3.3–5.7 CI). The contact area reduced on forefoot and rearfoot with MFG and GOIG and midfoot and rearfoot with MFG. Maximum force was reduced on foot with MFG after T3 and T6. The peak pressure was reduced on the forefoot with MFG and COIG and on midfoot and rearfoot with MFG. Conclusions The mechanical treatment with customized insole and minimalist flexible footwear during gait training program during six months in women with calcaneal spur reduced the calcaneus pain, increased function and health feet and reduced plantar load on the rearfoot, midfoot and forefoot. However, the footwear alone was more effective than when combined customized insole, given the greater efficacy on clinical and biomechanical aspects. Trial registration ClinicalTrials.gov NCT03040557 (date of first registration: 02/02/2017).

Abstract Background Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions. Methods We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice. Results In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice. Conclusions Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials.

Parkinson's disease (PD) is one of the most prevalent neurological diseases, described by complex clinical phenotypes. The manifestations of PD include both motor and non-motor symptoms. We constituted an experimental protocol for the assessment of PD motor signs of lower extremities. Using a pair of sensor insoles, data were recorded from PD patients, Elderly and Adult groups. Assessment of PD patients has been performed by neurologists specialized in movement disorders using the Movement Disorder Society—Unified Parkinson's Disease Rating Scale (MDS-UPDRS)-Part III: Motor Examination, on both ON and OFF medication states. Using as a reference point the quantified metrics of MDS-UPDRS-Part III, severity levels were explored by classifying normal, mild, moderate, and severe levels of PD. Elaborating the recorded gait data, 18 temporal and spatial characteristics have been extracted. Subsequently, feature selection techniques were applied to reveal the dominant features to be used for four classification tasks. Specifically, for identifying relations between the spatial and temporal gait features on: PD and non-PD groups; PD, Elderly and Adults groups; PD and ON/OFF medication states; MDS-UPDRS: Part III and PD severity levels. AdaBoost, Extra Trees, and Random Forest classifiers, were trained and tested. Results showed a recognition accuracy of 88%, 73% and 81% for, the PD and non-PD groups, PD-related medication states, and PD severity levels relevant to MDS-UPDRS: Part III ratings, respectively. [ABSTRACT FROM AUTHOR]

Background: Foot complications occur in conjunction with poorly controlled diabetes. Plantar forefoot ulceration contributes to partial amputation in unstable diabetics, and the risk increases with concomitant neuropathy. Reducing peak plantar forefoot pressure reduces ulcer occurrence and recurrence. Footwear and insoles are used to offload the neuropathic foot, but the success of offloading is dependent on patient adherence. This study aims to determine which design and modification features of footwear and insoles improve forefoot plantar pressure offloading and adherence in people with diabetes and neuropathy. Methods: This study, involving a series of N-of-1 trials, included 21 participants who had a history of neuropathic plantar forefoot ulcers. Participants were recruited from two public hospitals and one private podiatry clinic in Sydney, New South Wales, Australia. This trial is non-randomised and unblinded. Participants will be recruited from three sites, including two high-risk foot services and a private podiatry clinic in Sydney, Australia. Mobilemat™ and F-Scan® plantar pressure mapping systems by TekScan® (Boston, USA) will be used to measure barefoot and in-shoe plantar pressures. Participants' self-reports will be used to quantify the wearing period over a certain period of between 2 and 4 weeks during the trial. Participant preference toward footwear, insole design and quality-of-life-related information will be collected and analysed. The descriptive and inferential statistical analyses will be performed using IBM SPSS Statistics (version 27). And the software NVivo (version 12) will be utilised for the qualitative data analysis. Discussion: This is the first trial assessing footwear and insole interventions in people with diabetes by using a series of N-of-1 trials. Reporting self-declared wearing periods and participants' preferences on footwear style and aesthetics are the important approaches for this trial. Patient-centric device designs are the key to therapeutic outcomes, and this study is designed with that strategy in mind. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000699965p. Registered on June 23, 2020 [ABSTRACT FROM AUTHOR]

The analysis of gait patterns and plantar pressure distributions via insoles is increasingly used to monitor patients and treatment progress, such as recovery after surgeries. Despite the popularity of pedography, also known as baropodography, characteristic effects of anthropometric and other individual parameters on the trajectory of the stance phase curve of the gait cycle have not been previously reported. We hypothesized characteristic changes of age, body height, body weight, body mass index and handgrip strength on the plantar pressure curve trajectory during gait in healthy participants. Thirty-seven healthy women and men with an average age of 43.65 ± 17.59 years were fitted with Moticon OpenGO insoles equipped with 16 pressure sensors each. Data were recorded at a frequency of 100 Hz during walking at 4 km/h on a level treadmill for 1 minute. Data were processed via a custom-made step detection algorithm. The loading and unloading slopes as well as force extrema-based parameters were computed and characteristic correlations with the targeted parameters were identified via multiple linear regression analysis. Age showed a negative correlation with the mean loading slope. Body height correlated with Fmeanload and the loading slope. Body weight and the body mass index correlated with all analyzed parameters, except the loading slope. In addition, handgrip strength correlated with changes in the second half of the stance phase and did not affect the first half, which is likely due to stronger kick-off. However, only up to 46% of the variability can be explained by age, body weight, height, body mass index and hand grip strength. Thus, further factors must affect the trajectory of the gait cycle curve that were not considered in the present analysis. In conclusion, all analyzed measures affect the trajectory of the stance phase curve. When analyzing insole data, it might be useful to correct for the factors that were identified by using the regression coefficients presented in this paper.

Background: Flatfoot is common among children. Symptomatic flexible flatfoot is one of the various types which needs treatment. Wearing insoles is considered one of the conservative therapies, but its effects are still uncertain. This study aims to provide evidence for the efficacy of insoles treatment among school-aged children with symptomatic flexible flatfoot. Methods: Patient who were Children who were diagnosed with symptomatic flexible flatfoot and received insoles treatment in authors' institute were retrospectively included. Their ages, body mass index, pain positions, pain frequency, valgus angle, arch index and visual analogue scale (VAS) score were collected before and after insole treatment. Results: A total of 32 children were included in this study. The results showed that wearing insoles for 2 years caused a significant improvement in pain frequency, valgus angle, arch index and VAS score. Conclusions: This study indicated that pediatric symptomatic flexible flatfoot could be relieved by wearing insoles for 2 years. Insole treatment might be a workable option for pediatric symptomatic flexible flatfoot in children older than 6 years old. [ABSTRACT FROM AUTHOR]

Background and Objectives: Plantar fasciitis (PF) is a prevalent musculoskeletal disease, with inflammation at the origin of the plantar fascia, that affects sedentary people, particularly middle-aged women. Foot pain and functional limitations lead patients to seek treatment. Investigate the therapeutic effect of conservative treatment combining a custom insole with minimalist flexible shoes and the shoes alone in a gait-training protocol, in the short and long term, in women with PF. Materials and Methods: Design: A randomized, controlled, and single-blind trial. Setting: Biomechanics laboratory. Participants: 36 women, 26 with acute PF and 10 controls. Intervention: Gait-training protocol wearing the minimalist shoes alone (SG, n = 12, age: 46.4 ± 9.6, height: 1.60 ± 0.2, BMI: 28.8 ± 4.2), with a custom insole in the shoes (CIG, n = 14, age: 48.9 ± 9.8, height: 1.60 ± 0.1, BMI: 26.7 ± 5.6), and control (CG, n = 10, age: 46.1 ± 10.7, height: 1.61 ± 0.2, BMI: 26.4 ± 4.8). Evaluations were performed at baseline (T0) and after three (T3) and six (T6) months. The intervention had a duration of six months (six hours a day, seven days a week). Primary outcomes were rearfoot pain (visual analogue scale), the Foot Function Index (FFI), Foot Health Status Questionnaire (FHSQ-Br), and 6 min walk test (6MWT). The secondary outcomes were plantar pressure distribution during gait, measured by the pressure platform, and foot posture. Results: The CIG was effective for reducing pain and improving the FPI after T6 compared to CG. The FPI, FHSQ-Br and 6MWT demonstrated improvements after T6 in both the CIG and SG, compared to the CG. After T6, contact area (rearfoot) and maximum force (forefoot) reduced with CIG. Maximum force (midfoot and rearfoot) reduced with CIG and SG, as did peak pressure (forefoot and midfoot) in relation to CG. Conclusions: A customized insole associated with minimalist flexible shoes during a gait-training protocol can be recommended as a more effective treatment than minimalist flexible shoes alone over the short and long term, for reduction in calcaneus pain, increased function and foot health, and improved walking through reduced plantar load in women with PF. [ABSTRACT FROM AUTHOR]

The correct distribution of loads on foot, known as plantar pressures, is a relevant parameter for evaluating the evolution of some diseases. Anomalies can lead to pain and discomfort in other body parts. Diabetes changes foot tissues and compromises biomechanics, resulting in ulcers and, eventually, amputation. Customized insoles allow the redistribution of plantar pressures and are a complementary strategy to diabetes management. Nowadays, scanning and 3D printing technology can generate faster and more accurate customized insoles opening new opportunities for local medical device development. This study reports the development of 3D-printed insoles using two polymers, thermoplastic polyether-polyurethane and thermoplastic polyurethane polyester-based polymer, and the evaluation of plantar pressure distribution in walk trials using a clinical protocol and low-cost electronic system. The two 3D-printed insoles performed as well as a standard insole. No significant difference was found in average peak pressure distribution. The digital manufacturing workflow of customized insoles can be implemented in middle-income countries. Three-dimensionally printed insoles have the potential for diabetes management, and further material evaluations are needed before using them in health facilities. [ABSTRACT FROM AUTHOR]

There is a need for unobtrusive and valid tools to collect gait parameters in patients with Parkinson's disease (PD). The novel promising tools are pressure-sensing insoles connected to a smartphone app; however, few studies investigated their measurement properties during simple or challenging conditions in PD patients. This study aimed to examine the validity and reliability of gait parameters computed by pressure-sensing insoles (FeetMe® insoles, Paris, France). Twenty-five PD patients (21 males, mean age: 69 (7) years) completed two walking assessment sessions. In each session, participants walked on an electronic pressure-sensitive walkway (GaitRite®, CIR System Inc., Franklin, NJ, USA) without other additional instructions (i.e., single-task condition) and while performing a concurrent cognitive task (i.e., dual-task condition). Spatiotemporal gait parameters were measured simultaneously using the pressure-sensing insoles and the electronic walkway. Concurrent validity was assessed by correlation coefficients and Bland–Altman methodology. Test–retest reliability was examined by intraclass correlation coefficients (ICC) and minimal detectable changes (MDC). The validity results showed moderate to excellent correlations and good agreement between the two systems. Concerning test–retest reliability, moderate-to-excellent ICC values and acceptable MDC demonstrated the repeatability of the measured gait parameters. Our findings support the use of these insoles as complementary instruments to conventional tools during single and dual-task conditions. [ABSTRACT FROM AUTHOR]

Saleh S Altayyar Biomedical Technology Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi ArabiaCorrespondence: Saleh S Altayyar Tel +966505456035Email stayyar@ksu.edu.saPurpose: High plantar pressure is one of the factors associated with foot ulceration in diabetic patients. High-risk limbs could eventually be identified through this approach. The study was conducted to evaluate the difference in the barefoot and in-shoe plantar pressure among diabetic males and females.Patients and Methods: A cross-sectional study was conducted and purposive sampling was employed for the recruitment of subjects in King Abdullah walking center. The dynamic plantar pressure generated by each subject was recorded using “novel footprint software” and up to five successful trials were collected for each subject of right and left foot.Results: The mean age of female and male patients was 50.6 ± 13.4 and 46.07 ± 11.17, respectively. The mean difference between the weights was higher in males. The barefoot peak plantar pressure between gender in left limb was found significant. Moreover, the mean difference in plantar pressure at maximum concentration and maximum force of right and left limb between males and females was found statistically significant. The mean difference in in-shoe plantar pressure at maximum force of left limb between males and females was found statistically significant.Conclusion: As the prevalence of diabetes is increasing, the risk of plantar pressure also increasing simultaneously. The difference in plantar pressure among diabetic males and females is critically important as our study indicated that the bare foot and in-shoe plantar pressure was found higher in males than females as males had higher weight than females. Further longitudinal studies are required to be conducted in this context.Keywords: diabetes mellitus, foot injuries, insoles, neuropathy, plantar pressure

Background: Postural balance (PB) is an important component skill for professional dancers. However, the effects of different types of postures and different underfoot surfaces on PB have not adequately been addressed.Purpose: The main aim of this study was to investigate the effect of different conditions of footwear, surfaces, and standing positions on static and dynamic PB ability of young ballet dancers.Methods: A total of 36 male and female young professional ballet dancers (aged 14-19 years) completed static and dynamic balance testing, measured by head and lumbar accelerometers, while standing on one leg in the turnout position, under six different conditions: (1) "relaxed" posture; (2) "ballet" posture; (3) barefoot; (4) ballet shoes with textured insoles; (5) barefoot on a textured mat; and (6) barefoot on a spiky mat.Results: A condition effect was found for static and dynamic PB. Static PB was reduced when dancers stood in the ballet posture compared with standing in the relaxed posture and when standing on a textured mat and on a spiky mat (p < .05), and static PB in the relaxed posture was significantly better than PB in all the other five conditions tested. Dynamic PB was significantly better while standing in ballet shoes with textured insoles and when standing on a spiky mat compared with all other conditions (p < .05).Conclusions: The practical implications derived from this study are that both male and female dancers should try to be relaxed in their postural muscles when practicing a ballet aligned position, including dance practice on different types of floors and on different types of textured/spiky materials may result in skill transfer to practice on normal floor surfaces, and both static and dynamic PB exercises should be assessed and generalized into practical dance routines. [ABSTRACT FROM AUTHOR]

• This study aimed to investigate the effects of foot orthoses application on lower limb mechanics in adults with flat-feet. • We observed greater effects of foot orthoses application on walking mechanics in the studies that used the foot posture index. • We recommend to uniformly use the foot posture index as a foot posture measure in future studies. This systematic review with meta -analysis aimed to investigate the effects of foot orthoses (FO) application on lower limb joint angles and moments in adults with flexible flat-feet during walking. The following five databases were systematically searched from inception until March 2024: Scopus, PubMed, EMBASE, PEDro, and Cochrane Central Register of Controlled Trials (CENTRAL). Between-group standardized mean differences (SMDs) with 95% confidence intervals were computed using a random-effects model. Study heterogeneity was assessed using the I2-index. Twenty-four studies were identified and meta -analyzed. Studies were then categorized according to the applied flat-feet assessment method: (1) foot posture index (FPI-6) or clinical observation; (2) foot print arch index or radiography; (3) arch height index (including navicular drop, the arch height index, navicular height normalized to foot length [NNHT]); (4) forefoot varus method; (5) rearfoot eversion or resting calcaneal stance position (RCSP). The meta -analysis showed significant effects of FO application during walking on peak rearfoot eversion (ten studies: moderate SMDs), peak ankle dorsiflexion (five studies: small SMDs), and eversion (seven studies: moderate SMDs). This meta -analysis indicated significant effects of FO application on peak ankle eversion moment (five studies: small SMDs) and peak knee adduction moment (six studies: small SMDs). We observed greater effects of FO application on walking mechanics in the studies that used the FPI-6 method for the assessment of foot posture. Since previous research showed particularly high test–retest reliability measures for the FPI-6 method, we recommend to uniformly use this type of foot posture measure in future studies. [ABSTRACT FROM AUTHOR]

Backround: Calcaneal spurs are described as bony outgrowths arising on medial calcaneal, where inappropriate footwear can promote disease progression.Objective: Investigate the effectiveness of mechanical treatment with customized insole and minimalist flexible footwear during gait training program in women with calcaneal spur.Methods: Design: A single-blinded, randomized and controlled trial.Setting: Biomechanics laboratory.Participants: Forty-three women, 29 with calcaneal spur and 14 control.Intervention: Gait training program with use of the minimalist flexible footwear (MFG n = 15, age: 48.9 ± 9.4, height: 1.61 ± 0.1, BMI: 32.1 ± 7.0) and customized insole on footwear (COIG n = 14, age: 50.3 ± 5.8, height: 1.62 ± 0.1, BMI: 32.2 ± 4.3) and control (CG n = 14, age: 47.8 ± 8.6, height: 1.63 ± 0.1, BMI: 27.5 ± 4.5), followed of the evaluations: baseline (T0) and after three (T3) and six (T6) months. Duration of the intervention was of the six months consecutive for at least 42 h per week (six hours a day, seven days a week). Outcome primary were calcaneus pain (visual analogue scale), Foot Function Index (FFI), Foot Health Status Questionnaire (FHSQ-Br) and 6-min walk test (6MWT). Secondary was plantar pressure distribution by a pressure platform system during gait and static index foot posture (FPI).Statistical Analysis: analysis of variance for repeated measure and between groups were used to detect treatment-time interactions (α = 5%). Effect size with D Cohen's also was used between T0 and after six (T6) months of intervention.Results: The MFG and COIG were effective at reducing pain after six months (MFG: 2.5-4.5 CI, p = 0.001; COIG: 1.5-3.5 CI, p = 0.011). The FFI and FHSQ-Br showed improvements with MFG and COIG after T6 (MFG: 13.7-15.4 CI, p = 0.010; COIG: 11.3-15.0 CI, p = 0.001). The 6MWT increased with MFG (589.3-622.7 CI) and COIG (401.3-644.7 CI) and foot pronation was decreased after T3 and T6 MFG (FPI Right: 4.2-5.4 CI; Left: 3.6-5.4 CI) COIG (FPI Right: 3.4-6.8 CI; Left: 3.3-5.7 CI). The contact area reduced on forefoot and rearfoot with MFG and GOIG and midfoot and rearfoot with MFG. Maximum force was reduced on foot with MFG after T3 and T6. The peak pressure was reduced on the forefoot with MFG and COIG and on midfoot and rearfoot with MFG.Conclusions: The mechanical treatment with customized insole and minimalist flexible footwear during gait training program during six months in women with calcaneal spur reduced the calcaneus pain, increased function and health feet and reduced plantar load on the rearfoot, midfoot and forefoot. However, the footwear alone was more effective than when combined customized insole, given the greater efficacy on clinical and biomechanical aspects.Trial Registration: ClinicalTrials.gov NCT03040557 (date of first registration: 02/02/2017). [ABSTRACT FROM AUTHOR]

Cerebral palsy (CP) is a common cause of motor disability, and pedobarography is a useful, non-invasive, portable, and accessible tool; is easy to use in a clinical setting; and can provide plenty of information about foot–soil interaction and gait deviations. The reliability of this method in children with CP is lacking. The aim of this study is to investigate test–retest reliability and minimal detectable change (MDC) of plantar pressure insole variables in children with CP. Eight children performed two trials 8 ± 2.5 days apart, using foot insoles to collect plantar pressure data. Whole and segmented foot measurements were analyzed using intraclass correlation coefficients (ICC). The variability of the data was measured by calculating the standard error of measurement (SEM) and the MDC/ICC values demonstrated high test–retest reliability for most variables, ranging from good to excellent (ICC ≥ 0.60). The SEM and the MDC values were considered low for the different variables. The variability observed between sessions may be attributed to the heterogeneous sub-diagnosis of CP. [ABSTRACT FROM AUTHOR]