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Prolonged workplace standing is commonplace and associated with a range of lower limb issues. Evaluating footwear interventions aiming to modify plantar pressure during standing is essential as the body is static, creating a different requirement for footwear. Previous research associates medial midfoot pressure with greater perceived comfort and identifies arch height as the most variable element of foot shape. Targeting footwear mass customization within this area may better address differences within the target wearers. This study aims to evaluate a modular insole system for its ability to modify plantar pressure during standing. Twenty-five participants completed a static and dynamic standing protocol for 60 seconds whilst measuring in-shoe peak and mean plantar pressure (KPa) and contact area (%). Individuals wore three insole options targeted towards different medial arch shapes (A– low arch, B– medium arch, C– high arch) and rated them for comfort. Participants received guidance to self-identify foot shape (low, medium, or high arch). Comparisons were drawn across the three insole profiles and between the insole rated as most comfortable (preferred), and the insole that matched the self-identified foot shape (matched). As insole arch height increased, medial midfoot pressure and contact area significantly increased, alongside significant reductions in first metatarsal pressure and contact. Preference was spread across insoles A, B, and C (56%, 32%, 12% of participants, respectively). Sixteen participants had different matched and preferred insoles, with significantly greater medial midfoot pressure and contact in the matched insole. The modular insole enabled different wear experiences, however, results suggest that individuals selected insoles lower than their foot shape. Providing adequate medial arch support enables redistribution of pressure which may enable greater comfort during the workday. [ABSTRACT FROM AUTHOR]

Running is the basis of many sports and has highly beneficial effects on health. To increase the understanding of running, DSPro® insoles were developed to collect running parameters during tasks. However, no validation has been carried out for running gait analysis. The aims of this study were to assess the test–retest reliability and criterion validity of running gait parameters from DSPro® insoles compared to a motion-capture system. Equipped with DSPro® insoles, a running gait analysis was performed on 30 healthy participants during overground and treadmill running using a motion-capture system. Using an intraclass correlation coefficient (ICC), the criterion validity and test–retest reliability of spatiotemporal parameters were calculated. The test–retest reliability shows moderate to excellent ICC values (ICC > 0.50) except for propulsion time during overground running at a fast speed with the motion-capture system. The criterion validity highlights a validation of running parameters regardless of speeds (ICC > 0.70). This present study validates the good criterion validity and test–retest reliability of DSPro® insoles for measuring spatiotemporal running gait parameters. Without the constraints of a 3D motion-capture system, such insoles seem to be helpful and relevant for improving the care management of active patients or following running performance in sports contexts. [ABSTRACT FROM AUTHOR]

In this randomized clinical trial, we compared the early effects of polyethylene (PE), polyurethane (PU), and Carbon Fiber insoles in the treatment of PF using a set of patient-reported outcomes. Patients were randomly allocated one of the three prefabricated insoles – Carbon Fiber (n = 14), PU (n = 14), or PE (n = 17) for regular use. Their response was recorded using PROMIS 3a (for pain intensity), PROMIS 4a (for pain interference), FAOS (Foot and Ankle Outcome Score), and VAS for pain at baseline, two, six, and twelve weeks. The PROMIS pain intensity scores improved in both the Carbon Fiber and the PE groups starting at the 6th week (p = 0.04) and 2nd week (p = 0.002), respectively. PROMIS pain interference scores also showed positive trends in these two groups (p = 0.02, p = 0.004, respectively). Prefabricated Carbon Fiber and PE insoles showed significant pain-reducing effects in patients with PF. Level I, Randomized controlled trial. [ABSTRACT FROM AUTHOR]

Backgrounds: Freezing of gait (FoG) is a common and debilitating symptom of Parkinson's disease (PD) that can lead to falls and reduced quality of life. Wearable sensors have been used to detect FoG, but current methods have limitations in accuracy and practicality. In this paper, we aimed to develop a deep learning model using pressure sensor data from wearable insoles to accurately detect FoG in PD patients. Methods: We recruited 14 PD patients and collected data frommultiple trials of a standardized walking test using the Pedar insole system. We proposed temporal convolutional neural network (TCNN) and applied rigorous data filtering and selective participant inclusion criteria to ensure the integrity of the dataset. We mapped the sensor data to a structured matrix and normalized it for input into our TCNN. We used a train-test split to evaluate the performance of the model. Results: We found that TCNN model achieved the highest accuracy, precision, sensitivity, specificity, and F1 score for FoG detection compared to othermodels. The TCNN model also showed good performance in detecting FoG episodes, even in various types of sensor noise situations. Conclusions: We demonstrated the potential of using wearable pressure sensors andmachine learningmodels for FoG detection in PD patients. The TCNNmodel showed promising results and could be used in future studies to develop a real-time FoG detection system to improve PD patients' safety and quality of life. Additionally, our noise impact analysis identifies critical sensor locations, suggesting potential for reducing sensor numbers. [ABSTRACT FROM AUTHOR]

Background: Integrating diverse sensor technologies into smart insoles offers significant potential for monitoring biomechanical metrics; enhancing sports performance; and managing therapeutic interventions, diseases, disorders, and other health-related issues. The variation in sensor types and applications requires a systematic review to synthesize existing evidence and guide future innovations. Objectives: This review aims to identify, categorize, and critically evaluate the various sensors used in smart insoles, focusing on their technical specifications, application scopes, and validity. Methods: Following the PRISMA guidelines, a search was conducted in three major electronic databases, namely, PubMed, Scopus, and Web of Science, for relevant literature published from 2014 to 2024. Other works not located in the mentioned databases were added manually by parallel searches on related themes and suggestions from the website of the databases. To be eligible, studies were required to describe sensor implementation in insoles, specify the sensor types, and report on either validation experiments or practical outcomes. Results: The search identified 33 qualifying studies. Proper analysis revealed a dominance of pressure sensors, with accelerometers and gyroscopes also being widely used. Critical applications included gait analysis, posture correction, and real-time athletic and rehabilitation feedback. The review also examined the relative effectiveness of different sensor configurations. Conclusions: This systematic review comprehensively classifies sensor technologies within smart insoles and highlights their broad application potential across various fields. Future research should aim to standardize measurement protocols, enhance sensor integration, and advance data processing techniques to boost functionality and clinical applicability. [ABSTRACT FROM AUTHOR]

Persons with diabetic peripheral neuropathy (DPN) may face challenges such as balance issues due to reduced somatosensory feedback and an increased risk of developing diabetic foot ulcers (DFUs) due to increased plantar pressure. Pressure reducing footwear is thought to further impair balance. We introduced 3D-printed rocker midsoles and self-adjusting insoles that are able to reduce elevated plantar pressure values and aimed to prevent balance deterioration. However, their effect on the balance during walking (dynamic stability) is not analyzed yet. Is dynamic stability of persons with DPN impaired compared to healthy individuals and what is the effect of the 3D-printed rocker midsoles and self-adjusting insoles on the dynamic stability in this population? Dynamic stability, specifically the margins of stability (MOS) in the anterior-posterior (AP) and medio-lateral (ML) direction, was measured in ten healthy and nineteen persons with DPN. Independent-samples t-test was applied to analyze the difference in the MOS between groups. One-way repeated measures analyses of variance (ANOVA) was conducted to test the difference between the therapeutic footwear combinations within the DPN group. There is no significant difference between the healthy and DPN group in MOS-AP. MOS-ML is significantly larger in DPN compared to the healthy participants. Using the self-adjusting insole shows a significantly lower (negative) MOS-AP compared to when using a rocker shoe within the DPN group. This study provides valuable information on whether DPN and our therapeutic footwear have a negative effect on the dynamic stability. DPN does not have a negative effect on dynamic stability in the AP direction. For the ML direction, DPN seems to cause larger MOS-ML by likely using a compensation strategy (e.g., wider steps) while our experimental footwear does not further impair the MOS-ML. • DPN causes no change in anterior-posterior margins of stability (MOS-AP). • No negative effect of therapeutic footwear on MOS-AP. • No negative effect of therapeutic footwear on MOS in medio-lateral (ML) direction. • DPN causes larger MOS-ML as possible compensation strategy. [ABSTRACT FROM AUTHOR]

Introduction: Plantar orthoses are widely used in the prevention and treatment of foot and lower-limb disorders. Plantar orthoses can generally be classified as prefabricated devices; however, many prefabricated devices can be customized. Customized orthotic insoles are usually prescribed with the goal of improving foot function. However, evidence that customized orthoses modify foot function in a predictable and dose-responsive manner is limited, and there is currently no consensus on how orthoses should be prescribed. Consequently, a high variability in orthotic prescriptions by physicians is observed. The aim of this study is to propose an orthotic insole prescription form (INSPECTOR) that is clear, easy, and replicable by all professionals involved. Methods: All known clinical assessments and tests with high sensitivity and specificity indices, positive and negative predictive value, positive likelihood ratio, and negative likelihood ratio were included in the form. Result: The result of this study is a form that guides the clinician step by step toward an appropriate and correct foot prescription. Conclusions: INSPECTOR has several potential advantages; it is a step-by-step guide for the physician, starting with basic tasks such as anamnesis, functional prognosis, and prescription of the foot orthosis, and ending with the choice of the target area for the foot orthosis and the material to be used. The module lists scientifically validated and internationally recognized tests, making it understandable by professionals in all countries. Finally, it can reduce the differences between prescribed and finished orthopedic insoles, thus avoiding wasting money or material on reconstruction or construction [ABSTRACT FROM AUTHOR]

The number of people with diabetes is rising day-by-day, which also raises the incidence of diabetic ulcers, sensation loss in the foot’s plantar area, and in extreme instances, amputations. Using customized shoes, unloading orthoses, insoles, and other strategies may help control these issues to some degree. In this work, a novel modular diabetic insole was designed and fabricated to effectively offload the abnormal or peak plantar pressures in diabetic patients. The pressure values in the plantar region were quantified using an in-house-developed plantar pressure-measuring insole consisting of force sensitive resistor (FSR) sensors. The effectiveness of the modular diabetic insole was tested qualitatively and quantitatively. The qualitative performance of the insole was reported using Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) in terms of subjective parameters like comfort, ease of use, effectiveness, etc. and calculated as 4.7 ± 0.18. Thereafter, the wearable pressure-measuring insole was used to investigate the feasibility of modular insole for the plantar pressure offloading during standing and walking conditions. It was observed that the maximum average zonal pressure (AZP) was reduced by up to 99% from 121.30 ± 3.72 kPa to 0.22 ± 0.18 kPa for the standing condition whereas it was reduced to 6.76 ± 2.03 kPa from 197.71 ± 3.21 kPa with a percentage value of 96% for the walking condition. In conclusion, the findings of this work validate the effectiveness of the modular diabetic insole as an intervention tool for diabetic foot ulcer prevention.

Gait phase monitoring wearable sensors play a crucial role in assessing both health and athletic performance, offering valuable insights into an individual's gait pattern. In this study, we introduced a simple and cost-effective capacitive gait sensor manufacturing approach, utilizing a micropatterned polydimethylsiloxane dielectric layer placed between screen-printed silver electrodes. The sensor demonstrated inherent stretchability and durability, even when the electrode was bent at a 45-degree angle, it maintained an electrode resistance of approximately 3 Ω. This feature is particularly advantageous for gait monitoring applications. Furthermore, the fabricated flexible capacitive pressure sensor exhibited higher sensitivity and linearity at both low and high pressure and displayed very good stability. Notably, the sensors demonstrated rapid response and recovery times for both under low and high pressure. To further explore the capabilities of these new sensors, they were successfully tested as insole-type pressure sensors for real-time gait signal monitoring. The sensors displayed a well-balanced combination of sensitivity and response time, making them well-suited for gait analysis. Beyond gait analysis, the proposed sensor holds the potential for a wide range of applications within biomedical, sports, and commercial systems where soft and conformable sensors are preferred. [ABSTRACT FROM AUTHOR]

• Comparison of foot insole impressions using the Reel measurement methodology. • Measurements to the first and fourth toes were least variable. • Measurements from the heel to the third and fifth toes were most variable. • Foot insole impressions were assessed by experienced and inexperienced analysts. • The measurements of experienced analysts were more precise. In forensic podiatry, footprints have been shown to provide a valuable source of discriminatory information. Footprints may be found in various forms, such as bare footprints, sock-clad footprints, or as impressions on insoles within footwear. This study utilized quantitative measures of foot impressions on pairs of insoles from shoes worn by the same person from a population of 31 adults. The measurements were determined by using the Reel method and comprised measurements from the heel to the tips of the toes and width of the ball. The purpose of the study was to assess the margin of error for these measurements to determine whether they were sufficiently accurate for forensic use. A secondary purpose of this study was to determine whether the analyst's experience or lack thereof in forensic podiatry had an impact on the precision of measurement data. The insole foot impressions were assessed by two podiatrists with forensic podiatry experience in footprint analysis, footprint research, and in using the Reel method of footprint measurement, as well as by three students of podiatric medicine without any such experience. A statistical analysis of the data from the study was performed using SPSS v28 (IBM SPSS Statistics for Windows, Version 28.0. Armonk, NY: IBM Corp). The most reliable measurements were of forefoot width, heel to first toe, heel to second toe, and heel to fourth toe. The greatest variation occurred in the measurements of the heel to the third and fifth toes. The measurements of the forensic podiatrist analysts showed less variability than those of the podiatry students, suggesting that measurement precision is related to the experience of the analyst. [ABSTRACT FROM AUTHOR]

The number of people with diabetes is rising day-by-day, which also raises the incidence of diabetic ulcers, sensation loss in the foot's plantar area, and in extreme instances, amputations. Using customized shoes, unloading orthoses, insoles, and other strategies may help control these issues to some degree. In this work, a novel modular diabetic insole was designed and fabricated to effectively offload the abnormal or peak plantar pressures in diabetic patients. The pressure values in the plantar region were quantified using an in-house-developed plantar pressure-measuring insole consisting of force sensitive resistor (FSR) sensors. The effectiveness of the modular diabetic insole was tested qualitatively and quantitatively. The qualitative performance of the insole was reported using Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) in terms of subjective parameters like comfort, ease of use, effectiveness, etc. and calculated as 4.7 ± 0.18. Thereafter, the wearable pressure-measuring insole was used to investigate the feasibility of modular insole for the plantar pressure offloading during standing and walking conditions. It was observed that the maximum average zonal pressure (AZP) was reduced by up to 99% from 121.30 ± 3.72 kPa to 0.22 ± 0.18 kPa for the standing condition whereas it was reduced to 6.76 ± 2.03 kPa from 197.71 ± 3.21 kPa with a percentage value of 96% for the walking condition. In conclusion, the findings of this work validate the effectiveness of the modular diabetic insole as an intervention tool for diabetic foot ulcer prevention. [ABSTRACT FROM AUTHOR]

Background: Hallux valgus (HV) morphological alterations impact forefoot kinetics. Surgery aims to restore both the morphology and function. Plantar pressure (PP) distribution systems represent an innovative additional tool to evaluate the hallux functional outcome after surgery in order to assess the hallux dorsiflexion, coupled with plantar flexion of the first ray. However, the literature reports limited evidence regarding the rebalancing of the plantar pressure distribution following surgery. The purpose of the present study was to examine the PP distribution in HV patients before and after a distal metatarsal osteotomy using a novel anatomically based protocol for in-shoe plantar load analysis during gait. Methods: A consecutive series of 18 patients with mild-to-moderate symptomatic HV who underwent a distal metatarsal osteotomy (S.E.R.I. technique) were prospectively evaluated using clinical scores (AOFAS and NRS), radiographic parameters (hallux valgus angle, intermetatarsal angle), and PP measurements via W-INSHOE© (Medicapteurs, Balma, France). Data were collected preoperatively and 12 months after surgery. Results: At 12 months follow-up, 3 patients were lost to follow-up, leaving 15 patients (24 HV) for examination. Both clinical and radiographical outcomes showed significant improvements from the pre- to postoperative periods. The PP distribution pattern revealed a significant increase in the peak pressure under the first metatarsal head associated with a significant increase in the peak pressure under the central metatarsals area between the pre- and postoperative periods. Conclusions: PP measurement systems hold promise as an additional clinical tool, yet current findings remain inconclusive. Further long-term follow-up studies that incorporate additional parameters are warranted. [ABSTRACT FROM AUTHOR]

Background: Asymmetric gait patterns are mostly observed in hemiplegic stroke patients. These abnormal gait patterns resulting in abnormal speed, and decreased ability in daily of activity living. Objective: This study aimed to determine the immediate changes in gait parameters and plantar pressure during elevation by wearing an insole on the sound side lower extremity of patients with hemiplegia. Methods: Thirty-six participants were recruited, comprising those with a post-stroke follow-up of ≥3 months and a functional ambulation category score of ≥2. The participants were asked to walk with and without a 1 cm insole in the shoe of their sound side, and the order of wearing or not wearing the insole was randomized. Gait parameters, bilateral gait parameters, and dynamic plantar pressure were measured using the GAITRite Walkway System. Results: Paired t-test was used to examine immediate changes in gait parameters and plantar pressure with and without insoles during walking in the same group. Overall, gait velocity and step length significantly decreased (p < 0.05), whereas step time significantly increased (p < 0.05). The swing phase of the affected sidelower extremities significantly increased (p < 0.05), and the stance phase significantly decreased (p < 0.05). Double-support unloading phase (pre-swing phase) significantly increased (p < 0.05). The changes in plantar pressure were significantly increased in some lateral zones and significantly decreased in the medial zone of the mid-hindfoot, both in terms of pressure per time and peak pressure (p < 0.05). Conclusion: Although this study did not show immediate positive effects on gait parameters and gait cycle, it is expected that sensory input from the sole of the foot through changes in plantar pressure may help improve gait asymmetry and regulate postural symmetry. [ABSTRACT FROM AUTHOR]

Foot orthoses (FOs) are often prescribed by clinicians to treat foot and ankle conditions, prevent running injuries, and enhance performance. However, the lack of higher-order synthesis of clinical trials makes it challenging for clinicians to adopt an evidence-based approach to FOs' prescriptions. Research question : Do FOs with different modifications alter lower extremity running kinematics and kinetics? A systematic search of seven databases was conducted from inception to February 2023. The analysis was restricted to healthy adults without foot musculoskeletal impairments and studies that compared the FOs effects with the controls. The methodological quality of the 35 studies that met the eligibility criteria was evaluated using the modified Downs and Black checklist. The random effects model estimated the standardized mean difference (SMD) with 95% confidence intervals and effect sizes. Sub-group analyses based on FOs type were performed to assess the potential effects of the intervention. Our findings indicated that both custom and off-the-shelf arch-support FOs reduced peak plantar pressure at the medial heel (SMD=−0.35, and SMD=−1.03), lateral heel (SMD=−0.50, and SMD=−0.53), and medial forefoot (SMD=−0.20, and SMD=−0.27), but increased plantar pressure at the mid-foot (SMD=0.30, and SMD=0.56). Compared with the controls, significant increases (SMD=0.36) in perceived comfort were found with custom FOs. A reduction (SMD=−0.58) in initial ankle inversion was found when a raised heel cup was integrated with arch-support FOs. A medial post integrated with arch support exhibited a reduced ankle (SMD=−1.66) and tibial (SMD=−0.63) range of motion. Custom FOs, however, unfavorably affected the running economy (SMD=−0.25) and perceived exertion (SMD=0.20). Significance : Although FOs have been reported to have some positive biomechanical effects in healthy populations without musculoskeletal impairments or running-related issues, they need to be optimized and generalized to achieve better running performance and prevent injury. • Foot orthoses have both positive and negative effects on running kinetics and kinematics. • Foot orthoses reduce peak plantar pressure as well as ankle and tibial moments. • Foot orthoses control ankle and tibial motion at coronal and transverse planes. • Effects of foot orthoses on hip and knee kinematics were not evident. [ABSTRACT FROM AUTHOR]

Squatting is a common movement in daily activities, athletic training, rehabilitation programs, and even in the workplace. Identifying the effects of various foot wedges on thigh muscle activity during squatting can help specialists in terms of rehabilitation, injury prevention, physical preparation, and occupational optimization. In this study, systematic literature searches in six electronic databases (Cochrane Library, PubMed, Google Scholar, Web of Science, ScienceDirect, and Scopus) were conducted up to December 2023. Fifteen studies met the inclusion criteria (total n = 269 subjects). The results showed that posterior wedges significantly increased the overall activity of thigh muscles (p < 0.001, 12 studies). No significant change was observed for anterior (p = 0.730, six studies), medial (p = 0.169; three studies), and lateral wedges (p = 0.989, two studies). Compared with a non-wedge condition, the activity of the vastus medialis (p < 0.001, eight studies) was significantly higher using a posterior wedge during squatting, as was the activity of the rectus femoris (p = 0.021, five studies) using the anterior wedge. It seems that thigh muscle activation is modifiable with a change in footwear design, which may be useful during sports training, rehabilitation, or daily work routines. [ABSTRACT FROM AUTHOR]

Assessing plantar pressure is crucial for fabricating diabetic insoles and preventing diabetic foot ulcers (DFUs), which are caused by increased plantar pressure. However, the commonly used methods for assessing plantar pressure distribution involve professional sensor-based equipment and expertise, which are costly and time-consuming. Given the qualitative association between ink footprint images and plantar pressure, this study proposes using the footprint images to predict the quantitative values of dynamic plantar pressure in barefoot and 4 different insole conditions (including Nora Lunalastik EVA, Nora Lunalight A fresh, Pe-Lite, and PORON® Medical 4708) based on a multilayer perceptron (MLP) neural network model. To provide more precise insole material recommendations for specific foot regions for better plantar pressure distribution, the plantar of the foot is divided into 5 regions: the toes, metatarsal heads, medial midfoot, lateral midfoot, and heel. Patch-based MLP with localization embedding is introduced to learn the correspondence between ink density and plantar pressure information. Ground-truth data collected from 52 diabetes patients is constructed as a dataset named diabetes-footprint-to-pressure and used to train and validate the model. The mean absolute error (MAE) of the models for the barefoot and 4 insole conditions is 5.51% (33.06 kPa), 3.99% (23.94 kPa), 4.85% (29.10 kPa), 4.25% (25.50 kPa), and 3.57% (21.42 kPa) of the sensing range, respectively. Compared to traditional methods for plantar pressure assessment, this approach streamlines the process of acquiring the overall and regional dynamic plantar pressure with barefoot and 4 different insole materials. Clinicians can quickly provide recommendations on the type of insole material for individual patients.

INTRODUCTION: Orthosis and physical therapy are two conservativemanagements for knee osteoarthritis (OA), but the question is which is better for alleviating pain and improving function? The aim of this study was to compare two interventions of orthosis and physical therapy on pain and function in patients with knee OA. Methods: In this quasi-experimental study, 31 individuals with medial knee OA were recruited into two groups including orthosis group (combination of insole and brace [n = 14]) and physical therapy group (n = 17). Pain severity was measured by visual analog scale (VAS) andWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Also, daily activity was measured by the WOMAC questionnaire at baseline and after 6-week follow-up. Wilcoxon signed rank and Mann-Whitney U tests were used to determine significant difference for intragroup and intergroup comparisons, respectively. Results: The orthosis group (using both knee brace and LWLs) had a better result for pain score related to VAS than the physical therapy group immediately after and 6 weeks of using the intervention, with a significant difference between the two groups (P = 0.006). Regarding the WOMAC items including pain and daily activity, both groups had significant differences after the 6-week period of using the intervention, with no significant difference between the groups. Conclusions: Based on the findings, pain and daily activity related to the WOMAC questionnaire were improved in both orthosis and physical therapy groups, with no differences between the two interventions. The orthosis group had better results in pain related to VAS. Clinical Relevance: The aim of this study was to find whether physical therapy or orthosis best improves pain and function of knee OA patients. [ABSTRACT FROM AUTHOR]

Functional insoles can reduce foot injuries caused by running. In this paper, ten male volunteers from the Track and Field Department of Guilin University of Electronic Technology were selected as subjects to test the biomechanical characteristics of the foot, such as plantar pressure, impulse, and center line pressure distribution, when using normal insoles and shock-absorbing functional insoles made of latex, ethyl vinyl acetate (EVA), and conventional insoles. The results showed that the plantar pressure and impulse were mainly concentrated on the first toe, the middle of the metatarsal, and the lateral part of the heel. After using the shock-absorbing insoles, the average pressure and impulse of the first toe, second to fifth toe, lateral metatarsal, and lateral heel were significantly reduced, while the average pressure intensity and impulse of the medial metatarsal, middle metatarsal, and medial heel were significantly increased; the center line of pressure became longer and straighter, indicating that the running stability was improved. [ABSTRACT FROM AUTHOR]

Ankle sprain is one of the common injuries among athletes and the general public. It seems that limiting the range of motion of ankle inversion can have positive effects on reducing the recurrence rate of ankle sprains. Therefore, the aim of this research is to use medical insoles to prevent excessive ankle movements. 10 soccer players with ankle sprains participated in this research. Kinematic data were collected using a motion recording system including four Vicon cameras and light-reflecting markers with a sampling rate of 100 Hz in two conditions running with and without insoles. Then the peak range of motion of inversion/eversion, dorsiflexion/plantarflexion, abduction/adduction in the ankle and flexion movements, internal/external rotation, abduction/adduction in the knee and flexion/extension movements, internal/external rotation and abduction/adduction in the hip joint in two conditions, with and without medical insoles was evaluated. Repeated measurement analysis of variance was used for intragroup comparison with a significance level (P=0.05) for statistical analysis. The results of this research showed that medical insoles reduce ankle dorsiflexion (p=0.036, d=1.14), inversion (p=0.003, d=1.44) and abduction (p=0.007: d=1.6). Also, the use of insoles decreased the internal rotation of the knee (p=0.04, d=0.61). Therefore, the use of insoles reduces the kinematic risk factors of ankle sprain and helps the stability of the ankle joint during running. As a result, the use of medical insoles can be suggested as a suitable therapeutic intervention to prevent ankle sprains. [ABSTRACT FROM AUTHOR]

This study presents the development of insoles using 3D scanning and additive manufacturing; additionally, the feasibility of implementing cellular structures in their design was evaluated. Using finite element models, the displacements and Von Mises stresses in the insoles were obtained considering the exerted pressures of a person during walking. The insoles developed in this work presented a decrease of 91.48% in deformation while the maximum Von Mises stress increased by 32.62%, compared with what other authors reported. The Von Mises stresses and displacements in the insole were calculated when two cellular topologies, triply periodic minimal surfaces (TPMS) and body-centered cubic (BCC), and different relative densities (10.33%, 14.67%, and 20.19%) were implemented. When compared to solid insoles, the Von Mises stresses and displacements for the models with cellular structures increased. The maximum Von Mises stresses and displacements resulted for the insoles with a relative density of 10.33%; for the insole with the BCC cellular structure, the displacement was 2.06 mm, and the Von Mises stress was 22.17 MPa, while for the TPMS structure, these were 2.7 mm and 23.84 MPa, respectively. The designs were additively manufactured, and the printing defects were visually characterized. [ABSTRACT FROM AUTHOR]

Yan Fu,1,&ast; Hongji Pu,2,&ast; Qun Huang,2,&ast; Peng Qiu,2 Deyin Zhao,3 Yong Cheng1 1Department of Nursing, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 2Department of Vascular Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 3Second Ward of General Surgery, Suzhou Hospital of Anhui Medical University (Suzhou Municipal Hospital of Anhui Province), Anhui, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Yong Cheng; Deyin Zhao, Email cy7107@163.com; 9168722@qq.comIntroduction: Critical limb ischemia (CLI) is a severe condition characterized by inadequate blood flow to the lower extremities, often leading to tissue damage and amputation. CLI is characterized by microcirculatory dysfunction, muscle tissue necrosis, and inflammation. Patients may suffer from the traumatic pain and the increase of plantar pressure, and foot care for patients with CLI has become the “last mile” to improve their life quality. Traditional shoe insoles often lack individual customization, failing to address the unique anatomical needs and hemodynamic characteristics of patients. The study aims to investigate the effects of this innovative intervention on improving the clinical outcomes, and quality of life in CLI patients.Methods and Analysis: This Critical Limb Ischemia Hemodynamic Insole Study is a randomized controlled study performed to explore the effect of a 3D printing insole on foot care of CLI patients. This study recruitment began on November 1, 2021. Patients with CLI confirmed by clinical symptoms and imaging were recruited as the research objects. Participants will be randomly assigned to either the experimental group, which will receive 3D-printed insoles customized based on their hemodynamics, or the control group, which will receive traditionally manufactured insoles. Both groups were followed up for up to 24 months after surgery, including claudication distance, claudication time, pain score, rehospitalization, etc.Trial Registration Number: ChiCTR2100051857.Keywords: 3D printing, insole, hemodynamics, critical limb ischemia

Running is the basis of many sports and has highly beneficial effects on health. To increase the understanding of running, DSPro® insoles were developed to collect running parameters during tasks. However, no validation has been carried out for running gait analysis. The aims of this study were to assess the test–retest reliability and criterion validity of running gait parameters from DSPro® insoles compared to a motion-capture system. Equipped with DSPro® insoles, a running gait analysis was performed on 30 healthy participants during overground and treadmill running using a motion-capture system. Using an intraclass correlation coefficient (ICC), the criterion validity and test–retest reliability of spatiotemporal parameters were calculated. The test–retest reliability shows moderate to excellent ICC values (ICC > 0.50) except for propulsion time during overground running at a fast speed with the motion-capture system. The criterion validity highlights a validation of running parameters regardless of speeds (ICC > 0.70). This present study validates the good criterion validity and test–retest reliability of DSPro® insoles for measuring spatiotemporal running gait parameters. Without the constraints of a 3D motion-capture system, such insoles seem to be helpful and relevant for improving the care management of active patients or following running performance in sports contexts.

Background: Integrating diverse sensor technologies into smart insoles offers significant potential for monitoring biomechanical metrics; enhancing sports performance; and managing therapeutic interventions, diseases, disorders, and other health-related issues. The variation in sensor types and applications requires a systematic review to synthesize existing evidence and guide future innovations. Objectives: This review aims to identify, categorize, and critically evaluate the various sensors used in smart insoles, focusing on their technical specifications, application scopes, and validity. Methods: Following the PRISMA guidelines, a search was conducted in three major electronic databases, namely, PubMed, Scopus, and Web of Science, for relevant literature published from 2014 to 2024. Other works not located in the mentioned databases were added manually by parallel searches on related themes and suggestions from the website of the databases. To be eligible, studies were required to describe sensor implementation in insoles, specify the sensor types, and report on either validation experiments or practical outcomes. Results: The search identified 33 qualifying studies. Proper analysis revealed a dominance of pressure sensors, with accelerometers and gyroscopes also being widely used. Critical applications included gait analysis, posture correction, and real-time athletic and rehabilitation feedback. The review also examined the relative effectiveness of different sensor configurations. Conclusions: This systematic review comprehensively classifies sensor technologies within smart insoles and highlights their broad application potential across various fields. Future research should aim to standardize measurement protocols, enhance sensor integration, and advance data processing techniques to boost functionality and clinical applicability.

We investigated the effects of hindfoot and forefoot eversion on the knee's positional and rotational displacement, plantar pressure, and foot discomfort in a standing posture, beyond the traditional focus on external knee adduction moments (EKAM) in lateral wedge insoles. Twenty-six healthy participants underwent hindfoot eversion from 0 to 10 degrees in 2-degree increments, and forefoot eversion from 0 degrees to the hindfoot eversion angle in 2-degree increments in a standing posture. At each eversion angle, the knee's medial displacement, EKAM's moment arm decrease, plantar pressure changes, and foot discomfort were obtained and compared across varying angles. Both hindfoot-only and entire-foot eversion led to significant medial knee displacement and the EKAM's moment arm decrease, with more pronounced effects in entire-foot eversion. At each hindfoot eversion angle, increasing forefoot eversion resulted in significant medial knee displacement and EKAM's moment arm decrease. Lower leg rotations were not significantly affected in hindfoot-only eversion but displayed significant medial tilting and internal rotation in entire-foot eversion at specific combinations. Varying eversion angles significantly influenced the forefoot pressure, with heel pressure remaining unaffected. Notably, the lateral forefoot pressure increased significantly as the forefoot eversion angle increased, particularly at higher hindfoot eversion angles. Foot discomfort increased significantly with higher eversion angles, particularly in entire-foot eversion, and also increased significantly as the forefoot eversion angle increased at higher hindfoot eversion angles. Insole configurations incorporating 6–10 degrees of hindfoot eversion and 40–60% forefoot eversion of the hindfoot angle may offer optimized biomechanical support for knee osteoarthritis patients. [ABSTRACT FROM AUTHOR]

Abstract—In innovative research, human footsteps are harnessed as a backup energy source. Researchers have developed shoe insoles equipped with a mini AC generator, which efficiently converts mechanical energy into electrical energy. This generator incorporates gears, a diode, capacitors, and an integrated circuit to regulate the output voltage, maintaining a steady 5 V. The electrical energy is stored in a battery via a DC step-up mechanism. When activated, this setup produces 4.99 V, 9.1 A, and 36.37 W of power. The study employed a three-cell storage battery with a capacity of 1800mAh for temporary energy storage. Charging the battery required 40 pumps, consuming 45.46 watts. Renewable energy sources, such as this innovative use of human footsteps, offer sustainability, environmental friendliness, and long-term cost-effectiveness. By converting mechanical energy into electrical energy, the mini AC generator embedded in the shoe insoles maximizes the utilization of human movement. This electrical energy is efficiently stored in a battery for future use through the DC step-up mechanism. The study's findings highlight the potential of tapping into renewable energy sources to meet our energy needs sustainably. [ABSTRACT FROM AUTHOR]

Wireless wearable insoles are interesting tools to collect gait parameters during daily life activities. However, studies have to be performed specifically for each type of insoles on a big data set to validate the measurement in ecological situations. This study aims to assess the criterion validity and test-retest reliability of gait parameters from wearable insoles compared to motion capture system. Gait of 30 healthy participants was recorded using DSPro® insoles and a motion capture system during overground and treadmill walking at three different speeds. Criterion validity and test-retest reliability of spatio-temporal parameters were estimated with an intraclass correlation coefficient (ICC). For both systems, reliability was found higher than 0.70 for all variables (p < 0.001) except for minimum toe clearance (ICC < 0.50) with motion capture system during overground walking. Regardless of speed and condition of walking, Speed, Cadence, Stride Length, Stride Time and Stance Time variables were validated (ICC > 0.90; p < 0.001). During walking on treadmill, loading time was not validated during slow speed (ICC < 0.70). This study highlights good criterion validity and test-retest reliability of spatiotemporal gait parameters measurement using wearable insoles and opens a new possibility to improve care management of patients using clinical gait analysis in daily life activities. [ABSTRACT FROM AUTHOR]

It was aimed to investigate the effect of custom made insoles on baropodometric analysis parameters in individuals with pes planus, using objective measurement and production methods. 100 individuals with pes planus, aged between 4-18 years in the study. Individuals who met the inclusion criteria and the medial longitudinal arch index were included in the study. Valgus angles of individuals, plantar measurements of the feet before the use of insoles and after 6 months of the use of insoles were evaluated with the Sensor Medica®? device. When the measurement results of the ankle valgus angles of the individuals before and after the insoles were examined, it was observed that there was a statistical decrease in the mean results in both feet (p<0,05). When the plantar pressure results were examined, the load on the medial side of the right foot was reduced significantly (p=0,012). Although there was a decrease in medial longitudinal arch of the right foot, it was not significant. There were no change in the lateral side of the right foot and the medial side of the right rearfoot. The load on the medial left rearfoot and the left medial longitudinal arch were reduced significantly (p=0,004, p=0.021). In study in individuals with pes planus, it was concluded that the foot should be well evaluated before and after technological based applications. Whether the insoles used provide benefits in foot development should be followed up with controls and their suitability should be checked, and changes in their physical capacities should be observed. [ABSTRACT FROM AUTHOR]

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

Background and Aims The use of medical insoles is one of the non-surgical treatment methods for improving the gait pattern of individuals with leg length discrepancy (LLD). However, the long-term effect of insoles on lower limb joint dynamics in these individuals is still unclear. This study aims to investigate and compare the long-term effect of inner and outer insoles on selected dynamics variables of the lower limb joints in men with LLD during the stance phase of gait. Methods This is a randomized clinical trial with a pre-test/post-test design on 18 men with mild LLD, randomly divided into two parallel groups of inner insole and outer insole. Selected dynamics parameters were measured by six cameras and a force plate during the stance phase of gait. Both groups used the insole for 12 weeks for at least four hours per day. Repeated-measures ANCOVA was used to test the hypothesis. P≤0.05 was statistically significant. Results After 12 weeks of using insoles, the peak lateral pelvic tilt decreased significantly in the inner insole group (P=0.041 for short leg, and P=0.008 for long leg) and outer insole group (P=0.026 for short leg, P=0.007 for long leg). The peak knee abduction moment (P=0.022 for inner insole, P=0.007 for outer insole) and peak hip abduction moment (P=0.006 for inner insole, P=0.005 for outer insole) also decreased significantly. In the outer insole group, the peak anterior pelvic tilt showed a significant change in the post-test stage compared to the pre-test stage (P=0.014 for short leg, and P=0.033 for long leg). There was no significant difference between the two groups in the selected dynamics variables (P>0.05). Conclusion The long-term use of inner and outer medical insoles, by causing a change in the lower limb joint dynamics, can lead to a positive adaptation in men with mild LLD. There is no significant difference in the long-term effect of inner and outer insoles. [ABSTRACT FROM AUTHOR]

Maria Danko, Jan Sekac, Eva Dzivakova, Jozef Zivcak, Radovan Hudak Department of Biomedical Engineering and Measurement, Technical University of Kosice, Kosice, Slovak RepublicCorrespondence: Maria Danko, Technical University of Kosice, Letna 9, Kosice, 040 01, Slovak Republic, Tel +421 55 602 2382, Email maria.danko@tuke.skPurpose: The study’s starting point is to find a low-cost and best-fit solution for comfortable movement for a recreational runner with knee pain using an orthopedic device. It is a case study. The research aims to apply digitization, CAD/CAM tools, and 3D printing to create an individual 3D running insole. The objective is to incorporate flexible shape optimization would provide comfort reductions in foot plantar pressures in one subject with knee pain while running. The test hypothesis was if it is possible to make it from one material. For this purpose, we created a new digital workflow based on the Decision Tree method and analyzed pain and comfort scores during user testing of prototypes.Patient and Methods: The input data were obtained during a professional examination by a specialist doctor in the orthopedic outpatient clinic in the motion laboratory (DIERS 4D Motion Lab, Germany) with the output of data on the proband’s complex movement stereotype. Surface and volumetric data were obtained in the biomedical laboratory with the 3D scanner. We modified the digital 3D foot models in 3D mesh software, developed the design in SW Gensole (Gyrobot, UK), and finally incorporated the internal structure and the surface layer of the insole data of the knowledge from the medical examination, comfort analyses, and scientific studies findings.Results: Four complete 3D-printed prototypes (n=4) with differences in density and correction elements were designed. All of them were fabricated on a 3D printer (Prusa i3 MK3S, Czech Republic) with flexible TPU material suitable for skin contact. The Participant tested each of them five times in the field during a workout and final insoles three months on the routine training.Conclusion: A novel workflow was created for designing, producing, and testing full 3D-printed insoles. The product is fit for immediate use.Keywords: insole, orthotic, digitization, 3D printing, algorithm, foot

Gait phase monitoring wearable sensors play a crucial role in assessing both health and athletic performance, offering valuable insights into an individual’s gait pattern. In this study, we introduced a simple and cost-effective capacitive gait sensor manufacturing approach, utilizing a micropatterned polydimethylsiloxane dielectric layer placed between screen-printed silver electrodes. The sensor demonstrated inherent stretchability and durability, even when the electrode was bent at a 45-degree angle, it maintained an electrode resistance of approximately 3 Ω. This feature is particularly advantageous for gait monitoring applications. Furthermore, the fabricated flexible capacitive pressure sensor exhibited higher sensitivity and linearity at both low and high pressure and displayed very good stability. Notably, the sensors demonstrated rapid response and recovery times for both under low and high pressure. To further explore the capabilities of these new sensors, they were successfully tested as insole-type pressure sensors for real-time gait signal monitoring. The sensors displayed a well-balanced combination of sensitivity and response time, making them well-suited for gait analysis. Beyond gait analysis, the proposed sensor holds the potential for a wide range of applications within biomedical, sports, and commercial systems where soft and conformable sensors are preferred.

Squatting is a common movement in daily activities, athletic training, rehabilitation programs, and even in the workplace. Identifying the effects of various foot wedges on thigh muscle activity during squatting can help specialists in terms of rehabilitation, injury prevention, physical preparation, and occupational optimization. In this study, systematic literature searches in six electronic databases (Cochrane Library, PubMed, Google Scholar, Web of Science, ScienceDirect, and Scopus) were conducted up to December 2023. Fifteen studies met the inclusion criteria (total n = 269 subjects). The results showed that posterior wedges significantly increased the overall activity of thigh muscles (p < 0.001, 12 studies). No significant change was observed for anterior (p = 0.730, six studies), medial (p = 0.169; three studies), and lateral wedges (p = 0.989, two studies). Compared with a non-wedge condition, the activity of the vastus medialis (p < 0.001, eight studies) was significantly higher using a posterior wedge during squatting, as was the activity of the rectus femoris (p = 0.021, five studies) using the anterior wedge. It seems that thigh muscle activation is modifiable with a change in footwear design, which may be useful during sports training, rehabilitation, or daily work routines.

The exploitation of bio-based foams implies an increase in the use of renewable biological resources to reduce the rapid consumption of petroleum-derived resources. Both tannins and furfuryl alcohol are derived from forestry resources and are, therefore, considered attractive precursors for the preparation of tannin–furanic foams. In addition, toughening modification of tannin–furanic foams using polyvinyl alcohol (PVOH) results in a more flexible network-like structure, which imparts excellent flexibility to the foams, whose relative properties are even close to those of polyurethane foams, which are the most used for fabrication of insoles for athletes. In addition, the addition of PVOH does not affect the thermal insulation properties of the foams by testing the thermal conductivity, resilience, and elongation at break, while reducing the brittleness of the samples and improving the mechanical properties. Also, the observation of the morphology of the foam shows that the compatibility between PVOH and tannin–furanic resin is good, and the cured foam does not show fragmentation and collapse, while the bubble pore structure is uniform. The developed flexible foam derived from biomass resources endows the foam with good thermal insulation properties and high mechanical properties, and the samples exhibit suitable physical parameters to be used as flexible insoles for athletes. [ABSTRACT FROM AUTHOR]

Insole construction is considered to be related to stability in sports, and custom-made insoles with their scientifically tailored approach and effective construction are considered to be the main means of adjusting posture and reducing risk in sports. We have designed a non-100% full-fit design insole (CDI) with an arch support insole and metatarsal liner to determine whether this insole can be adapted to lower limb kinematics. Eleven healthy volunteers participated in this randomized crossover test in which a motion capture and 3D gait analysis system was used to measure the subjects’ lower limb kinematic data while exercising at different slopes and speeds wearing three different insoles: CDI, control Insole (CI) and arch support insoles (ASI). In addition, the experiments introduced the speed and slope factor, analyzed the extent to which speed slope affects joint angle using UNIANOVA, and compared the performance differences between the three insoles in different planes in pairs. The CDI inhibited ankle dorsiflexion and knee flexion in the sagittal plane; in the frontal plane, CDI reduced knee adduction and hip abduction angles. There was a statistically significant difference (p < 0.05) between the change in joint angle and the velocity slope. Slope*speed had a greater effect on the ankle and knee joints (%sig>30%). The results show that the CDI has better kinematic adjustability in the ankle and knee joints due to its superior insole design approach. Therefore, wearing the CDI may be an effective way of reducing risks in sports. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The effects of insoles on managing knee osteoarthritis (KOA) symptoms remain controversial. This systematic review provides insights into the therapeutic effects and outcomes of insole use in older adults with KOA. MATERIALS AND METHODS: The PubMed database was reviewed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). The articles’ titles, abstracts, and eligibility per the inclusion criteria were screened for relevance. Duplicated articles were removed, and full-text articles were retrieved for further assessment, in accordance with the eligibility criteria. The included articles have been analyzed for general information, participants, and relevant findings, such as painful symptoms, loading rate, and external knee adduction moment (EKAM). RESULTS: The initial search identified 335 articles. Nine studies, including seven randomized controlled trials, one cross-sectional study, and one cohort study, were included for review per the eligibility criteria. There were 639 KOA patients, of which the majority were female, diagnosed with Kellgren-Lawrence grades 2-3, with a mean age of 54.5 years. The lateral wedge insole helped reducing EKAM and loading rates in patients with KOA. We detetced no significant reduction in pain following the use of lateral wedge insoles. However, lateral wedge insoles combined with customized arch support showed significant improvements in pain and physical function in KOA patients. CONCLUSIONS: Lateral wedge insoles with arch support significantly improved pain and physical function in patients with KOA. Other insoles did not provide significant positive outcomes regarding pain reduction or joint deterioration in KOA patients. [ABSTRACT FROM AUTHOR]

This pilot study aimed to investigate the use of sensorimotor insoles in pain reduction, different orthopedic indications, and the wearing duration effects on the development of pain. Three hundred and forty patients were asked about their pain perception using a visual analog scale (VAS) in a pre–post analysis. Three main intervention durations were defined: VAS_post: up to 3 months, 3 to 6 months, and more than 6 months. The results show significant differences for the within-subject factor "time of measurement", as well as for the between-subject factor indication (p < 0.001) and worn duration (p < 0.001). No interaction was found between indication and time of measurements (model A) or between worn duration and time of measurements (model B). The results of this pilot study must be cautiously and critically interpreted, but may support the hypothesis that sensorimotor insoles could be a helpful tool for subjective pain reduction. The missing control group and the lack of confounding variables such as methodological weaknesses, natural healing processes, and complementary therapies must be taken into account. Based on these experiences and findings, a RCT and systematic review will follow. [ABSTRACT FROM AUTHOR]

Abstract Background Therapeutic footwear and insoles are preventative strategies to reduce elevated plantar pressures associated with diabetic foot ulcer risk. An insole intervention appropriate for chairside delivery optimising plantar foot pressure reduction in people with diabetes has been developed. Aim To explore the feasibility and acceptability of testing an optimised insole compared with an active control insole to reduce plantar pressures for people with diabetic peripheral neuropathy. Methods A double-blinded multi-centre feasibility RCT with an embedded qualitative study. Participants were randomised to either an optimised insole group (intervention) or a standard cushioned insole group (active control). Participants were assessed at baseline, 3, 6, and 12 months with clinical outcomes of foot ulceration and mean peak plantar pressure (MPPP) reduction. An embedded qualitative study involved semi-structured interviews with 12 study participants and three podiatrists to explore their experiences of the intervention and trial procedures. Data were analysed using descriptive statistics (quantitative data) and thematic analysis (qualitative data). Results Screened were142 patients from which 61 were recruited; 30 participants were randomised to the intervention group and 31 to the active control group. Forty-two participants completed the study. At 12 months, 69% of the patient-reported questionnaires were returned and 68% of the clinical outcomes were collected. There were 17 incidences of foot ulceration occurring in 7/31 of the active control group and 10/30 in the intervention group. Mean difference in MPPP between the intervention and active control groups for all regions-of-interest combined favoured the intervention. Thematic analysis revealed three themes; accepting the study, behaviour and support during study procedures, and impact from study participation. Conclusion The results of the feasibility RCT suggest that the optimised insole holds promise as an intervention, and that a full RCT to evaluate the clinical and cost-effectiveness of this intervention is feasible and warranted for people with diabetic peripheral neuropathy. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN16011830 . Registered 9th October 2017.

Foot-related problems are prevalent across the globe, and this issue is aggravated by the presence of diabetes mellitus. Diabetic-foot-related issues include extreme foot pain, plantar corns, and diabetic foot ulcers. To assess these conditions, accurate characterization of plantar pressure is required. In this work, an in-shoe, low-cost, and multi-material pressure measuring insole, based on a piezoresistive material, was developed. The device has a high number of sensors, and was tested on 25 healthy volunteers and 25 patients with different degrees of diabetes. The working range of the device was observed to be 5 kPa to 900 kPa, with an average hysteresis error of 3.25%. Plantar pressure was found to increase from healthy to diabetic volunteers, in terms of both standing and walking. In the case of the diabetic group, the-high pressure contact area was found to strongly and positively correlate (R2 = 0.78) with the peak plantar pressure. During the heel strike phase, the diabetic volunteers showed high plantar pressure on the medial heel region. In regard to the toe-off phase, the central forefoot was found to be a prevalent site for high plantar pressure across the diabetic volunteers. The developed device is expected not only to assist in the prediction of diabetic ulceration or re-ulceration, but also to provide strategies and suggestions for foot pressure alleviation and pain mitigation.

Abstract Background Bracing and exercise methods were used in scoliosis rehabilitation and proven effective. There was little evidence about the efficacy of insoles on scoliosis. Objective This study aimed to investigate the effects of 3D personalized insoles on curve magnitude, postural stability, and quality of life (QOL) in moderate adolescent idiopathic scoliosis (AIS) patients. Methods Thirty-six volunteers with adolescent idiopathic scoliosis, who had moderate curves (20°-45°), were randomly divided into the experimental and control groups. The control group received traditional rehabilitation with bracing and exercises, and the experimental group received the insole interventions in addition to traditional rehabilitation. The outcome measures were Cobb angle, angle of trunk rotation (ATR), postural stability, and quality of life (Scoliosis Research Society-22 questionnaire). Measurements were conducted at baseline examination, two months and six months. Results After two and six months of treatment, the Cobb angle and ATR in both groups were significantly decreased as compared with the baseline (p 0.05). There was a significant difference in the sagittal balance index at six months compared to the control group (p 0.05). Conclusion Combining bracing with exercise in patients with moderate AIS is effective. 3D personalized insoles cannot reduce the Cobb angle and angle of trunk rotation of patients with moderate AIS but might have the potential to improve postural stability.

Featured Application: Quasi-static finite element model to adjust the stiffness of 3D-printed insoles during walking for patients with diabetic foot by using ankle moments and joint reaction forces as efficient boundary conditions. Diabetes-adapted insoles are essential in prevention and rehabilitation of foot ulcers in diabetic foot syndrome. However, their manufacture is labour-intensive and costly. Therefore, the study aims to present an alternative method that allows the individual adjustment of the stiffness of the insoles using the finite element (FE) method and subsequent 3D printing. In the study, 3D gait analysis followed by musculoskeletal modelling was used to determine the boundary conditions of a healthy subject for the FE model. While muscle forces are elaborately implemented in most studies, this FE model presented a more efficient way by using ankle moments and joint reaction forces. The deviation between the simulated plantar peak pressure and the experimentally determined using the Pedar system amounted to 234 kPa in the heel area and 30 kPa in the toe area. The stiffness of the individual insole was adjusted by applying soft insole plugs in areas where high plantar pressures occurred during walking. Three different Young's moduli were analysed in these areas (0.5 MPa, 1.0 MPa, 1.5 MPa). The computer-based approach to adjust the stiffness of an individual insole revealed a plantar peak pressure reduction by 37% in the heel area and by 119% in the toe area with a Young's modulus of 0.5 MPa. The presented method could be a valuable tool in the cost-efficient development and engineering of subject-specific 3D-printed insoles for patients with diabetic foot syndrome. [ABSTRACT FROM AUTHOR]

This study focuses on the assessment of the mechanical effect produced by Morton's extension as an orthopedic intervention in patients with bilateral foot pronation posture, through a variation in hindfoot and forefoot prone-supinator forces during the stance phase of gait. A quasi-experimental and transversal research was designed comparing three conditions: barefoot (A); wearing footwear with a 3 mm EVA flat insole (B); and wearing a 3 mm EVA flat insole with a 3 mm thick Morton's extension (C), with respect to the force or time relational to the maximum time of supination or pronation of the subtalar joint (STJ) using a Bertec force plate. Morton's extension did not show significant differences in the moment during the gait phase in which the maximum pronation force of the STJ is produced, nor in the magnitude of the force, although it decreased. The maximum force of supination increased significantly and was advanced in time. The use of Morton's extension seems to decrease the maximum force of pronation and increase supination of the subtalar joint. As such, it could be used to improve the biomechanical effects of foot orthoses to control excessive pronation. [ABSTRACT FROM AUTHOR]

Insoles are used to treat various foot diseases, including plantar foot, diabetic foot ulcers, and refractory plantar fasciitis. In this study, we investigated the effects of 3-dimensional image-based (3-D) insole in healthy volunteers with no foot diseases. Additionally, the comfort of the 3-D insole was compared with that of a custom-molded insole. A singlecenter, randomized, open clinical trial was conducted to address the effectiveness of insole use in a healthy population with no foot or knee disease. Two types of arch support insoles were evaluated for their effectiveness: a 3-D insole and a custom-molded insole. Fifty Korean volunteers participated in the study and were randomly allocated into the "3-D insole" (n = 40) or "custom-molding insole" (n = 10) groups. All subjects wore 3-D insoles or custommolded insoles for 2 weeks. The sense of wearing shoes (Visual Analog Scale [VAS] and score) and fatigue of the foot were used to assess the insole effects at the end of the 2-week study period. The 3-D insole groups showed significantly improved sense of wearing shoes (VAS, p = 0.0001; score, p = 0.0002) and foot fatigue (p = 0.0005) throughout the study period. Although the number of subjects was different, the custom-molding insole group showed no significant changes in the sense of wearing shoes (VAS, 0.1188; score, p = 0.1483). Foot fatigue in the 3-D insole group improved significantly (p = 0.0005), which shows that a 3-D insole might have favorable effects on foot health in a healthy population. [ABSTRACT FROM AUTHOR]