OBJECTIVE: To investigate relationships between static foot posture, dynamic plantar foot forces and knee pain in people with medial knee osteoarthritis (OA).
METHODS: Data from 164 participants with symptomatic, moderate to severe radiographic medial knee OA were analysed. Knee pain was self-reported using a numerical rating scale (NRS; scores 0-10; higher scores worse) and the Knee Injury and Osteoarthritis Outcome Score pain subscale (KOOS; scores 0-100; lower scores worse). Static foot posture was assessed using clinical tests (foot posture index, foot mobility magnitude, navicular drop). Dynamic plantar foot forces (lateral, medial, whole foot, medial-lateral ratio, arch index) were measured using an in-shoe plantar pressure system while walking. Relationships between foot posture and plantar forces (independent variables) and pain (dependent variables) were evaluated using linear regression models, unadjusted and adjusted for sex, walking speed, Kellgren & Lawrence grade, shoe category, and body mass (for dynamic plantar foot forces).
RESULTS: No measure of static foot posture was associated with any knee pain measure. Higher medial-lateral foot force ratio at midstance, and a higher arch index during overall stance, were weakly associated with higher knee pain on the NRS (regression coefficient = 0.69, 95% confidence interval (CI) 0.09 to 1.28) and KOOS (coefficient=3.03, 95% CI 0.71 to 5.35) pain scales, respectively.
CONCLUSIONS: Dynamic plantar foot forces, but not static foot posture, were associated with knee pain in people with medial knee OA. However, the amount of pain explained by increases in plantar foot force was small; thus, these associations are unlikely to be clinically meaningful.

BACKGROUND: Motor coordination concerns are estimated to affect 5%-6% of school-aged children. Motor coordination concerns have variable impact on children\'s lives, with gait and balance often affected. Textured insoles have demonstrated positive impact on balance and gait in adults with motor coordination disorders related to disease or the ageing process. The efficacy of textured insoles in children is unknown. Our primary aim was to identify the feasibility of conducting a randomised controlled trial involving children with motor control issues. The secondary aim was to identify the limited efficacy of textured insoles on gross motor assessment balance domains and endurance in children with movement difficulties.
METHODS: An assessor-blinded, randomised feasibility study. We advertised for children between the ages of 5-12 years, with an existing diagnosis or developmental coordination disorder or gross motor skill levels assessed as 15th percentile or below on a norm-referenced, reliable and validated scale across two cities within Australia. We randomly allocated children to shoes only or shoes and textured insoles. We collected data across six feasibility domains; demand (recruitment), acceptability (via interview) implementation (adherence), practicality (via interview and adverse events), adaptation (via interview) and limited efficacy testing (6-min walk test and balance domain of Movement ABC-2 at baseline and 4 weeks).
RESULTS: There were 15 children randomised into two groups (eight received shoes alone, seven received shoes and textured insoles). We experienced moderate demand, with 46 potential participants. The insoles were acceptable, however, some parents reported footwear fixture issues requiring modification. The 6-min walk test was described as problematic for children, despite all but one child completing. Social factors impacted adherence and footwear wear time in both groups. Families reported appointment locations and parking impacting practicality. Underpowered, non-significant small to moderate effect sizes were observed for different outcome measures. Improvement in balance measures favoured the shoe and insole group, while gait velocity increase favoured the shoe only group.
CONCLUSIONS: Our research indicates that this trial design is feasible with modifications such as recruiting with a larger multi-disciplinary organisation, providing velcro shoe fixtures and using a shorter timed walk test. Furthermore, progressing to a larger well-powered randomised control trial is justified considering our preliminary, albeit underpowered, efficacy findings.
BACKGROUND: This trial was retrospectively registered with the Australian and New Zealand Clinical Trial Registration: ACTRN12624000160538.

This study seeks to explore the correlation between cortical activation and the Infinity Walk pattern, examining how the influence of foot overpronation and footwear may impact motor control. Functional near-infrared spectroscopy (fNIRS), a portable and user-friendly neuroimaging technique, was used to measure hemodynamical changes in six individuals with non-critical pronation degrees. Participants perform the Infinity Walk under various footwear conditions while wearing an fNIRS portable imaging device. Results indicate a consistent hemodynamic pattern in both hemispheres during the Infinity Walk, with no significant differences observed across subjects and footwear conditions in the prefrontal cortex (PFC), pre-motor area, the supplementary motor cortex (PMA & SMC), the primary motor cortex (PMC), and Wernicke\'s area (WA). The impact of pronation and footwear on motor control remains inconclusive due to inconsistent hemodynamic patterns. Notably, the activation patterns in Broca\'s area (BA) and the temporal gyrus (TG) differ significantly from other brain regions. The balanced hemodynamic responses in the bilateral hemispheres may be attributed to the Infinity Walk\'s inherent walking pattern. These findings indicate a need for further investigation into the Infinity Walk to examine the similarities and distinctions in activation patterns within specific brain regions. Additionally, the impact of pronation necessitates more substantial experimental research to establish a correlation between pronation and cortical hemodynamics.

The objective of this study was to analyse the influence of materials and their position within the upper assembly on the behaviour of casual footwear using finite element simulation tools. The study was carried out on three models of casual footwear, which are identical in terms of design lines, varying only in the materials of the upper assembly, namely calfskin leather (M1), knitted fabric (M2), and combination of knitted fabric and calfskin leather (M3). The footwear models were designed according to the design constraints specific to casual footwear. The foot was reconstructed based on the shoe last obtained based on anthropometric data. Material definition, 3D models editing, setting up analysis conditions, and constraints were performed using the Ansys 17.2 software. Gait biomechanics were taken into account to define the loading model, force distribution, force values, and constraints. The study evaluates footwear behaviour in terms of directional deformation (Z axis), equivalent von Mises stress, and equivalent elastic strain distribution. This paper explores a methodology that has the potential to enhance the footwear design and manufacturing process, providing designers with information about the deformations and stress distribution on upper parts of the footwear product.

BACKGROUND: Preventing foot ulcers in people with diabetes can increase quality of life and reduce costs. Despite the availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesize that a multimodal treatment approach incorporating various footwear, self-management, and education interventions that matches an individual person\'s needs can reduce the risk of ulcer recurrence with beneficial cost-utility. The aim of this study is to assess the effect on foot ulcer recurrence, footwear adherence, and cost-utility of an integrated personalized assistive devices approach in high-risk people with diabetes.
METHODS: In a parallel-group multicenter randomized controlled trial, 126 adult participants with diabetes mellitus type 1 or 2, loss of protective sensation based on the presence of peripheral neuropathy, a healed plantar foot ulcer in the preceding 4 years, and possession of any type of custom-made footwear will be included. Participants will be randomly assigned to either enhanced therapy or usual care. Enhanced therapy consists of usual care and additionally a personalized treatment approach including pressure-optimized custom-made footwear, pressure-optimized custom-made footwear for indoor use, at-home daily foot temperature monitoring, and structured education, which includes motivational interviewing and personalized feedback on adherence and self-care. Participants will be followed for 12 months. Assessments include barefoot and in-shoe plantar pressure measurements; questionnaires concerning quality of life, costs, disease, and self-care knowledge; physical activity and footwear use monitoring; and clinical monitoring for foot ulcer outcomes. The study is powered for 3 primary outcomes: foot ulcer recurrence, footwear adherence, and cost-utility, the primary clinical, patient-related, and health-economic outcome respectively.
CONCLUSIONS: This is the first study to integrate multiple interventions for ulcer prevention into a personalized state-of-the-art treatment approach and assess their combined efficacy in a randomized controlled trial in people with diabetes at high ulcer risk. Proven effectiveness, usability, and cost-utility will facilitate implementation in healthcare, improve the quality of life of high-risk people with diabetes, and reduce treatment costs.
BACKGROUND: ClinicalTrials.gov NCT05236660. Registered on 11 February 2022.

Footwear outsole design is an important factor for shoe-floor friction and for preventing slipping. Shoes with small, uniformly-separated tread blocks (often included on slip-resistant shoes) have decreased slip risk due to their increased friction and better under-shoe fluid drainage. However, these traction performance metrics (friction and fluid drainage) diminish with wear. This study quantifies shoe traction performance in response to natural wear and compares the relationship between common wear metrics: time, distance walked, and worn region size (WRS). Participants wore two pairs of shoes in the workplace for up to 11 months and the distance walked was tracked with a pedometer. After each month of wear, traction performance and WRS of each shoe were measured. Traction performance was quantified by the under-shoe available coefficient of friction and fluid force during a simulated slip condition. Increased wear (months worn, distance walked, and WRS) was associated with decreased traction performance. A WRS of 800 mm2 was associated with reductions in friction of 16-38% and increases in fluid force by 286-528%. Three and six months of wear were associated with WRS values of 251 mm2 and 462 mm2 and distances of 203 km and 519 km, respectively. A walking distance of 500 km was associated with a WRS of 406 mm2. This study showed that all these wear metrics are good indicators of shoe traction performance loss. Thus, the most practical metric in a particular application can be selected. We argue that WRS may be the best indicator due to variations in wear rate from the user and environment. Therefore, tracking footwear usage and monitoring outsole wear can aid in shoe replacement recommendations to reduce slips and falls.

BACKGROUND: Plantar fasciitis is a debilitating clinical condition and is one of the most common causes of heel pain. The risk factors include frequent and prolonged running, obesity, a sedentary lifestyle, work-related weight bearing, and inappropriate footwear. Ultrasonography being a non-invasive, cost-effective, and easily available modality is a useful adjunct in the diagnosis.
METHODS: A prospective observational study was conducted among 30 patients with unilateral plantar fasciitis. The diagnosis was based on history and examination. Heel pad thickness and plantar fascia thickness were recorded using ultrasonography.
RESULTS: The ultrasonography results showed increased plantar fascia and heel pad thickness in the affected limb with plantar fasciitis than the normal one (p<0.001). The BMI was positively correlated with the heel pad thickness (p<0.05). The receiver operating characteristic (ROC) curve showed 90% sensitivity and 60% specificity for heel pad thickness (p<0.001).
CONCLUSIONS: Ultrasonography is a sensitive and specific tool to identify patients with plantar fasciitis.

BACKGROUND: Chronic hip pain is common and disabling and is largely due to osteoarthritis (OA). Self-management is recommended by international OA clinical guidelines yet there are few effective treatment options. Footwear has been suggested as a self-management approach, given that foot motion influences hip forces. Currently, guidelines advocate \'stable supportive\' shoes for people with OA, however this is based solely on expert opinion given no research has investigated whether these shoes are effective at reducing symptoms in people with OA-related chronic hip pain. Therefore, this randomized controlled trial (RCT) aims to determine if stable supportive footwear reduces hip pain during walking compared to flat flexible footwear in people with chronic hip pain consistent with OA.
METHODS: This trial is a 6-month, participant- and assessor-blinded, pragmatic, comparative effectiveness, superiority RCT conducted in Melbourne, Australia. We are recruiting 120 participants aged over 45 years with chronic hip pain consistent with OA from the community. Following baseline assessment, participants are randomized to receive either i) stable supportive shoes or ii) flat flexible shoes. Participants are permitted to choose two different pairs of shoes in their allocated group from a range of options that match prespecified shoe classification criteria. They are advised to wear either pair of study shoes daily for a minimum of 6 hours each day for 6 months. The primary outcome is the 6-month change in average hip pain on walking in the last week. Secondary outcomes include changes in other measures of hip pain, symptoms, function in daily living and sports and recreation, hip-related quality of life, pain at other sites, adverse events, and physical activity. Other measures include co-intervention use, adherence, shoe comfort, descriptive characteristics, footwear characteristics, and objective foot measures.
CONCLUSIONS: This RCT will determine whether stable supportive shoes reduce hip pain during walking more than flat flexible shoes in people with chronic hip pain. Outcomes will help to inform footwear recommendations in international clinical guidelines for OA-related chronic hip pain, which to date have been based solely on expert opinion because of an absence of RCTs.
BACKGROUND: Australian New Zealand Clinical Trials Registry reference: ACTRN12621001532897.

One of the recommendations for individuals with knee osteoarthritis (OA) is the use of specific footwear, such as sturdy or cushioned shoes. However, the long-term use effects of using cushioned shoes on the pain and spatiotemporal gait parameters in individuals with knee OA are yet to be reported. We therefore aimed to compare the efficacy of cushioned sport footwear versus sham shoes on motor functions, pain and gait characteristics of individuals with knee OA who used the shoes for 3 months. In a double-blinded study, we provided 26 individuals with knee OA with cushioned sport shoes and 12 individuals with knee OA with similar sport shoes without cushioning for 3 months. The gait analysis, the timed up and go (TUG) test and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) were conducted and the pain levels were measured at the baseline, 1 month, and 3 months after the baseline. We found that the cushioned shoes reduce the amount of pain (based on WOMAC) in the affected knee and increase functionality in the research group, but not in the control group. Gait velocity and cadence were increased in both groups. Gait spatiotemporal parameters and their symmetry were unaffected during the intervention. We conclude that the use of cushioned shoes should be recommended to individuals with knee OA for alleviating pain.

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.
CONCLUSIONS: 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.
BACKGROUND: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000699965p. Registered on June 23, 2020.