BACKGROUND: The field of medical grade footwear is dynamic. Originally, a field where individual knowledge, expertise and skills determined the footwear and its outcomes, now becoming a more evidence-based and data-driven field with protocols and systems in place to create appropriate footwear. However, scientific evidence concerning medical grade footwear is still limited. Evidently, all stakeholders, from patients to pedorthists to rehabilitation physicians, will profit from a larger evidence-base in this field. A widely supported research agenda is an essential first step to advance and facilitate new knowledge.
METHODS: We formed a multidisciplinary team and followed the methodology from Dutch medical societies for the development of a research agenda on medical grade footwear. This consisted of seven steps: (1) inventory of relevant questions with users and professionals; (2) analyses of responses; (3) analyses of existing knowledge and evidence; (4) formulating research questions; (5) prioritising research questions by users and professionals; (6) finalising the research agenda and (7) implementing the research agenda.
RESULTS: In phase 1, 109 participants completed a survey, including 50% pedorthists, 6% rehabilitation physicians and 3% users. Participants provided 228 potential research questions. In phases 2-4, these were condensed to 65 research questions. In phase 5, 152 participants prioritised these 65 research questions, including 50% pedorthists, 13% rehabilitation physicians and 9% users. In phase 6, the final research agenda was created, with 26 research questions, categorised based on the International Classification of Functioning Disability and Health \'process description assistive devices\'. In phase 7, an implementation meeting was held with over 50 stakeholders (including users and professionals), resulting in seven applications for research projects based on one or more research questions from the research agenda.
CONCLUSIONS: This research agenda structures and guides knowledge development within the field of medical grade footwear in the Netherlands and elsewhere. We expect that this will help to stimulate the field to tackle the research questions prioritised and with that to advance scientific knowledge in this field.

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.

Objective  To compare the spatial-temporal parameters and walking kinematics of toddlers wearing biomimetic shoes, regular shoes (daily use owned shoes), and barefoot. Methods  Spatial-temporal parameters (speed, step length, and stride width), the mean vertical displacement of the center of mass (COM), knee flexion peak, and maximal foot height were analyzed. Results  Children were not different in biomimetic shoes and barefoot conditions on speed, step length, and COM vertical displacement. There was no difference among conditions on stride width and foot height. The knee flexion peak was greater in shod conditions than barefoot. The regular shoes showed greater COM vertical displacement than biomimetic shoes and barefoot. Conclusion  The findings showed that shoes affected the walking pattern in young children, but a shoe with a biomimetic design had a lesser effect on the walking pattern.

This study aimed to develop an insertion technique for intramuscular EMG recording of the oblique head of adductor hallucis (AddH) and first dorsal interosseous (FDI) muscles in humans via the dorsum of the foot, and report feasibility of intramuscular EMG data acquisition during walking in shoes. In eight individuals without musculoskeletal pain or injury (5 males; 32 ± 8 years), intramuscular electrodes were inserted into AddH (oblique head) and FDI through the right foot\'s dorsum (between metatarsals I-II) with ultrasound guidance. The ultrasound transducer was positioned on the plantar surface. Intramuscular EMG was also recorded from abductor hallucis, tibialis posterior, flexor digitorum longus and peroneus longus. Participants performed six overground walking trials wearing modified shoes, and rated pain associated with the intramuscular electrodes during walking (numerical rating scale, 0-10). High-quality EMG recordings were obtained from intrinsic and extrinsic foot muscles. Analyses of power spectral densities indicated that movement artefacts commonly observed during gait were removed by filtering. Pain associated with AddH/FDI electrodes during walking was low (median[IQR] 1[2]; range 0-4) and similar to other sites. Findings demonstrate that intramuscular EMG recording from AddH (oblique head) and FDI using this insertion technique is feasible and associated with minimal pain when walking in shoes.

BACKGROUND: During city running or marathon races, shifts in level ground and up-and-down slopes are regularly encountered, resulting in changes in lower limb biomechanics. The longitudinal bending stiffness of the running shoe affects the running performance.
OBJECTIVE: This research aimed to investigate the biomechanical changes in the lower limbs when transitioning from level ground to an uphill slope under different longitudinal bending stiffness (LBS) levels in running shoes.
METHODS: Fifteen male amateur runners were recruited and tested while wearing three different LBS running shoes. The participants were asked to pass the force platform with their right foot at a speed of 3.3 m/s ± 0.2. Kinematics data and GRFs were collected synchronously. Each participant completed and recorded ten successful experiments per pair of shoes.
RESULTS: The range of motion in the sagittal of the knee joint was reduced with the increase in the longitudinal bending stiffness. Positive work was increased in the sagittal plane of the ankle joint and reduced in the keen joint. The negative work of the knee joint increased in the sagittal plane. The positive work of the metatarsophalangeal joint in the sagittal plane increased.
CONCLUSIONS: Transitioning from running on a level surface to running uphill, while wearing running shoes with high LBS, could lead to improved efficiency in lower limb function. However, the higher LBS of running shoes increases the energy absorption of the knee joint, potentially increasing the risk of knee injuries. Thus, amateurs should choose running shoes with optimal stiffness when running.

OBJECTIVE: Shoe longitudinal bending stiffness (LBS) is often considered to influence running economy (RE) and thus, running performance. However, previous results are mixed and LBS levels have not been studied in advanced footwear technology (AFT). The purpose of this study was to evaluate the effects of increased LBS from curved carbon fiber plates embedded within an AFT midsole compared to a traditional running shoe on RE and spatiotemporal parameters.
METHODS: Twenty-one male trained runners completed three times 4 min at 13 km/h with two experimental shoe models with a curved carbon fiber plate embedded in an AFT midsole with different LBS values (Stiff: 35.5 N/mm and Stiffest: 43.1 N/mm), and a Control condition (no carbon fiber plate: 20.1 N/mm). We measured energy cost of running (W/kg) and spatiotemporal parameters in one visit.
RESULTS: RE improved for the Stiff shoe condition (15.71 ± 0.95 W/kg; p < 0.001; n2 = 0.374) compared to the Control condition (16.13 ± 1.08 W/kg; 2.56%) and Stiffest condition (16.03 ± 1.19 W/kg; 1.98%). However, we found no significant differences between the Stiffest and Control conditions. Moreover, there were no spatiotemporal differences between shoe conditions.
CONCLUSIONS: Changes in LBS in AFT influences RE suggesting that moderately stiff shoes have the most effective LBS to improve RE in AFT compared to very stiff shoes and traditional, flexible shoe conditions while running at 13 km/h.

Hallux valgus (HV) is a frequent forefoot deformity affecting about 23% of adults and 35.7% of people over 65. The exact etiology is not fully understood. The first ray plays a significant role in walking cause it bears the principal amount of weight and maintains the position of the medial arch. Several factors that deteriorate the integrality of the first ray, such as foot deformities, restrictive footwear, and pes planus, may be ascribed to the HV occurrence. Before any surgical correction, conservative treatment should always be initiated first. Currently, there is no consensus that conservative management by shoe modification and foot orthoses could correct the pathology or terminate the clinical worsening of the condition.From a careful analysis of the literature, proper footwear should be a shoe with an adequate length, wide toe box, cushioned sole, and a lowered heel to not increase the load on the metatarsal heads and cause pain. Personalized 3D printed customized toe spreaders may be applied in patients with HV, improving symptoms and bringing pain relief. Compensating the subtalar joint hyperpronation through foot orthoses plays a fundamental role in the HV development, preventing or at least controlling the condition\'s progress; this, along with weight reduction and regular physical activity.Data obtained suggest that dynamic foot orthoses prefer a biomechanical type with 3/4-length, which is less likely to negatively affect the dorsal or medial pressures, which instead were noted to increase with the sulcus- and full-length orthoses.Although some studies suggest that foot orthoses would favor the correction of HV deformity, results have been very variable and just in few studies appear to correct HV or reduce its progression, improving symptoms and bringing pain relief. In the case of HV surgical correction, orthoses seem to maintain the correct position acquired over time.

BACKGROUND: Minimalist shoes (MS) are beneficial for foot health. The foot is a part of the posterior chain. It is suggested that interventions on the plantar foot sole also affect the upper segments of the body. This study aimed to investigate the local and remote effects along the posterior chain of four weeks of MS walking in recreationally active young adults.
METHODS: 28 healthy participants (15 female, 13 male; 25.3 ± 5.3 years; 70.2 ± 11.9 kg; 175.0 ± 7.8 cm) were randomly assigned to a control- or intervention group. The intervention group undertook a four-week incremental MS walking program, which included 3,000 steps/day in the first week, increasing to 5,000 steps/day for the remaining three weeks. The control group walked in their preferred shoe (no MS). We assessed the following parameters in a laboratory at baseline [M1], after the four-week intervention [M2], and after a four-week wash-out period [M3]: Foot parameters (i.e., Foot Posture Index-6, Arch Rigidity Index), static single-leg stance balance, foot-, ankle-, and posterior chain range of motion, and muscle strength of the posterior chain. We fitted multiple hierarchically built mixed models to the data.
RESULTS: In the MS group, the Foot Posture Index (b = -3.72, t(51) = -6.05, p < .001, [-4.94, 2.51]) and balance (b = -17.96, t(49) = -2.56, p = .01, [-31.54, 4.37]) significantly improved from M1 to M2, but not all other parameters (all p >.05). The improvements remained at M3 (Foot Posture Index: b = -1.71, t(51) = -2.73, p = .009, [-4,94,0.48]; balance: b = -15.97, t(49) = -2.25, p = .03, [-29.72, 2.21]).
CONCLUSIONS: Walking in MS for four weeks might be advantageous for foot health of recreationally active young adults but no chronic remote effects should be expected.

Footwear has the potential to reduce soft-tissue vibrations (STV) but responses are highly subject-specific. Recent evidence shows that compressive garments minimizing STV have a beneficial effect on neuromuscular (NM) fatigue. The aim was to determine whether an individualized midsole hardness can minimize STV and NM fatigue during a half marathon. Twenty experienced runners were recruited for three visits: a familiarization session including the identification of midsole minimizing and maximizing STV amplitude (MIN and MAX, respectively), and two half marathon sessions at 95% of speed at the second ventilatory threshold. STV of the gastrocnemius medialis (GM) muscle, running kinetics, foot strike pattern, rating perceived exhaustion (RPE), and midsole liking were recorded every 3 km. NM fatigue was assessed on plantar flexors (PF) before (PRE) and after (POST) the half marathon. At POST, PF central and peripheral alterations and changes in contact time, step frequency, STV median frequency, and impact force frequency as well as foot strike pattern were found in both MIN and MAX. No significant differences in damping, STV main frequency, flight time, duty factor, and loading rate were observed between conditions whatever the time period. During the half marathon, STV amplitude of GM significantly increased over time for the MAX condition (+13.3%) only. Differences between MIN and MAX were identified for RPE and midsole liking. It could be hypothesized that, while significant, the effect of midsole hardness on STV is too low to substantially affect NM fatigue.

Osteoarthritis (OA) affecting the first metatarsophalangeal joint (hallux rigidus) is common and painful. Several non-surgical treatments have been proposed; however, few have been adequately evaluated. Since the original 2010 review, several studies have been published necessitating this update.
To determine the benefits and harms of non-surgical treatments for big toe OA.
We used standard, extensive Cochrane search methods. The latest search was February 2023.
We included randomised trials that compared any type of non-surgical treatment versus placebo (or sham), no treatment (such as wait-and-see) or other treatment.
We used standard Cochrane methods. The major outcomes were pain, function, quality of life, radiographic joint structure, adverse events and withdrawals due to adverse events. The primary time point was 12 weeks. We used GRADE to assess the certainty of evidence.
This update includes six trials (547 participants). The mean age of participants ranged from 32 to 62 years. Trial durations ranged from 4 to 52 weeks. Treatments were compared in single trials as follows: arch-contouring foot orthoses versus sham inserts; shoe-stiffening inserts versus sham inserts; intra-articular injection of hyaluronic acid versus saline (placebo) injection; arch-contouring foot orthoses versus rocker-sole footwear; peloid therapy versus paraffin therapy; and sesamoid mobilisation, flexor hallucis longus strengthening and gait training plus physical therapy versus physical therapy alone. Certainty of the evidence was limited by the risk of bias and imprecision. Meta-analysis was not performed due to the heterogeneity of interventions. We reported numerical data for the 12-week time point for the three trials that used a placebo/sham control group. Arch-contouring foot orthoses versus sham inserts One trial (88 participants) showed that arch-contouring foot orthoses probably lead to little or no difference in pain, function, or quality of life compared to sham inserts (moderate certainty). Mean pain (0-10 scale, 0 no pain) with sham inserts was 3.9 points compared to 3.5 points with arch-contouring foot orthoses; a difference of 0.4 points better (95% (CI) 0.5 worse to 1.3 better). Mean function (0-100 scale, 100 best function) with sham inserts was 73.3 points compared to 65.5 points with arch-contouring foot orthoses; a difference of 7.8 points worse (95% CI 17.8 worse to 2.2 better). Mean quality of life (-0.04-100 scale, 100 best score) with sham inserts was 0.8 points compared to 0.8 points with arch-contouring foot orthoses group (95% CI 0.1 worse to 0.1 better). Arch-contouring foot orthoses may show little or no difference in adverse events and withdrawal due to adverse events compared to sham inserts (low certainty). Adverse events (mostly foot pain) were reported in 6 out of 41 people with sham inserts and 4 out of 47 people with arch-contouring foot orthoses (RR 0.58, 95% CI 0.18 to 1.92). Withdrawals due to adverse events were reported in 0 out of 41 people with sham inserts and 1 out of 47 people with arch-contouring foot orthoses (Peto OR 6.58, 95% CI 0.13 to 331). Shoe-stiffening inserts versus sham inserts One trial (100 participants) showed that shoe-stiffening inserts probably lead to little or no difference in pain, function, or quality of life when compared to sham inserts (moderate certainty). Mean pain (0-100 scale, 0 no pain) with sham inserts was 63.8 points compared to 70.1 points with shoe-stiffening inserts; a difference of 6.3 points better (95% CI 0.5 worse to 13.1 better). Mean function (0-100 scale, 100 best function) with sham inserts was 81.0 points compared to 84.9 points with shoe-stiffening inserts; a difference of 3.9 points better (95% CI 3.3 worse to 11.1 better). Mean quality of life (0-100 scale, 100 best score) with sham inserts was 53.2 points compared to 53.3 points with shoe-stiffening inserts; a difference of 0.1 points better (95% CI 3.7 worse to 3.9 better). Shoe-stiffening inserts may show little or no difference in adverse events and withdrawal due to adverse events, compared to sham inserts (low certainty). Adverse events (mostly foot pain, blisters, and spine/hip pain) were reported in 31 out of 51 people with sham inserts and 29 out of 49 people with shoe-stiffening inserts (RR 0.94, 95% CI 0.42 to 2.08). Withdrawals due to adverse events were reported in 1 out of 51 people with sham inserts and 2 out of 49 people with shoe-stiffening inserts (Peto OR 2.08, 95% CI 0.19 to 22.23). Hyaluronic acid versus placebo One trial (151 participants) showed that a single intra-articular injection of hyaluronic acid probably leads to little or no difference in pain or function compared to placebo (moderate certainty). Mean pain (0-100 scale, 0 no pain) with placebo was 72.5 points compared to 68.2 points with hyaluronic acid; a difference of 4.3 points better (95% CI 2.1 worse to 10.7 better). Mean function (0-100 scale, 100 best function) was 83.4 points with placebo compared to 85.0 points with hyaluronic acid; a difference of 1.6 points better (95% CI 4.6 worse to 7.8 better). Hyaluronic acid may provide little or no difference in quality of life (0-100 scale, 100 best score) which was 79.9 points with placebo compared to 82.9 points with hyaluronic acid; a difference of 3.0 better (95% CI 1.4 worse to 7.4 better; low certainty). There may be fewer adverse events with hyaluronic acid compared to placebo. Adverse events (mostly pain at the injection site) were reported in 43 out of 76 people with placebo compared with 27 out of 75 people with hyaluronic acid (RR 0.64, 95% CI 0.44 to 0.91; low certainty). No participants withdrew from either group due to adverse events. The effects on radiographic joint structure were not reported in any study.
The existing evidence regarding the benefits and harms of non-surgical treatments for big toe OA is limited. There is moderate-certainty evidence, based upon three single placebo/sham-controlled trials, that there are no clinically important benefits of arch-contouring foot orthoses, shoe-stiffening inserts, or a single intra-articular injection of hyaluronic acid. Further placebo-controlled trials are needed to evaluate the effectiveness of non-surgical treatments for big toe OA.