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The aim of this study was to shed light on a crucial issue through a comprehensive evaluation of the cost-effectiveness and cost-utility of a cutting-edge web-based foot-ankle therapeutic exercise program (SOPeD) designed for treating modifiable risk factors for ulcer prevention in individuals with diabetes-related peripheral neuropathy (DPN). In this randomized controlled trial, 62 participants diagnosed with DPN were assigned to the SOPeD software or received usual care for diabetic foot. Primary outcomes were DPN symptoms and severity, foot pain and function, and quality-adjusted life years (QALYs). Between-group comparisons provided 95% confidence intervals. The study also calculated incremental cost-effectiveness and cost-utility ratios (ICERs), analyzed direct costs from a healthcare perspective, and performed a sensitivity analysis to assess uncertainty. The web-based intervention effectively reduced foot pain, improved foot function and showed favorable cost-effectiveness, with ICERs ranging from (USD) $5.37-$148.71 per improvement in different outcomes. There is a high likelihood of cost-effectiveness for improving DPN symptoms and severity, foot pain, and function, even when the minimum willingness-to-pay threshold was set at $1000.00 USD. However, the intervention did not prove to be cost-effective in terms of QALYs. This study reveals SOPeD's effectiveness in reducing foot pain, improving foot function, and demonstrating cost-effectiveness in enhancing functional and clinical outcomes. SOPeD stands as a potential game-changer for modifiable risk factors for ulcers, with our findings indicating a feasible and balanced integration into public health systems. Further studies and considerations are vital for informed decisions to stakeholders and the successful implementation of this preventive program on a larger scale.Trial Registration: ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.

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INTRODUCTION: Diabetes is a highly prevalent disease that negatively impacts people's health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention-a foot-ankle exercises programme alongside educational strategies-in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes. METHODS AND ANALYSIS: This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed. ETHICS AND DISSEMINATION: This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals. TRIAL REGISTRATION NUMBER: NCT05639478.

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Background: People with diabetes and diabetic peripheral neuropathy (DPN) often develop calluses due to toe misalignment and increased plantar pressure. Untreated, these issues can progress into ulcers, making early intervention crucial. This trial protocol aims to evaluate the efficacy and safety of customized silicone digital orthoses in preventing ulcers, pre-ulcerative lesions, and peak pressure during gait in people with DPN. Methods: In this superiority randomized controlled parallel trial with single-blind assessment, 60 participants will be allocated to the control group (CG) or the intervention group (IG). The CG will receive specialized nurse-administered foot care, including callus removal, nail care guidance, and self-care education. The IG will receive the same care plus a customized silicone orthosis for toe realignment for 6 months. Assessments will occur at baseline and 3 and 6 months for the primary outcomes (pre-ulcerative lesions and ulcer incidence) and secondary outcomes (pressure distribution, foot function and health, quality of life, safety, and comfort). Two-way ANOVAs (p < .05) will assess group, time, and group by time effects following an intention-to-treat approach. Conclusion: Although recommended for foot ulcer prevention, custom silicone orthosis adoption remains limited due to the low certainty of evidence. This trial seeks to provide more consistent evidence for the use of toe orthoses in preventing callus and ulcer formation for individuals with DPN. Trial registry: ClinicalTrials.gov (NCT05683106) "Effects of Customized Silicone Digital Orthoses in People with Diabetic Neuropathy" (registered on December 20, 2022).

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BACKGROUND: Alterations in vibration perception among children and adolescents with Charcot-Marie-Tooth disease might explain observed changes in foot posture. Therefore, this cross-sectional study compared the vibration perception of the lower limbs in youths with and without Charcot-Marie-Tooth disease and verified the cut-off value of the distal vibration perception for the Charcot-Marie-Tooth group. In addition, associations between dynamic plantar pressure, vibration perception and isometric muscle strength were investigated. METHODS: Participants aged 9-18 (Charcot-Marie-Tooth group n = 32; Typical group n = 32) had vibration perception measured by a 128-Hz graduated tuning fork. The static and dynamic foot posture were evaluated by the Foot Posture Index and pressure distribution measuring system, respectively. For the Charcot-Marie-Tooth group, a hand-held dynamometer evaluated the isometric muscle strength of the lower limbs. FINDINGS: Children with Charcot-Marie-Tooth disease presented impaired vibration perception at the distal phalanx of the hallux and head of the first metatarsal compared to their typically developing peers, while adolescents with Charcot-Marie-Tooth disease showed impairment in all the tested regions compared to their typically developing peers. The cut-off value for vibration perception for participants with Charcot-Marie-Tooth disease was 5.7, considering the original grade of the tuning-fork 128 Hz. Among the associations established for the Charcot-Marie-Tooth group, a greater vibration perception at the distal phalanx of the hallux was associated with a longer rearfoot contact time (ß = 31.02, p = 0.04). INTERPRETATION: These new findings may guide the clinical evaluation and rehabilitation treatment for children and adolescents with Charcot-Marie-Tooth disease.

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BACKGROUND: This exploratory study aimed to investigate the extent to which mechanical properties of the plantar skin and superficial soft tissue (hardness, stiffness, and thickness) and vibration perception thresholds (VPTs) predict plantar pressure loading during gait in people with diabetes compared to healthy controls. METHODS: Mechanical properties, VPTs, and plantar loadings during gait at the heel and first metatarsal head (MTH) of 20 subjects with diabetes, 13 with DPN, and 33 healthy controls were acquired. Multiple regression analyses were used to predict plantar pressure peaks and pressure-time integrals at both locations based on the mechanical properties of the skin and superficial soft tissues and VPTs. RESULTS: In the diabetes group at the MTH, skin hardness associated with 30-Hz (R2 = 0.343) and 200-Hz (R2 = 0.314) VPTs predicted peak pressure at the forefoot. In the controls at the heel, peak pressure was predicted by the skin thickness, hardness, and stiffness associated with 30-Hz (R2 = 0.269, 0.268, and 0.267, respectively) and 200-Hz (R2 = 0.214, 0.247, and 0.265, respectively) VPTs. CONCLUSION: The forefoot loading of people with diabetes can be predicted by the hardness of the skin when combined with loss of vibration perception at low (30-Hz) and high (200-Hz) frequencies. Further data from larger sample sizes are needed to confirm the current findings.

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BACKGROUND: Foot-ankle exercises could improve pain and function of individuals with KOA and need to be tested. OBJECTIVE: To investigate whether an 8-week foot-ankle muscle strengthening program is effective for individuals with KOA to reduce pain and improve function. METHODS: In this randomized controlled trial, individuals diagnosed with clinical and radiographic KOA were randomized into the intervention (supervised foot-ankle strengthening exercise program three times a week for 8 weeks) or control (usual care and recommendations of the healthcare team) group. Effectiveness was assessed by changes in clinical and functional outcomes between baseline and 8 weeks with pain as the primary outcome. ANCOVA tests using the intervention group as a reference and sex, body mass index, and baseline values as covariates assessed between-group differences. RESULTS: The intervention group showed lower pain scores (-4.4 units; 95%CI = -7.5, -1.1), better function (-7.1 units; 95%CI = -12.7, -1.4), higher total functional score (-11.9 units; 95%CI = -20.7, -3.1), with confidence intervals indicating a potential for the differences to be clinically meaningful, and better scores for the 30-s chair stand test (2.7 repetitions; 95%CI = 1.1, 4.1), with a confidence interval indicating a moderate clinically meaningful difference, compared to the controls. CONCLUSION: The 8-week foot-ankle exercise program showed positive, and potentially clinically meaningful, effects on knee pain and physical function among individuals with KOA, when compared to usual care. TRIAL REGISTRATION: NCT04154059. https://clinicaltrials.gov/ct2/show/NCT04154059.

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BACKGROUND: Follow-up report of secondary outcomes of a randomized, single-blinded, parallel controlled trial that investigated the benefits of a foot-ankle therapeutic exercise program on foot-ankle kinematics, plantar pressure, and lower limb kinetics during gait in individuals with diabetic neuropathy (DPN). METHODS: Sixty-six participants with DPN were randomly allocated into a control group (CG; n = 31), which received usual care, and an intervention group (IG; n = 35), which received usual care plus a 12-week group-based foot-ankle exercise program. Outcomes were assessed at baseline and 12 weeks by an assessor blinded to group allocation. RESULTS: The generalized linear mixed model and intention-to-treat analysis revealed a greater hip extensor moment at push-off and greater hallux contact area in the IG than CG after 12 weeks. A within-group analysis revealed a larger arch height during stance and higher peak pressure and pressure-time integral at the central forefoot region in the IG after 12 weeks compared to baseline. There were no other significant group difference or changes over time in foot-ankle kinematics or in any other joint moment related to overall lower limb biomechanics. CONCLUSION: The increases in hip moment at push-off and hallux surface contact area suggest an improvement in the propulsion phase with greater participation of the toes in foot rollover after 12 weeks of a group-based foot-ankle exercises program for people with DPN. Individual face-to-face, longer-term, and more intensive interventions may be needed to positively influence foot-ankle biomechanics and pressure parameters in other plantar areas.

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Background: Although alternating dual-task (ADT) training is functionally easier for older adults, a large part of the motor and cognitive tasks is simultaneously performed, especially during activities of daily living that require maintaining body balance. Objective: To evaluate the effects of mixed dual-task training on mobility, cognitive function, and balance in community-dwelling older adults. Methods: Sixty participants were randomly allocated at a 1:1 ratio into the experimental group-single motor task (SMT) and simultaneous dual task (SDT) interchangeably in stage 1 (for 12 weeks) and after strictly with SDT in stage 2 (the last 12 weeks)-or into the control group-only SMT and SDT interchangeably in stages 1 and 2. Gait parameters were acquired by two inertial sensors. Physical and cognitive performance were acquired by specific questionnaires. Generalized linear mixed models were used for analyzing interaction and main effects. Results: No between-group difference was observed for gait performance. Both protocols improved mobility (mean change ((MC) = 0.74)), dual-task effect (MC = -13.50), lower limb function (MC = 4.44), static (MC = -0.61), and dynamic balance (MC = -0.23), body sway (MC = 4.80), and cognitive function (MC = 41.69). Conclusion: Both dual-task training protocols improved these outcomes.

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Previous studies have shown the efficacy of foot-ankle exercises in people with diabetic peripheral neuropathy (DPN), but the quality of evidence is still low. This proof-of-concept study pursues preliminary evidence for potential clinical and gait biomechanical benefits from an internet-based foot-ankle therapeutic exercise program for people with DPN. We randomized 30 individuals with DPN (IWGDF risk category 1 or 2) into either the control group (CG) receiving the usual care or the intervention group (IG) receiving the usual care plus an internet-based foot-ankle exercise program, fully guided by the Sistema de Orientação ao Pé Diabético (SOPeD; translation: Diabetic Foot Guidance System) three times per week for 12 weeks. We assessed face-to-face clinical and biomechanical outcomes at baseline, 12 weeks, and 24 weeks (follow up). Participants had good adherence to the proposed intervention and it led to only mild adverse events. The IG showed improvements in the ankle and first metatarsophalangeal joint motion after 12 and 24 weeks, changed forefoot load absorption during foot rollover during gait after 24 weeks, reduced foot pain after 12 weeks, and improved foot function after 24 weeks. A 12-week internet-based foot-ankle exercise program using the SOPeD software (version 1.0) has the potential to reduce foot pain, improve foot function, and modify some important foot-ankle kinematic outcomes in people with DPN.

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This study investigated the effectiveness of an 8-week foot-core exercise training program on foot-ankle kinematics during running and also on running kinetics (impact loads), with particular interest in biomechanical outcomes considered risk factors for running-related injuries in recreational runners. A single-blind, randomized, controlled trial was conducted with 87 recreational runners randomly allocated to either the control (CG) or intervention (IG) group and assessed at baseline and after 8 weeks. The IG underwent foot-core training 3 times/week, while the CG followed a placebo lower-limb stretching protocol. The participants ran on a force-instrumented treadmill at a self-selected speed while foot-segment motion was captured simultaneously with kinetic measurements. After the intervention, there were statistically significant changed in foot biomechanics, such as: IG participants strike the ground with a more inverted calcaneus and a less dorsiflexed midfoot than those in the CG; at midstance, ran with a less plantarflexed and more adducted forefoot and a more abducted hallux; and at push-off, ran with a less dorsiflexed midfoot and a less adducted and more dorsiflexed hallux. The IG runners also had significantly decreased medial longitudinal arch excursion (p = 0.024) and increased rearfoot inversion (p = 0.037). The 8-week foot-core exercise program had no effect on impact (p = 0.129) and breaking forces (p = 0.934) or on vertical loading rate (p = 0.537), but it was positively effective in changing foot-ankle kinematic patterns."

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BACKGROUND: Diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN) compromises the structures of the musculoskeletal system, especially in the foot-ankle complex. Foot-related exercises can be a promising tool to be incorporated in health care programs to manage and prevent musculoskeletal complications resulting from DM and DPN progression. OBJECTIVE: To present the development, validation, and usability evaluation of a booklet that directs training and personalizes the progression of a home-based program of foot-ankle exercises. METHODS: The booklet containing a foot-ankle exercise program developed in a previous clinical trial was validated using the Delphi technique, with a multi-professional jury of experts who assessed the content of the material, language, individual education, exercise execution, exercise quality, and material implementation. The validated version was evaluated through telephone interview by a convenience sample of 10 individuals with DPN regarding its relevance, health education, comprehension, and usability. RESULTS: The validation process with experts was performed in two rounds achieving 100% agreement in the second round. During the usability evaluation process the main complaint of users was that performing all the exercises was very tiring and took too much time out of their daily routine. Thus, the number of repetitions for each exercise was changed from 30 to 12. CONCLUSION: The booklet is a material for prevention and management of the impacts of DM and DPN progression by improving the musculoskeletal function of the foot-ankle. This material provides an exercise regime with a personalized progression based on the perceived effort of the users.

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This study sought to determine whether a foot-ankle therapeutic exercise program can improve daily physical activity (i.e. number of steps) and fast and self-selected gait speed in people with diabetic peripheral neuropathy (DPN). In this single-blind randomized controlled trial and intention-to-treat analysis, 78 volunteers with DPN were allocated into a control group, which received usual care, and an intervention group (IG), which received usual care plus a 12-week foot-ankle exercise program. The adherence at 12 weeks rate in the IG was 92.3% (36 participants) and the dropout was 5.1% in the control group (2 participants). The number of steps and self-selected gait speed did not change significantly in either group (p > 0.05), although a 1,365-step difference between groups were observed at 1-year followup. The 12-week foot-ankle therapeutic exercises improved significantly fast-gait speed (primary outcome) (p = 0.020), ankle range of motion (p = 0.048), and vibration perception (secondary outcomes) (p = 0.030), compared with usual-care at 12 weeks. At 24 weeks, the IG showed better quality of life than controls (p = 0.048). At 1-year, fast-gait speed and vibration perception remained higher in the IG versus controls. Overall, the program may be a complementary treatment strategy for improving musculoskeletal and functional deficits related to DPN.Trial registration ClinicalTrials.gov NCT02790931 (06/06/2016).

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OBJECTIVE: To evaluate the effect of a 24-week dual-task training with progression from variable to fixed priority on the concern about falling, confidence in balance, quality of life, and depression symptoms in community-dwelling older adults. METHODS: A total of 60 participants (60-80 y.o.) were randomly allocated into a dual-task training group with progression from variable to fixed priority (experimental group) or into a dual-task training group with variable priority (control group). RESULTS: No between-group difference was observed after the intervention. A significant time effect showed a reduction in concern about falling [mean difference (MD) = -2.91)] and depression symptoms (MD = -1.66), an increase in the physical function (MD = 7.86), overall mental health (MD = 5.82), perception of vitality, energy, and less fatigue (MD = 10.45), general perception of overall health (MD = 6.81), and their health compared to the last year (MD = 11.89). CONCLUSION: The experimental protocol was not superior to the control one. However, both protocols improved these outcomes.

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BACKGROUND: Running carries the risk of several types of running-related injuries (RRIs), especially in the lower limbs. The variety of risk factors and the lack of strong evidence for several of these injury risks hinder the ability to draw assertive conclusions about them, hampering the implementation of effective preventive strategies. Because the etiology of RRIs seems to be multifactorial, the presence of RRI risk factors might influence the outcome of therapeutic strategies in different ways. Thus, further investigations on how risk and protective factors influence the incidence and prevention of RRIs should be conducted. PURPOSE: To investigate the predictive effect of well-known risk factors and 1 protective factor-foot-core training-on the incidence of lower limb RRIs in recreational runners. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Middle- and long-distance recreational runners (N = 118) were assessed at baseline and randomly allocated to either an intervention group (n = 57) or a control group (n = 61). The intervention group underwent an 8-week (3 times/wk) foot-core training program. Participants were followed for a year after baseline assessment for the occurrence of RRIs. Logistic regression with backward elimination of variables was used to develop a model for prediction of RRI in recreational runners. Candidate predictor variables included age, sex, body mass index, years of running practice, number of races, training volume, training frequency, previous RRI, and the foot-core exercise training. RESULTS: The final logistic regression model included 3 variables. As previously shown, the foot-core exercise program is a protective factor for RRIs (odds ratio, 0.40; 95% CI, 0.15-0.98). In addition, older age (odds ratio, 1.07; 95% CI, 1.00-1.14) and higher training volume (odds ratio, 1.02; 95% CI, 1.00-1.03) were risk factors for RRIs. CONCLUSION: The foot-core training was identified as a protective effect against lower limb RRI, which can be negatively influenced by older age and higher weekly training volume. The predictive model showed that RRIs should be considered a multivariate entity owing to the interaction among several factors. REGISTRATION: NCT02306148 (ClinicalTrials.gov identifier).

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The purpose of this study is to identify homogenous subgroups of foot-ankle (FA) kinematic patterns among recreational runners and further investigate whether differences in baseline movement patterns can influence the mechanical responses to a foot-core exercise intervention program. This is a secondary analysis of data from 85 participants of a randomized controlled trial (clinicaltrials.gov - NCT02306148) investigating the effects of an exercise-based therapeutic approach focused on FA complex. A validated skin marker-based multi-segment foot model was used to acquire kinematic data during the stance phase of treadmill running. Kinematic features were extracted from the time-series data using a principal component analysis, and the reduced data served as input for a hierarchical cluster analysis to identify subgroups of FA movement patterns. FA angle time series were compared between identified clusters and the mechanical effects of the foot-core exercise intervention was assessed for each subgroup. Two clusters of FA running patterns were identified, with cluster 1 (n = 36) presenting a pattern of forefoot abduction, while cluster 2 (n = 49) displayed deviations in the proximal segments, with a rearfoot adduction and midfoot abduction throughout the stance phase of running. Data from 29 runners who completed the intervention protocol were analyzed after 8-weeks of foot-core exercises, resulting in changes mainly in cluster 1 (n = 16) in the transverse plane, in which we observed a reduction in the forefoot abduction, an increase in the rearfoot adduction and an approximation of their pattern to the runners in cluster 2 (n = 13). The findings of this study may help guide individual-centered treatment strategies, taking into account their initial mechanical patterns.

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This study sought to assess the feasibility of design, adherence, satisfaction, safety and changes in outcomes followed by a home-based foot-ankle exercise guided by a booklet in individuals with diabetic peripheral neuropathy (DPN). 20 participants were allocated usual care [control group (CG)] or usual care plus home-based foot-ankle exercises [intervention group (IG)] for 8 weeks. For feasibility, we assessed contact, preliminary screening and recruitment rates, adherence, and using a 5-point Likert scale to satisfaction and safety of the booklet. In the IG, we assessed preliminary changes in DPN symptoms, DPN severity (classified by a fuzzy model) and foot-ankle range of motion between baseline and Week 8. In the first 20 weeks, 1310 individuals were screened for eligibility by phone contact. Contact rate was 89% (contacted participants/20w), preliminary screening success 28% (participants underwent screening/20w), and recruitment rate 1.0 participants/week (eligible participants/20w). The recruitment rate was less than the ideal rate of 5 participants/week. The adherence to the exercises programme was 77%, and the dropout was 11% and 9% for the IG and CG, respectively. In the IG, participants' median level of satisfaction was 4 (IQR: 4-5) and perceived safety was 3 (IQR: 3-5). IG significantly decreased the DPN severity (p = 0.020), increased hallux relative to forefoot (first metatarsal) range of motion (ROM) (p < 0.001) and decreased maximum forefoot relative to hindfoot (midfoot motion) dorsiflexion during gait (p = 0.029). The home-based programme was feasible, satisfactory, safe and showed preliminary positive changes in DPN severity and foot motion during gait.Trial Registration ClinicalTrials.gov, NCT04008745. Registered 02/07/2019. https://clinicaltrials.gov/ct2/show/NCT04008745 .

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BACKGROUND: The dynamic plantar pressure patterns of children and adolescents with Charcot-Marie-Tooth (CMT) disease and its relationship to musculoskeletal alterations may help to understand the natural history of the disease and improve therapeutic interventions. RESEARCH QUESTION: The study compared dynamic plantar pressure patterns in children and adolescents with and without CMT. It also tested the associations between isometric muscle strength (IMS), passive range of motion (ROM), foot posture and dynamic plantar pressure patterns in CMT. METHODS: This cross-sectional study compared children and adolescents (aged 8-18 years) with CMT (n = 40) with a typical group (n = 40). The plantar pressure distribution during gait was recorded, and the contact area (CA), peak pressure (PP), contact time (CT) and pressure-time integral (PTI) in five foot regions (rearfoot, midfoot lateral, midfoot medial, lateral forefoot and medial forefoot) were analysed. The IMS of the dorsiflexors and plantar flexors, passive ROM, and foot posture were also recorded. RESULTS: PP (medial midfoot and medial forefoot) and PTI (rearfoot, lateral midfoot and medial forefoot) were higher in children with CMT compared with the typical group. The adolescents with CMT presented a less CA (whole foot) and a higher CT (medial midfoot) when compared with typical group. For CMT, in the medial midfoot, plantar flexor IMS associated with PP (ß=-11.54, p = 0.01) and PTI (ß=-3.38, p = 0.04); supinated foot posture associated with PP (ß = 33.89, p = 0.03) and PTI (ß = 12.01, p = 0.03). SIGNIFICANCE: Children with CMT showed clear changes in most of the dynamic plantar pressure variables, while adolescents with CMT showed changes mostly in CA and CT. This information together with the associations established between supinated foot, dorsiflexion ROM and plantar flexions IMS can be useful for guiding rehabilitation professionals in their therapies.

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BACKGROUND: Diabetic neuropathy dramatically affects musculoskeletal structure and function of the lower limbs by impairing their muscle strength and mobility. Specific muscle strengthening through physiotherapy strategies appears to be promising; however, adherence to physiotherapy treatment is low in people with chronic diseases. Thus, an internet-based foot-ankle exercise program was created as a potential telerehabilitation alternative for people with diabetes to improve their self-monitoring and self-care management. This study assessed the feasibility, safety, acceptability, and changes in foot health and neuropathy symptoms in people with diabetes after 12 weeks of the intervention program with the Sistema de Orientação ao Pé diabético - Diabetic Foot Guidance System (SOPeD). METHODS: Fourteen individuals were recruited and randomized to either the usual care (control group) or usual care plus an internet-based foot-ankle exercise program through SOPeD (intervention group) three times per week for 12 weeks. For feasibility, we assessed contact and recruitment rates per week; program adherence, determined as completing over 70% of the 36 sessions; and participant satisfaction and safety assessed through a questionnaire and scored on a 5-point Likert scale. We assessed changes in neuropathy symptoms and foot health and functionality from baseline to 12 weeks estimating differences or median of differences and 95% confidence intervals in the intervention group. RESULTS: In 24 weeks, of the 822 patients in the database, 192 were contacted, 65 were assessed for eligibility, and 20 were considered eligible. The recruitment rate was 0.83 participants per week. Fourteen out of the 20 eligible participants agreed to participate, resulting in recruitment success of 70%. Adherence to the program was 66.7%, and there was no dropout. Participants' median level of satisfaction was 5.0 (IQR: 4.5-5.0) and perceived safety was 5.0 (IQR: 5.0-5.0). CONCLUSION: The internet-based foot-ankle exercise program using SOPeD is feasible, satisfactory, and safe. Although this study had moderate adherence and a zero-dropout rate, recruitment needs to be improved in the larger trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04011267 . Registered on 8 July 2019.

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BACKGROUND: Running-related injuries (RRIs) are a pervasive menace that can interrupt or end the participation of recreational runners in this healthy physical activity. To date, no satisfactory treatment has been developed to prevent RRIs. PURPOSE: To investigate the efficacy of a novel foot core strengthening protocol based on a ground-up approach to reduce the incidence of RRIs in recreational long-distance runners over the course of a 1-year follow-up. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: The participants, 118 runners, were assessed at baseline and randomly allocated to either an intervention group (n = 57) or a control group (n = 61). The intervention group received an 8-week training course focused on the foot-ankle muscles, followed by remotely supervised training thereafter. Assessments consisted of 3 separate biomechanical evaluations of foot strength and foot posture and a weekly report on each participant's running distance, pace, and injury incidence over 12 months. RESULTS: The control group participants were 2.42 times (95% CI, 1.98-3.62) more likely to experience an RRI within the 12-month study period than participants in the intervention group (P = .035). Time to injury was significantly correlated with Foot Posture Index (P = .031; r = 0.41) and foot strength gain (P = .044; r = 0.45) scores. This foot exercise program showed evidence of effective RRI risk reduction in recreational runners at 4 to 8 months of training. CONCLUSION: Recreational runners randomized to the new foot core strengthening protocol had a 2.42-fold lower rate of RRIs compared with the control group. Further studies are recommended to better understand the underlying biomechanical mechanisms of injury, types of injuries, and subgroups of runners who might benefit maximally. REGISTRATION: NCT02306148 (ClinicalTrials.gov identifier).

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