Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study.

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.

The effects of the use of customized silicone digital orthoses on pre-ulcerative lesions and plantar pressure during walking in people with diabetic neuropathy: A study protocol for a randomized controlled trial.

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).

Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis.

AIMS: Prevention of foot ulcers in persons with diabetes is important to help reduce the substantial burden on both individual and health resources. A comprehensive analysis of reported interventions is needed to better inform healthcare professionals about effective prevention. The aim of this systematic review and meta-analysis is to assess the effectiveness of interventions to prevent foot ulcers in persons with diabetes who are at risk thereof. MATERIALS AND METHODS: We searched the available scientific literature in PubMed, EMBASE, CINAHL, Cochrane databases and trial registries for original research studies on preventative interventions. Both controlled and non-controlled studies were eligible for selection. Two independent reviewers assessed risk of bias of controlled studies and extracted data. A meta-analysis (using Mantel-Haenszel's statistical method and random effect models) was done when >1 RCT was available that met our criteria. Evidence statements, including the certainty of evidence, were formulated according to GRADE. RESULTS: From the 19,349 records screened, 40 controlled studies (of which 33 were Randomised Controlled Trials [RCTs]) and 103 non-controlled studies were included. We found moderate certainty evidence that temperature monitoring (5 RCTs; risk ratio [RR]: 0.51; 95% CI: 0.31-0.84) and pressure-optimised therapeutic footwear or insoles (2 RCTs; RR: 0.62; 95% CI: 0.26-1.47) likely reduce the risk of plantar foot ulcer recurrence in people with diabetes at high risk. Further, we found low certainty evidence that structured education (5 RCTs; RR: 0.66; 95% CI: 0.37-1.19), therapeutic footwear (3 RCTs; RR: 0.53; 95% CI: 0.24-1.17), flexor tenotomy (1 RCT, 7 non-controlled studies, no meta-analysis), and integrated care (3 RCTs; RR: 0.78; 95% CI: 0.58-1.06) may reduce the risk of foot ulceration in people with diabetes at risk for foot ulceration. CONCLUSIONS: Various interventions for persons with diabetes at risk for foot ulceration with evidence of effectiveness are available, including temperature monitoring (pressure-optimised) therapeutic footwear, structured education, flexor tenotomy, and integrated foot care. With hardly any new intervention studies published in recent years, more effort to produce high-quality RCTs is urgently needed to further improve the evidence base. This is especially relevant for educational and psychological interventions, for integrated care approaches for persons at high risk of ulceration, and for interventions specifically targeting persons at low-to-moderate risk of ulceration.

Clinical and biomechanical effectiveness of foot-ankle exercise programs and weight-bearing activity in people with diabetes and neuropathy: A systematic review and meta-analysis.

BACKGROUND: Most interventions to prevent foot ulcers in people with diabetes do not seek to reverse the foot abnormalities that led to the ulcer. Foot-ankle exercise programs target these clinical and biomechanical factors, such as protective sensation and mechanical stress. Multiple RCTs exist investigating the effectiveness of such programs, but these have never been summarised in a systematic review and meta-analysis. METHODS: We searched the available scientific literature in PubMed, EMBASE, CINAHL, Cochrane databases and trial registries for original research studies on foot-ankle exercise programs for people with diabetes at risk of foot ulceration. Both controlled and non-controlled studies were eligible for selection. Two independent reviewers assessed the risk of bias of controlled studies and extracted data. Meta-analysis (using Mantel-Haenszel's statistical method and random effect models) was performed when >2 RCTs were available that met our criteria. Evidence statements, including the certainty of evidence, were formulated according to GRADE. RESULTS: We included a total of 29 studies, of which 16 were RCTs. A foot-ankle exercise programme of 8-12 weeks duration for people at risk of foot ulceration results in: (a) no increase or decrease risk of foot ulceration or pre-ulcerative lesion (Risk Ratio (RR): 0.56 (95% CI: 0.20-1.57)); (b) no increase or decrease risk of adverse events (RR: 1.04 (95% CI: 0.65-1.67)); (c) not increase or decrease barefoot peak plantar pressure during walking (Mean Difference (MD): -6.28 kPa (95% CI: -69.90-57.34)); (d) no increase or decrease health-related quality of life (no meta-analysis possible). Likely results in increases in ankle joint and first metatarsalphalangeal joint range of motion (MD: 1.49° (95% CI: -0.28-3.26)) may result in improvements in neuropathy signs and symptoms (MD: -1.42 (95% CI: -2.95-0.12)), may result in a small increase in daily steps in some people (MD: 131 steps (95% CI: -492-754)), and may not increase or decrease foot and ankle muscle strength and function (no meta-analysis was possible). CONCLUSIONS: In people at risk of foot ulceration, a foot-ankle exercise programme of 8-12 weeks duration may not prevent or cause diabetes-related foot ulceration. However, such a programme likely improves the ankle joint and first metatarsalphalangeal joint range of motion and neuropathy signs and symptoms. Further research is needed to strengthen the evidence base, and should also focus on the effects of specific components of foot-ankle exercise programs.

Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2023 update).

AIMS: This is the 2023 International Working Group on the Diabetic Foot guideline on the prevention of foot ulcers in persons with diabetes, which updates the 2019 guideline. This guideline is targeted at clinicians and other healthcare professionals. MATERIALS AND METHODS: We followed the Grading of Recommendations, Assessment, Development and Evaluations methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature including, where appropriate, meta-analyses, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where (sufficient) evidence was not available, and a weighing of the desirable and undesirable effects of an intervention, as well as patient preferences, costs, equity, feasibility and applicability. RESULTS: We recommend screening a person with diabetes at very low risk of foot ulceration annually for the loss of protective sensation and peripheral artery disease, and screening persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate persons at-risk about appropriate foot self-care, educate not to walk without suitable foot protection, and treat any pre-ulcerative lesion on the foot. Educate moderate-to-high risk people with diabetes to wear properly fitting, accommodative, therapeutic footwear, and consider coaching them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking, to help prevent plantar foot ulcer recurrence. Consider advising people at low-to-moderate risk to undertake a, preferably supervised, foot-ankle exercise programme to reduce ulcer risk factors, and consider communicating that a total increase in weight-bearing activity of 1000 steps/day is likely safe with regards to risk of ulceration. In people with non-rigid hammertoe with pre-ulcerative lesion, consider flexor tendon tenotomy. We suggest not to use a nerve decompression procedure to help prevent foot ulcers. Provide integrated foot care for moderate-to-high-risk people with diabetes to help prevent (recurrence of) ulceration. CONCLUSIONS: These recommendations should help healthcare professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer-free days and reduce the patient and healthcare burden of diabetes-related foot disease.

Potential predictive effect of mechanical properties of the plantar skin and superficial soft tissue, and vibration perception on plantar loading during gait in individuals with diabetes.

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.

Effects of a foot-ankle muscle strengthening program on pain and function in individuals with knee osteoarthritis: a randomized controlled trial.

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.

Effects of foot-ankle exercises on foot-ankle kinematics, plantar pressure, and gait kinetics in people with diabetic neuropathy: Secondary outcomes from a randomized controlled trial.

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.

Impact of biomechanics on therapeutic interventions and rehabilitation for major chronic musculoskeletal conditions: A 50-year perspective.

The pivotal role of biomechanics in the past 50 years in consolidating the basic knowledge that underpins prevention and rehabilitation measures has made this area a great spotlight for health practitioners. In clinical practice, biomechanics analysis of spatiotemporal, kinematic, kinetic, and electromyographic data in various chronic conditions serves to directly enhance deeper understanding of locomotion and the consequences of musculoskeletal dysfunctions in terms of motion and motor control. It also serves to propose straightforward and tailored interventions. The importance of this approach is supported by myriad biomechanical outcomes in clinical trials and by the development of new interventions clearly grounded on biomechanical principles. Over the past five decades, therapeutic interventions have been transformed from fundamentally passive in essence, such as orthoses and footwear, to emphasizing active prevention, including exercise approaches, such as bottom-up and top-down strengthening programs for runners and people with osteoarthritis. These approaches may be far more effective inreducing pain, dysfunction, and, ideally, incidence if they are based on the biomechanical status of the affected person. In this review, we demonstrate evidence of the impact of biomechanics and motion analysis as a foundation for physical therapy/rehabilitation and preventive strategies for three chronic conditions of high worldwide prevalence: diabetes and peripheral neuropathy, knee osteoarthritis, and running-related injuries. We conclude with a summary of recommendations for future studies needed to address current research gaps.

Could an Internet-Based Foot-Ankle Therapeutic Exercise Program Modify Clinical Outcomes and Gait Biomechanics in People with Diabetic Neuropathy? A Clinical Proof-of-Concept Study.

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.

Effects of Foot-Core Training on Foot-Ankle Kinematics and Running Kinetics in Runners: Secondary Outcomes From a Randomized Controlled Trial.

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."

Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: a randomized controlled trial.

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).

Development of a customized booklet of foot-ankle exercises for people with diabetes mellitus as a management and prevention tool for musculoskeletal complications: A customized booklet of foot-ankle exercises for people with diabetes.

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.

Predictive Effect of Well-Known Risk Factors and Foot-Core Training in Lower Limb Running-Related Injuries in Recreational Runners: A Secondary Analysis of a Randomized Controlled Trial.

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).

Accuracy and correlation between skin-marker based and radiographic measurements of medial longitudinal arch deformation.

Static and dynamic measurements of the medial longitudinal arch (MLA) in the foot are critical across different clinical and biomechanical research fields. While MLA deformation can be estimated using skin-markers for gait analysis, the current understanding of the correlates between skin-marker based models and radiographic measures of the MLA is limited. This study aimed at assessing the correlation and accuracy of skin-marker based measures of MLA deformation with respect to standard clinical X-ray based measures, used as reference. 20 asymptomatic subjects without morphological alterations of the foot volunteered in the study. A lateral X-ray of the right foot of each subject was taken in monopodalic upright posture with and without a metatarsophalangeal-joint dorsiflexing wedge. MLA angle was estimated in the two foot postures and during gait using 16 skin-marker based models, which were established according to the marker set of a validated multi-segment foot kinematic protocol. The error of each model in tracking MLA deformation was assessed and correlated with respect to standard radiographic measurements. Estimation of MLA deformation was highly affected by the skin-marker models. Skin-marker models using the marker on the navicular tuberosity as apex of the MLA angle showed the smallest errors (about 2 deg) and the largest correlations (R = 0.64-0.65; p < 0.05) with respect to the radiographic measurements. According to the outcome of this study, skin-marker based definitions of the MLA angle using the navicular tuberosity as apex of the arch may provide a more accurate estimation of MLA deformation with respect to that from radiographic measures.

The Mechanoreceptor's Role in Plantar Skin Changes in Individuals with Diabetes Mellitus.

Mechanical skin properties (MSPs) and vibration perception thresholds (VPTs) show no relationship in healthy subjects. Similar results were expected when comparing MSP and VPT in individuals with diabetes mellitus (DM) and with diabetic (peripheral-)neuropathy (DPN). A healthy control group (33 CG), 20 DM and 13 DPN participated in this cross-sectional study. DM and DPN were classified by using a fuzzy decision support system. VPTs (in µm) were measured with a modified vibration exciter at two different frequencies (30 and 200 Hz) and locations (heel, first metatarsal head). Skin hardness (durometer readings) and thickness (ultrasound) were measured at the same locations. DPN showed the highest VPTs compared to DM and CG at both frequencies and locations. Skin was harder in DPN compared to CG (heel). No differences were observed in skin thickness. VPTs at 30 and 200 Hz correlated negatively with skin hardness for DPN and with skin thickness for DM, respectively. This means, the harder or thicker the skin, the better the perception of 30 or 200 Hz vibrations. Changes in MSP may compensate the loss of sensitivity up to a certain progression of the disease. However, the influence seems rather small when considering other parameters, such as age.

Low and High Frequency Vibration Perception Thresholds Can Improve the Diagnosis of Diabetic Neuropathy.

Recent studies demonstrate neuropathic changes with respect to vibration sensitivity for different measurement frequencies. This study investigates the relationship between vibration perception thresholds (VPTs) at low and high frequencies at two plantar locations and diabetic peripheral neuropathy (DPN) severity in diabetes mellitus (DM) subjects with DPN. We examine differences of VPTs between participants with DM, with DPN, as well as healthy controls. The influence of anthropometric, demographic parameters, and DM duration on VPTs is studied. Thirty-three healthy control group subjects (CG: 56.3 ± 9.9 years) and 33 with DM are studied. DM participants are subdivided into DM group (DM without DPN, n = 20, 53.3 ± 15.1 years), and DPN group (DM with DPN, n = 13, 61.0 ± 14.5 years). VPTs are measured at the first metatarsal head (MTH1) and heel (30 Hz, 200 Hz), using a customized vibration exciter. Spearman and Pearson correlations are used to identify relationships between VPTs and clinical parameters. ANOVAs are calculated to compare VPTs among groups. Significant correlations are observed between DPN severity (by fuzzy scores) and VPTs at both locations and frequencies (MTH1_30 Hz vs. fuzzy: r = 0.68, p = 0.011; Heel_30 Hz vs. fuzzy: r = 0.66, p = 0.014; MTH1_200 Hz vs. fuzzy: r = 0.73, p = 0.005; Heel_200 Hz vs. fuzzy: r = 0.60, p = 0.032). VPTs in CG and DM groups are significantly smaller than the DPN group, showing higher contrasts for the 30 Hz compared to the 200 Hz measurement. The correlations between fuzzy scores and VPTs confirm the relevance of using low and high frequencies to assess a comprehensive foot sensitivity status in people with DM.

Subgroups of Foot-Ankle Movement Patterns Can Influence the Responsiveness to a Foot-Core Exercise Program: A Hierarchical Cluster Analysis.

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.

Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II.

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 .