Search

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 Trial Registration ClinicalTrials.gov, NCT04008745. Registered 02/07/2019. https://clinicaltrials.gov/ct2/show/NCT04008745.

Background This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals’ foot health and quality of life. Based on the current trends of self-monitoring and self-care, providing a tool with foot-related exercises and educational care may help patients to avoid or reduce the musculoskeletal complications resulting from DPN, improving autonomous performance in daily living tasks. The aim of this trial is to evaluate the effects of an educational booklet for foot care and foot muscle strengthening on DPN symptoms and severity, clinical outcomes, and gait biomechanics in patients with DPN. Methods/design The FOotCAre (FOCA) trial II study has been designed as a single-blind, two-parallel-arm randomized controlled trial. It will include 48 patients with DPN who will be randomly allocated to a control (recommended foot care by international consensus with no foot exercises) group or an intervention (foot-related exercises using an educational booklet three times/week at home for 8 weeks) group. Participants from both groups will be assessed at baseline, after 8 weeks, and at 16 weeks for follow-up. The primary outcomes are the DPN symptoms and severity, and the secondary outcomes are foot–ankle kinematics, gait kinetics, plantar pressure distribution during gait, tactile and vibratory sensitivities, foot strength, functional balance, and foot health and functionality. Discussion The booklet is a management tool that allows users to be autonomous in their treatment by choosing how and where to perform the exercises. This allows the patients to perform the exercises regularly as a continuous habit for foot care and health, which is an important element in the management of the diabetic foot. As the booklet focuses on specific foot–ankle exercises, we expect that it will improve the clinical aspects of DPN and produce beneficial biomechanical changes during gait, becoming a powerful self-management tool that can be easily implemented to improve the performance of daily living tasks. Trial registration ClinicalTrials.gov, NCT04008745. Registered on 2 July 2019.

Background Functional independence and safe mobility, especially in older people, mostly rely on the ability to perform dual tasks, particularly during activities with variable- and fixed-priority attention. The aim of this study is to compare the dual-task training with progression from variable- to fixed-priority instructions versus dual-task training with variable-priority on gait speed in community-dwelling older adults. Methods This is an assessor- and participant-blinded, two-arm, randomized controlled trial with 60 community-dwelling male and female older adults between the ages of 60 and 80 years old. Participants will be randomly allocated into either the intervention group or the control group using a computer-generated permuted block randomization schedule. The intervention group will undertake a progressive dual-task training in which the participants will be progressively submitted to dual-task walking and postural balance exercises with variable- to fixed-priority instructions. The control group will be submitted to dual-task training with variable-priority attention exercises. Both groups will receive 48 sessions lasting for 60 min each over 24 weeks. The primary outcome will be the gait speed under single- and dual-task conditions. Secondary outcomes will include spatiotemporal gait parameters, functional balance, executive function, falls, quality of life, and depression symptoms. All the analyses will be based on the intention-to-treat principle. Discussion This is the first assessor- and participant-blinded, two-arm, randomized controlled trial with 6 months of intervention and an additional 6-month post-training follow up aiming to evaluate the effectiveness of training with progression from variable- to fixed-priority instructions on gait biomechanics, postural balance, falls episodes, executive functioning, and quality of life in community-dwelling older adults. If our hypotheses are confirmed, this training protocol can be implemented widely to improve gait speed and other functional activities and quality of life in community-dwelling older adults. This study protocol can be used to improve these functional aspects of community-dwelling older adults. This study may also contribute to future guidelines for the improvement of these clinical and biomechanical aspects in older people. Trial registration ClinicalTrials.gov Identifier - NCT03886805, Registered 22 March 2019.

BackgroundThis study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN.Methods/designFootcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12 weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be foot–ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance.DiscussionAs there is no evidence about the efficacy of rehabilitation technology in reducing DPN symptoms and severity or improving biomechanical, clinical, and functional outcomes for people with DPN, this research can contribute substantially to clarifying the therapeutic merits of software interventions. We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN. This rehabilitation technology is freely available, and we intend to introduce it into the public health system in Brazil after demonstrating its effectiveness.Trial registrationClinicalTrials.gov,NCT04011267. Registered on 8 July 2019.

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).

While lower limb biomechanics of people with diabetes are well described, the effects of diabetes type and of peripheral neuropathy on foot joint kinematics have not been addressed in depth. A total of 70 patients with type 1 (n = 25) and type 2 (n = 45) diabetes mellitus, with and without peripheral neuropathy, underwent functional evaluation via gait analysis using an established multisegment foot kinematic model. ANCOVA was performed to assess differences in foot joints’ range of motion (ROM) between groups with diabetes and a control group by accounting for the effects of age, body mass index (BMI) and normalized walking speed. Statistical parametric mapping was used to assess differences in temporal patterns of foot joint motion across normalized gait cycle. Small but significant correlations were found between age, BMI, speed and foot joints’ ROM. Regardless of diabetes type and presence of neuropathy, all subgroups with diabetes showed limited ROM at the midtarsal and tarsometatarsal joints. Increased midtarsal joint dorsiflexion and adduction was associated with increased tarsometatarsal joint plantarflexion. After accounting for the effect of covariates, diabetes is associated with reduced ROM and to alterations of the kinematic patterns, especially at the midtarsal and tarsometatarsal joints, irrespective of type and neuropathy.

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.

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.

Minimal footwear has existed for tens of thousands of years and was originally designed to protect the sole of the foot. Over the past 50 yr, most footwear has become increasingly more cushioned and supportive. Here, we review evidence that minimal shoes are a better match to our feet, which may result in a lower risk of musculoskeletal injury.

The medial-longitudinal arch (MLA) is perhaps the most important feature characterizing foot morphology. While current skin-markers based models of the MLA angle used in stereophotogrammetry allow to estimate foot arch shape and deformation, these do not always appear consistent with foot anatomy and with standard clinical definitions. The aim of this study was to propose novel skin-markers based measures of MLA angle and investigate their reliability during common motor tasks. Markers on the calcaneus, navicular tuberosity, first metatarsal head and base, and on the two malleoli were exploited to test eight definitions of MLA angle consistent with foot anatomy, both as angles between two 3-dimensional vectors and as corresponding projections on the sagittal plane of the foot. The inter-trial, inter-session and inter-examiner reliability of each definition was assessed in multiple walking and running trials of two volunteers, tested by four examiners in three sessions. Inter-trial variability in walking was in the range 0.7–1.2 deg, the inter-session 2.8–7.5 deg, and the inter-examiner in the range 3.7–9.3 deg across all MLA definitions. The Rizzoli Foot Model definition showed the lowest inter-session and inter-examiner variability. MLA measures presented similar variability in walking and running. This study provides preliminary information on the reliability of MLA measurements based on skin-markers. According to the present study, angles between 3-dimensional vectors and minimal marker sets should be preferred over sagittal-plane projections. Further studies should be sought to investigate which definition is more accurate with respect to the real MLA deformation in different loading conditions.

The aim of this study is to investigate (i) the effect of live and recorded verbal encouragement on muscle activity and ankle force; (ii) the effect of communication/extroversion on the variables; (iii) the reliability intra and inter examiners of the variables. Twenty healthy-youngers were assessed by surface electromyography of tibialis anterior and ankle flexion force by an ergometer twice, with one week apart. No difference was found between ankle force (p = 0.373) and root mean square values (RMS) (p = 0.207) for any of the conditions assessed on day 1 nor between examiners 1 and 2 for both live and recorded conditions in RMS (p = 0.207) and force (p = 0.373). Between the 1st and 7th days, there were no differences for any of the conditions on RMS (main effect “Day” p = 0.261, “condition” p = 0.568, interaction p = 0.936) or force (main effect“Day” p = 0.889, “condition” p = 0.781, interaction p = 0.961). Intraclass correlation coefficients (ICCs) for the ankle force were, for without verbal encouragement (ICC2, k = 0.880), live verbal encouragement of examiner 1 (ICC2, k = 0.870), and recorded verbal encouragement of examiner 1 (ICC2, k = 0.920). RMS without verbal encouragement condition (ICC2, k = 0.860), live verbal encouragement of examiner 1 (ICC2, k = 0.930) and recorded verbal encouragement of examiner 1 (ICC2, k = 0.920). Reproducibility between the two examiner’s live encouragements for ankle force (ICC3, k = 0.981) and RMS (ICC3, k = 0.920). There was no effect of the presence or type of the augmented feedback in RMS and ankle force. We conclude that verbal encouragement does not influence ankle torque or muscle activity and there is good to excellent intra and inter rater reliability for subjects’ performance regardless of verbal encouragement modality. In addition, we observed that psychological traits Communication and Emotional stability does not affect the subjects’ strength performance at the ankle.

Background Diabetic polyneuropathy (DPN) negatively affects foot and ankle function (strength and flexibility), which itself affects the daily physical activity and quality of life of patients. A physical therapy protocol aiming to strengthen the intrinsic and extrinsic foot muscles and increase flexibility may be a promising approach to improve lower-extremity function, prevent further complications, and improve autonomy for daily living activities in these patients. Thus, the inclusion of a specific foot-related exercises focused on the main musculoskeletal impairments may have additional effects to the conventional interventions in the diabetic foot. Methods/Design A prospective, parallel-group, outcome-assessor blinded, randomized controlled trial (RCT) will be conducted in 77 patients with DPN who will be randomly allocated to usual care (control arm) or usual care with supervised foot-ankle exercises aiming to increase strengh and flexibility twice a week for 12 weeks and remotely supervised foot-ankle exercises for a year through a web software. Patients will be evaluated 5 times in a 1 year period regarding daily physical activity level, self-selected and fast gait speeds (primary outcomes), foot ulcer incidence, ulcer risk classification, neuropathy testing, passive ankle range of motion, quality of life, foot health and functionality, foot muscle strength, plantar pressure, and foot-ankle kinematics and kinetics during gait. Discussion This study aims to assess the effect of a foot-ankle strength and flexibility program on a wide range of musculoskeletal, activity-related, biomechanical, and clinical outcomes in DPN patients. We intend to demonstrate evidence that the year-long training program is effective in increasing gait speed and daily physical activity level and in improving quality of life; foot strength, functionality, and mobility; and biomechanics while walking. The results will be published as soon as they are available. Trial registration This study has been registered at ClinicalTrials.gov as NCT02790931 (June 6, 2016) under the name “Effects of foot muscle strengthening in daily activity in diabetic neuropathic patients”. Electronic supplementary material The online version of this article (10.1186/s12891-018-2323-0) contains supplementary material, which is available to authorized users.

Background The goal was to examine the feasibility of a randomized controlled trial (RCT) on the effect of a therapeutic foot-ankle training program to prevent injury in long-distance runners. First, we evaluated (i) the access to participants and recruitment success; (ii) participants' satisfaction and adherence to the program; (iii) the effect of the training program to improve foot muscle strength and change foot biomechanics; and, second, we used the collected data for a post hoc sample size calculation. Methods/design We randomized 31 healthy long-distance recreational runners to either an 8-week foot-ankle muscle strength-training program (intervention) or a stretching protocol (control). The recruitment rate was the number of eligible participants per week of recruitment; recruitment success, the ratio between scheduled baseline visits and initially eligible participants. Participant satisfaction was assessed by a questionnaire, and adherence to the training program was recorded in a Web-based software, both at the 8-week mark. Program effect was assessed by hallux and toe muscle strength using a pressure platform, foot muscle cross-sectional area using magnetic resonance imaging and foot kinematics during running using 3D gait analysis; assessments were done at baseline and after 8 and 16 weeks. A post hoc power analysis was performed on foot strength and the biomechanical data was collected. Results In two weeks of recruitment, 112 initially eligible subjects were screened, 81 of whom were deemed eligible and 31 had a baseline study visit, giving a recruitment rate of 40.5 subjects/week and recruitment success of 28%. Participants' adherence was 97%, and satisfaction scored a median >3 out of 5 on a Likert scale on all questions. The cross-sectional area of the abductor hallucis (P = 0.040) and flexor digitorum brevis (P = 0.045) increased significantly at 8 weeks in the intervention group. The post hoc sample sizes for almost all the strength and biomechanical parameters were below those of the 112 subjects calculated as the original sample size for clinical outcome (running-related injury). Conclusion Results show that this RCT is feasible, given an accessible study population that is willing to participate and that perceives the training program as positive and adheres to the program. The training program leads to several positive outcomes on muscle strength that justifies assessing clinical outcomes in this RCT.

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.

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).

Different location and incidence of lower extremity injuries have been reported in rearfoot strike (RFS) and forefoot strike (FFS) recreational runners. These might be related to functional differences between the two footstrike patterns affecting foot kinematics and thus the incidence of running injuries. The aim of this study was to investigate and compare the kinematic patterns of foot joints between naturally RFS and FFS runners. A validated multi-segment foot model was used to measure 24 foot kinematic variables in long-distance recreational runners while running on a treadmill. These variables included the three-dimensional relative motion between rearfoot, midfoot, and forefoot segments. The footstrike pattern was identified using kinematic data and slow-motion videos. Functional analysis of variance was used to compare the time series of these variables between RFS (n = 49) and FFS (n = 25) runners. In FFS runners, the metatarsal bones were less tilted with respect to the ground, and the metatarsus was less adducted with respect to the calcaneus during stance. In early stance, the calcaneus was more dorsiflexed with respect to the shank and returned to a more plantarflexed position at push-off. FFS runners showed a more adducted calcaneus with respect to the shank and a less inverted midfoot to the calcaneus. The present study has showed that the footstrike angle characterizes foot kinematics in running. These data may help shed more light on the relationship between foot function and running-related injuries.

Foot-ankle strengthening and mobility exercises are part of international guideline recommendations for people at risk of diabetic foot disease. We examined the feasibility and preliminary efficacy of a 12-week foot-ankle exercise program on clinical, functional and biomechanical outcomes in people with diabetic neuropathy (DPN). We randomly allocated 30 people with DPN to usual care (control) or usual care plus a supervised exercise program (intervention). For feasibility, we assessed recruitment rate and participant adherence and satisfaction. For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests (p &lt, 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants&rsquo, satisfaction had a mean (SD) of 4.57 (0.70) out of 5. The intervention group significantly improved on toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures increased over time, controls showed significantly increased heel peak pressures and force. The exercise program was feasible, based on a moderate recruitment rate and an adherent and satisfied population, and the intervention showed several positive preliminary effects over time compared to usual care.

IntroductionStudies have indicated that hip and knee muscle strengthening are effective in reducing pain, improving self-reported function and increasing lower limb strength, without, however, decreasing knee joint overload during gait in patients with knee osteoarthritis (KOA). Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain. The aim of this paper is to investigate whether an 8-week therapeutic foot-ankle exercise programme improves pain, functionality, foot strength, foot kinematics and knee joint overload during gait, and decreases medication intake in individuals with KOA.Methods and analysisThis two-arm, prospectively registered, randomised controlled trial with blinded assessors will involve 88 patients with medial tibiofemoral osteoarthritis. Subjects will be randomly allocated to a control group that will receive no specific foot intervention and will follow treatment recommended by the medical team; or an intervention group that will undergo an 8-week physiotherapist-supervised strengthening programme for extrinsic and intrinsic foot muscles, three times a week. The primary outcome will be the pain domain of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcomes include WOMAC stiffness and function domains, total WOMAC score, physical function, foot muscle isometric strength, foot kinematics and knee kinetics during gait, and medication intake. Data will be analysed on intention-to-treat principles and a per protocol basis.Ethics and disseminationInvestigators and sponsors will communicate trial results to participants and healthcare professionals through scientific databases and social media. In addition, findings will be reported in peer-review publications, and at national and international conference presentations. Ethics approval: Ethics Committee of the Universidade Federal de São Carlos, São Carlos, SP, Brazil (N° 3.488.466).Trial registration numberNCT04154059.

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the prevention of foot ulceration in persons with diabetes and updates the 2015 IWGDF prevention guideline. We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. We recommend to screen a person at very low risk for ulceration annually for loss of protective sensation and peripheral artery disease and persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate the at-risk patient about appropriate foot self-care and treat any pre-ulcerative sign on the foot. Instruct moderate-to-high risk patients to wear accommodative properly fitting therapeutic footwear, and consider instructing them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking to prevent plantar foot ulcer recurrence. In patients that fail non-surgical treatment for an active or imminent ulcer, consider surgical intervention; we suggest not to use a nerve decompression procedure. Provide integrated foot care for high-risk patients to prevent ulcer recurrence. Following these recommendations will help health care professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer-free days, and to reduce the patient and health care burden of diabetic foot disease.

Objectives To investigate the effects of a foot training program on muscle morphology and strength as well as running biomechanics in healthy recreational runners. Design Proof-of-concept, single-blind randomized controlled trial. Settings Runners were allocated to a control (CG) or an intervention (IG) group. The intervention focused on strengthening the intrinsic foot muscles and their activation during weight-bearing activities. All participants were assessed at baseline and after 8-weeks. Participants Twenty-eight healthy recreational long-distance runners not habituated to minimalist running shoes or barefoot running. Main outcomes measures Outcomes were hallux and toes strength; foot function, cross-sectional area and volume of the abductor hallucis (ABH), abductor digiti minimi (ABV), flexor digitorum brevis (FDB), and flexor hallucis brevis; medial longitudinal arch range of motion and stiffness; vertical and antero-posterior propulsive impulses during running. Results Compared to the CG, an increase was found in the IG for the volume of all muscles investigated and for vertical propulsive impulse during running. Correlations were found between vertical propulsive impulse and volume of ABH(r = 0.40), ABV(r = 0.41), and FDB(r = 0.69). Conclusion The foot exercise protocol effectively increased intrinsic foot muscle volume and propulsive forces in recreational runners. This shows that intrinsic muscle strengthening affects running mechanics and suggests that it may improve running performance.

It is well recognized that diabetes and peripheral neuropathy have a detrimental effect on gait. However, there are large variations in the results of studies addressing this aspect due to the heterogeneity of diabetic population in relation to presence and severity of diabetes complications. The aim of this study is to adopt an unsupervised classification technique to better elucidate the gait changes throughout the entire spectrum of diabetes and neuropathy.Sixty subjects were assessed and classified into four groups using a fuzzy logic model: 13 controls (55 ± 7years), 18 diabetics subjects without neuropathy (59 ± 6 years, 11 ± 7 diabetes years), 7 with mild neuropathy (56 ± 4years, 19 ± 7 diabetes years), and 22 with moderate to severe neuropathy (57 ± 5 years, 14 ± 8 diabetes years). Data were gathered by six infrared cameras at 100 Hz regarding lower limb joint kinematics (angles and angular velocities) and the relative phase for the hip-ankle, hip-knee, and knee-ankle were calculated. The K-means clustering algorithm was adopted to classify subjects considering the whole kinematics time series. A one-way ANOVA test was used to compare both clinical and kinematics parameters across clusters.Only the classification based on the intralimb coordination variables succeeded in defining 5 well separated clusters with the following clinical characteristics: controls were grouped mainly in Cluster 2, diabetics in Cluster 4, and neuropathic subjects in Cluster 5 (which included various degrees of severity). Hip-ankle coordination in Clusters 4 and 5 were significantly different (p0.05) with respect to Cluster 2, mainly in the stance phase. During the swing phase, differences were observed in the ankle-knee coordination (p0.05) across clusters.Classification based on intralimb coordination patterns succeeded in efficiently categorize gait alterations in diabetic subjects. It can be speculated that variables extracted from sagittal plane kinematics might be adopted as a support to clinical decision making in diabetes.

Background The Michigan Neuropathy Screening Instrument is an easy-to-use questionnaire aimed at screening and detecting diabetic polyneuropathy. Objective To translate and cross-culturally adapt the MNSI to Brazilian Portuguese and evaluate its measurement properties. Methods Two bilingual translators translated from English into Brazilian Portuguese and made a synthetic version. The synthetic version was back translated into English. A committee of specialists and the translator checked the cultural adaptations and developed a pre-final questionnaire in Brazilian Portuguese (prefinal version). In pretesting, the prefinal version was applied to a sample of 34 subjects in which each subject was interviewed to determine whether they understood each item. For the later assessment of measurement properties, 84 subjects were assessed. Results A final Brazilian Portuguese version of the instrument was produced after obtaining 80% agreement (SEM 0.92), reasonable construct validity for the association between the MNSI and Neuropathy Symptom Score (r = 0.46, p Conclusions The Brazilian Portuguese version of the MNSI is suitable for application in the Brazilian diabetic population and is a reliable tool for the screening and detection of DPN. The MNSI can be used both in clinical practice and also for research purposes.

Background Pompoir is a technique poorly studied in the literature that claims to improve pelvic floor strength and coordination. This study aims to investigate the pelvic floor muscles' coordination throughout the vaginal canal among Pompoir practitioners and non-practitioners by describing a high resolution map of pressure distribution. Methods This cross-sectional, study included 40 healthy women in two groups: control and Pompoir. While these women performed both sustained and “waveform” pelvic floor muscle contractions, the spatiotemporal pressure distribution in their vaginal canals was evaluated by a non-deformable probe fully instrumented with a 10 × 10 matrix of capacitive transducers. Findings Pompoir group was able to sustain the pressure levels achieved for a longer period (40% longer, moderate effect, P = 0.04). During the “waveform” contraction task, Pompoir group achieved lower, earlier peak pressures (moderate effect, P = 0.05) and decreased rates of contraction (small effect, P = 0.04) and relaxation (large effect, P = 0.01). During both tasks, Pompoir group had smaller relative contributions by the mid-region and the anteroposterior planes and greater contributions by the caudal and cranial regions and the latero-lateral planes. Interpretation Results suggest that specific coordination training of the pelvic floor muscles alters the pressure distribution profile, promoting a more-symmetric distribution of pressure throughout the vaginal canal. Therefore, this study suggests that pelvic floor muscles can be trained to a degree beyond strengthening by focusing on coordination, which results in changes in symmetry of the spatiotemporal pressure distribution in the vaginal canal.

Objective The purpose of this study was to compare the electromyographic pattern of core muscles during intermediate Pilates mat exercises between healthy people and those with low back pain. Methods We evaluated healthy participants (n = 19; mean ± standard deviation [SD]: age 28 ± 8 years, body mass 65 ± 10 kg, height 160.0 ± 9.1 cm) and a low back pain group (n = 13; mean ± SD: age 30 ± 9 years, body mass 67 ± 12 kg, height 170.0 ± 6.6 cm). Electromyographic analysis assessed the multifidus, external oblique, internal oblique, and rectus abdominis muscles during classical Pilates exercises (single leg stretch, criss-cross, and dead bug). We calculated the root mean square normalized by maximum voluntary contraction, and the time of peak activation was provided by a linear envelope and normalized by the total movement cycle. Results The criss-cross exercise presented the highest values of root mean square for trunk flexors (rectus abdominis and oblique) compared with the other exercises, followed by the single leg stretch and the dead bug, which had similar muscle activation. The single leg stretch presented more activation of the rectus abdominis and oblique, whereas the criss-cross and dead bug created more activation of the oblique compared with the multifidus and rectus. Conclusions The Pilates exercises presented different muscle recruitment patterns, and allowed the activation of the lumbopelvic stabilizing muscles even in the first session for healthy individuals and those with chronic low back pain.

We developed an intravaginal instrumented probe (covered with a 10×10 matrix of capacitive sensors) for assessing the three-dimensional (3D) spatiotemporal pressure profile of the vaginal canal. The pressure profile was compared to the pelvic floor (PF) digital assessment, and the reliability of the instrument and repeatability of the protocol was tested. We also tested its ability to characterize and differentiate two tasks: PF maximum contraction and Valsalva maneuver (maximum intra-abdominal effort with downward movement of the PF). Peak pressures were calculated for the total matrix, for three major sub-regions, and for 5 planes and 10 rings throughout the vaginal canal. Intraclass correlation coefficients indicated excellent inter- and intra-rater reliability and intra-trial repeatability for the total and medial areas, with moderate reliability for the cranial and caudal areas. There was a moderate correlation between peak pressure and PF digital palpation [Spearman's coefficient r=0.55 (p

Background Skeletal muscle strength is poorly described and understood in diabetic participants with diabetic peripheral neuropathy. This study aimed to investigate the extensor and flexor torque of the knee and ankle during concentric, eccentric, and isometric contractions in men with diabetes mellitus type 2 with and without diabetic peripheral neuropathy. Methods Three groups of adult men (n = 92), similar in age, body mass index, and testosterone levels, were analyzed: 33 non-diabetic controls, 31 with type 2 diabetes mellitus, and 28 with diabetic peripheral neuropathy. The peak torques in the concentric, eccentric, and isometric contractions were evaluated using an isokinetic dynamometer during knee and ankle flexion and extension. Findings Individuals with diabetes and diabetic peripheral neuropathy presented similar low concentric and isometric knee and ankle torques that were also lower than the controls. However, the eccentric torque was similar among the groups, the contractions, and the joints. Interpretation Regardless of the presence of peripheral neuropathy, differences in skeletal muscle function were found. The muscle involvement does not follow the same pattern of sensorial losses, since there are no distal-to-proximal impairments. Both knee and ankle were affected, but the effect sizes of the concentric and isometric torques were found to be greater in the participants' knees than in their ankles. The eccentric function did not reveal differences between the healthy control group and the two diabetic groups, raising questions about the involvement of the passive muscle components.

Purpose: To quantify how postural stability is modified during experimental pain while performing different cognitively demanding tasks. Methods: Sixteen healthy young adults participated in the experiment. Pain was induced by intramuscular injection of hypertonic saline solution (1 mL, 6%) in both vastus medialis and vastus lateralis muscles (0.9% isotonic saline was used as control). The participants stood barefoot in tandem position for 1 min on a force plate. Center of pressure (CoP) was recorded before and immediately after injections, while performing two cognitive tasks: (i) counting forwards by adding one; (ii) counting backwards by subtracting three. CoP variables—total area of displacement, velocity in anterior–posterior (AP-velocity) and medial–lateral (ML-velocity) directions, and CoP sample entropy in anterior–posterior and medial–lateral directions were displayed as the difference between the values obtained after and before each injection and compared between tasks and injections. Results: CoP total area (− 84.5 ± 145.5 vs. 28.9 ± 78.5 cm 2) and ML-velocity (− 1.71 ± 2.61 vs. 0.98 ± 1.93 cm/s) decreased after the painful injection vs. Control injection while counting forward (P < 0.05). CoP total area (12.8 ± 53.9 vs. − 84.5 ± 145.5 cm 2), ML-velocity (− 0.34 ± 1.92 vs. − 1.71 ± 2.61 cm/s) and AP-velocity (1.07 ± 2.35 vs. − 0.39 ± 1.82 cm/s) increased while counting backwards vs. forwards after the painful injection (P < 0.05). Conclusion: Pain interfered with postural stability according to the type of cognitive task performed, suggesting that pain may occupy cognitive resources, potentially resulting in poorer balance performance.

Background Prevention of diabetic foot ulcers is important. Preventative treatment mostly targets and aims to improve modifiable risk factors of foot ulceration. While effectiveness of interventions in ulcer prevention has been systematically reviewed, their effectiveness in improving modifiable risk factors is unknown. Methods The available medical scientific literature in PubMed, Excerpta Medica Database, and the Cochrane database was searched for original research studies on six interventions to treat modifiable risk factors for diabetic foot ulceration (ie, education for patients; education for professionals; self-management; pre-ulcer treatment; orthotic interventions; and foot- and mobility-related exercises). We assessed interventions for eight outcomes (ie, patients' knowledge; treatment adherence; professionals' knowledge; pre-ulcers; mechanical stress; neuropathy symptoms; foot/ankle joint mobility; and foot function). Both controlled and noncontrolled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers and extracted and presented in evidence and risk of bias tables. Results We included 72 publications (26 with a controlled study design and 46 noncontrolled). We found that structured education may improve foot self-care behaviour of patients, yearly foot examinations, and foot disease knowledge of health care professionals. Callus removal reduces peak plantar pressure. Custom-made therapeutic footwear can be effective in reducing plantar pressure and may reduce callus. Foot- and mobility-related exercises may improve neuropathy symptoms and foot and ankle joint range of motion, while they do not seem to reduce peak plantar pressure; evidence for their effect on foot strength is conflicting. Conclusions Structured education for patients and health care professionals, callus removal, custom-made therapeutic footwear, and foot- and mobility-related exercises may be beneficial for improving modifiable risk factors for foot ulceration. However, we generally found low quality of evidence for interventions targeting modifiable risk factors for ulceration in persons with diabetes, with frequently inconsistent or limited results available per intervention and outcome.

Background: The control of foot trajectory during swing phase is important to achieve safe clearance with the ground. Complexity of a physiological control system arises from the interaction of structural units and regulatory feedback loops that operate to enable the organism to adapt to a non-static environment. Diabetic polyneuropathy (DPN) impairs peripheral feedback inputs and alters ankle control during gait, which might affect toe clearance (ToC) parameters and its complexity, predisposing DPN-subjects to tripping and falling. Research question: How do different DPN-severity degrees change ToC trajectory and minimum ToC, and its complexity during gait of diabetic subjects? Methods: 15 healthy controls and 69 diabetic subjects were assessed and classified into DPN-severity degrees by an expert fuzzy model: absent (n = 26), mild (n = 21) and severe (n = 22). Three-dimensional kinematics was measured during comfortable walking. ToC was the minimum vertical distance between the marker placed at the first metatarsal head and the ground during swing. Mean ToC, ToC standard deviation (SD) between trials, and sample entropy (SaEn) and standard deviation (SD) of ToC trajectory were calculated from the ToC temporal series. ANOVA and ANCOVA (with the walking speed as the covariate) and Bonferroni pairwise post-hoc tests (P < 0.05) were used to compare groups. Results: Mean ToC and ToC SD did not show differences between groups (ANCOVA F = 0.436; df = 3; P = 0.705; F=1.719; df=3; P=0.170, respectively). ToC trajectory SD also did not show differences between groups (ANCOVA F = 3.98; df = 3; P = 0.755). Severe-DPN subjects showed higher ToC_Traj_SaEn than controls (ANCOVA F=2.60; df=3; P = 0.05). Significance: Severe-DPN subjects showed a more complex pattern of overall foot-ankle trajectory in swing phase in comparison to controls, although did not present lower minimum ToC values. The higher complexity of ToC might lead to an increase in the motor system output (more strategies, increase in variability), resulting in a more unstable system and selected motor strategies.

The pelvic floor has been poorly studied from a biomechanical perspective probably because of its complex structure comprised of many muscle layers and multiple muscle insertions with concave format in a three-dimensional architecture. An objective assessment of the pelvic floor muscles' (PFM) physical and mechanical capabilities is highly recommended to document changes in PFM function throughout rehabilitation protocols. Besides the magnitude of PFM force-generating capacity, other force/pressure-related parameters are important for the continence mechanism and sexual function, which are also correlated to different urogynecological dysfunctions. The existing devices for PFM assessment can be classified as manometers, dynamometers, electromyographers, or imaging techniques. So far, there is no perfect instrument or gold standard; however, each method has its advantages and disadvantages, and some of them will be discussed in this chapter. Recently, a new objective and reliable mechanical tool has been developed, being capable of measuring the magnitude and spatiotemporal distribution of pressures along the vaginal canal, taking into account the PFM structure, the directions of PFM contractions, and its ventro-cephalic resultant force. In this chapter, this device will be described and some of its clinical applications will be shown.

AimsTo develop and validate the content of a free web-based software (desktop and mobile applications) for the self-management of and customised foot-ankle exercises for people with diabetes and diabetic neuropathy.MethodsThe development of the programme was based on gamification principles and addressed three main areas: foot care recommendations; self-assessment of feet according to the main complications of diabetic neuropathy; and customised foot-ankle exercises to strengthen muscles, increase the range of motion and improve functionality. The content was validated using the Delphi methodology and a quantitative approach in two rounds with diabetes specialists (n = 9) and users with diabetes (n = 20). A 70% approval rate was considered sufficient in the second round for final validation purposes. The data analysis was conducted using descriptive statistics, absolute and relative frequencies and the content-validity index (CVI).ResultsAmong specialists, the CVI was 0.812 after the first round, and final approval was 100% after the second round. Among users, the CVI was 0.902 in the first round, and the final approval was 97%.ConclusionThis free access web software was developed based on the high agreement rating between specialists and users and has the potential to prevent complications arising from diabetic polyneuropathy. It allows for self-monitoring and promotes personalised exercises, following a preventive model that can be applied in primary and secondary care services as a complementary treatment for chronic complications. However, further steps to validate the software in a larger population are recommended.

This study compared lower limb external rotation kinematic patterns during sautes in first position in beginners and experienced ballet dancers with various training backgrounds. The ability to attain a perfect turnout is traditionally thought to be a fundamental aspect of classical ballet, and turnout is identified in the literature as one of the leading causes of dance-related injuries and technical limitations among dancers. Twenty-eight ballet dancers of different technical levels and methods (three groups) were assessed. Coefficients of variation (CV), range of motion (ROM), and mean external rotation angles of hip, knee, and ankle in first position saute were calculated. Differences among groups were tested with ANOVAs (Tukey's post hoc; p < 0.05). The hip mean external rotation values found during the jump were different between both experienced groups from different training backgrounds (p = 0.02). The inexperienced group presented a significantly greater hip external rotation CV compared to the experienced groups (p ≤ 0.001). There were no differences between groups for values of external rotation at the knee and ankle. It is concluded that higher technical level dancers produce lower variability of hip external rotation while performing saute in first position. Ballet training background also seems to influence the hip external rotation pattern. Moreover, the knee contributes decisively to turnout composition, not only the hip, as expected.

BACKGROUND: The risk factors for the development of plantar fasciitis (PF) have been associated with the medial longitudinal arch (MLA), rearfoot alignment and calcaneal overload. However, the relationships between the biomechanical variables have yet to be determined. OBJECTIVE: The goal of this study was to investigate the relationships between the MLA, rearfoot alignment, and dynamic plantar loads in runners with unilateral PF in acute and chronic phases. METHOD: Cross-sectional study which thirty-five runners with unilateral PF were evaluated: 20 in the acute phase (with pain) and 15 with previous chronic PF (without pain). The MLA index and rearfoot alignment were calculated using digital images. The contact area, maximum force, peak pressure, and force-time integral over three plantar areas were acquired with Pedar X insoles while running at 12 km/h, and the loading rates were calculated from the vertical forces. RESULTS: The multiple regression analyses indicated that both the force-time integral (R2=0.15 for acute phase PF; R2=0.17 for chronic PF) and maximum force (R2=0.35 for chronic PF) over the forefoot were predicted by an elevated MLA index. The rearfoot valgus alignment predicted the maximum force over the rearfoot in both PF groups: acute (R2=0.18) and chronic (R2=0.45). The rearfoot valgus alignment also predicted higher loading rates in the PF groups: acute (R2=0.19) and chronic (R2=0.40). CONCLUSION: The MLA index and the rearfoot alignment were good predictors of plantar loads over the forefoot and rearfoot areas in runners with PF. However, rearfoot valgus was demonstrated to be an important clinical measure, since it was able to predict the maximum force and both loading rates over the rearfoot.

Diabetic polyneuropathy is an insidious and long-term complication of this disease. Synergistic treatments and preventive actions are crucial because there are no clear boundaries for determining when health professionals should intervene or what intervention would best avoid the consequences of neuropathy. Until now, most therapies to any diabetic individual were applied only after the patient's limb was ulcerated or amputated. The loss of muscle and joint functions is recognized as the main cause of plantar overloading. However, if foot and ankle exercises are performed following the early diagnosis of diabetes, they can enable the patient to maintain sufficient residual function to interact with the environment. This article summarizes the current knowledge about the musculoskeletal deficits and biomechanical alterations caused by neuropathy. It also describes the potential benefits of foot and ankle exercises for any diabetic patient that is not undergoing the plantar ulcer healing process. We concentrate on the prevention of the long-term deficits of neuropathy. We also discuss the main strategies and protocols of therapeutic exercises for joints and muscles with deficits, which are applicable to all diabetic patients with mild to moderate neuropathy. We describe further efforts in exploiting the applicability of assistive technologies to improve the adherence to an exercise program. Following the contemporary trends towards self-monitoring and self-care, we developed a software to monitor and promote personalized exercises with the aim of improving autonomous performance in daily living tasks. Initiatives to prevent the complications of functional diabetes are highly recommended before it is too late for the patient and there is no longer an opportunity to reverse the tragic consequences of neuropathy progression.

Prevention of foot ulcers in patients with diabetes is extremely important to help reduce the enormous burden on both patient and health resources. A comprehensive analysis of reported interventions is not currently available, but is needed to better inform caregivers about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to prevent first and recurrent foot ulcers in persons with diabetes who are at-risk for ulceration. The available medical scientific literature in PubMed, EMBASE, CINAHL, and the Cochrane database was searched for original research studies on preventative interventions. Both controlled and non-controlled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers, and extracted and presented in evidence and risk of bias tables. From the identified records, a total of 30 controlled studies (of which 19 RCTs) and another 44 non-controlled studies were assessed and described. Few controlled studies, of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, multiple RCTs with low risk of bias show the benefit for the use of daily foot skin temperature measurements and consequent preventative actions, as well as for therapeutic footwear that demonstrates to relieve plantar pressure and that is worn by the patient. To prevent recurrence, some evidence exists for integrated foot care when it includes a combination of professional foot treatment, therapeutic footwear and patient education; for just a single session of patient education, no evidence exists. Surgical interventions can be effective in selected patients, but the evidence base is small. The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong, but is small for the use of other, sometimes widely applied, interventions, and is practically non-existent for the prevention of a first foot ulcer and non-plantar foot ulcer. More controlled studies of high quality are needed in these areas.

Efforts have been made to retard the progressive debilitating pain and joint dysfunction in patients with knee osteoarthritis. We aimed to evaluate the therapeutic effect of a low-cost minimalist footwear on pain, function, clinical and gait-biomechanical aspects of elderly women with knee osteoarthritis.Throughout a randomized, parallel and controlled clinical trial, fifty-six patients with medial knee osteoarthritis were randomly allocated to an intervention (n=28) or control group (n=28), and assessed at baseline and after three and six months. The intervention involved wearing Moleca(®) footwear for at least 6h/day, 7 days/week, over 6 months. The pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index was the primary outcome. The secondary outcomes were the other subscales, Lequesne score, distance walked in 6 min, knee oedema and effusion, knee adduction moment and paracetamol intake. Intention-to-treat analysis was performed using two-way casewise ANOVA (.05) and Cohen's d coefficient.Intervention group showed improvement in pain (effect size: 1.41, p.001), function (effect size: 1.22, p=.001), stiffness (effect size: 0.76, p=.001), Lequesne score (effect size: 1.07, p.001), and reduction by 21.8% in the knee adduction moment impulse (p=.017) during gait wearing Moleca(®). The analgesic intake was lower in the intervention group.The long-term use of Moleca(®) footwear relieves pain, improves self-reported function, reduces the knee loading while wearing Moleca(®), refrains the increase of analgesic intake in elderly women with knee osteoarthritis and can be considered as a conservative mechanical treatment option. ClinicalTrials.gov (NCT01342458).

Skin-markers based multi-segment models are growing in popularity to assess foot joint kinematics in different motor tasks. However, scarce is the current knowledge of the effect of high-energy motor tasks, such as running, on the repeatability of these measurements. This study aimed at assessing and comparing the inter-trial, inter-session, and inter-examiner repeatability of skin-markers based foot kinematic measures in walking and running in healthy adults. The repeatability of 24 kinematic measures from an established multi-segment foot model were assessed in two volunteers during multiple barefoot walking and running trials by four examiners in three sessions. Statistical Parametric Mapping (1D-SPM) analysis was performed to assess the degree of shape-similarity between patterns of kinematic measurements. The average inter-trial variability across measurements (deg) was 1.0 ± 0.3 and 0.8 ± 0.3, the inter-session was 3.9 ± 1.4 and 4.4 ± 1.5, and the inter-examiner was 5.4 ± 2.3 and 5.7 ± 2.2, respectively in walking and running. Inter-session variability was generally similar between the two motor tasks, but significantly larger in running for two kinematic measures (p 0.01). Inter-examiner variability was generally larger than inter-trial and inter-session variability. While no significant differences in frame-by-frame offset variability was detected in foot kinematics between walking and running, 1D-SPM revealed that the shape of kinematic measurements was significantly affected by the motor task, with running being less repeatable than walking. Although confirmation on a larger population and with different kinematic protocols should be sought, attention should be paid in the interpretation of skin-markers based kinematics in running across sessions or involving multiple examiners.

Studies have shown the short- and long-term effects of wearing minimalist footwear in reducing knee loads in patients with knee osteoarthritis (OA). This study aimed to investigate the mechanisms underpinning the reduction in external knee adduction moment (EKAM) in older adult women who wore this type of footwear through a randomized controlled trial. Fifty-six participants with medial compartment knee OA were equally allocated to either an intervention group (IG) that wore minimalist footwear (Moleca®) or to a control group (CG) that continued regular clinical treatment for OA for six months. The influence of lower limb joint kinematics and joint frontal moments, center of pressure displacement, and foot progression angle in predicting the reduction of EKAM were assessed after a six-month intervention. Surprisingly, none of the seven independent variables predicted the first peak EKAM in the multiple regression model for the IG. For the CG, the increase of one unit in the first peak of the hip adduction moment resulted in a 1.01 units increase in the first peak EKAM. Additionally, a one-unit reduction in the ankle eversion angle resulted in an increase of 0.16 units in the percent change in the first peak EKAM. Thus, wearing the Moleca® shoe for six months helped the participants keep a natural gait pattern without increasing the hip moment or the ankle inversion angle compared to the women who did not wear the Moleca® footwear. ClinicalTrials.gov (NCT01342458).

A well-functioning pelvic floor muscle plays an important role in maintaining urinary continence. The aim of this study was to describe and compare the intravaginal pressure profile using a multisensor device along the vaginal length in women with and without urinary incontinence (UI), while performing pelvic floor muscle tasks. Fifty-four adult pre-menopausal women (31 continent and 23 incontinent) participated in this cross-sectional observational cohort study. The intravaginal pressure profile was assessed at rest, during maximum and sustained pelvic floor muscle contractions, using the Pliance® multisensor device. Between-group comparisons were performed considering the overall pressure and the pressure profile of 10-subregions along the vaginal length. In the overall pressure assessment, women with UI presented lower pressures at rest, similar pressures during maximum contraction and lower capacity to maintain pressure during sustained contraction compared to those in the continent group. The pressure profile assessment showed between-group differences that were consistent throughout tasks, with the incontinent group presenting lower pressures than the continent group, specifically in the mid-vaginal length, around 3-4 cm from the vaginal opening. We observed consistent deficits in pressure generation in incontinent compared to continent women, precisely in the region of the pelvic floor muscles. With this protocol and novel instrument, we obtained a reliable and consistent intravaginal pressure profile of continent and incontinent women. This approach could assist clinicians in the assessment of pelvic floor muscle function and foster a better understanding of the urinary incontinence mechanism.

Background Pelvic floor pressure distribution profiles, obtained by a novel instrumented non-deformable probe, were used as the input to a feature extraction, selection, and classification approach to test their potential for an automatic diagnostic system for objective female urinary incontinence assessment. We tested the performance of different feature selection approaches and different classifiers, as well as sought to establish the group of features that provides the greatest discrimination capability between continent and incontinent women. Methods The available data for evaluation consisted of intravaginal spatiotemporal pressure profiles acquired from 24 continent and 24 incontinent women while performing four pelvic floor maneuvers: the maximum contraction maneuver, Valsalva maneuver, endurance maneuver, and wave maneuver. Feature extraction was guided by previous studies on the characterization of pressure profiles in the vaginal canal, where the extracted features were tested concerning their repeatability. Feature selection was achieved through a combination of a ranking method and a complete non-exhaustive subset search algorithm: branch and bound and recursive feature elimination. Three classifiers were tested: k-nearest neighbors (k-NN), support vector machine, and logistic regression. Results Of the classifiers employed, there was not one that outperformed the others; however, k-NN presented statistical inferiority in one of the maneuvers. The best result was obtained through the application of recursive feature elimination on the features extracted from all the maneuvers, resulting in 77.1% test accuracy, 74.1% precision, and 83.3 recall, using SVM. Moreover, the best feature subset, obtained by observing the selection frequency of every single feature during the application of branch and bound, was directly employed on the classification, thus reaching 95.8% accuracy. Although not at the level required by an automatic system, the results show the potential use of pelvic floor pressure distribution profiles data and provide insights into the pelvic floor functioning aspects that contribute to urinary incontinence.

Introduction: This study evaluates the complexity of force and surface electromyography (sEMG) during knee extension and flexion at low-level isometric contractions in individuals with different degrees of diabetic peripheral neuropathy (DPN). Methods: Ten control and 38 diabetic participants performed isometric contractions at 10%, 20%, and 30% of maximal voluntary contraction. Knee force and multichannel sEMG from vastus lateralis (VL) and biceps femoris were acquired. The SD of force and sample entropy (SaEn) of both force and sEMG were computed. Results: Participants with moderate DPN demonstrated high force-SD and low force-SaEn. Severely affected participants showed low SaEn in VL at all force levels. Discussion: DPN affects the complexity of the neuromuscular system at the knee for the extension task during low-level isometric contractions, with participants in the later stages of the disease (moderate and severe) demonstrating most of the changes. Muscle Nerve 57: 112–121, 2018.