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 .

Sensorimotor and gait training improves proprioception, nerve function, and muscular activation in patients with diabetic peripheral neuropathy: a randomized control trial.

OBJECTIVES: To examine the effect of sensorimotor and gait training on proprioception, nerve function, and muscle activation in diabetic peripheral neuropathy (DPN) patients. METHODS: Thirty-eight (25 male and 13 female) participants with DPN were selected and randomly allocated to intervention and control group. Participants in the intervention group were provided sensorimotor and gait training for eight weeks (3 days/week) along with diabetes and foot care education; participants in the control group received diabetes and foot care education only. Outcome measures involved proprioception, nerve conduction studies of peroneal and tibial nerve, and activation of lower limb muscles and multifidus while standing with eyes open and eyes closed, and treadmill walking. RESULTS: Mixed ANOVA revealed significant time effect and time×group interaction of proprioception in all four directions (p<0.05). The conduction velocity of peroneal nerve revealed significant time effect (p=0.007) and time×group interaction (p=0.022). Interaction effect was found to be significant for medial gastrocnemius and multifidus while standing with eyes open as well as with eyes closed (p≤0.004). Only multifidus showed significant group (p=0.002) and interaction effect (p=0.003) during walking. CONCLUSIONS: Sensorimotor and gait training is an effective tool for improvement of proprioception and nerve function. It benefits muscle activation around ankle and multifidus during postural control and walking in DPN patients. Clinical Trials Registry - India, National Institute of Medical Statistics (Indian Council of Medical Research): Registration Number - CTRI/2017/08/009328.

Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial.

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.

Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I.

BACKGROUND: This 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/DESIGN: Footcare (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. DISCUSSION: As 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 REGISTRATION: ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.

An exercise program for people with severe peripheral neuropathy and diabetic foot ulcers - a case series on feasibility and safety.

Purpose: To examine a non-weightbearing exercise program for persons with severe peripheral neuropathy (PN) and a diabetic foot ulcer in terms of feasibility and safety.Materials and methods: Five men (mean (SD) age of 68.2 (7.1) years) with diabetes, severe peripheral neuropathy and an active foot ulcer, participated in a 10-week exercise program. Program adherence, patient satisfaction, healing of foot ulcers, adverse advents, ability to perform activities of daily life, and changes in muscle strength were assessed.Results: All participants completed the program with a session attendance from 85 to 95%, and with high satisfaction (≥9 points on a 10-point numeric rating scale). Only minor adverse events occurred, and ulcers were reduced for all participants, from a median of 1.9 (IQR, 1.1-7.3) cm2 to 0.0 (0.0-3.0) cm2. The distance on stationary bike was improved from a mean (SD) of 3.30 (1.1) to 5.36 (0.5) kilometers, and strength training loads were progressed. Ability to perform in self-selected activities of daily living improved from a median of 4.3 (2-5) to 6.7 (5-8) on the Patient Specific Functional Scale (0-10 points), while maximal isometric knee-extension muscle strength improved with 23%.Conclusions: A non-weightbearing exercise program for people with diabetes, severe peripheral neuropathy and foot ulcers seems feasible and safe. Further studies are needed to confirm these findings.Implications for rehabilitationAn exercise program designed for people with severe peripheral neuropathy and diabetic foot ulcers can be safe by means of not compromising healing of foot ulcers.Feasible in terms of attendance and progression.An alternative to passive waiting for ulcer to heal in a population already deconditioned.

Effect of diverse physical rehabilitative interventions on static postural control in diabetic peripheral neuropathy: a systematic review.

BACKGROUND AND PURPOSE: There are diverse forms of rehabilitative techniques available to improve postural control in diabetic peripheral neuropathy but little is known about the efficacy of these techniques. The primary focus of this review is to find out the effectiveness of diverse rehabilitative interventions in improving postural control in type 2 induced diabetic peripheral neuropathy. Methods: Two reviewers independently scrutinized the included studies. The selected studies underwent quality assessment by PEDro scale. Randomized Controlled Trial (RCT) having a score of 4 or more were included in the review. A search was conducted in PUBMED, MEDLINE, CINAHL, EMBASE, PROQUEST, Science Direct, Cochrane Library, Physiotherapy Evidence Database (PEDro) and Google Scholar. The Medical Subject Headings (MeSH) related to the interventions were also taken into account. Results: A total of 563 studies were identified and finally 8 studies were included in the review process. The included studies were 3 in task-specific balance training, 1 in treadmill, 1 in strengthening, 2 in whole body vibration, and 1 study in pilates analyzing posture using static posturography. No RCTs were reportedly found under tai chi and yoga. Conclusions: Interventions related to task-specific approach in balance training, treadmill, strengthening, WBV showed improvement in static postural control. Intervention with pilates did not show any beneficial effects. However, there still remains a need for quality trials as the results of these studies were ambivalent in interpretation and quality of the studies were limited by small sample size and higher attrition rates.

Integrative studies to design and validate wearable footwear among neuropathic patients.

Uncontrolled high blood sugar levels leads to diabetic neuropathy, which is usually develops slowly. Damaged nerves stop sending messages or may send message slowly at the wrong times. The propsed model is an insole for individuals with peripheral neuropathy conditions, where the peak plantar pressure value is measured at specified locations of the foot by means of a pressure sensor, which can be accessed via  a mobile applications; Simultaneously, a stimulation is given at acupressure points of the foot to relieve pain at definite intervals of time, based on the signals from the controller. A controller is being used to perform these operations which will be transmitted to the mobile application via Bluetooth terminal.

Effects of a task-based biofeedback training program on improving sensorimotor function in neuropathic hands in diabetic patients: a randomized controlled trial.

BACKGROUND: Symptoms of diabetic hands have been gradually elucidated, however the interventions for these hand problems are typically underemphasized. Few studies have discussed intervention effects on sensorimotor problems in hands, which prevent diabetic patients from executing their daily routines and lower their quality of life (QoL). AIM: This study has investigated the effects of task-based biofeedback training compared with home-based programs on sensorimotor function and QoL in diabetic patients with neuropathic hands. DESIGN: A single blind randomized controlled trial. SETTING: Outpatient clinic at a university hospital. POPULATION: Thirty-eight patients with diabetic hand neuropathy whose sensorimotor functions were impaired based on screening with a pinch-holding-up activity (PHUA) test. METHODS: Participants were randomly assigned to either a computerized evaluation and re-education biofeedback (CERB) (N.=20) or a home-based (tendon gliding exercise in conjunction with resistive exercise) (N.=18) group. The primary outcome was sensorimotor control of a hand using the PHUA test. Secondary outcomes included changes in Semmes-Weinstein monofilament, two-point discrimination, the Purdue Pegboard test and a self-reported QoL questionnaire. The measurements were conducted before and after a 6-week treatment program. RESULTS: The CERB group significantly improved efficiency in pinch force output during the PHUA test by reducing the percentage of maximum pinch strength (change from 34.5±11.66 to 30.7±10.16%, P=0.001), and there was a statistically significant between-group difference (P=0.00, 95% CI: -12.59 to -3.34, F=9.42). The CERB group showed superior treatment effects as compared to the control group on the two-point discrimination results (P=0.01) as well as the pin insertion subtests in the Purdue pegboard test (P=0.01). The QoL results also revealed significant between-group differences in several items of the Diabetes-39 (P<0.05). CONCLUSIONS: This study showed that a task-based biofeedback training program provides superior benefits for restoration of hand sensorimotor functioning in diabetic patients as compared to a home-based program combining tendon gliding exercise and resistive exercise. CLINICAL REHABILITATION IMPACT: Using task-based biofeedback training as one of the rehabilitation strategies may be an effective approach for restoration of sensory function, precision pinch performance, hand dexterity, and QoL for patients with diabetes-related neuropathy.

The effect of exercise therapy combined with psychological therapy on physical activity and quality of life in patients with painful diabetic neuropathy: a systematic review.

Background and aims Approximately 25% of patients with diabetes mellitus type 2 (DMII) develop painful diabetic neuropathy (PDN). PDN is known to affect both mental and physical wellbeing, resulting in anxiety, depression, low quality of life and physical disability. Pharmacological treatment of PDN aims at pain relief and is often ineffective and/or has many side effects. Rehabilitation treatment modalities that are designed to help the patient deal with PDN related complaints, are mostly focussed on either physical (e.g. exercise therapy) or psychological aspects (e.g. cognitive behavioural therapy, CBT). There is emerging evidence that PDN can be approached from a biopsychosocial perspective, in which physical and psychosocial aspects are integrated. From this biopsychosocial approach it is plausible that integrated treatment modalities such as acceptance commitment therapy (ACT) or exposure in vivo (EXP) could be effective in patients with PDN. The objective of this review was to provide an overview of the current evidence on the effects of rehabilitation treatments that combine exercise therapies with psychological therapies in order to improve physical activity (PA) and quality of life (QoL) in patients with PDN. Methods Systematic review of the current literature. EMBASE, MEDLINE, Medline In-Process citations and e-Pubs ahead-of-print, Pedro, Web of Science, PsycINFO, CENTRAL, PubMed and Google Scholar were searched. All studies on interventions combining exercise therapy with psychological interventions in patients with PDN, aged >18 years, were included. Outcome measures were PA, QoL. Results The search resulted in 1603 records after removing duplicates. After screening on titles and abstracts, 100 records remained. From these, not one study reported on interventions that combined exercise therapy with psychological interventions. Through a secondary hand search, a total of three reviews were identified that described a total of five studies regarding either physical or psychological interventions in patients with PDN. These studies reported moderate effects of (1) mindfulness meditation on QoL, (2) CBT on pain severity, (3) mindfulness-based stress reduction intervention on function, health-related QoL, pain catastrophizing and depression, (4) aerobic exercise on QoL and (5) Tai Chi on glucose control, balance, neuropathic symptoms, and some dimensions of QoL in patients with PDN. All studies were of a moderate quality, and results should be interpreted with caution. Conclusions Based on increasing knowledge in the domain of chronic pain, it could be assumed that integrated rehabilitation treatments for patients with PDN are beneficial. There is no literature to support this and more research should be done on integrated biopsychosocial interventions in patients with PDN. Implications This empty review highlights the importance that more research should be done on integrated biopsychosocial interventions in patients with PDN. Currently, our research group is performing a study on the effects of EXP treatment in patients with PDN.

A Review of Beneficial Low-Intensity Exercises in Diabetic Peripheral Neuropathy Patients.

The American Diabetic Association standards of medical care for diabetic patients recommends moderate intensity exercise to help manage diabetes; however, this recommendation may be unmanageable for patients who have become inactive or unable to reach this intensity. The purpose of this review is to determine if low-intensity exercises demonstrate improvement in diabetic peripheral neuropathy symptoms in order to utilize these exercises as a starting point for inactive patients. Studies in low-intensity exercises from 2013 to May 2018 were systematically searched in PubMed, SCOPUS, and Cochrane Library databases. The studies in this research have shown that low-intensity resistance exercises have promising outcomes such as improvements in pain interference with daily activities, pain thresholds, and reductions in neuropathy symptoms. Low-intensity aerobic therapy adds to the quality of life of the patient, and increases in strength of the lower limbs show an improvement in foot sensation and a reduction in pain and tingling symptoms.

Charcot neuroarthropathy patient education among podiatrists in Scotland: a modified Delphi approach.

BACKGROUND: This evaluation sought to determine current Charcot neuroarthropathy (CN) diabetes patient education practices among Scottish National Health Service (NHS) and academic podiatrists and evaluate novel visual tools and develop expert consensus for future practice. METHODS: Questionnaires collected mixed qualitative and quantitative responses, analysed concurrently within a convergence coding matrix. Delphi methodology permitted member-checking and agreement of consensus over two rounds. RESULTS: Fourteen participants (16.28%) completed a Round One questionnaire, leading to the generation of four themes; Experience; Person-Centred Care and the Content and Context of CN patient education. Seven consensus statements were subsequently developed and six achieved over 80% agreement among 16 participants (18.60%) with a Round Two questionnaire. Respondents agreed CN patient education should be considered for all 'At-risk' individuals with diabetic peripheral neuropathy (DPN). Verbal metaphors, including the 'rocker-bottom' foot, soft or brittle bones, collapsing, walking on honeycomb and a shattering lightbulb were frequently employed. Visual tools, including visual metaphors and The Charcot Foot Thermometer, were positively evaluated and made available online. CONCLUSIONS: Key findings included respondent's belief that CN education should be considered for all individuals with DPN and the frequent use of simile, analogy and metaphor in CN education. The concept of 'remission' proved controversial due to its potential for misinterpretation.

The effects of vibro-medical insole on sensation and plantar pressure distribution in diabetic patients with mild-to-moderate peripheral neuropathy.

BACKGROUND: The first aim of this study was to determine the effect of a vibro-medical insole on pressure sensation and the second was to measure the effects of a vibro-medical insole with and without random noise on plantar pressure distribution in diabetic patients with mild-to-moderate peripheral neuropathy. METHODS: Twenty patients with mild-to-moderate diabetic neuropathy were recruited in the clinical trial pre-test, post-test study. A medical insole was made for each participant and a vibratory system was inserted into it. Pressure sensation was evaluated before and after the 30-min walk using the vibro-medical insole with added random noise by Semmes-Weinstein Monofilaments. Peak pressure data was measured before and after 30-min walking with a vibro-medical insole with and without random noise by the Pedar-x system. FINDINGS: Pressure sensations showed improvement after 30-min walking with the vibro-medical insole with added random noise at the heel, metatarsophalangeal heads and hallux of both feet in all participants (p < 0.05). Peak pressure decreased significantly in the heel, MTP2,3, MTP4,5 and hallux (p < 0.05) and increased in midfoot (p < 0.05) using the vibro-medical insole with and without random noise compared to the shoe only condition. Only the peak pressure of the heel region decreased using the vibro-medical insole with random noise compared to without random noise (p = 0.006). INTERPRETATION: Thirty minute walking with a vibro-medical insole seems to improve pressure sensation and alter peak pressure in diabetic patients with mild-to-moderate peripheral neuropathy. This work suggests that vibro-medical insoles can be used for daily living activities and possibly decreases the risk of ulceration in diabetic neuropathy patients.

The Effectiveness of Aerobic Exercise in Improving Peripheral Nerve Functions in Type 2 Diabetes Mellitus: An Evidence Based Case Report.

BACKGROUND: peripheral neuropathy is known as one of most common complication in diabetes mellitus type 2 patient. This complication is caused by uncontrolled condition of blood glucose level in long periode. Regular physical activity in moderate to high intensity is beneficial in management of diabetes mellitus. This report aimed to know the effectiveness of aerobic exercise in causing improved peripheral functions in type 2 diabetes mellitus. METHODS: literature searching using several related keywords in Medline®, Pubmed®, and Cochrane library, following inclusion and exclusion criteria. RESULTS: Dixit et al suggested that a heart rate intensity of 40-60% aerobic exercise of 30-45 min duration per session for eight weeks suggest an important impact in controlling diabetic peripheral neuropathy. Kluding PM et al suggested that significantly improved selected measures of peripheral nerve function ("worst" pain levels and MNSI score), glycemic control (HbA1c), and resting heart rate. CONCLUSION: the studies showed significant benefit of aerobic exercise, despite the short duration of exercise being used as intervention towards improvement in peripheral nerve function. However, further studies with large samples and longer duration of intervention are needed to confirm the finding.

The effects of Vibro-medical insole on vibrotactile sensation in diabetic patients with mild-to-moderate peripheral neuropathy.

Peripheral sensory neuropathy seems to be the main risk factor for diabetic foot ulceration. Previous studies demonstrated that stochastic resonance can improve the vibrotactile sensation of diabetic patients. The aim of this study was to evaluate the effects of Vibro-medical insole on pressure and vibration sensation in diabetic patients with mild-to-moderate peripheral neuropathy. A total of 20 patients with mild-to-moderate diabetic neuropathy were included in the pre-test and post-test clinical trial study. Vibro-medical insole consists of medical insole and vibratory system. Medical insole was made independently for each participant and vibratory system was inserted in it. Pressure and vibration sensation were evaluated before and after 30-min walking with Vibro-medical insole. Semmes-Weinstein monofilaments and tuning fork were used to evaluate pressure and vibration sensation, respectively. Pressure sensation showed significantly improvement using Vibro-medical insole at the heel, first and fifth metatarsophalangeal heads, and hallux of both feet in all participants (p < 0.001). Vibration sensation also improved at the big toe of both feet with 256 Hz tuning fork (p < 0.05) but no statistically significant effect was found with 128 Hz tuning fork (p > 0.05). Vibro-medical insole significantly improved pressure and vibration sensation of the foot in diabetic patients with mild-to-moderate peripheral neuropathy. The results suggest that Vibro-medical insole can be used for daily living activities to overcome sensory loss in diabetic neuropathy patients.

Neural Mobilization Attenuates Mechanical Allodynia and Decreases Proinflammatory Cytokine Concentrations in Rats With Painful Diabetic Neuropathy.

Background: Painful diabetic neuropathy (PDN) is a common complication in patients with diabetes. It is related to ischemic nerve damage and the increase in the levels of proinflammatory mediators, such as tumor necrosis factor α (TNF-α) and interleukin 1ß (IL-1ß). Neural mobilization may have the potential to alleviate PDN, but it has not yet been tested. Also, the physiological mechanism of neural mobilization is unclear. Objective: The objective of this study was to investigate treatment effect and physiological mechanism of neural mobilization. Design: This was an experimental study using rats with streptozocin (or streptozotocin)-induced type 1 diabetes. Methods: Three groups were used in the study, the control group (vehicle), the diabetes group (PDN group), and the neural mobilization treatment group (PDN-NM group) (n = 6). Rats in the vehicle group were healthy rats. Rats in the PDN and PDN-NM groups were rats with diabetes. Rats in the PDN-NM group received treatment in the right sciatic nerve, whereas rats in the PDN group did not. Mechanical pain sensitivity and the levels of IL-1ß and TNF-α in the sciatic nerve branches and trunk, the L4 to L6 dorsal horn ganglion, and the spinal cord dorsal horn were measured. Results: Techanical allodynia was alleviated after treatment, but the effect was limited to the treatment side. The concentrations of proinflammatory cytokines were decreased in the nerves that received treatment compared with those on the other side, indicating that neural mobilization may reduce mechanical sensitivity by decreasing the concentrations of local sensitizing agents. Limitations: A limitation of this study was that no direct measurement of nerve blood flow was done. Conclusions: The results of this study showed that neural mobilization effectively alleviated mechanical allodynia in rats with PDN. The side that received treatment had lower concentrations of TNF-α and IL-1ß in the sciatic nerve branches and sciatic nerve trunk; this result may have been related to the alleviation of mechanical allodynia.

Lower-extremity dynamics of walking in neuropathic diabetic patients who wear a forefoot-offloading shoe.

BACKGROUND: A forefoot-offloading shoes has a negative-heel rocker outsole and is used to treat diabetic plantar forefoot ulcers, but its mechanisms of action and their association with offloading and gait stability are not sufficiently clear. METHODS: Ten neuropathic diabetic patients were tested in a forefoot-offloading shoe and subsequently in a control shoe with no specific offloading construction, both worn on the right foot (control shoe on left), while walking at 1.2m/s. 3D-instrumented gait analysis and simultaneous in-shoe plantar pressure measurements were used to explain the shoe's offloading efficacy and to define centre-of-pressure profiles and left-to-right symmetry in ankle joint dynamics (0-1, 1:maximum symmetry), as indicators for gait stability. FINDINGS: Compared to the control shoe, peak forefoot pressures, vertical ground reaction force, plantar flexion angle, and ankle joint moment, all in terminal stance, and the proximal-to-distal centre-of-pressure trajectory were significantly reduced in the forefoot-offloading shoe (P<0.01). Peak ankle joint power was 51% lower in the forefoot-offloading shoe compared to the control shoe: 1.61 (0.35) versus 3.30 (0.84) W/kg (mean (SD), P<0.001), and was significantly associated with forefoot peak pressure (R2=0.72, P<0.001). Left-to-right symmetry in the forefoot-offloading shoe was 0.39 for peak ankle joint power. INTERPRETATION: By virtue to their negative-heel rocker-outsole design, forefoot-offloading shoes significantly alter a neuropathic diabetic patient's gait towards a reduced push-off power that explains the shoe's offloading efficacy. However, gait symmetry and stability are compromised, and may be factors in the low perceived walking discomfort and limited use of these shoes in clinical practice. Shoe modifications (e.g. less negative heel, a more cushioning insole) may resolve this trade-off between efficacy and usability.

Positive effects of plantar vibration training for the treatment of diabetic peripheral neuropathy: A pilot study.

PURPOSE: To evaluate the effectiveness of 8-week low-frequency plantar vibration training on patients with sensorimotor diabetic peripheral neuropathy (DPN). PARTICIPANTS: Twelve patients took part in the investigation. RESULTS: An increase of the nerve conductive velocity of soral and peroneal nerves of feet, increased postural stability, and disappearance of the pain and tingling were observed. CONCLUSION: The obtained results provide evidence for beneficial effects of 8-week plantar vibration training in patients with DPN.

The effect of foot plantar massage on balance and functional reach in patients with type II diabetes.

OBJECTIVE: The aim of this study was to investigate the effect of manual foot plantar massage (classic and friction massage) on functional mobility level, balance, and functional reach in patients with type II diabetes mellitus (T2 DM). METHODS: A total of 38 subjects diagnosed with T2 DM were included in the study. A healthy control group could not be formed in this study. After the subjects' socio-demographic data were obtained, Timed Up & Go (TUG) Test, functional reach test (FRT), one-leg standing test with eyes open-closed, and Visual Analogue Scale (VAS) to measure foot pain intensity were performed. The results were also divided and assessed in three groups according to the ages of the individuals (40-54, 55-64, and 65 and over). RESULTS: As a result of statistical analysis, a difference was found in the values obtained from TUG, FRT, and one-leg standing test with eyes open and closed (p < 0.05). Following the massage, TUG values significantly decreased comparison with those before the massage, whereas the values of FRT and one-leg standing test with eyes open and closed significantly increased compared with those before the massage (p > 0.05). According to age groups, there were statistical differences (p < 0.05) between the TUG, one-leg standing test with eyes open and closed test values of the individuals before and after the massage. CONCLUSIONS: The results of our study indicated that application of plantar massage to patients with T2 DM caused an improvement in balance, functional mobility, and functional reach values. An increase in body balance and functional mobility may explain the improvement in TUG. Foot massage to be added to rehabilitation exercise programs of DM patients will be important in improving balance and mobility of patients.

Aerobic exercise improves measures of vascular health in diabetic peripheral neuropathy.

AIMS: Aerobic exercise improves vascular endothelial function in people with Type 2 diabetes mellitus (T2DM). There is minimal information available regarding vascular health in people with T2DM and diabetic peripheral neuropathy (DPN). Thus, the primary aim of this secondary analysis was to determine whether a 16-week aerobic exercise intervention could improve vascular health in people with T2DM and DPN. A secondary aim was to explore the relationship between changes in flow-mediated dilation (FMD) and the number of years since diagnosis of DPN. METHODS: We examined whether a 16-week aerobic exercise intervention would improve vascular health in people with T2DM and DPN. We used Doppler ultrasound to assess brachial artery diameter and peak shear at baseline and post-exercise. Paired t-tests were used to determine whether the outcome measures improved from baseline to post-intervention. Pearson correlation assessed the relationship between DPN (years) and the percent change score (pre- to post-intervention) for FMD. RESULTS: Seventeen individuals were included in the data analysis. After the intervention, peak diameter increased (3.9 (0.5) to 4.0 (0.5) mm; p = 0.07). Time to peak shear occurred at 60.5 (24.6) seconds when compared to baseline at 68.2 (22.7) seconds; p = 0.17. We found that a longer duration (in years) of DPN demonstrated a fair, negative relationship (r = -0.41, p = 0.19) with the percent change in FMD. CONCLUSION: Aerobic exercise was beneficial for improving measures of vascular health but these were not statistically significant. The magnitude of change may be affected by the duration of DPN.

Physical Training and Activity in People With Diabetic Peripheral Neuropathy: Paradigm Shift.

Diabetic peripheral neuropathy (DPN) occurs in more than 50% of people with diabetes and is an important risk factor for skin breakdown, amputation, and reduced physical mobility (ie, walking and stair climbing). Although many beneficial effects of exercise for people with diabetes have been well established, few studies have examined whether exercise provides comparable benefits to people with DPN. Until recently, DPN was considered to be a contraindication for walking or any weight-bearing exercise because of concerns about injuring a person's insensitive feet. These guidelines were recently adjusted, however, after research demonstrated that weight-bearing activities do not increase the risk of foot ulcers in people who have DPN but do not have severe foot deformity. Emerging research has revealed positive adaptations in response to overload stress in these people, including evidence for peripheral neuroplasticity in animal models and early clinical trials. This perspective article reviews the evidence for peripheral neuroplasticity in animal models and early clinical trials, as well as adaptations of the integumentary system and the musculoskeletal system in response to overload stress. These positive adaptations are proposed to promote improved function in people with DPN and to foster the paradigm shift to including weight-bearing exercise for people with DPN. This perspective article also provides specific assessment and treatment recommendations for this important, high-risk group.