Affordable web-based foot-ankle exercise program proves effective for diabetic foot care in a randomized controlled trial with economic evaluation.

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

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

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

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

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

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

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

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

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

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 .

Foot-ankle functional outcomes of using the Diabetic Foot Guidance System (SOPeD) for people with diabetic neuropathy: a feasibility study for the single-blind randomized controlled FOotCAre (FOCA) trial I.

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.

Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial.

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 < 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants' 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.

The Association Between Rearfoot Motion While Barefoot and Shod in Different Types of Running Shoes in Recreational Runners.

The rearfoot angle (RFA) is a biomechanical variable widely used to determine the rearfoot motion (RM). Shoe manufacturers began to develop running shoes with RM control that would supposedly alter foot-ground interaction mechanics and neutralize excessive pronation or supination; moreover, some studies have not shown differences in rearfoot motion in shod condition compared to barefoot. This study intended to answer three questions: Do the shoes runners wear correspond to their respective barefoot RM? Does the eversion angle change during shod running, regardless the shoes worn? Can footwear designed for a specific RM (supination, pronation, neutral) correct or neutralize the eversion angle of runners? One hundred and eleven runners (38.6 ± 9.7years; 74.9 ± 12.0kg; 1.74 ± 0.08 m), who ran an average of 32 ± 17km/week, were included in this cross-sectional study. They had their RFA measured by a motion capture system when running barefoot and wearing their habitual running shoes (shod condition). Chi-squared test was used to assess associations between barefoot and shod condition and RFA was compared between conditions using Wilcoxon tests (p = 0.05). There was no association between the type of running shoe and barefoot RM (p > 0.05). There was an association between RFA when barefoot and when shod (p < 0.05). Among all participants classified as neutral, 61% continued to exhibit a normal/neutral RFA when wearing their habitual shoes. Among the overpronators, 100% showed a change in the RM to either normal or supinator. Among the participants classified as supinators, 62% exhibited normal pronation when shod even without using the appropriate footwear, claimed by the manufacturer. Only 44.1% of the sample chose the correct running shoe for their barefoot RM. The majority of runners did not choose their shoes designed for their natural type of RM. The rearfoot eversion angle changed an average 4 degrees when running shod and the RM barefoot altered quite a lot when using a running shoe. The running shoes did not correct the pronation detected barefoot, as claimed by the manufacturers.

Foot function and strength of patients with diabetes grouped by ulcer risk classification (IWGDF).

BACKGROUND: The stratification system from the International Working Group on the Diabetic Foot (IWGDF) was used to classify the participants as to the ulcer risk. However, it is not yet known what the classification groups' individual deficits are regarding sensitivity, function, and musculoskeletal properties and mechanics. This makes it difficult to design proper ulcer prevention strategies for patients. Thus, this study aimed to investigate the foot function, foot strength and health of people with diabetes mellitus (DM)-with or without DPN-while considering the different ulcer risk classifications determined by the IWGDF. METHODS: The subject pool comprised 72 people with DM, with and without DPN. The patients were divided into three groups: Group 0 (G0), which comprised diabetic patients without DPN; Group 1 (G1), which comprised patients with DPN; and Group 2 (G2), which comprised patients with DPN who had foot deformities. The health and foot function of the subjects' feet were assessed using a foot health status questionnaire (FHSQ-BR) that investigated four domains: foot pain, foot function, footwear, and general foot health. The patients' foot strength was evaluated using the maximum force under each subject's hallux and toes on a pressure platform (emed q-100, Novel, Munich, Germany). RESULTS: Moderate differences were found between G0 and G1 and G2 for the foot pain, foot function, general foot health, and footwear. There was also a small but significant difference between G0 and G2 in regards to hallux strength. CONCLUSION: Foot health, foot function and strength levels of people with DM and DPN classified by the ulcer risk are different and this must be taken into account when evaluating and developing treatment strategies for these patients.

Rehabilitation technology for self-care: Customised foot and ankle exercise software for people with diabetes.

AIMS: To 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. METHODS: The 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). RESULTS: Among 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%. CONCLUSION: This 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.

Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial.

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".

Cross-cultural adaptation and measurement properties of the Brazilian Version of the Michigan Neuropathy Screening Instrument.

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<0.01%) among diabetic patients and specialists. We obtained excellent intra-rater reliability (ICC3,1=0.90), inter-rater reliability (ICC2,1=0.90) and within-subject reliability ICC3,1=0.80, excellent internal consistency (Cronbach's alpha>0.92), reasonable construct validity for the association between the MNSI and Neuropathy Symptom Score (r=0.46, p<0.05) and excellent association between the MNSI and Neuropathy Disability Score (r=0.79, p<0.05). We did not detect floor and ceiling effects (<9.5% of patients with maximum scores). 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.