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.

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

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

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

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

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

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

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

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

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.

Later stages of diabetic neuropathy affect the complexity of the neuromuscular system at the knee during low-level isometric contractions.

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.

Altered leg muscle activity in volleyball players with functional ankle instability during a sideward lateral cutting movement.

OBJECTIVES: To study the activation patterns of tibialis anterior, peroneus longus and gastrocnemius lateralis muscles during a lateral shuffle maneuver in volleyball players with functional instability of the ankle joint. DESIGN: Observational case-control study. SETTING: Research laboratory. PARTICIPANTS: Sixteen players with functional instability and 18 matched controls. MAIN OUTCOME MEASURES: RMS values of tibialis anterior, peroneus longus and gastrocnemius lateralis muscles for the 50 ms before initial ground contact, timing of onset of muscle activity and linear envelopes for the period of ground contact were calculated. RESULTS: Onset values showed similar patterns of activation for both groups. In healthy subjects, gastrocnemius lateralis activated earlier, followed by peroneus longus and tibialis anterior. In the unstable subjects, gastrocnemius lateralis and peroneus longus activated at the same time, followed by tibialis anterior. Unstable subjects also presented lower peroneus longus activity during the 50 ms before initial ground impact, a lower peroneus longus peak magnitude and a higher gastrocnemius lateralis peak magnitude. CONCLUSIONS: Volleyball players with ankle functional instability showed decreased peroneus longus activity before ground impact that may predispose them to repetitive sprains and explain their "giving way" sensation, since peroneus longus is the main ankle evertor and an important stabilizer against sudden and excessive inversion.