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.

BackgroundDiabetic 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/DesignA 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.DiscussionThis 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 registrationThis 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 materialThe online version of this article (10.1186/s12891-018-2323-0) contains supplementary material, which is available to authorized users.

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).

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 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.