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.

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.

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.

BackgroundThe 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.MethodsThe 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).ResultsModerate 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.ConclusionFoot 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.

Exercise rehabilitation and education are important strategies for preventing the progression of diabetic neuropathy-related musculoskeletal deficits. The purpose of this randomized controlled trial was to investigate the effect of an 8-week home-based foot–ankle exercise program using an educational booklet on clinical outcomes (foot muscle strength and functionality; functional balance; diabetic neuropathy symptoms and severity; tactile and vibratory sensitivities; plantar pressure distribution; and foot–ankle, knee, and hip biomechanics during gait). Fifty participants with neuropathy were randomly allocated into an intervention group (59.1 ± 6.4 years, 23.5 ± 4.8 kg/m2, males = 6, females = 19) that performed the exercises for 8 weeks and a control group (56.5 ± 9.4 years, 22.9 ± 3.6 kg/m2, males = 5, females = 20) that received usual care recommendations. Generalized estimating equation method and intention-to-treat approaches were adopted. No significant differences were found for any clinical outcome after 8 weeks. Heel contact area increased in the intervention group compared to controls (p = 0.043, mean difference = 2.7 cm) and heel peak pressure was increased in controls compared to intervention (group effect p = 0.020, mean difference = -64.16 kPa) at 8 weeks. Controls showed increased joint moments for the hip at heel strike (p = 0.007) and for the knee and hip at push off over 8 and 16 weeks (p < 0.001 and p = 0.009, respectively). Although the intervention is easy to perform and showed a good adherence (72%), home-based foot–ankle exercise programs are unlikely to sufficiently modify the main risk factors related to foot ulcers and to change foot–ankle kinematics and kinetics.

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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.