Web-based Foot-ankle Exercises Can Modify Clinical And Biomechanical Outcomes In Diabetic Neuropathy: A Randomized Controlled Trial

From the 2000s to the present day, significant scientific advances have been made concerning foot-ankle exercise programs targeting modifiable risk factors for ulcers. These programs were included for the first time in 2019 in the International Guidelines for foot ulcers prevention and they have been shown success in the treatment of the main musculoskeletal risk factors for ulcers and gait biomechanics in people with diabetic peripheral neuropathy (DPN). However, the effectiveness of a web-based foot-ankle therapeutic exercise program - the Diabetic Foot Guidance System (SOPeD, www.soped.com.br) have not yet been evaluated. PURPOSE: To evaluate the effectiveness of the SOPeD web-based on DPN-related outcomes and gait biomechanics over a 12-week period for people with DPN. METHODS: In this randomized controlled trial, 62 participants with DPN were randomly assigned to the SOPeD group or to the usual care group. The primary outcomes were DPN symptoms and severity; the secondary outcomes were foot pain and function, functional reach, plantar pressure distribution during gait, and foot-ankle kinematics and kinetics during gait. Generalized Estimating Equations were used to estimate between-group differences. RESULTS: While primary outcomes were unaffected by the SOPeD program, secondary outcomes indicated enhancements over usual care. Notably, functional reach improved at 12 weeks (MD = 3.35 cm; 95%CI: 0.02, 6.68), and foot pain decreased at 24 weeks (MD = 20.18 score; 95%CI: 4.04, 36.33). Forefoot loads decreased at 12 weeks, but increased at 24 weeks in the SOPeD group compared to the usual care group. Ankle plantarflexion during push-off increased in the intervention group at the 24-week follow-up (MD = 2.82 degree; 95%CI: 1.42, 4.22) relative to the usual care group. CONCLUSION: The 12-week SOPeD exercise program effectively reduced foot pain and improved functional reach. Modest changes in plantar pressure and ankle motion during gait were observed at 12 weeks, with significant improvements emerging at 24 weeks. Nevertheless, it is worth noting that the observed effects at 24 weeks were more pronounced, and therefore, it might be interesting to conduct longer exercise protocols to observe better results. This work was supported by Sao Paulo Research Foundation [FAPESP 2021/00807-8; 2019/02522-0] and by the National Council for Scientific and Technological Development, Brazil (CNPq) [302558/2022-5; 28/2018 FOCA Trial 407252/2018-5].