Effect of the use of Diabetic Foot Guidance Software (SOPeD) in the prevention and treatment of musculoskeletal dysfunctions of the foot in people with diabetic neuropathy: a randomized controlled clinical trial - FOotCAre (FOCA I)

Author(s)

Jane Suelen Silva Pires Ferreira

• Document type: Doctoral Thesis
• Press: São Paulo.
• Institution: Universidade de São Paulo (USP). Faculdade de Medicina (FM/SBD)
• Defense date: 2024-09-13

Examining board members

Isabel de Camargo Neves Sacco; Leonardo Oliveira Pena Costa; Rina Maria Pereira Porta; Ana Carolina Basso Schmitt

• Advisor: Isabel de Camargo Neves Sacco

Abstract

Although there is substantial and significant evidence pointing to the effectiveness of foot and ankle exercises in reducing the signs and symptoms of diabetic peripheral neuropathy (DPN) and treating associated musculoskeletal changes, the quality of this evidence remains low. Due to the increasing number of people with diabetes and their frequent complications, technological solutions to enhance adherence and access to essential treatment and care have been developed. Moreover, in light of the global health pandemic, the use of technologies for the treatment and monitoring of chronic conditions has become indispensable. Therefore, considering that (i) DPN results in various chronic changes, such as debilitating symptoms, loss of protective foot sensation, musculoskeletal and lower limbs biomechanical deficits; (ii) continuous self-care and self-management are important ways to prevent dysfunctions and severe complications, such as ulcers and amputations; (iii) accessible technological tools have the potential to broaden reach and democratize access to care and treatment; this work sought to understand the impact of an intervention based on a web software (Diabetic Foot Guidance System, SOPeD, www.soped.com.br) for the preventive care of ulcers and the treatment of risk factors for diabetic foot. This thesis addressed several objectives in different papers; the first being to outline of physiotherapeutic intervention protocol, including guidance for self-care and self- management, and a foot-ankle exercise program to prevent ulcers and treat musculoskeletal and biomechanical deficits in people with diabetes and DPN. The second objective was to test the feasibility, safety, satisfaction, and adherence of participants to this program. Finally, a randomized controlled clinical trial was conducted, with blinded assessors, to investigate the effectiveness of this program at 12 and 24 weeks, regarding clinical and functional outcomes, such as DPN symptoms and severity, tactile and vibratory sensitivity, foot-ankle range of motion, functional reach, foot muscle strength, and gait biomechanics. The developed program lasted 12 weeks, totaling 36 sessions, with each session consisting of 8 exercises. This program is personalized according to individual physical capabilities, and its progression is based on an algorithm integrated into the software that adjusts the training volume and intensity based on the perceived and reported effort by the user. The exercise program and the clinical trial protocol were considered feasible and practicable, despite the difficulty in contacting (success rate of 23%) and recruiting (success rate of 70%) participants. The program was considered safe by participants (median score of 5 out of 5), satisfactory (median score of 5 out of 5), and had an adherence rate of 66.7% of the total offered sessions (36). As the final part of this thesis, a randomized controlled clinical trial included 62 individuals who were divided into two groups: intervention and control, and assessed at baseline, after 12 weeks of intervention, and after 24 weeks of follow-up. The main results showed that the SOPeD-based program was able to improve functional reach after 12 weeks, enhance foot function, reduce foot pain, and increase plantar flexion during the push-off phase of gait after 24 weeks. Additionally, the program was safe with minimal adverse events and can be considered an effective alternative for the prevention and treatment of some modifiable risk factors for ulcers (AU)

• FAPESP's process: 19/02522-0 - Rehabilitation technology for prevention of musculoskeletal and foot dysfunctions of people with Diabetes Mellitus: FootCAre (FoCa) prevention randomized controlled trial
• Grantee: Jane Suelen Silva Pires Ferreira
• Support Opportunities: Scholarships in Brazil - Doctorate