Rehabilitation technology for prevention of foot musculoskeletal dysfunctions and treatment of people with Diabetes Mellitus: FOotCAre (FOCA) proof of concept and cost-utility analysis

Abstract

Considering several foot-ankle musculoskeletal changes in people with Diabetic Peripheral Neuropathy (DPN) and the need for self-care in order to avoid more serious complications, a foot-ankle therapeutic exercise program for muscles strengthening and mobility gain, can be an effective prevention strategy for ulcers in this population. However, adherence to exercise programs in general is usually low. Therefore, a software that customizes foot-ankle exercises was developed as a potential alternative for telerehabilitation for people with diabetes to improve their self-monitoring and self-care management. With the recent inclusion in the International Guidelines of foot-related exercises as a preventive strategy, an economic evaluation of these programs becomes important. This type of evaluation allows health managers and decision-makers to more clearly assess the costs and benefits of treatments and allocate resources more effectively. In addition, in order to carry out a Health Technology Assessment, which is necessary to include a new therapy in the SUS (preventive foot exercise program), a complete assessment is necessary, including: effectiveness, safety and economic evaluation. Thus, the doctoral project, with a view to implementing this strategy in the SUS in the future, aims to evaluate the feasibility, safety, cost-utility and potential effectiveness of a therapeutic foot-ankle exercise protocol using the SOPeD (Diabetic Foot Guidance System) in the clinical responses of DPN (symptoms, tactile and vibratory sensitivity), gait biomechanics, muscle strength and foot functionality. To assess the potential effectiveness of SOPeD, a proof of concept study - FOot CAre (FOCA) will be carried out, with random allocation and blinding of the evaluators. The sample will consist of 30 participants, who will be randomly allocated to the control or intervention groups and evaluated in 3 moments. Outcomes include kinematics and kinetics of the foot-ankle and plantar pressure during gait, symptoms and DPN severity, strength of the foot muscles, functionality and general foot health and quality of life. To assess the cost-utility, the Quality-Adjusted Life Year (QALY) will be calculated as the product of the change in utility values (result of the intervention on quality of life) by the survival time (life gains in years). The Incremental Cost-Utility Ratio (ICUR) will also be calculated to measure the cost-utility of different strategies, with the incremental cost related to each effect unit, in this case measured in QALY. The hypotheses of this study are that the intervention group will improve DPN symptoms, decrease the DPN severity, improve sensitivity, muscle strength, foot functionality and quality of life, when compared to the control group after 12 weeks of intervention; that these effects of the intervention remain after 24 weeks of follow-up; that the adherence to the use of this self-care tool will be equal to or greater than 70%, that this technology is feasible and safe and has a better utility cost when compared to the usual care. (AU)