Rehabilitation technology for prevention of musculoskeletal dysfunctions and treatment of people's feet with diabetes mellitus: study FOotCAre (FOCA) proof of concept

Abstract

Considering the various musculoskeletal alterations of the foot and ankle in people with diabetic polyneuropathy (PND) and the need for self-care to avoid more serious complications such as ulcers and amputations, the inclusion of an exercise protocol for foot treatment, based on self-care, may be an effective method of prevention for this population. The aim of this project is to evaluate the feasibility, safety and potential efficacy of a rehabilitation technology (Diabetic Foot Guidance System software that customizes a protocol of therapeutic exercises for the foot and ankle of people with Diabetes) and its effects on the clinical responses of PND (symptoms, tactile and vibratory sensitivity), gait biomechanics, muscle strength and foot function. To evaluate the potential efficacy of the Software, a proof of concept study will be carried out - Foot CAre (FOCA), with random allocation and blindness of the evaluators. The sample will be composed of all individuals recruited and screened from eligibility criteria over a 12-month period. These will be allocated randomly in the control or intervention groups and evaluated pre and post treatment. The assessment includes kinematic and kinetic analysis of the foot and ankle, and plantar pressure during gait, PND symptoms, PND severity, foot muscle strength, functionality and general foot health. The hypothesis of this study is that the intervention group will improve the neuropathic symptoms, decrease the severity of neuropathy, improve sensitivity, muscle strength and foot function, when compared to the control group after 12 weeks of intervention, that adherence to the use of this tool self-care will be equal to or greater than 75% and that this technology is feasible and safe. (AU)