Evaluation of the effects and experience of using the SOPeD Exercise program for Feet and Ankles by individuals with Diabetic Foot: a randomized clinical trial
- Conditions
- Diabetic FootC18.452.394.750
- Registration Number
- RBR-7t6g86c
- Lead Sponsor
- niversidade Federal de Minas Gerais
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Individuals aged between 18 and 75 will be included; without distinction of race, sex or gender; residents of the city of Belo Horizonte/MG; diagnosis of type 1 or 2 diabetes mellitus, at high risk of foot ulceration (classification 3 in the International Working Group on the Diabetic Foot - IWGDF criteria), diagnosis of neuropathic diabetic foot (Peripheral Diabetic Neuropathy - moderate DPN - score 5.0 less than or equal to x less than 8.0 or severe - score greater than or equal to 8.0) according to the Decision Support System for the Classification of Diabetic Polyneuropathy, using Fuzzy logic, non-ischemic (ischemia equal to 0 according to the WIfI Classification proposed by the Society for Vascular Surgery); ulceration and/or minor amputation in only one of the lower limbs (LL); previous independence in functional mobility with or without the use of an assistive device; absence of dementia or signs of cognitive changes measured by the Mini-Mental State Examination (MMSE); access to an electronic device with internet access (computer, tablet, smartphone); who have the presence of another person in their home for support; and who accept to participate in the study and sign the Free and Informed Consent Form (TCLE).
It will be excluded from the study those who: have previous major amputation in lower limbs; present a new injury or amputation during the study that prevents the execution of the exercise program; are or will undergo any type of motor rehabilitation in lower limbs during the study; have already undergone orthopedic surgery on the lower limbs; have an indication for surgery or arthroplasty; readmission in hospitals during the study; presenting rheumatological and neurological diseases; have severe visual impairment such as severe diabetic retinopathy; aphasia, mental, behavioral or mood disorders diagnosed and recorded in the medical record document.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate adherence, satisfaction and safety in the use of SOPeD software at the end of the study, by identifying the frequency of access to the software, structured satisfaction and safety questionnaires developed by Crunivel-Júnior et al. (2021), and individual semi-structured interviews guided by a script prepared by the researchers themselves;Evaluate the symptoms of diabetic peripheral neuropathy (DPN), isometric foot muscle strength and ankle range of motion, at the beginning and at the end of the study, using the respective standardized instruments: Michigan Neuropathy Screening Instrument (MNSI-Brazil); E-lastic isometric dynamometer; and Universal Goniometer. <br>
- Secondary Outcome Measures
Name Time Method It is expected to find an improvement in the functionality of the foot and ankle, in the functional performance of activities of daily living and in the quality of life of the participants, assessed using the respective standardized instruments, at the beginning and at the end of the study: Foot Health Status Questionnaire ( FHSQ-BR); Modified Barthel Index; and EQ-5D