RBR-7t6g86c进行中(未招募)Unknown
Evaluation of the effects and subjective experience of using the SOPeD Exercise software for Feet and Ankles by individuals with Diabetic Foot: a randomized clinical trial - SOPeD Diabetic Foot Guidance System
niversidade Federal de Minas Gerais0 个研究点开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18Y 至 75Y(—)
入选标准
- •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).
排除标准
- •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.
研究者
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