Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment: Effects of Sensorineural Telerahabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The effects of neurosensory telerehabilitation in elderly subjects with MCI
研究概览
简要总结
Globally, approximately 55 million people suffer from dementia, and 60-70% of cases are due to Alzheimer's disease (AD). Increasing scientific evidence highlights that the pathological changes underlying AD and other forms of dementia begin long before the onset of symptoms. Mild cognitive impairment (MCI) is a clinical condition that in people over 65 shows a prevalence ranging from 3% to 22%. The characteristics of MCI are the presence of a subjective memory disorder and a reduced ability to learn new information with normal general cognitive functioning, normal ability to perform daily activities and the absence of other conditions, such as depression, that could justify the memory disorder. Currently, the diagnosis of MCI is based exclusively on clinical evaluation, including neuropsychological tests.
Currently, there are no therapies available to prevent and/or treat dementia and the options for intervention are represented by treatments such as physical exercise and cognitive treatment. These practices refer to the concept of cognitive reserve. Computerized cognitive training (CCT) is characterized by being a personalized intervention, allows multi-domain training and increases the cognitive processes of patients with MCI. The National Low Vision Center has been using a software called nLIFE EyeFitness for several years, certified as a Class I Medical device. It allows you to carry out individualized rehabilitation exercises at home, using your own PC or tablet, with monitoring by the Center's operators. The exercises currently present stimulate attention, short-term visual memory, reaction time, executive function, working memory and, therefore, also appear suitable for stimulating subjects with MCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 60 years with a diagnosis of aMCI
- •Signing of informed consent
排除标准
- •Age <60 years
- •History of dementia
- •Diabetes mellitus
- •Uncontrolled hypertension
- •Diagnosis of major depression
- •Age-related macular degeneration
- •Media opacity and vitreoretinal pathologies that may preclude a correct evaluation
- •• Failure to obtain informed consent
研究组 & 干预措施
Sperimental
All patients will undergo:
- Standardized battery of tests for the diagnosis of cognitive decline corresponding to the BDM (Battery for Mental Deterioration
- Global assessment measure of cognitive status (Minimal Mental State Examination - MMSE)
- Complete eye examination
- Tonometry
- Visual acuity for distance (ETDRS) and near (MNRead)
- Reading speed (IrestTEST)
- Microperimetry
- Psychological evaluation
- Patients with visual impairment randomized to receive neurovisual rehabilitation treatment will carry out neurosensory rehabilitation remotely.
干预措施: nLIFE EyeFitness (Device)
Control
All patients will undergo:
- Standardized battery of tests for the diagnosis of cognitive decline corresponding to the BDM (Battery for Mental Deterioration
- Global assessment measure of cognitive status (Minimal Mental State Examination - MMSE)
- Complete eye examination
- Tonometry
- Visual acuity for distance (ETDRS) and near (MNRead)
- Reading speed (IrestTEST)
- Microperimetry
- Psychological evaluation
结局指标
主要结局
The effects of neurosensory telerehabilitation in elderly subjects with MCI
时间窗: 8 months
Evaluate the effects of neurosensory telerehabilitation in terms of reduction of cognitive deterioration by evaluating the scores of neuropsychological questionnaires in use in clinical practice after using the remote neurovisual rehabilitation platform in use at the Polo Nazionale di Ipovisione
次要结局
- Evaluation the effects of neurosensory telerehabilitation on visual tests score(8 months)
