Neuropsychological Profile of a Portuguese Patient's Group With Multiple Sclerosis and Results of a Cognitive Rehabilitation Program
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 主要终点
- Effect of an intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with multiple sclerosis or clinical isolated syndrome.
研究概览
简要总结
The purpose of the study is to determine the effect of an web-based intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with multiple sclerosis or clinical isolated syndrome.
详细描述
Objectives
Primary:
1. To determine the effect of an intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with multiple sclerosis or clinical isolated syndrome.
Secondary:
- To characterize the neuropsychological profile of a population of patients with multiple sclerosis or clinical isolated syndrome.
- To evaluate the relation between Expended Disability Status Scale score and cognitive dysfunction.
- To evaluate the impact of depression on neuropsychological performance.
- To evaluate the relation between cognitive dysfunction and the 9-hole peg test.
- To evaluate the relation between cognitive dysfunction and the 25-foot walk test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with MS diagnosed according to McDonald criteria from 2010 and clinical isolated syndrome patients.
- •Age ≥18 years old.
- •Informed consent.
排除标准
- •Disease relapse in the last month.
- •Corticotherapy in the last month.
- •Expended Disability Status Scale score >6,0.
研究组 & 干预措施
Intervention group
Cognitive training.
干预措施: Cognitive training (Other)
Placebo group
Placebo task.
干预措施: Placebo task (Other)
结局指标
主要结局
Effect of an intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with multiple sclerosis or clinical isolated syndrome.
时间窗: 3 months
Two neuropsychological assessments were made: at baseline and at 3 months with the same neuropsychological battery to all the patients. After that, the statistically significant differences between the two study groups (comparing the standard deviations from the normative values of each test), will be accessed. The tests will be analysed separately and globally as a battery.
次要结局
- Relation between Expended Disability Status Scale score and cognitive dysfunction.(Baseline)
- Impact of depression on neuropsychological performance.(Baseline)
- Relation between cognitive dysfunction and the 9-hole peg test.(Baseline)
- Relation between cognitive dysfunction and the 25-foot walk test.(Baseline)
- Neuropsychological profile of a population of patients with multiple sclerosis or clinical isolated syndrome.(Baseline)
- Percentage of patients with Cognitive Dysfunction(Baseline)
研究者
Ivânia A Alves, MD
MD
Campus Universitário de Santiago