Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 439
- 试验地点
- 2
- 主要终点
- Unified Parkinson Disease Rating Scale
研究概览
简要总结
this study is aimed to evaluate the effectiveness of an Multidisciplinary Intensive Rehabilitation Treatment in Advanced Stages of Parkinson's Disease.
In the last years, several evidences highlighted the need of a multidisciplinary and intensive approach to achieve good results in early stage of disease.
Hypothesis is that this approach is effectiveness also in moderate and advanced stages of disease
详细描述
Parkinson's Disease (PD) is a progressive neurodegenerative disease clinically characterized by motor and non-motor symptoms.
Dopamine replacement therapy (DRT) is the standard treatment for the motor symptom of PD, however DRT does not reduce axial PD symptoms such as freezing of gait, postural instability and balance disturbances. Further, long-term DRT could negatively impact on cognitive and motivational functions and leads to different motor and behavioural side effects. Therefore, the pharmacological approach becomes less effective in the moderate and advanced stages of disease.
The investigators testing the hypothesis that this approach is effectiveness also in moderate and advanced stages of disease In according with Hoehn and Yahr scale (H&Y) we identified 353 parkinsonian patients on stage 3, 79 subjects on stage 4 and 7 subjects on stage 5.
Clinical scores were assessed at baseline and after 4 weeks by neurologists and physiotherapists expert in movement disorders. All evaluations were performed in the morning, one hour after taking drugs. The assessment included: Unified Parkinson's Disease Rating Scale (UPDRS), for clinical evaluation, Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Six Minutes Walking Test (6MWT), Freezing of Gait Questionnaire (FOGQ) and Abnormal Involuntary Movements Scale (AIMS) for motor symptoms evaluation and, finally, Parkinson's Disease Disability Scale (PDDS), for evaluation of the functional impact of the disease. Since in the advanced stages of PD one of the most troublesome complication includes cognitive disorders, a Neuropsychologist performed a cognitive assessment at the admission. The neuropsychological profile was explored using the Mini Mental State Examination (MMSE), a tool for screening of cognitive impairment, and the Frontal Assessment Battery (FAB) for the evaluation of frontal lobe dysfunctions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinica diagnosis of Parkinson Disease
排除标准
- •comorbidity with other neurological conditions
结局指标
主要结局
Unified Parkinson Disease Rating Scale
时间窗: 4 weeks
six-minutes walking test
时间窗: 4 weeks
Time up and go Test
时间窗: 4 weeks
Berg Balance Scale
时间窗: 4 weeks
Parkinson's Disease Disability Scale
时间窗: 4 weeks
Freezing of Gait Questionnaire
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
Ilaria Zivi
MD
Ospedale Generale Di Zona Moriggia-Pelascini
