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临床试验/NCT02731170
NCT02731170Unknown不适用

Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.

Ospedale Generale Di Zona Moriggia-Pelascini2 个研究点 分布在 1 个国家目标入组 439 人开始时间: 2014年1月1日最近更新:
适应症

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

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

发起方
Ospedale Generale Di Zona Moriggia-Pelascini
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilaria Zivi

MD

Ospedale Generale Di Zona Moriggia-Pelascini

研究点 (2)

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