Does Cognitive Impairment Affect Rehabilitation Outcome in Parkinson's Disease?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 438
- 试验地点
- 2
- 主要终点
- Unified Parkinson's Disease Rating Scale
研究概览
简要总结
In order to explore the question how an intensive, goal-based and aerobic rehabilitation treatment, addressed to act on motor and mental aspects, affects motor and functional symptoms in PD patients with normal cognition and with different level of cognitive impairment. Hypothesis is that a specific rehabilitation program based on motor-cognitive training and repetition, can affect positively the rehabilitation outcome regardless of baseline cognitive profile.
详细描述
Objective
This study is aimed to evaluate the impact of cognitive decline on rehabilitation outcomes in Parkinson's disease (PD). While cognitive status is considered as a determinant of rehabilitation outcome, no studies about this issue have been performed before.
Methods: 438 PD patients hospitalized for a 4-weeks Multidisciplinary Intensive Rehabilitation Treatment (MIRT) were enrolled. According to Mini Mental State Examination (MMSE), patients were divided into: normal cognition (MMSE 27-30), mild cognitive impairment (MMSE 21-26), moderate or severe cognitive impairment (MMSE ≤ 20). According to Frontal Assessment Battery (FAB), subjects were divided into patients with normal (FAB ≥ 13.8) and pathological (FAB < 13.8) score. The outcomes measures were: Unified Parkinson's Disease Rating Scale (UPDRS), Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Six Minutes Walking Test (6MWT), Parkinson's Disease Disability Scale (PDDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinsonian patients according to the UK Brain Bank criteria
排除标准
- •Major stroke, possible hydrocephalus or brain tumor observed on CT scan or brain MRI
- •Major depression, active psychosis or clinically significant psychiatric disorders
- •Visual or auditory disturbances that prevent the neuropsychological assessment
- •The increase in drug dosage during hospitalization
结局指标
主要结局
Unified Parkinson's Disease Rating Scale
时间窗: 4 weeks
次要结局
- Berg Balance Scale(4 weeks)
研究者
Ilaria Zivi
MD
Ospedale Generale Di Zona Moriggia-Pelascini