跳至主要内容
临床试验/NCT05748028
NCT05748028招募中不适用

Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms: Identification of Predictive Patterns of Rehabilitation Outcome and Evaluation of the Impact on Quality of Life

Istituti Clinici Scientifici Maugeri SpA18 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2019年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
280
试验地点
18
主要终点
Prevalence and Characterization of Pain

研究概览

简要总结

The goal of this observational study is to learn about the impact of the different types of pain and of the domains involved in the autonomic disorders of inpatients and outpatients diagnosed with Parkinson disease (PD) and multiple system atrophy (MSA) admitted to Istituti Clinici Scientifici Maugeri Centers.

The main aims are:

Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms (MSA) Evaluate the effect of rehabilitation on pain and autonomic symptoms Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms (MSA) Assess the impact of pain and autonomic symptoms on quality of life. Participants will perform neurological examination, rehabilitation program and clinical scales.

Researchers will compare the two groups of patients (PD and MSA) and the effect of the rehabilitation on pain, autonomic symptoms and quality of life.

详细描述

2% of the population over 65 is affected by Parkinson's disease (PD) or parkinsonism. This represents a significant burden on the health service in countries where the elderly represent 1/5 of the general population. In recent years there has been increased attention on the presence of non-motor disorders in PD patients. Among these, pain and autonomic symptoms are more frequently present and contribute to the worsening of disability and quality of life of the affected patient.

How much the presence of pain and autonomic symptoms can affect the rehabilitation outcome and how much the rehabilitation treatment itself can improve the painful or autonomic symptomatology is not known, but rehabilitation has an important role in the management of diseases where there are no real treatments capable of cure or slow down the neurodegenerative process.

In the Maugeri Clinical Scientific Institutes, patients with Parkinson's disease or parkinsonism are hospitalized or followed as outpatients and a personalized rehabilitation setting is ideal for being able to evaluate the patient in a sufficiently wide time frame to be able to appreciate significant changes in clinical parameters.

The greater knowledge of the impact of the different types of pain and of the domains involved in the autonomic dysfunction will help the clinician to better manage the patient's disability and will contribute to the definition of specific rehabilitation strategies aimed to improve the patient's quality of life.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Parkinson's Disease or Multiple System Atrophy according to current international criteria (Gilman S et al, 2008; Postuma RB et al. 2015).
  • Mini-Mental State Examination score at least 10

排除标准

  • vascular or pharmacological parkinsonism
  • diabetes mellitus
  • hepatic or renal dysmetabolism,
  • hypothyroidism or hyperthyroidism
  • assumption of potentially neurotoxic drugs

研究组 & 干预措施

Parkinson Disease

Patients affected by Parkinson's disease admitted for rehabilitation in Maugeri Clinical Scientific Institutes

干预措施: Rehabilitation (Other)

Parkinson Disease

Patients affected by Parkinson's disease admitted for rehabilitation in Maugeri Clinical Scientific Institutes

干预措施: Administration of Clinical scales (Other)

Multiple System Atrophy

Patients affected by Multiple System Atrophy admitted for rehabilitation in Maugeri Clinical Scientific Institutes

干预措施: Rehabilitation (Other)

Multiple System Atrophy

Patients affected by Multiple System Atrophy admitted for rehabilitation in Maugeri Clinical Scientific Institutes

干预措施: Administration of Clinical scales (Other)

结局指标

主要结局

Prevalence and Characterization of Pain

时间窗: At the end of the rehabilitation program, an average of 30 days

Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms through KING'S PAIN score

Prevalence and Characterization of Pain

时间窗: At the recruitment

Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms through KING'S PAIN score

次要结局

  • Autonomic symptoms(At the end of the rehabilitation program, an average of 30 days)
  • Autonomic symptoms(At the recruitment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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