Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.
研究概览
简要总结
The purpose of this study is to investigate the clinical correlates of the effects of the COVID-19 pandemic on patients with Functional movement disorder (FMD) and Parkinson s Disease (PD).
Primary objectives:
To evaluate the change in neurological symptoms domain of the survey between pre and post-COVID 19 in FMD and PD patients.
Secondary objectives:
- To evaluate the change in total score of the survey between pre and post COVID 19 in FMD and PD patients
- To evaluate the change in other symptom domains of the survey between pre and post COVID 19 in FMD and PD patients. Domains include: Mood/Energy, sleep, symptoms of abnormal movements related or unrelated to primary disease, physical health and exercise related change
Exploratory objectives:
- To evaluate whether there is a modifying effect of disease group in the changes in total score or symptom domains
- To evaluate whether there is a relationship between disease severity and changes in total score or symptom domains
- To evaluate whether there is a correlation between changes across symptom domains
- To evaluate whether there is a correlation in raw score across symptom domains within each period
Research Methods:
Data will be solely collected through the use of online instruments via CiSTAR as a designed questionnaire.
Questionnaire items
A questionnaire aimed at determining the effects of the COVID 19 pandemic and subsequent isolation on functional state of patients with FMD and PD.
The questionnaire items include:
Items investigating Mood/Energy before and after COVID 19 out break
Items investigating Sleep habits before and after COVID 19 out break
Items investigating Neurological symptoms before and after COVID 19 out break
Items investigating daily functioning before and after COVID 19 out break
Items investigating Exercise habits before and after COVID 19 out break
No questionnaire items will be actionable , which are items that would identify an imminent risk for participant safety requiring urgent and immediate medical or psychiatric
详细描述
The purpose of this study is to investigate the clinical correlates of the effects of the COVID-19 pandemic on patients with Functional movement disorder (FMD) and Parkinson s Disease (PD).
Primary objectives:
To evaluate the change in neurological symptoms domain of the survey between pre and post-COVID 19 in FMD and PD patients.
Secondary objectives:
- To evaluate the change in total score of the survey between pre and post COVID 19 in FMD and PD patients
- To evaluate the change in other symptom domains of the survey between pre and post COVID 19 in FMD and PD patients. Domains include: Mood/Energy, sleep, symptoms of abnormal movements related or unrelated to primary disease, physical health and exercise related change
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.
时间窗: December 2021
Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.
次要结局
未报告次要终点