Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Tremors measurement by ActiMyo®
研究概览
简要总结
Pre-QuantiPark is a pilot study to evaluate the reliability and responsiveness of ActiMyo measured activity in PD patients. The purpose of the study is to provide validation of the ActiMyo, an innovative home-recording device enabling use in clinical trials and as an innovative tool for PD patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Parkinson Disease Patients Group #1
PD patients with programmed levodopa challenge
干预措施: Levodopa acute challenge (Drug)
Parkinson Disease Patients Group #1
PD patients with programmed levodopa challenge
干预措施: Controlled environment tests (series of tasks of everyday life) (Other)
Parkinson Disease Patients Group #1
PD patients with programmed levodopa challenge
干预措施: ActiMyo recording (Device)
Parkinson Disease Patients Group #1
PD patients with programmed levodopa challenge
干预措施: Diary completion (Other)
Parkinson Disease Patients Group #2
PD patients without programmed levodopa challenge
干预措施: Controlled environment tests (series of tasks of everyday life) (Other)
Parkinson Disease Patients Group #2
PD patients without programmed levodopa challenge
干预措施: ActiMyo recording (Device)
Parkinson Disease Patients Group #2
PD patients without programmed levodopa challenge
干预措施: Diary completion (Other)
Healthy volunteers
Healthy volunteers
干预措施: Controlled environment tests (series of tasks of everyday life) (Other)
Healthy volunteers
Healthy volunteers
干预措施: ActiMyo recording (Device)
Healthy volunteers
Healthy volunteers
干预措施: Diary completion (Other)
结局指标
主要结局
Tremors measurement by ActiMyo®
时间窗: Baseline
PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Small steps will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation.
Small steps measurement by ActiMyo®
时间窗: Baseline
PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Small steps will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation.
Dyskinesia measurement by ActiMyo®
时间窗: Baseline
PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Dyskinesia will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation.
次要结局
- Continuous home activity measurement by ActiMyo®(2 weeks)
- Everyday life tasks measurement by ActiMyo®(Baseline)
- Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo®(2 weeks)