An Open Multi-centre Investigation to Evaluate the Performance of the Paragit Sleeve With build-in sEMG Sensors, Kinetic Sensors, and Smart-textile to Measure and Monitor Motor Symptoms and Treatment-induced Dyskinesia in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Dyskinesia
研究概览
简要总结
This investigation is undertaken to:
- Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and
- To assess the safety and tolerability of the device in patients with PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson disease: Clinically diagnosed
- •Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49)
- •Experiencing at least two of following symptoms and/or side effect on a daily basis:
- •Bradykinesia
- •Dyskinesia (treatment side effect)
- •Provision of informed consent, i.e., the subject must be able to:
- •Read and understand the Patient Information and Consent Form
- •Sign the Patient Information and Consent Form.
排除标准
- •Known allergy/hypersensitivity to any material in direct contact with the skin (stainless steel, silicone and polyester)
- •Other neurological diseases
结局指标
主要结局
Dyskinesia
时间窗: During the clinical assessment, and for the following 24h.
The device will assess rigidity, measured with superficial EMG \[Volts\], and inertial measurement unit \[m/s2\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Tremor
时间窗: During the clinical assessment, and for the following 24h.
Tremor will be assessed using the device, measured with superficial EMG \[Volts\], and inertial measurement unit \[m/s2\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Bradykinesia
时间窗: During the clinical assessment, and for the following 24h.
Bradykinesia will be assessed using the device, measured inertial measurement unit \[m/s2\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Rigidity
时间窗: During the clinical assessment, and for the following 24h.
The device will assess rigidity, measured with superficial EMG \[Volts\], and inertial measurement unit \[m/s2\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
次要结局
- Usability(During the clinical assessment , and for the following 24h.)
- Safety(During the clinical assessment , and for the following 24h.)