Digital BIOmarkers for the Assessment of Motor Status in Parkinson's Disease Patients with CLInical and ThErapeutic Application
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Biomarkers in supervised and unsupervised conditions
研究概览
简要总结
The goal of this observational study is to define digital biomarkers of motor symptoms in Parkinson's disease patients using wearable devices. The main questions it aims to answer is:
- Is there a biomarkers that allows the identification of PD from healthy controls?
- Is there a biomarkers that can identify the severity of the disease?
- Is there a biomarkers with clinical and therapeutic application that can be used in clinical and free living conditions to monitor the evolution of the disease?
Participants have to perform a set of guided exercises related to the MDS-UPDRS guide and daily living tasks, in supervised and unsupervised conditions.
详细描述
The participants must perform a set of exercises related to the MDS-UPDRS III scale and some free-living activities. These tasks must be performed wearing a smartwatch.
The activities will be done in supervised clinical and unsupervised free-living environments. The participants must perfom a baseline and a final assesment in supervised conditions and a week of free living monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Parkinson's disease based on the UK Brain Bank criteria.
- •Affiliated with Asociación Parkinson Madrid.
- •Minimal or mild disease severity, defined by a Hoehn and Yahr scale score of ≤ 2.
- •Be capable of performing the prescribed exercises independently.
- •Maintain daily functioning without dependence on caregivers.
排除标准
- •Hoehn and Yahr scale score of > 2.
- •Have undergone deep brain stimulation, used dopamine infusion pumps, or have conditions mimicking PD symptoms (e.g., progressive supranuclear palsy, Lewy body dementia, multiple system atrophy, or other parkinsonian syndromes)
- •Experience motor symptom fluctuations throughout the day.
结局指标
主要结局
Biomarkers in supervised and unsupervised conditions
时间窗: 1 year
A comparation between the biomarkers defined in supervised settings versus those defined in free-living environments.
Biomarkers for the identification of PD patients
时间窗: 1 year
A set of biomarkers will be defined for the identification of PD patients by comparing their data with that of healthy subjects.
biomarkers for the prediction MDS-UPDRS scores in PD patients
时间窗: 1 year
A collection of biomarkers will be calculated to predict MDS-UPDRS scores in PD patients
次要结局
未报告次要终点
研究者
Ignacio Pavón García
Associate Professor
Universidad Politecnica de Madrid