The CloudUPDRS Smartphone Software in Parkinson's Study - a Pilot Dual-site, Open Label Study Comparing the Validity of Smartphone Software for Monitoring the Symptoms and Signs of Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Validity of smartphone software for home monitoring in Parkinson's disease
研究概览
简要总结
This study compares the validity and usability of smartphone software for home monitoring of symptoms and signs in Parkinson's disease as compared to the current clinical gold standard - the Unified Parkinsons Disease Rating Scale.
详细描述
Parkinson's Disease (PD) is a neurodegenerative condition, which when treated can result in fluctuating motor activity - sometimes too much movement, sometimes too little.
A series of tests, run on a smartphone, will be used to evaluate the motor signs of Parkinson's and related to a clinical evaluation based on the Unified Parkinson's Disease Rating Scale. 60 participants will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Diagnosed with probable idiopathic Parkinson's Disease according to Brain Bank criteria (Gibb and Lees, 1988).
- •Over 18 years old.
- •Achieve >20/30 on the Montreal Cognitive Assessment (MOCA).
- •They must have been on the current Parkinson's Disease medication schedule for at least a week and have no plans to change this during the period of testing.
- •They must have the capacity to consent to take part in the study.
- •They must be able to understand English to the level of being able to operate the phone software, follow its instructions and be able to answer the study questions.
排除标准
- •Acute medical illness.
- •Any other co-morbidity that in the opinion of the Investigator may preclude their participation in the study.
- •Unable to consent to the study.
研究组 & 干预措施
Clinical Assessment
Motor assessment will be performed by a clinician using the Unified Parkinson's Disease Rating Scale.
干预措施: Clinical assessment (Other)
Smartphone assessment
CloudUPDRS smartphone software assessment will be performed.
干预措施: CloudUPDRS smartphone software assessment (Device)
结局指标
主要结局
Validity of smartphone software for home monitoring in Parkinson's disease
时间窗: 3 years
The primary objective is to measure the validity (bias and reliability) of the smartphone UPDRS (smartphone derived UPDRS). The primary objective outcome measure is the accuracy (and error) of the smartphone UPDRS predictions of the clinical UPDRS rating score. This will be ascertained by using multiple cross-validation runs in which the data are randomly split into 'calibration' and 'testing' cohorts. The model will be trained on the 'calibration' dataset, and the accuracy and error from the out-of-sample predictions will be summarised into a mean accuracy and error score.
次要结局
未报告次要终点