A Prospective Longitudinal Assessment of Parkinson's Disease Functional Impairment and Disability Via Mobile Health Technology
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Personal Kinetigraph
研究概览
简要总结
The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in Parkinson's disease patients.
详细描述
Mobile health technologies include the wearable sensor technologies that are body-worn and passively collect information and mobile devices like smartphones that can be frequently used by patients to actively or passively collect information. However, there has been limited comparison of different wearable technologies to validated clinical rating scales to allow us to come to a consensus about their utility in both clinical practice and research trials. Data from mobile health technologies in Parkinson's Disease (PD) have not been validated to use in the place of clinician rating scales. It is also not clear if the information obtained with the devices consistently correlates with change on the clinician scales and longitudinal motor decline. Technological challenges, such as the feasibility (safety, compliance) of use devices in patients with neurodegenerative disease, change in equipment and algorithms over time, collaboration with companies who may own patents, and other issues may also limit their use in healthcare and research. The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in PD patients. The hypothesis is that there will be an association between data from mobile health technologies and data obtained from validated questionnaires/scales, indicating that these technologies are a reliable means of monitoring motor symptomatology and functional impairment and disability over time. The primary aims of the study are to compare information on continuously-measured patient-reported PD-related functional impairment and disability changes from traditional validated questionnaires to continuously-measured health-related data from a battery of novel mobile health technologies, and to assess the feasibility (compliance, safety, satisfaction) of PD patients to use a battery of novel mobile health technologies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD as defined by the UK Brain Bank Criteria
- •Disease duration between 2-13 years
- •Aged 35-68 years
- •Hoehn & Yahr stage 3 or less when in the levodopa-"ON" state
排除标准
- •Atypical parkinsonism including 18F-dopa PET patterns consistent with this
- •MMSE score of < 24 or evidence for dementia using DSM-IV criteria
- •Unable to do normal copying of interlocking pentagons and semantic fluency score <20 over 90 secs
- •Ongoing major medical or psychiatric disorder including depression and psychosis
- •Other concomitant treatment with neuroleptics
- •Significant drug induced dyskinesias (>2 for any body part on the AIMS scale)
- •Previous neurosurgery Unable to be imaged using MRI
结局指标
主要结局
Personal Kinetigraph
时间窗: 3 months
Watch containing accelerometer and gyroscope for measurement of motor symptoms of PD
Kinesia 360
时间窗: 3 months
2 sensor straps to wrist and ankle containing accelerometer and gyroscope for measurement of motor symptoms of PD.
MDS-UPDRS
时间窗: 6 months
Part I assesses the non-motor aspects of experiences of daily living in the week prior to the visit. Part II assesses the motor aspects of experiences of daily living in the week prior to the visit. Part III assesses motor disabilities of a subject at the time of the visit and Part IV assesses motor complications in the week prior to the visit. A total of 46 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment.
次要结局
未报告次要终点