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临床试验/NCT02696603
NCT02696603进行中(未招募)不适用

Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)

Sage Bionetworks2 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2015年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20,000
试验地点
2
主要终点
Results of participant self-assessment surveys

研究概览

简要总结

The purpose of this study is to understand variation in the symptoms of Parkinson disease. This study uses an iPhone app to record these symptoms through questionnaires and sensors.

详细描述

Living with Parkinson disease means coping with symptoms that change every day. Yet these changes are not tracked frequently enough. Most people with Parkinson disease see a clinician only once or twice a year. This study measures changes in Parkinson disease symptoms in real time using an app. The app remotely monitors Parkinson disease symptoms using surveys and the sensors on mobile devices. This study may contribute to increasing our understanding of the variability in Parkinson disease symptoms. This knowledge could be used to improve quality of life for people living with Parkinson disease.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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

入选标准

  • Age 18 years
  • Have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
  • Be able to read and understand an official language of the country of participation
  • Be able to provide informed consent (i.e., pass assessment quiz)
  • Be willing to follow study procedures

排除标准

  • Age 17 years or younger
  • Not a resident of the of a country where the app is approved for use
  • Not have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
  • Not be able to read and understand an official language of the country of participation
  • Not be able to give informed consent
  • Not be willing to follow study procedures

研究组 & 干预措施

Participants with Parkinson disease

Experimental

People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Participant self-assessment surveys (Behavioral)

Participants with Parkinson disease

Experimental

People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Phonation (Behavioral)

Participants with Parkinson disease

Experimental

People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Gait and balance (Behavioral)

Participants with Parkinson disease

Experimental

People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Memory (Behavioral)

Participants with Parkinson disease

Experimental

People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Dexterity (Behavioral)

Participants with Parkinson disease

Experimental

People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Participant open-response writing (Behavioral)

Participants with Parkinson disease

Experimental

People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Parkinson mPower mobile application (Other)

Participants without Parkinson disease

Experimental

People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Memory (Behavioral)

Participants without Parkinson disease

Experimental

People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Participant self-assessment surveys (Behavioral)

Participants without Parkinson disease

Experimental

People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Phonation (Behavioral)

Participants without Parkinson disease

Experimental

People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Gait and balance (Behavioral)

Participants without Parkinson disease

Experimental

People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Dexterity (Behavioral)

Participants without Parkinson disease

Experimental

People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Participant open-response writing (Behavioral)

Participants without Parkinson disease

Experimental

People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

干预措施: Parkinson mPower mobile application (Other)

结局指标

主要结局

Results of participant self-assessment surveys

时间窗: Through study completion, an average of 1 year

Results of participant self-assessment surveys will be analyzed using descriptive statistics. These results may also be compared with other intervention results.

App usage data for assessment of participant engagement

时间窗: Through study completion, an average of 1 year

App usage data is used to gauge participant engagement throughout the study period. These results may also be compared with other intervention results.

Sequence length from memory intervention

时间窗: Through study completion, an average of 1 year

The investigators assess the sequence length completed in the Memory intervention. These results may also be compared with other intervention results.

iPhone screen touch sensor data on rhythm, speed, and location of taps from dexterity intervention

时间窗: Through study completion, an average of 1 year

The investigators assess participant dexterity through a combination of steadiness, speed, and tap precision. These results may also be compared with other intervention results.

Qualitative analysis of participant open-response and app usage data to assess participant acceptance of app-based research

时间窗: Through study completion, an average of 1 year

App usage data and qualitative participant feedback are used to assess participant understanding and acceptance of app-based research. These results may also be compared with other intervention results.

Digital audio signals of sustained phonation from phonation intervention

时间窗: Through study completion, an average of 1 year

The investigators extract features from the digital audio signals of sustained phonations. The investigators apply feature selection and classifier algorithms and analyze these phonations using methods similar to those employed in the Parkinson Voice Initiative (http://www.parkinsonsvoice.org/science.php). These results may also be compared with other intervention results.

Gyroscope and accelerometer sensor measurements from gait and balance intervention

时间窗: Through study completion, an average of 1 year

The investigators examine step-dependent and sequence-dependent features from gyroscope and accelerometer sensors. The investigators apply feature selection and classifier algorithms to analyze these data. These results may also be compared with other intervention results.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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