Wearable Movement Sensors for Assessing Motor Impairments and Dyskinesias in Parkinson Disease (APDMclinic)
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ClinicalTrials.gov Identifier: NCT01648803 |
Recruitment Status
:
Completed
First Posted
: July 24, 2012
Last Update Posted
: November 10, 2015
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Sponsor:
University of Rochester
Information provided by (Responsible Party):
Michelle Burack, University of Rochester
Tracking Information | ||||
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First Submitted Date | July 19, 2012 | |||
First Posted Date | July 24, 2012 | |||
Last Update Posted Date | November 10, 2015 | |||
Study Start Date | January 2012 | |||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
1-3Hz gyroscope signal power [ Time Frame: 30 second windows spanning the observation period ] | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT01648803 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Wearable Movement Sensors for Assessing Motor Impairments and Dyskinesias in Parkinson Disease | |||
Official Title | Wearable Movement Sensors for Assessing Motor Impairments and Dyskinesias in Parkinson Disease | |||
Brief Summary | The purpose of this study is to measure motor fluctuations and dyskinesias in patients with Parkinson's disease using movement sensors (accelerometers and gyroscopes) to determine if this is a feasible measure to use in addition to self report, and eventually the goal will be to replace self report with a more reliable measure such as movement sensors. | |||
Detailed Description | Patients with Parkinson disease and motor fluctuations will wear movement sensors during their regular clinic visit with the principal investigator. The visit will be videotaped and medication status (ON without dyskinesia, ON with dyskinesia, or OFF) will be independently rated from review of the video. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | The initial study population for this pilot study will consist of approximately 20 people. The study will be comprised of approximately equal numbers of men and women. The gender and ethnic origins of the patients seen in the University of Rochester Movement Disorders Center (from which subjects will be recruited) are approximately 60% male and 40% female; 91% Caucasian, 1% African American, 1% Hispanic, and 0.5% Asian (6% Unknown). There are no restrictions on gender or race, however non-english speaking patients will be excluded as the consent form will initially only be available in English. Parkinson disease is exceedingly rare in children and only adults will be enrolled for this study. | |||
Condition | Parkinson Disease | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
12 | |||
Original Estimated Enrollment |
20 | |||
Actual Study Completion Date | June 2013 | |||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01648803 | |||
Other Study ID Numbers | RSRB39530 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Michelle Burack, University of Rochester | |||
Study Sponsor | University of Rochester | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | University of Rochester | |||
Verification Date | November 2015 |