Wearable Movement Sensors for Assessing Motor Impairments and Dyskinesias in Parkinson Disease (APDMclinic)

Tracking Information
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; (submitted: November 9, 2015)	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
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.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: November 9, 2015)	12
Original Estimated Enrollment; (submitted: July 23, 2012)	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: Participants who will be included in the study have probable or definite idiopathic PD (CAPSIT criteria (23)), Hoehn & Yahr stage 2-4;; One or more of the following PD-associated motor impairments experienced in the week prior to enrollment (based on history and/or examination): motor fluctuations (end of dose wearing off with hypokinesia and/or levodopa-induced choreiform dyskinesias), tremor, freezing of gait, or frequent falls (≥ 1 per week). Exclusion Criteria: Neurological disorders (other than PD) or orthopedic deficits that, in the investigator's judgement, contribute substantially to impaired movement (e.g. stroke with motor sequelae;; Essential tremor;; Severe osteoarthritis);; Cognitive impairment sufficiently severe to interfere with informed consent.
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Michelle A Burack, MD PhD University of Rochester Medical Center Dept. of Neurology
PRS Account	University of Rochester
Verification Date	November 2015