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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01648803
First Posted: July 24, 2012
Last Update Posted: November 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michelle Burack, University of Rochester
July 19, 2012
July 24, 2012
November 10, 2015
January 2012
June 2013   (Final data collection date for primary outcome measure)
1-3Hz gyroscope signal power [ Time Frame: 30 second windows spanning the observation period ]
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Complete list of historical versions of study NCT01648803 on ClinicalTrials.gov Archive Site
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Wearable Movement Sensors for Assessing Motor Impairments and Dyskinesias in Parkinson Disease
Wearable Movement Sensors for Assessing Motor Impairments and Dyskinesias in Parkinson Disease
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
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.
Parkinson Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2013
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01648803
RSRB39530
No
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Michelle Burack, University of Rochester
University of Rochester
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Principal Investigator: Michelle A Burack, MD PhD University of Rochester Medical Center Dept. of Neurology
University of Rochester
November 2015