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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Michelle Burack, University of Rochester

ClinicalTrials.gov Identifier:

NCT01648803

First received: July 19, 2012

Last updated: November 9, 2015

Last verified: November 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2012

Last Updated Date

November 9, 2015

Start Date ^ICMJE

January 2012

Primary Completion Date

June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

1-3Hz gyroscope signal power [ Time Frame: 30 second windows spanning the observation period ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01648803 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Parkinson Disease

Intervention ^ICMJE

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2013

Primary Completion Date

June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01648803

Other Study ID Numbers ^ICMJE

RSRB39530

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Michelle Burack, University of Rochester

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michelle A Burack, MD PhD

University of Rochester Medical Center Dept. of Neurology

PRS Account

University of Rochester

Verification Date

November 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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