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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01648803
Other study ID # RSRB39530
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2012
Est. completion date June 2013

Study information

Verified date October 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1-3Hz gyroscope signal power 30 second windows spanning the observation period
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