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

Parkinson Disease Clinical Trial

— APDMclinic  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648803
• Other study ID #: RSRB39530
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

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