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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Michelle Burack, University of Rochester
ClinicalTrials.gov Identifier:
NCT01648803
First received: July 19, 2012
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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.


Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Wearable Movement Sensors for Assessing Motor Impairments and Dyskinesias in Parkinson Disease

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Estimated Enrollment: 20
Study Start Date: January 2012
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648803

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14618
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Michelle A Burack, MD PhD University of Rochester Medical Center Dept. of Neurology
  More Information

No publications provided

Responsible Party: Michelle Burack, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT01648803     History of Changes
Other Study ID Numbers: RSRB39530
Study First Received: July 19, 2012
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dyskinesias
Parkinson Disease
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 14, 2014