ClinicalTrials.gov
ClinicalTrials.gov Menu

Kinesia HomeView - Home Diary Comparison

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.
ClinicalTrials.gov Identifier: NCT01920425
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.

Brief Summary:
The objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView to electronic and hand-written diaries for tracking medication state in the home. Demonstrating comparable or superior results will further support use of the Kinesia HomeView system as an outcome measure in clinical drug trials.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Kinesia HomeView Other: Hand-written diary Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Kinesia HomeView - Home Diary Comparison
Study Start Date : July 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Hand-written diary first
Participants in this group will use the hand-written diary for the first two week and switch to Kinesia HomeView and the electronic diary for the second two weeks.
Device: Kinesia HomeView
Motion sensor based telemedicine system for assessment of movement disorder motor symptoms in the home. Includes automated motor assessment using motion sensor and electronic dyskinesia diary.

Other: Hand-written diary
Hand-written paper diary indicating state (Off, On without dyskinesias, on with non-troublesome dyskinesias, on with troublesome dyskinesias) at 30 minute intervals.

Kinesia HomeView first
Participants in this group will use Kinesia HomeView and the electronic diary for the first two week and switch to the hand-written diary for the second two weeks.
Device: Kinesia HomeView
Motion sensor based telemedicine system for assessment of movement disorder motor symptoms in the home. Includes automated motor assessment using motion sensor and electronic dyskinesia diary.

Other: Hand-written diary
Hand-written paper diary indicating state (Off, On without dyskinesias, on with non-troublesome dyskinesias, on with troublesome dyskinesias) at 30 minute intervals.




Primary Outcome Measures :
  1. Test-retest reliability [ Time Frame: 4 weeks ]
    Test-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries.


Secondary Outcome Measures :
  1. Kinesia HomeView usability questionnaire [ Time Frame: After 4 weeks ]
    Questionnaires on the usability of Kinesia HomeView will be completed following the 4-week data collection period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's disease
  • On a stable antiparkinsonian medication regimen that includes levodopa for at least 4 weeks
  • Experiencing dyskinesia more than 25% of the waking day (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 32)
  • With dyskinesias at least moderately disabling (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 33)
  • Capable of accurately completing diaries
  • Capable of accurately using Kinesia HomeView

Exclusion Criteria:

  • Significant medical or psychiatric illness
  • Subjects not capable of following the required clinical instructions
  • Serious medical conditions that would compromise safety

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920425


Locations
United States, Ohio
Great Lakes NeuroTechnologies Inc
Valley View, Ohio, United States, 44125
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
Investigators
Principal Investigator: Dustin A Heldman, PhD Great Lakes NeuroTechnologies Inc.

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT01920425     History of Changes
Other Study ID Numbers: 1311DH
1311DH ( Other Identifier: Great Lakes NeuroTechnologies )
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Great Lakes NeuroTechnologies Inc.:
Parkinson's disease
dyskinesia
fluctuations
tremor
bradykinesia
levodopa

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases