Back to resultsKinesia HomeView - Home Diary Comparison
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kinesia HomeView
Hand-written diary
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Parkinson's disease, dyskinesia, fluctuations, tremor, bradykinesia, levodopa
Eligibility 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
Sites / Locations
- Great Lakes NeuroTechnologies Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Hand-written diary first
Kinesia HomeView first
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Test-retest reliability
Test-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries.
Secondary Outcome Measures
Kinesia HomeView usability questionnaire
Questionnaires on the usability of Kinesia HomeView will be completed following the 4-week data collection period.
Full Information
NCT ID
NCT01920425
First Posted
August 7, 2013
Last Updated
January 8, 2016
Sponsor
Great Lakes NeuroTechnologies Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01920425
Brief Title
Kinesia HomeView - Home Diary Comparison
Official Title
Kinesia HomeView - Home Diary Comparison
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Lakes NeuroTechnologies Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, dyskinesia, fluctuations, tremor, bradykinesia, levodopa
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand-written diary first
Arm Type
Other
Arm Description
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.
Arm Title
Kinesia HomeView first
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Kinesia HomeView
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hand-written diary
Intervention Description
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 Measure Information:
Title
Test-retest reliability
Description
Test-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Kinesia HomeView usability questionnaire
Description
Questionnaires on the usability of Kinesia HomeView will be completed following the 4-week data collection period.
Time Frame
After 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dustin A Heldman, PhD
Organizational Affiliation
Great Lakes NeuroTechnologies Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Lakes NeuroTechnologies Inc
City
Valley View
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Kinesia HomeView - Home Diary Comparison
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