Kinesia HomeView - Home Diary Comparison

Study Overview
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Brief Summary
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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.

Official Title
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Kinesia HomeView - Home Diary Comparison

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Kinesia HomeView
* Other: Hand-written diary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hand-written diary first<br>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<br>* 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.<br>Other: Hand-written diary<br>* Hand-written paper diary indicating state (Off, On without dyskinesias, on with non-troublesome dyskinesias, on with troublesome dyskinesias) at 30 minute intervals.<br>|
| Other: Kinesia HomeView first<br>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<br>* 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.<br>Other: Hand-written diary<br>* Hand-written paper diary indicating state (Off, On without dyskinesias, on with non-troublesome dyskinesias, on with troublesome dyskinesias) at 30 minute intervals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest reliability | Test-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinesia HomeView usability questionnaire | Questionnaires on the usability of Kinesia HomeView will be completed following the 4-week data collection period. | After 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, dyskinesia, fluctuations, tremor, bradykinesia, levodopa