Kinesia HomeView

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-09-30

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.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Intervention Type DEVICE

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.

Hand-written diary

Intervention Type OTHER

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.

Group Type OTHER

Kinesia HomeView

Intervention Type DEVICE

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.

Hand-written diary

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No