Kinesia HomeView - Home Diary Comparison

N/ACompletedNCT01920425

Great Lakes NeuroTechnologies Inc.2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

Kinesia HomeViewDEVICE

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 diaryOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Great Lakes NeuroTechnologies Inc

Valley View, Ohio, United States

Outcomes

Primary Outcomes

Test-retest reliability

Test-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries.

Time frame: 4 weeks

Secondary Outcomes

Kinesia HomeView usability questionnaire

Questionnaires on the usability of Kinesia HomeView will be completed following the 4-week data collection period.

Time frame: After 4 weeks

Data from ClinicalTrials.gov

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