Kinesia HomeView - Home Diary Comparison

January 8, 2016 updated by: Great Lakes NeuroTechnologies Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Valley View, Ohio, United States, 44125
        • Great Lakes NeuroTechnologies Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Great Lakes NeuroTechnologies Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 12, 2013

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1311DH (Other Identifier: Great Lakes NeuroTechnologies)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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