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Completed

NCT Number: NCT01920425

Kinesia HomeView - Home Diary Comparison

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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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Hypokinesia Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies Tremor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Great Lakes NeuroTechnologies Inc

Valley View, Ohio, 44125, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesia HomeView

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

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Great Lakes NeuroTechnologies Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 12, 2013
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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