An interventional study of KHV reporting and Standard care in Parkinson's Disease, sponsored by Great Lakes NeuroTechnologies Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2016-04-28.
Sponsored by Great Lakes NeuroTechnologies Inc. · Not applicable, Interventional, and Supportive care
The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms.
Currently, there is limited access to movement disorder specialist centers for a significant portion of the PD population. Treatment effectiveness is judged during office visits by improvement of patient motor symptoms and quality of life. Clinicians evaluate patients by having them perform specific motor tasks and rating the severity on a 0-4 scale. A major limitation is that a single evaluation in a clinical setting may not accurately reflect motor symptom fluctuations experienced over the course of a day, week, or month. Clinicians currently lack effective, affordable medical devices that can be easily delivered to a patient's home for monitoring symptoms on a more continuous basis as motor symptoms typically change throughout the day. Kinesia HomeView provides a repeatable, automated system clinicians can use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home. The investigators hypothesize use of the Kinesia HomeView system will improve outcomes and decrease costs especially for patient populations in areas not in close proximity to movement disorder specialists.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 21 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Great Lakes NeuroTechnologies Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinicians will view the motor symptom severity reports and videoconference to titrate medications.
Device: KHV reporting · Procedure: Standard care
Subjects in this group will still use KHV at home to minimize any placebo effects that could be attributed to using the system; however, clinicians will view the motor symptom severity reports and videoconference to titrate medications solely for the experimental subjects.
Procedure: Standard care
Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications.
Also known as: Kinesia HomeView
Subjects will receive the same disease management as if they were not participating in this study.
Percent of subjects completing remote assessments
Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments.
Time frame: 7 Months
Percent of remote assessments completed
Percent of remote home-based Kinesia-HomeView automated motor assessments successfully completed .
Time frame: 7 Months
KHV Motor Scores
Tremor, bradykinesia, and dyskinesia scores given by the KHV system.
Time frame: 7 Months
KHV measured fluctuations
Changes in KHV motor scores throughout each day.
Time frame: 7 Months
PDQ-39 responses
PDQ-39 quality of life survey responses.
Time frame: 7 Months
PACIC responses
The Patient Assessment of Care for Chronic Conditions (PACIC) is a questionnaire that measures specific actions or qualities of care
Time frame: 7 Months
PAM-13 responses
The Patient Activation Measure (PAM) assessment gauges the knowledge, skills and confidence essential to managing one's own health and healthcare.
Time frame: 7 Months
Number of clinic visits
Time frame: 7 Months
Number of patient/clinician communications
Time frame: 7 Months
Number and type of medication changes
Time frame: 7 Months
Number of videoconferences completed
Time frame: 7 Months
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 7 Months
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Great Lakes NeuroTechnologies Inc.