Kinesia 360 Parkinson's Monitoring Study

Study Overview
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Brief Summary
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Kinesia 360 is an ambulatory symptom monitoring device for Parkinson's Disease (PD). The aim of this study is to investigate the impact, validation, and usability of the Kinesia 360 system.

Detailed Description
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This is a five-month study of 45 subjects (approximately 15 subjects per site), consisting of adult volunteers that have been clinically diagnosed with Parkinson's disease. Subjects will have a confirmed history of motor fluctuation with a variety of Parkinson's disease symptom severities. All subjects will user the Kinesia 360 system and complete motor diaries several times per month during the study period. Symptom reports will be provided to the treating clinical team. Motor function, quality of life, engagement, and satisfaction with care will be tracked throughout the study.

Official Title
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Kinesia 360 Multi-Center Parkinson's Monitoring Study

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Kinesia 360


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Parkinson's Disease, History of motor fluctuations (2 hrs/day of Off time and/or 1 hr/day of troublesome dyskinesia) Fluent in English Exclusion Criteria: Inability to carry out study activities Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety Subjects who have dementia, exhibited by Montreal Cognitive Assessment (MoCa) score of 22 or less. Subjects who have had Deep Brain Stimulation (DBS) surgery less than 6 months prior to study enrollment, or who are deemed by the study investigator to be highly likely to undergo DBS surgery during the 6 month study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesia 360 Users<br>Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors. | Device: Kinesia 360<br>* Kinesia 360 includes a mobile app and wireless motion sensors worn on the patient's wrist and ankle to quantify tremor, dyskinesias, and mobility throughout the day as he or she goes about normal activities. The app includes electronic diaries enable patients to rate their symptoms and log when medications are taken. Data is transferred to a cloud server where motor symptom reports are generated for clinician review.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of assigned days with confirmed use |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diary measured Off time |  | 5 months | 
| Diary measured On time with dyskinesia |  | 5 months | 
| Off time as measured by Kinesia 360 |  | 5 months | 
| On time with dyskinesia as measured by Kinesia 360 |  | 5 months | 
| PDQ-39 responses |  | 5 months | 
| Patient Assessment for Chronic Conditions (PACIC) responses |  | 5 months | 
| Patient Activation Measure (PAM)-13 responses |  | 5 months | 
| Number of clinic visits |  | 5 months | 
| Number of patient/investigator communications |  | 5 months | 
| Unified Parkinson's disease rating scale (UPDRS) |  | 5 months | 
| Duration of time with patient |  | 5 months | 
| Number and type of medication changes |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Dyskinesia, Tremor, Symptom Management, Technology, Wearable Sensors, Continuous Monitoring, Mobility