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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44AG044293-04 | U.S. NIH Grant/Contract | View source | |
| 5R44AG033947-05 | U.S. NIH Grant/Contract | View source | |
| Pro000048239 | Other Identifier | IRB of the Greenville Health System |
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| Name | Class |
|---|---|
| University of South Carolina School of Medicine, Greenville | UNKNOWN |
| University of Rochester | OTHER |
| Johns Hopkins University | OTHER |
| Prisma Health-Upstate |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kinesia 360 Users | Experimental | Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinesia 360 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| % of assigned days with confirmed use | 5 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dustin Heldman, PhD | Great Lakes NeuroTechnologies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21218 | United States | ||
| University of Rochester |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| OTHER |
| National Institute on Aging (NIA) | NIH |
| The Cleveland Clinic | OTHER |
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|
| 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 |
| Rochester |
| New York |
| 14642 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Greenville Health System | Greenville | South Carolina | 29615 | United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |