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The primary objective is to understand the utility of Personal KinetiGraph movement recording system data in the clinical management of Parkinson's disease (PD) in routine clinical care at a movement disorders clinic. Specifically:
This is a prospective, multicenter, randomized controlled trial. The study consists of 3 phases as follows:
Randomization phase: subjects undergo screening, baseline, interim and 90-day follow-up visits
Open-label phase: at the end of the 90-day randomization phase visit for PKG- Group subjects, the MDS will report on the PKG and review it with the subject, the subject will complete follow-ups with the MDS using the PKG information during the clinical assessment following the same process as the PKG+ Group during the randomization phase
Extended open-label follow-up phase: annual follow-ups for all subjects at 1, 2, and 3 years during which the MDS will use the PKG information during clinical assessments for all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personal KinetiGraph™ (PKG™) + | Experimental | For subjects in the PKG+ Group, the study MDS will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment. PKG results will be recorded in the PKG Reporting case report form (CRF). The study MDS will complete the MDS-Clinician Assessment CRF to denote patient-reported symptoms, treatable findings, and clinical management planning based on his/her routine clinical assessment procedures along with the PKG information. |
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| Personal KinetiGraph™ (PKG™) - | Active Comparator | For subjects in the PKG- Group (control group), the study Movement Disorder Specialist (MDS) will complete the MDS - Clinician Assessment CRF to denote patient-reported symptoms, treatable findings, and clinical management planning based on his/her routine clinical assessment procedures. The study Movement Disorder Specialist will be blinded to the PKG information until the second part of the 90-day follow-up visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personal KinetiGraph™ (PKG™) | Device | The Personal KinetiGraph™ (PKG™) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by Global Kinetics (GKC). The Personal KinetiGraph™ (PKG™) Movement Recording System consists of the following:
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of treatment changes with or without the use of PKG data | The proportion of patients in which the clinical management plan was changed in patients followed in the PKG- Group (clinician standard of care) compared to the PKG+ Group (clinician standard of care with the use of PKG data). | 90 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Pahwa, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutter Health | Sacramento | California | 95816 | United States | ||
| University of California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27273651 | Background | Maetzler W, Klucken J, Horne M. A clinical view on the development of technology-based tools in managing Parkinson's disease. Mov Disord. 2016 Sep;31(9):1263-71. doi: 10.1002/mds.26673. Epub 2016 Jun 7. | |
| 30032695 | Background | Pahwa R, Isaacson SH, Torres-Russotto D, Nahab FB, Lynch PM, Kotschet KE. Role of the Personal KinetiGraph in the routine clinical assessment of Parkinson's disease: recommendations from an expert panel. Expert Rev Neurother. 2018 Aug;18(8):669-680. doi: 10.1080/14737175.2018.1503948. Epub 2018 Jul 26. |
| Label | URL |
|---|---|
| Related Info | View source |
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|
| San Diego |
| California |
| 92037 |
| United States |
| Parkinson's Disease and Movement Disorders Center | Boca Raton | Florida | 33486 | United States |
| University of Florida | Gainesville | Florida | 32604 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66103 | United States |
| Johns Hopkins Medical Institute | Baltimore | Maryland | 21287 | United States |
| Michigan State University | East Lansing | Michigan | 49824 | United States |
| Northwell Health | Great Neck | New York | 11021 | United States |
| New York University | New York | New York | 10017 | United States |
| University of Texas | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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