An interventional study of Personal KinetiGraph™ (PKG™) in Parkinson Disease, sponsored by Global Kinetics Corporation. Active, not recruiting at 12 sites in United States. Open to participants aged 46 Years to 83 Years. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Global Kinetics Corporation · Not applicable, Interventional, and Supportive care
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
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 231 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Global Kinetics Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Personal KinetiGraph™ (PKG™)
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.
Device: Personal KinetiGraph™ (PKG™)
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: * A wrist-worn data logger designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. * An application to configure the data logger and transfer the acquired data at the end of a recording. * A series of algorithms that analyze the uploaded data, producing a report that is delivered to the clinician. The report contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.
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).
Time frame: 90 day
Plan to share: No
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Global Kinetics Corporation