NCT03741920

Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status

Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Global Kinetics Corporation · Industry
• Sex: All
• Age: 46 Years – 83 Years
• Healthy volunteers: Not accepted

Summary

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: 1. Measure medication use and clinical management plan changes in a large, multicenter cohort among participants undergoing a clinical assessment with an MDS in which the MDS reviews the participant's PKG during the clinical assessment in half of the enrolled participants (PKG + Group) and in half of the enrolled participants the MDS completes the clinical assessment without the PKG (PKG- Group). 2. Determine the association between frequency of medication changes, the PKG information, and other clinical assessments among participants with and without a PKG report of their PD motor status available to the clinician at the time of evaluation.

Detailed description

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 * PKG+ Group (standard of care clinical evaluation plus use of PKG data) * PKG- Group (standard of care clinical evaluation without use of PKG data - the MDS is blinded to PKG data) * Randomization ratio will be 1:1 with assignments generated in advance of the start of the trial by the unblinded statistician who will provide a list containing group assignments that will be available in an Electronic Database (EDC) for site use. * The clinical investigator, study site staff, and subject will not be blinded to the randomization assignment during the randomization phase of the study * 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-17
• Primary completion: 2021-02-18
• Completion: 2025-10-01
• First posted: 2018-11-15
• Last updated: 2025-09-04

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study