Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status
APPRISE
1 other identifier
interventional
231
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started May 2017
Longer than P75 for not_applicable parkinson-disease
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2017
CompletedFirst Submitted
Initial submission to the registry
November 12, 2018
CompletedFirst Posted
Study publicly available on registry
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedSeptember 4, 2025
August 1, 2025
3.8 years
November 12, 2018
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Personal KinetiGraph™ (PKG™) +
EXPERIMENTALFor 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.
Personal KinetiGraph™ (PKG™) -
ACTIVE COMPARATORFor 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Able and willing to sign a written informed consent for study participation
- Age 46 - 83 years at the time of consent (per PKG Indications for Use, see Technical Instructions Manual)
- Responsive to dopaminergic medications
You may not qualify if:
- Contraindication to increasing dopaminergic therapy, such as current or treated freezing gait, symptomatic postural hypotension, or bothersome hallucinations
- Wheelchair bound or bedridden
- Utilizing or planning advanced PD therapies (DBS, infusion, etc.)
- History of delirium in the past year
- In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints (e.g., subject able to complete PKG wear instructions per Patient Instruction Manual, or ability to comply with required study procedures and visit schedule)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Sutter Health
Sacramento, California, 95816, United States
University of California
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
Related Publications (2)
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.
PMID: 27273651BACKGROUNDPahwa 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.
PMID: 30032695BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajesh Pahwa, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2018
First Posted
November 15, 2018
Study Start
May 17, 2017
Primary Completion
February 18, 2021
Study Completion
October 1, 2025
Last Updated
September 4, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share