Parkinson DiseaseAPPRISENCT03741920
Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status
A study testing Personal KinetiGraph™ (PKG™) in people with Parkinson Disease, run by Global Kinetics Corporation at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 46 to 83 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Personal KinetiGraph™ (PKG™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 12 sitesUnited States
- Study dates
- 17 May 2017to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins Medical Institute
Baltimore, Maryland, 21287
Parkinson's Disease and Movement Disorders Center
Boca Raton, Florida, 33486
Michigan State University
East Lansing, Michigan, 49824
University of Florida
Gainesville, Florida, 32604
Northwell Health
Great Neck, New York, 11021
University of Texas
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66103
University of Miami
Miami, Florida, 33136
New York University
New York, New York, 10017
Sutter Health
Sacramento, California, 95816
University of California
San Diego, California, 92037
University of South Florida
Tampa, Florida, 33613
About this study
Official title: Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE)
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:
- 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).
- 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.
Read the 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
- Being tested
- Personal KinetiGraph™ (PKG™)
- Keywords
- Personal KinetiGraph (PKG) Movement Recording System
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Personal KinetiGraph™ (PKG™) |
| 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. Receives: Device: Personal KinetiGraph™ (PKG™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start17 May 2017
- Primary completion18 Feb 2021
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Kinetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajesh Pahwa, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741920
- Sponsor's protocol ID
- Study 002
- Acronym
- APPRISE
- Status last verified
- Aug 2025
- First submitted
- 12 Nov 2018
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27273651Pahwa 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.
PubMed 30032695
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE)
- ClinicalTrials.gov ID
- NCT03741920
- Acronym / sponsor ID
- APPRISE / Study 002
- Conditions
- Parkinson Disease
- Keywords
- Personal KinetiGraph (PKG) Movement Recording System
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Global Kinetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personal KinetiGraph™ (PKG™) + | Experimental | Device: Personal KinetiGraph™ (PKG™)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. |
| Personal KinetiGraph™ (PKG™) - | Active comparator | 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. |
Who may qualify
- Ages
- 46 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Personal KinetiGraph™ (PKG™) +, Personal KinetiGraph™ (PKG™) - |
Primary outcome
Evaluation of treatment changes with or without the use of PKG data
Time frame: 90 day
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 27273651Maetzler 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.
- Background: PubMed 30032695Pahwa 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajesh Pahwa, MD principal investigator
University of Kansas Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal KinetiGraph™ (PKG™) in people with Parkinson Disease, run by Global Kinetics Corporation at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of treatment changes with or without the use of PKG data (time frame: 90 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03741920, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.