Clinical trial NCT05251701: Personal KinetiGraph® Clinical Validation Study
Official title: Personal KinetiGraph® Clinical Validation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Movement Disorders
Parkinson Disease
Lead sponsor: Global Kinetics Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be identified from routine clinical care

Brief summary: The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®).

Detailed description: This is a prospective, observational research study of the Personal KinetiGraph (PKG) System. The PKG System is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. This study aims to clinically validate new PKG assessments such as walking, Device Assisted Therapy readiness, Percent Time Bradykinesia, Percent Time Dyskinesia, fall prediction, disease progression and non-motor. The clinical validation will require enrollment of both subjects with a diagnosis of movement disorder, such as Parkinson's disease, and healthy control subjects who do not a neurological disorder.

Eligibility criteria: Inclusion Criteria:

* Able and willing to sign a written informed consent for study participation
* Existing diagnosis of a movement disorder or a healthy control subject without diagnosis of a movement disorder

Exclusion Criteria:

* Bedridden, wheelchair confined, or requires the regular use of an assistive gait device (e.g., walker, cane, etc.)
* Occupation that involves repetitive movement or complete immobility (e.g., janitor, construction, or sedentary with no/limited arm movements such as a taxi driver)
* In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to complete the required PKG watch wear (e.g., subject unable to complete PKG wear instructions per Patient Instruction Manual), complete required assessments or interfere with data collection.

Primary outcomes:
measure: Evaluation of new PKG assessments to be clinically validated for Gait/walking using movement data collected from the PKG Watch
timeFrame: 2-3 years
measure: Evaluation of new PKG assessments to be clinically validated for Device Assisted Therapy readiness using movement data collected from the PKG Watch
timeFrame: 2-3 years
measure: Evaluation of new PKG assessments to be clinically validated for Percent Time Bradykinesia using movement data collected from the PKG Watch (PTB)
timeFrame: 2-3 years
measure: Evaluation of new PKG assessments to be clinically validated for Percent Time Dyskinesia (PTD) using movement data collected from the PKG Watch
timeFrame: 2-3 years
measure: Evaluation of new PKG assessments to be clinically validated for fall prediction using movement data collected from the PKG Watch
timeFrame: 2-3 years
measure: Evaluation of new PKG assessments to be clinically validated for disease progression using movement data collected from the PKG Watch
timeFrame: 2-3 years
measure: Evaluation of new PKG assessments to be clinically validated for non-motor outcomes using non-motor scales
timeFrame: 2-3 years
Secondary outcomes:
measure: Evaluation of PKG scores to assess differences by age category
timeFrame: 2-3 years
measure: To compare PKG scores to standard Parkinson's disease assessments such as the Movement Disorder Specialist Unified Parkinson's Disease Scale
timeFrame: 2-3 years
measure: To compare PKG scores to standard Parkinson's disease assessments such as Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: 2-3 years
measure: To compare PKG scores to standard Parkinson's disease assessments such as the Freezing of Gait Questionnaire (FOG-Q)
timeFrame: 2-3 years
measure: To compare PKG scores to standard Parkinson's disease assessments such as The Essential Tremor Rating Assessment Scale (TETRAS)
timeFrame: 2-3 years
measure: To compare PKG scores to subject diaries
timeFrame: 2-3 years
measure: To compare PKG scores to non-motor assessments such as the Non-Motor Symptoms Questionnaire (NMSQ)
timeFrame: 2-3 years
measure: To compare PKG scores to sleep assessments such as Epworth Sleepiness Scale (ESS) and Parkinson's Disease Sleep Scale (PDSS)
timeFrame: 2-3 years
measure: To compare PKG scores to the Montreal Cognitive Assessment (MoCA)
timeFrame: 2-3 years
measure: To compare PKG scores to quality of life measurements such as EuroQual 5-D (EQ-5D)
timeFrame: 2-3 years
measure: To evaluate product usability and satisfaction for PKG Watch, docking station and PKG Portal
timeFrame: 2-3 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Neuroscience Research
state: Arizona
Study officials:
affiliation: Z Neurosciences, LLC.
name: Zoltan Mari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griffiths RI, Kotschet K, Arfon S, Xu ZM, Johnson W, Drago J, Evans A, Kempster P, Raghav S, Horne MK. Automated assessment of bradykinesia and dyskinesia in Parkinson's disease. J Parkinsons Dis. 2012;2(1):47-55. doi: 10.3233/JPD-2012-11071.
citation: Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.
citation: Kotschet K, Johnson W, McGregor S, Kettlewell J, Kyoong A, O'Driscoll DM, Turton AR, Griffiths RI, Horne MK. Daytime sleep in Parkinson's disease measured by episodes of immobility. Parkinsonism Relat Disord. 2014 Jun;20(6):578-83. doi: 10.1016/j.parkreldis.2014.02.011. Epub 2014 Feb 24.
citation: Braybrook M, O'Connor S, Churchward P, Perera T, Farzanehfar P, Horne M. An Ambulatory Tremor Score for Parkinson's Disease. J Parkinsons Dis. 2016 Oct 19;6(4):723-731. doi: 10.3233/JPD-160898.