Personal KinetiGraph® Clinical Validation Study

NCT05251701 | Completed FDA Device

• 1 other identifier: Study 006
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Movement Disorders; Parkinson Disease

Outcome Measures

Primary Outcomes (7)

• Evaluation of new PKG assessments to be clinically validated for Gait/walking using movement data collected from the PKG Watch

  The PKG's step detection system and manual step counts may be compared between healthy controls and person's with Parkinson's disease, while their walking is video recorded.

  2-3 years

• Evaluation of new PKG assessments to be clinically validated for Device Assisted Therapy readiness using movement data collected from the PKG Watch

  For this outcome, patients may be classified as Device Assisted Therapy (DAT) criteria positive or criteria negative. DAT readiness may be evaluated using the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. PKG measurements may be compared to the patient's clinical characteristics and MDS-UPDRS scores.

  2-3 years

• Evaluation of new PKG assessments to be clinically validated for Percent Time Bradykinesia using movement data collected from the PKG Watch (PTB)

  Data collected from the PKG system may be compared to scores from the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).

  2-3 years

• Evaluation of new PKG assessments to be clinically validated for Percent Time Dyskinesia (PTD) using movement data collected from the PKG Watch

  Data collected from the PKG system may be compared to scores from the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).

  2-3 years

• Evaluation of new PKG assessments to be clinically validated for fall prediction using movement data collected from the PKG Watch

  PKG measurements may be compared to data collected from freezing of gait questionnaire (FOG-Q) and posture analysis. The FOG-Q assesses freezing of gait severity and consists of 4 questions, each scored from 0-4. Higher scores indicates more severe freezing of gait. Step count performance may also be used to evaluate fall prediction. The PKG's step detection system and manual step counts may be compared between healthy controls and person's with Parkinson's disease, while their walking is video recorded.

  2-3 years

• Evaluation of new PKG assessments to be clinically validated for disease progression using movement data collected from the PKG Watch

  Disease progression may be evaluated by predicting the levodopa response using severity levels of the Bradykinesia Score (BKS) and early morning Bradykinesia. Changes in PKG measurements may be compared to the MDS-UPDRS which evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms.

  2-3 years

• Evaluation of new PKG assessments to be clinically validated for non-motor outcomes using non-motor scales

  PKG system data may be compared to non-motor assessments such as the non-motor questionnaire (NMSQ). The NMSQ includes questions regarding non-motor symptoms such as difficulty swallowing, constipation, difficulty sleeping, cognition, mood. Higher scores indicate more non-motor symptoms.

  2-3 years

Secondary Outcomes (11)

• Evaluation of PKG scores to assess differences by age category

  2-3 years

• To compare PKG scores to standard Parkinson's disease assessments such as the Movement Disorder Specialist Unified Parkinson's Disease Scale

  2-3 years

• To compare PKG scores to standard Parkinson's disease assessments such as Parkinson's Disease Questionnaire (PDQ-39)

  2-3 years

• To compare PKG scores to standard Parkinson's disease assessments such as the Freezing of Gait Questionnaire (FOG-Q)

  2-3 years

• To compare PKG scores to standard Parkinson's disease assessments such as The Essential Tremor Rating Assessment Scale (TETRAS)

  2-3 years

Interventions

Personal KinetiGraph® (PKG®) System DEVICE

The PKG® System includes a wrist-worn device that records and measures movement patterns in conditions such as Parkinson's disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be identified from routine clinical care

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Global Kinetics Corporation: lead

Study Sites (1)

Tucson Neuroscience Research

Tucson, Arizona, 85710, United States

Location

Related Publications (4)

• 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.

  PMID: 23939408 BACKGROUND

• 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.

  PMID: 25928634 BACKGROUND

• 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.

  PMID: 24674770 BACKGROUND

• 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.

  PMID: 27589540 BACKGROUND

MeSH Terms

Conditions

Movement Disorders; Parkinson Disease

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Zoltan Mari, MD

  Z Neurosciences, LLC.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: February 23, 2022
• Study Start: December 9, 2022
• Primary Completion: August 16, 2023
• Study Completion: September 3, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-09

Locations

US (1)