Personal KinetiGraph® Clinical Validation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-09

Study Completion Date

2025-09-03

Brief Summary

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

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Detailed Description

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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.

Conditions

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Movement Disorders Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Personal KinetiGraph® (PKG®) System

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes