Personal KinetiGraph® Clinical Validation Study

Global Kinetics

Status: Completed

Conditions: Parkinson Disease; Movement Disorders

Treatments: Device: Personal KinetiGraph® (PKG®) System

Study type: Observational

Funder types: Industry

Identifiers

NCT05251701

Study 006

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design