NCT05251701

Personal KinetiGraph® Clinical Validation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: Global Kinetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Movement Disorders
• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-12-09
• Primary completion: 2023-08-16
• Completion: 2025-09-03
• First posted: 2022-02-23
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study