Using the PKG
Clinical Trial Services.
Developed by Global Kinetics Pty Ltd, the PKG® is an innovative digital health technology. The PKG system provides a continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson’s disease including bradykinesia, dyskinesia and tremor. The PKG also provides an assessment of daytime somnolence.
The PKG contains the following key components:
• Triaxial accelerometer collects movement data
• Vibration-based reminder to register medication dose
• Record of self-reported medication compliance
• Proprietary mathematical algorithm translates raw data
• Illustrates PD patient symptoms in relation to controls (individuals without PD)
• Remote-based passive data collection
• Continuous and Episodic models available.
- FDA 510(k) cleared
- Class IIa ARTG registered
- CE marked Class IIa
- Granted & National Phase 10 jurisdictions
- ISO 13485 Quality Management System Certified
- HIPAA & GDPR Compliant PHI Collection
Use in Clinical Trials
The PKG® system is a clinically validated system for objective, ambulatory and continuous assessment of movement disorder symptoms in Parkinson’s disease and overcomes a number of deficiencies in existing clinical trial outcome measures. In Parkinson’s disease, clinical trial outcomes are often based on subjective patient reported inputs, such as diaries, which are time consuming for patients and often inaccurate due to reliance on patient recollection and poor compliance. Traditional point-in-time rating scales (UPDRS, AIMS) are cumbersome and reliability is impacted by inter and intra-rater variability