Global Kinetics

Clinical Trials Services

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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 system includes a wrist-worn movement recording device called the PKG Watch, proprietary algorithms and a data-driven report known as the PKG.

Data is collected continuously by the PKG Watch during activities of daily living in the home environment and can be programmed to remind the patient, at their prescribed Parkinson’s disease medication times, to register that they’ve taken their Parkinson’s disease medication. The PKG Watch should be worn by the patient for 7 days.

At the end of the recording period, the data is uploaded for processing. The PKG is generated and is provided to the patient’s clinician, graphically and numerically depicting the movement of the patient. The PKG shows scores representative of bradykinesia and dyskinesia, compared to healthy controls, throughout the day and from day to day. Other information such as medication compliance, motor fluctuations, immobility, tremor and periods where the PKG Watch was not worn are also shown.

Regulatory Status

The PKG system has received regulatory clearance through FDA 510 (k) in the USA, CE mark in Europe and is TGA Class IIa ARTG 236583 listed in Australia.

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.

The PKG system can be deployed remotely and does not require subjects to attend a site visit. Further features and benefits of the PKG system are set out below:

PKG feature	Benefits in clinical studies
PKG is an objective assessment system	Delivers statistically reliable and reproducible data without the inter and intra-rater variability seen in traditional rating scales Objective quantification of the kinematics of core symptoms of Parkinson’s disease, including bradykinesia, dyskinesia and tremor
PKG is easy to use and requires minimal involvement by the patient	Allows for easy deployment by clinics as well as integration into clinical workflow and research protocols Passive data collection delivers high compliance, providing complete data while reducing technical impediments to patient inclusion
Real world data collection that can be initiated and managed remotely	In home assessment delivers symptom and medication response data that is free of ‘consultation room’ artefacts The PKG system can be initiated and managed remotely thereby reducing site attendance for subjects participating in a clinical study
PKG meets validation and regulatory requirements	The PKG is validated against currently used symptom rating scales such as UPDRS-III (movement scale) and modified AIMS FDA cleared, CE marked, TGA registered makes the PKG suitable for global, multicentre clinical studies
Comprehensive and robust data delivery	PKG data is presented in a tabulated format that is highly conducive to biostatistical analysis New research measures are being added regularly

Contact Us

If you would like to get in contact with us to discuss how you can utilise the PKG system to support your clinical trial, please complete the following enquiry form.