A BLINDED, CONTROLLED STUDY OF THE VALUE OF OBJECTIVE MEASUREMENT IN TREATING PARKINSON’S DISEASE.

Not Applicable

Completed

• Conditions: Parkinson's Disease; Neurological - Parkinson's disease

• Registration Number: ACTRN12618000197235
• Lead Sponsor: Florey Neuroscience Institute

Brief Summary

This study investigated whether the management of Parkinson’s disease (PD) was improved when clinical assessment and therapeutic decisions were aided by objective measurement using a wrist-worn device that measured levels of movement in people with Parkinson's (PwP). Medical conditions with effective therapies are usually managed with objective measurement and therapeutic "target ranges." PD has effective therapies, objective measurement has only recently become available. The PKG is a wrist-worn device which allows objective measurement of PD. 200 PwP were enrolled into 2 groups. There were 97 participants in the "PKG+" group (assessment of PD was made using standard clinical evaluation by a doctor who also had access to PKG information) and 103 in the "PKG-" group (assessment of PD made using only clinical evaluation). Changes were made to their therapies, or decisions made to refer on to more advanced treatments, was based on the doctor's assessment using the information they were supplied with. The study compared changes in the overall Parkinson's disease rating scale, called the MDS-UPDRS, in both groups. The results of the study showed that according to the MDS-UPDRS scores when the PKG was used, there were improvements in motor and non-motor signs of Parkinson’s disease.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-07
• Study Completion: 2019-12-18
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

Parkinson's Disease duration of 3-12 years
- Taking 3 or more doses of levodopa a day

Exclusion Criteria

Contraindication to increasing dopaminergic medications (e.g. hallucinations, orthostatic hypotension, likely resistance to dopaminergic medication).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of PD assessed using Total MDS-UPDRS scores.[4 months]

Secondary Outcome Measures

Name	Time	Method
Bradykinesia, dyskinesias and OFF time measured by the PKG.[4 months post study enrolment.];Measurement of quality of life symptoms as measured by the PDQ-39 assessment.[4 months post study enrolment.];Measurement of non-motor symptoms as measured by the SENS-PD assessment.[4 months post study enrolment..]