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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000197235
Acronym
Treat to Target
Enrollment
209
Registered
2018-02-07
Start date
2018-06-05
Completion date
2019-08-25
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The research project is testing a new way of managing Parkinson’s Disease. The new way of managing this involves the use of the Parkinson’s Kinetigraph (PKG) system, which includes a small, smart-watch like device that measures movements, worn on the wrist for 7 days. In diseases such as diabetes or heart disease, “targets” exist (e.g. blood sugar levels, cholesterol levels) in order to obtain optimal health. We believe that by “measuring” Parkinson’s Disease using the PKG, we can develop targets around the movement problems in PD. These targets help us define whether a person with PD has controlled or uncontrolled movements. Previous research studies demonstrate that the PKG can identify uncontrolled symptoms and lead to changes which improve quality of life. The aim of this project is to demonstrate that by utilising these targets, we can identify people with uncontrolled PD and treat them accordingly. If we can improve movement difficulties, we can hopefully improve quality of life.

Interventions

All participants will wear the Parkinson's Kinetigraph-watch for 7 days prior to the baseline visit and for any future visits. This will be organised by the Florey Study Team. The PKG-watch measures levels of bradykinesia and dyskinesia and provides a report ("the Parkinson's Kinetigraph- PKG"). Participants will be classified into one of two groups. They will then consult with the study doctor who will classify them as "controlled" or "uncontrolled" (based on their symptomatology) and treat the

All participants will wear the Parkinson's Kinetigraph-watch for 7 days prior to the baseline visit and for any future visits. This will be organised by the Florey Study Team. The PKG-watch measures levels of bradykinesia and dyskinesia and provides a report ("the Parkinson's Kinetigraph- PKG"). Participants will be classified into one of two groups. They will then consult with the study doctor who will classify them as "controlled" or "uncontrolled" (based on their symptomatology) and treat them according to their expertise. In Group 1), the participant PKG is available to the doctor, the participant is treated with anti-PD medications according to the doctor's judgement; Group 2) No PKG is available and the participant is treated according to the doctor's judgement. This cycle continues until all participants are classed as "controlled" (to a maximum of 4 visits). The time between visits is approximately 1 month (i.e. each cycle is approximately 1month long). Participants will be seen at the hospital clinics. Intervention adherence will be assessed by the study team by only utilising participant data where it is evident the PKG has been worn for a minimum of 5 days.

Sponsors

Florey Neuroscience Institute
Lead SponsorOther Collaborative groups

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
58 Years to 76 Years
Healthy volunteers
No

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026