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Dutch Parkinson, Cognition and Driving Ability study part two (DUPARC-drive 2): A study on fitness to drive in early phase Parkinson*s Disease patients.

Dutch Parkinson, Cognition and Driving Ability study part two (DUPARC-drive 2): A study on fitness to drive in early phase Parkinson*s Disease patients. - Fitness to drive in early phase Parkinson's disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50941
Enrollment
45
Registered
2021-09-29
Start date
2021-11-03
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

Parkinson Parkinson's disease

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis Parkinson*s disease, as confirmed by a neurologist specialized in Parkinson*s Disease, by the UK-Brain Bank Criteria. - Disease duration between 35-60 months, measured after time of diagnosis. - Active driver - Own a car or have access to a car - Age 18 to 75 - Dutch speaking - Willingness to cooperate and sign written informed consent

Exclusion criteria

Exclusion criteria: - Suffering from severe motion sickness; motion sickness is a risk factor for simulator sickness. - Use of category III medication, that may - according to current legislation - interfere with FTDr. The website www.rijveiligmetmedicijnen.nl will be used to check the classification of medication. - Presence of premorbid pathology, i.e. experienced cerebral infarction or chronic depression, non-related to Parkinson*s disease.

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be a cut-off score on the MoCA which has high, preferably 100% sensitivity and reasonable specificity (>70%) in predicting the failure on the CBR on-road driving assessment.

Secondary

MeasureTime frame
The study sample will be divided into a pass and fail group, based on the on-road driving assessment. Groups will be compared in terms of age, disease severity, and performance on motor-, cognitive- and driving simulator tests. In addition, regression analyses will be used to detect predictors for failing on-road driving assessment.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)