- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06131619
The Role of DLOTCA-G in the Cognitive Function Evaluation of Parkinson's Patients
March 19, 2024 updated by: Merve Akdeniz Leblebicier, Kutahya Health Sciences University
The Role of Dynamic Lowenstein Occupational Therapy Cognitive Assessment-Geriatric Version (DLOTCA-G) in the Cognitive Function Evaluation of Parkinson's Patients
The purpose of this study is to evaluate the usefulness of Dynamic Loewenstein's Occupational Therapy and Cognitive Assessment Scale for Geriatrics (DLOTCA-G) in parkinson patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study to evaluate the usefulness of Dynamic Loewenstein's Occupational Therapy and Cognitive Assessment Scale for Geriatrics (DLOTCA-G) in the early detection of cognitive impairment in parkinson patients aged 65 and over, with and without dementia.The investigators also aimed to compare the Mini Mental State Assessment Test with DLOTCA-G.
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kütahya, Turkey, 430020
- Kutahya Health Sciences University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Parkinson's dissease patients
Description
Inclusıon Criteria
- Parkinson's patients aged 65 years and older with and without cognitive impairment (60 patients) and healthy control patients (30 patients)
- Hoehnn Yahr Staging between 1 and 2.5 in patients with Parkinson's diseas
- Confirmed by brain MRI from patients without vascular dementia who routinely attend the Parkinson's follow-up outpatient clinic
- At least primary school graduates
- In patients with Parkinson's dissease patients with cognitive impairment, MMSE below 20 in primary school education level; below 24 in secondary, high school and university education level
- In patients with Parkinson's disease without cognitive impairment, MMSE 20 and above in primary school education level; 24 and above in secondary, high school and university education level Exclusıon Criteria
- Preexisting cognitive impairment
- Psychiatric disorders such as psychotic disorders, mood disorders, alcohol or drug abuse
- Severe language dysfunction and/or bilateral limb motor dysfunction and inability to participate in clinical psychology tests, severe visual and/or auditory impairments
- Patients with significant cerebral atrophy or neurological vascular lesions
- The Geriatric Depression Scale was administered to all participants, and participants with a total score of 13 or more out of 30 points were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Experimental
Parkinson's disease patients with cognitive impairment
|
All three groups were evaluated once with the DLOTCA-G, a cognitive assessment battery.
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|
Active Comparator
Parkinson's disease patients without cognıtıve impairment
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All three groups were evaluated once with the DLOTCA-G, a cognitive assessment battery.
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other
Health geriatric persons
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All three groups were evaluated once with the DLOTCA-G, a cognitive assessment battery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Lowenstein Occupational Therapy Cognitive Assessment-Geriatric Version
Time Frame: Baseline (First assessment)
|
The Dynamic Lowenstein Occupational Therapy Cognitive Assessment is an occupational performance measurement battery designed to assess basic cognitive skills and visual perception in adults with neurological deficits.
Consists 8 subtests: orientation, awareness, visual perception, spatial perception, praxis, visuomotor construction and thinking operations and memory.
All subtests of DLOTCA-G are scored between 1 - 4 points.
And higher scores indicate better cognitive performance.
There is no cut-off value for Parkinson's patients.
|
Baseline (First assessment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini Mental State Examination
Time Frame: Baseline (First assessment)
|
The Mini Mental State Examination is a brief screening tool that provides a quantitative assessment of cognitive impairment and to record cognitive changes over time.
It consists of five subscales: orientation, memory, attention and calculation, recall and language.
In the evaluation of the test, scores below 15 indicate low cognitive level, scores between 15 and 26 indicate medium cognitive level, and scores of 26 and above indicate high cognitive level.
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Baseline (First assessment)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2022
Primary Completion (Actual)
January 24, 2024
Study Completion (Actual)
March 17, 2024
Study Registration Dates
First Submitted
November 9, 2023
First Submitted That Met QC Criteria
November 9, 2023
First Posted (Actual)
November 14, 2023
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/15-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.