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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06131619
Other study ID # 2021/15-03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 5, 2022
Est. completion date March 17, 2024

Study information

Verified date March 2024
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 17, 2024
Est. primary completion date January 24, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 90 Years
Eligibility Inclusion 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 Exclusion 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 Design


Related Conditions & MeSH terms


Intervention

Other:
assesment of cognitive parameters with DLOTCA-G
All three groups were evaluated once with the DLOTCA-G, a cognitive assessment battery.

Locations

Country Name City State
Turkey Kütahya Health Sciences University Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dynamic Lowenstein Occupational Therapy Cognitive Assessment-Geriatric Version 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 Mini Mental State Examination 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. Baseline (First assessment)
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