The Role of DLOTCA-G in the Cognitive Function Evaluation of Parkinson's Patients

• Sponsor: Kutahya Health Sciences University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06131619
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Anticipated Duration (Months): 21.5
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: assesment of cognitive parameters with DLOTCA-G

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 Design

• Study Type: Observational
• Anticipated Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Role of Dynamic Lowenstein Occupational Therapy Cognitive Assessment-Geriatric Version (DLOTCA-G) in the Cognitive Function Evaluation of Parkinson's Patients
• Actual Study Start Date: Jun 5, 2022
• Anticipated Primary Completion Date: Jan 5, 2024
• Anticipated Study Completion Date: Mar 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental Parkinson's disease patients with cognitive impairment	Other: assesment of cognitive parameters with DLOTCA-G; All three groups were evaluated once with the DLOTCA-G, a cognitive assessment battery.
Active Comparator Parkinson's disease patients without cognıtıve impairment	Other: assesment of cognitive parameters with DLOTCA-G; All three groups were evaluated once with the DLOTCA-G, a cognitive assessment battery.
other Health geriatric persons	Other: assesment of cognitive parameters with DLOTCA-G; All three groups were evaluated once with the DLOTCA-G, a cognitive assessment battery.

Outcome Measures

Primary Outcome Measures

1. Dynamic Lowenstein Occupational Therapy Cognitive Assessment-Geriatric Version [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.

Secondary Outcome Measures

1. Mini Mental State Examination [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kütahya Health Sciences University	Kütahya		Turkey	430020

Sponsors and Collaborators

• Kutahya Health Sciences University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merve Akdeniz Leblebicier, assoc.prof dr, Kutahya Health Sciences University
• ClinicalTrials.gov Identifier: NCT06131619
• Other Study ID Numbers: 2021/15-03
• First Posted: Nov 14, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Merve Akdeniz Leblebicier, assoc.prof dr, Kutahya Health Sciences University: Parkinson Disease; DLOTCA-G
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Nov 18, 2023