Parkinson DiseaseNCT06131619
The Role of DLOTCA-G in the Cognitive Function Evaluation of Parkinson's Patients
An observational study of Parkinson Disease, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- assesment of cognitive parameters with DLOTCA-G
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2022to 17 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Parkinson's dissease patients
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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University
Kütahya, 430020
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- assesment of cognitive parameters with DLOTCA-G
- Keywords
- Parkinson Disease, DLOTCA-G
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assesment of cognitive parameters with DLOTCA-GOther
All three groups were evaluated once with the DLOTCA-G, a cognitive assessment battery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Parkinson's disease patients with cognitive impairment Receives: Other: assesment of cognitive parameters with DLOTCA-G | |
| Active Comparator | Parkinson's disease patients without cognıtıve impairment Receives: Other: assesment of cognitive parameters with DLOTCA-G | |
| other | Health geriatric persons Receives: Other: assesment of cognitive parameters with DLOTCA-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (First assessment)
Secondary outcomes (1)
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.
Measured: Baseline (First assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start5 Jun 2022
- Primary completion24 Jan 2024
- Study completion17 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Akdeniz Leblebicier, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131619
- Sponsor's protocol ID
- 2021/15-03
- Status last verified
- Mar 2024
- First submitted
- 9 Nov 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yaman F, Arikan FA, Soylu EA, Peksen E, Leblebicier MA, Ozlu A, Gokpinar HH, Yenen B, Kavuncu V. The role of dynamic Lowenstein occupational therapy and cognitive assessment scale for the elderly with Parkinson's disease. BMC Geriatr. 2026 Jun 19. doi: 10.1186/s12877-026-07844-6. Online ahead of print.
PubMed 42321630
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dynamic Lowenstein Occupational Therapy Cognitive Assessment-Geriatric Version (DLOTCA-G) in the Cognitive Function Evaluation of Parkinson's Patients
- ClinicalTrials.gov ID
- NCT06131619
- Acronym / sponsor ID
- 2021/15-03
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, DLOTCA-G
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 17 Mar 2024 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: assesment of cognitive parameters with DLOTCA-GParkinson's disease patients with cognitive impairment |
| Active Comparator | – | Other: assesment of cognitive parameters with DLOTCA-GParkinson's disease patients without cognıtıve impairment |
| other | – | Other: assesment of cognitive parameters with DLOTCA-GHealth geriatric persons |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Parkinson's dissease patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assesment of cognitive parameters with DLOTCA-GAll three groups were evaluated once with the DLOTCA-G, a cognitive assessment battery. | Other | Active Comparator, Experimental, other |
Primary outcome
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.
1 secondary outcome
Mini Mental State Examination
Time frame: Baseline (First assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Derived from this study: PubMed 42321630Yaman F, Arikan FA, Soylu EA, Peksen E, Leblebicier MA, Ozlu A, Gokpinar HH, Yenen B, Kavuncu V. The role of dynamic Lowenstein occupational therapy and cognitive assessment scale for the elderly with Parkinson's disease. BMC Geriatr. 2026 Jun 19. doi: 10.1186/s12877-026-07844-6. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Lowenstein Occupational Therapy Cognitive Assessment-Geriatric Version (time frame: Baseline (First assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06131619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.