StrokeNCT06313021
Turkish Version of the Brief Assessment of Cognitive Impairment in Individuals With Stroke Scale
An observational study of Stroke and Cognition, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Cognitive processing involves many interrelated cognitive domains, such as performing daily tasks, attention, language, and memory. 70% of individuals with stroke experience cognitive problems. Due to cognitive problems, individuals with stroke have difficulty processing and planning information. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- What is being tested?
- Reliability and Validity Study
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Dec 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It will consist of individuals with stroke over the age of 40 who come to the University Hospital for treatment.
Who may be able to join
- Individuals between the ages of 40 and 75,
- Individuals who volunteer to participate in the research,
- Individuals diagnosed with stroke,
- Individuals who do not have cooperation and communication problems
Who cannot join
- Those with neurological problems other than stroke (patients diagnosed with Alzheimer's, Parkinson's, Dementia, MS)
- Those with perceptual problems
- Individuals with cooperation and communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of the Validity and Reliability of the Turkish Version of the Brief Assessment of Cognitive Impairment in Individuals With Stroke Scale
Cognitive processing involves many interrelated cognitive domains, such as performing daily tasks, attention, language, and memory. 70% of individuals with stroke experience cognitive problems. Due to cognitive problems, individuals with stroke have difficulty processing and planning information. This situation negatively affects daily living activities and returning to work. Cognitive disorders that occur after stroke negatively affect the functional independence of individuals. At the same time, individuals with stroke have difficulty structuring and organizing information. The individual may not be able to pay sufficient attention during the activity in terms of planning, automatic attention and adaptation to the stages required by the job.
Cognitive evaluation should include cognition, orientation, and higher cortical functions because the cognitive process is a very complex process. Assessment methods frequently used in cognitive evaluation of stroke patients; Scales and tests such as Simple Mental Test, Mini Mental State Test, Montreal Cognitive Assessment Scale, Wechsler Memory and Intelligence Test are used. General problems with these evaluations; Some of them have a long application period, some of them have problems in perception of the patients, and some of them have a low power to distinguish the cognitive problems of the patients. When the Brief Assessment of Cognitive Impairment Scale, a newly introduced scale in the literature, is examined; It attracts attention because the items are very simple for patients to perceive, combine cognitive tests and cognitive questionnaires, have a short application period, and have not shown a ceiling or floor effect in previous studies. For all these reasons, this study was planned to conduct the Turkish validity and reliability study of the Brief Assessment of Cognitive Impairment Scale.
Read the detailed description
Cognition; It is a broad concept that includes mental processes such as an individual's perception, understanding, processing and remembering of information. Cognition includes many mental activities such as thinking, learning, memory, problem solving, attention, and language use. The importance of cognition is related to the individual's ability to understand his environment, learn, solve problems and make effective decisions in daily life. These processes can have a direct impact on an individual's education, work, relationships, and overall quality of life. Therefore, understanding and supporting cognition can help individuals manage and improve their lives more effectively.
A common consequence of stroke is impaired cognition. It is stated that in the three-year period after stroke, up to 39% of patients have cognitive impairment. There is a significant relationship between cognitive abilities and functional performance. Therefore, cognitive impairment may reduce the independence of people with stroke in performing basic activities of daily living (such as eating, dressing, and toileting) and activities of daily living (such as household chores and social interactions). As a result, people with post-stroke cognitive impairment often require ongoing care and support, which can put pressure on caregivers and society. Therefore, effective assessment of post-stroke cognition is crucial for stroke rehabilitation. Frequently used assessment methods in the cognitive evaluation of stroke patients include scales and tests such as Mini Mental State Test, Montreal Cognitive Assessment Scale, and Wechsler Memory and Intelligence Test. However, when these evaluations are examined, there are problems in detecting the cognitive effects of patients with different severities due to the long application times of some of them and the floor and ceiling effects in some of them. Therefore, we planned this study to test the Turkish validity and reliability of the Brief Assessment of Cognitive Impairment Scale, a new, simple diagnostic tool that combines cognitive tests and cognitive questionnaires, in stroke patients.
- Being tested
- Reliability and Validity Study
- Keywords
- stroke, cognition, validity, reliability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reliability and Validity StudyOther
Reliability and Validity Study
| Study group | Role | What they receive |
|---|---|---|
| stroke group | stroke group Receives: Other: Reliability and Validity Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Assessment of Cognitive Impairment Scale
The Brief Assessment of Cognitive Impairment was developed by Danish researchers to assess cognitive impairment and dementia. To practice BASIC, one needs a registration form, a picture card, a manual, and a stopwatch, like the stopwatch in our smartphone's clock app. BASIC consists of five parts: presentation of pictures for memory testing, patient-directed questions, fluency in naming supermarket products, recall of pictures, and assessor-directed questions. Assessor-directed questions can be administered before, during, or after the patient is evaluated. It is performed for evaluation in an environment free from distractions and with adequate lighting. If the patient uses glasses or hearing aids, these must be present. It is necessary to explain the purpose of the evaluation to the patient. The test consists of 11 questions. The lowest score is 0, the highest score is 25. As the score decreases, cognitive status worsens.
Measured: seven day
Secondary outcomes (2)
Mini Mental State Test
The test develoThe test developed by Folstein et al. in 1975 is the most widely used cognitive screening test. The test consists of 11 items; It is evaluated out of 30 points: 10 points for time and space orientation, 6 points for memory, 5 points for attention, 8 points for language and 1 point for visual-spatial function. 24-30 points are considered normal, 18-23 points are considered mild cognitive impairment, 12-17 points are considered moderately severe, and below 12 points are considered severe cognitive impairment. A standardized MMDT was created for the Turkish society and validity and reliability tests were conducted.
Measured: seven day
Sociodemographic Assessment
Before individuals; Parameters such as age, gender, marital status, educational status, profession, Brunnstrom level, stroke duration, side of stroke, affected vein, dominant extremity, smoking and alcohol use, assistive devices used, CV information, family history information and medications used will be questioned.
Measured: seven day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Jan 2024
- Primary completion15 Oct 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birol Onal, Ataturk University
- Investigators
- Birol Önal, Dr, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313021
- Sponsor's protocol ID
- 2023.12.03
- Status last verified
- Feb 2025
- First submitted
- 5 Mar 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Validity and Reliability of the Turkish Version of the Brief Assessment of Cognitive Impairment in Individuals With Stroke Scale
- ClinicalTrials.gov ID
- NCT06313021
- Acronym / sponsor ID
- 2023.12.03
- Keywords
- stroke, cognition, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 15 Mar 2024 (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.
Cognitive processing involves many interrelated cognitive domains, such as performing daily tasks, attention, language, and memory. 70% of individuals with stroke experience cognitive problems. Due to cognitive problems, individuals with stroke have difficulty processing and planning information. This situation negatively affects daily living activities and returning to work. Cognitive disorders that occur after stroke negatively affect the functional independence of individuals. At the same time, individuals with stroke have difficulty structuring and organizing information. The individual may not be able to pay sufficient attention during the activity in terms of planning, automatic attention and adaptation to the stages required by the job.
Cognitive evaluation should include cognition, orientation, and higher cortical functions because the cognitive process is a very complex process. Assessment methods frequently used in cognitive evaluation of stroke patients; Scales and tests such as Simple Mental Test, Mini Mental State Test, Montreal Cognitive Assessment Scale, Wechsler Memory and Intelligence Test are used. General problems with these evaluations; Some of them have a long application period, some of them have problems in perception of the patients, and some of them have a low power to distinguish the cognitive problems of the patients. When the Brief Assessment of Cognitive Impairment Scale, a newly introduced scale in the literature, is examined; It attracts attention because the items are very simple for patients to perceive, combine cognitive tests and cognitive questionnaires, have a short application period, and have not shown a ceiling or floor effect in previous studies. For all these reasons, this study was planned to conduct the Turkish validity and reliability study of the Brief Assessment of Cognitive Impairment Scale.
Detailed description
Cognition; It is a broad concept that includes mental processes such as an individual's perception, understanding, processing and remembering of information. Cognition includes many mental activities such as thinking, learning, memory, problem solving, attention, and language use. The importance of cognition is related to the individual's ability to understand his environment, learn, solve problems and make effective decisions in daily life. These processes can have a direct impact on an individual's education, work, relationships, and overall quality of life. Therefore, understanding and supporting cognition can help individuals manage and improve their lives more effectively.
A common consequence of stroke is impaired cognition. It is stated that in the three-year period after stroke, up to 39% of patients have cognitive impairment. There is a significant relationship between cognitive abilities and functional performance. Therefore, cognitive impairment may reduce the independence of people with stroke in performing basic activities of daily living (such as eating, dressing, and toileting) and activities of daily living (such as household chores and social interactions). As a result, people with post-stroke cognitive impairment often require ongoing care and support, which can put pressure on caregivers and society. Therefore, effective assessment of post-stroke cognition is crucial for stroke rehabilitation. Frequently used assessment methods in the cognitive evaluation of stroke patients include scales and tests such as Mini Mental State Test, Montreal Cognitive Assessment Scale, and Wechsler Memory and Intelligence Test. However, when these evaluations are examined, there are problems in detecting the cognitive effects of patients with different severities due to the long application times of some of them and the floor and ceiling effects in some of them. Therefore, we planned this study to test the Turkish validity and reliability of the Brief Assessment of Cognitive Impairment Scale, a new, simple diagnostic tool that combines cognitive tests and cognitive questionnaires, in stroke patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke group | – | Other: Reliability and Validity Studystroke group |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It will consist of individuals with stroke over the age of 40 who come to the University Hospital for treatment.
Key inclusion criteria (4 listed)
- Individuals between the ages of 40 and 75,
- Individuals who volunteer to participate in the research,
- Individuals diagnosed with stroke,
- Individuals who do not have cooperation and communication problems
Key exclusion criteria (3 listed)
- Those with neurological problems other than stroke (patients diagnosed with Alzheimer's, Parkinson's, Dementia, MS)
- Those with perceptual problems
- Individuals with cooperation and communication problems
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 |
|---|---|---|
| Reliability and Validity StudyReliability and Validity Study | Other | stroke group |
Primary outcome
Brief Assessment of Cognitive Impairment Scale
Time frame: seven day
The Brief Assessment of Cognitive Impairment was developed by Danish researchers to assess cognitive impairment and dementia. To practice BASIC, one needs a registration form, a picture card, a manual, and a stopwatch, like the stopwatch in our smartphone's clock app. BASIC consists of five parts: presentation of pictures for memory testing, patient-directed questions, fluency in naming supermarket products, recall of pictures, and assessor-directed questions. Assessor-directed questions can be administered before, during, or after the patient is evaluated. It is performed for evaluation in an environment free from distractions and with adequate lighting. If the patient uses glasses or hearing aids, these must be present. It is necessary to explain the purpose of the evaluation to the patient. The test consists of 11 questions. The lowest score is 0, the highest score is 25. As the score decreases, cognitive status worsens.
2 secondary outcomes
Mini Mental State Test
Time frame: seven day
Sociodemographic Assessment
Time frame: seven day
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 11 Feb 2025.
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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.
Birol Önal, Dr principal investigator
Ataturk University
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 Stroke and Cognition, run by Ataturk 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?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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 11 Feb 2025. 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?
Brief Assessment of Cognitive Impairment Scale (time frame: seven day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2025.