AphasiaNCT04386837
The Inter-rater Reliability of the Turkish Version of Aphasia Rapid Test for Stroke
An observational study of Aphasia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The Aphasia Rapid Test (ART) is a bedside aphasia screening test developed originally in French. The purpose of this study is to assess the inter-rater reliability of the Turkish version of the ART in stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia
- What is being tested?
- Turkish Aphasia Rapid Test
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 May 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of left MCA stroke patients who experienced a CVA within the last 10 days. These patients will consist of males and females with a minimum age of 18.
Who may be able to join
- Left MCA infarct due to CVA
- Right hand dominant
- Turkish as first language
- CVA within the last 10 days
Who cannot join
- Right or bilateral brain lesion
- Previous stroke
- Psychiatric disorder
- Other neurological disorder
- Cognitive impairment
- Endotracheal entubation prohibiting responses to test
Trial locations and contacts
1 site in 1 country.
About this study
The Aphasia Rapid Test (ART) is a bedside aphasia screening test developed originally in French. The purpose of this study is to assess the inter-rater reliability of the Turkish version of the ART in stroke patients.
Read the detailed description
The Aphasia Rapid Test (ART) was developed and validated originally in French to evaluate language skills in post-stroke patients (Azuar et al., 2013). It is a 26-point scale that takes less than 3 minutes to administer. The simplicity of the ART allows it be used bedside in acute post-stroke patients with little to no training needed. The items needed to administer the ART are also easy to access in healthcare settings (e.g., watch, pen, doctor's coat). Although the ART is not a diagnostic test, it is beneficial for tracking progress and determining prognosis in stroke patients.
The original ART was designed similar to the NIH Stroke Scale (NIHSS), a widely-used test in stroke patients. The NIHSS which assesses many areas of functioning (level of consciousness, gaze, visual ability, facial palsy, motor and sensory ability, limb ataxia, language, dysarthria, and extinction and inattention) was chosen because of its sensitivity to early changes in neurological status and high prognostic accuracy (http://www.nihstrokescale.org). The ART is an expanded version of the language section of the NIHSS. The total possible points on the ART is 26, which indicates the highest level of impairment. The test begins with the patient being asked to follow two one-step commands (up to two points each), a complex command (up to 3 points), repeat three nouns (up to 6 points), repeat a simple sentence (up to 2 points), and name three simple objects (up to 6 points). The next item requires a rating of dysarthria by the examiner (up to 3 points). On the final item, the patient is asked to name as many animals as they can think of in one minute (up to 4 points). With the exception of items 1a, 1b, and 6, there are no time restrictions on the test.
The purpose of the present study is to translate the original ART into Turkish to provide an efficient method for the evaluation of language skills in post-stroke Turkish-speaking patients and to assess its inter-rater reliability.
- Conditions
- Aphasia
- Being tested
- Turkish Aphasia Rapid Test
- Keywords
- stroke, aphasia, reliability
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Aphasia Rapid TestOther
Same
| Study group | Role | What they receive |
|---|---|---|
| Aphasics | Patients with a left MCA infarct due to CVA will be included in the study. Each subject will be administered an aphasia screening test less than 3 minutes in length. The same test will be administered by another clinician to the same patient within a maximum of 12 hours to assess the inter-rater reliability of the test. Receives: Other: Turkish Aphasia Rapid Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater reliability
The inter-rater reliability between two clinicians administering the same test
Measured: The test will be administered within a time frame of 12 hours by two clinicians
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Feb 2020
- Primary completion1 May 2021
- Study completion1 May 2021
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 AphasiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Kavakci, Ankara City Hospital Bilkent
- Investigators
- Mariam Kavakci, PhD, Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386837
- Sponsor's protocol ID
- AnkaraCHBilkentFTR1
- Status last verified
- Feb 2022
- First submitted
- 9 May 2020
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kavakci M, Koyuncu E, Tanriverdi M, Adiguzel E, Yasar E. The inter-rater reliability of the Turkish version of Aphasia Rapid Test for stroke. Top Stroke Rehabil. 2022 May;29(4):272-279. doi: 10.1080/10749357.2021.1923314. Epub 2021 Jun 1.
PubMed 34060434
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inter-rater Reliability of the Turkish Version of Aphasia Rapid Test for Stroke
- ClinicalTrials.gov ID
- NCT04386837
- Acronym / sponsor ID
- AnkaraCHBilkentFTR1
- Conditions
- Aphasia
- Keywords
- stroke, aphasia, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 13 May 2020 (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 Aphasia Rapid Test (ART) is a bedside aphasia screening test developed originally in French. The purpose of this study is to assess the inter-rater reliability of the Turkish version of the ART in stroke patients.
Detailed description
The Aphasia Rapid Test (ART) was developed and validated originally in French to evaluate language skills in post-stroke patients (Azuar et al., 2013). It is a 26-point scale that takes less than 3 minutes to administer. The simplicity of the ART allows it be used bedside in acute post-stroke patients with little to no training needed. The items needed to administer the ART are also easy to access in healthcare settings (e.g., watch, pen, doctor's coat). Although the ART is not a diagnostic test, it is beneficial for tracking progress and determining prognosis in stroke patients.
The original ART was designed similar to the NIH Stroke Scale (NIHSS), a widely-used test in stroke patients. The NIHSS which assesses many areas of functioning (level of consciousness, gaze, visual ability, facial palsy, motor and sensory ability, limb ataxia, language, dysarthria, and extinction and inattention) was chosen because of its sensitivity to early changes in neurological status and high prognostic accuracy (http://www.nihstrokescale.org). The ART is an expanded version of the language section of the NIHSS. The total possible points on the ART is 26, which indicates the highest level of impairment. The test begins with the patient being asked to follow two one-step commands (up to two points each), a complex command (up to 3 points), repeat three nouns (up to 6 points), repeat a simple sentence (up to 2 points), and name three simple objects (up to 6 points). The next item requires a rating of dysarthria by the examiner (up to 3 points). On the final item, the patient is asked to name as many animals as they can think of in one minute (up to 4 points). With the exception of items 1a, 1b, and 6, there are no time restrictions on the test.
The purpose of the present study is to translate the original ART into Turkish to provide an efficient method for the evaluation of language skills in post-stroke Turkish-speaking patients and to assess its inter-rater reliability.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aphasics | – | Other: Turkish Aphasia Rapid TestPatients with a left MCA infarct due to CVA will be included in the study. Each subject will be administered an aphasia screening test less than 3 minutes in length. The same test will be administered by another clinician to the same patient within a maximum of 12 hours to assess the inter-rater reliability of the test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of left MCA stroke patients who experienced a CVA within the last 10 days. These patients will consist of males and females with a minimum age of 18.
Key inclusion criteria (4 listed)
- Left MCA infarct due to CVA
- Right hand dominant
- Turkish as first language
- CVA within the last 10 days
Key exclusion criteria (6 listed)
- Right or bilateral brain lesion
- Previous stroke
- Psychiatric disorder
- Other neurological disorder
- Cognitive impairment
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 |
|---|---|---|
| Turkish Aphasia Rapid TestSame | Other | Aphasics |
Primary outcome
Inter-rater reliability
Time frame: The test will be administered within a time frame of 12 hours by two clinicians
The inter-rater reliability between two clinicians administering the same test
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 22 Feb 2022.
- Derived from this study: PubMed 34060434Kavakci M, Koyuncu E, Tanriverdi M, Adiguzel E, Yasar E. The inter-rater reliability of the Turkish version of Aphasia Rapid Test for stroke. Top Stroke Rehabil. 2022 May;29(4):272-279. doi: 10.1080/10749357.2021.1923314. Epub 2021 Jun 1.
- Individual participant dataSharing planned: Undecided
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Mariam Kavakci, PhD study director
Ankara City Hospital Bilkent
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 Aphasia, run by Ankara City Hospital Bilkent 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 6 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 22 Feb 2022. 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?
Inter-rater reliability (time frame: The test will be administered within a time frame of 12 hours by two clinicians). 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 NCT04386837, 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 22 Feb 2022.