Stroke, AcuteNCT04739514
Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients
A study testing Exercises for dysphagia rehabilitation in people with Stroke, Acute, run by Nazife Kapan at 1 site in Turkey (Türkiye).
Trial summary
Stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. Dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.The aim of this study is to evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Exercises for dysphagia rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 30 Jun 2021
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with acute stroke by neurology
- Having trouble swallowing
- 18-85 years old, volunteers
Who cannot join
- Unconscious
- Uncooperative
- Those with oropharyngeal structural damage
- Patients with malignancies involving the head and neck region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Şehir Hastanesi
Ankara
Nazife Kapan, Dr., 03125526000, nazifekapan@gmail.com
Müyesser Aras, Prof. Dr., 03125526000, drmuyesser@hotmail.com
About this study
Stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. Dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.The aim of this study is to evaluate the clinical evaluation of swallowing in stroke patients and to determine the factors affecting the severity and prognosis of dysphagia in patients with dysphagia.Fifty-five patients with acute stroke and dysphagia who were admitted to Ankara City Hospital Neurology Clinic and diagnosed with stroke by neurology and who did not meet the exclusion criteria will be included in this study. When the patients are admitted to the neurology clinic and will be discharged, they will be evaluated three times, in the first month after discharge.
Read the detailed description
Stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. Dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.The aim of this study is to evaluate the clinical evaluation of swallowing in stroke patients and to determine the factors affecting the severity and prognosis of dysphagia in patients with dysphagia.Fifty-five patients with acute stroke and dysphagia who were admitted to Ankara City Hospital Neurology Clinic and diagnosed with stroke by neurology and who did not meet the exclusion criteria will be included in this study. When the patients are admitted to the neurology clinic and will be discharged, they will be evaluated three times, in the first month after discharge. Clinical evaluations will be made by the responsible investigator in the examination room. Patients will be evaluated with a bedside swallowing screening test. Patients will be divided into 3 groups as mild, moderate and severe dysphagia according to the test. The patients will be evaluated while they are in the neurology clinic and 1 month after the treatment is given.
- Conditions
- Stroke, Acute
- Being tested
- Exercises for dysphagia rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises for dysphagia rehabilitationOther
Diet modifications, postural exercises, compensatory exercises, swallowing exercises
| Study group | Role | What they receive |
|---|---|---|
| Mild dysphagia | Active comparator | Not described Receives: Other: Exercises for dysphagia rehabilitation |
| Moderate dysphagia | Active comparator | Not described Receives: Other: Exercises for dysphagia rehabilitation |
| Severe dysphagia | Active comparator | Not described Receives: Other: Exercises for dysphagia rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gugging swallowing screening test
The gugging test is a validated test in the assessment of bedside swallowing. This test was defined as 20 points (no dysphagia), 15-19 (mild dysphagia), 10-14 (moderate dysphagia) and 9 points or less (severe dysphagia).
Measured: Change from Baseline Gugging swallowing screening test at 1 months
Eating assessment tool-10
The eating assessment tool-10 is a test that evaluates dysphagia symptoms and severity without any food intake. This test is a test consisting of 10 questions in total and scoring the questions between "no problem" and "serious problem". As the score increases, the severity of dysphagia increases.
Measured: Change from Baseline Gugging swallowing screening test at 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazife Kapan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazife Kapan, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739514
- Sponsor's protocol ID
- AŞH-NK-TEZ
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Broadley S, Cheek A, Salonikis S, Whitham E, Chong V, Cardone D, Alexander B, Taylor J, Thompson P. Predicting prolonged dysphagia in acute stroke: the Royal Adelaide Prognostic Index for Dysphagic Stroke (RAPIDS). Dysphagia. 2005 Fall;20(4):303-10. doi: 10.1007/s00455-005-0032-y.
PubMed 16633876Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
PubMed 28122885
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients
- ClinicalTrials.gov ID
- NCT04739514
- Acronym / sponsor ID
- AŞH-NK-TEZ
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Nazife KapanUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 4 Feb 2021 (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.
Stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. Dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.The aim of this study is to evaluate the clinical evaluation of swallowing in stroke patients and to determine the factors affecting the severity and prognosis of dysphagia in patients with dysphagia.Fifty-five patients with acute stroke and dysphagia who were admitted to Ankara City Hospital Neurology Clinic and diagnosed with stroke by neurology and who did not meet the exclusion criteria will be included in this study. When the patients are admitted to the neurology clinic and will be discharged, they will be evaluated three times, in the first month after discharge.
Detailed description
Stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. Dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.The aim of this study is to evaluate the clinical evaluation of swallowing in stroke patients and to determine the factors affecting the severity and prognosis of dysphagia in patients with dysphagia.Fifty-five patients with acute stroke and dysphagia who were admitted to Ankara City Hospital Neurology Clinic and diagnosed with stroke by neurology and who did not meet the exclusion criteria will be included in this study. When the patients are admitted to the neurology clinic and will be discharged, they will be evaluated three times, in the first month after discharge. Clinical evaluations will be made by the responsible investigator in the examination room. Patients will be evaluated with a bedside swallowing screening test. Patients will be divided into 3 groups as mild, moderate and severe dysphagia according to the test. The patients will be evaluated while they are in the neurology clinic and 1 month after the treatment is given.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild dysphagia | Active comparator | Other: Exercises for dysphagia rehabilitation |
| Moderate dysphagia | Active comparator | Other: Exercises for dysphagia rehabilitation |
| Severe dysphagia | Active comparator | Other: Exercises for dysphagia rehabilitation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with acute stroke by neurology
- Having trouble swallowing
- 18-85 years old, volunteers
Key exclusion criteria (4 listed)
- Unconscious
- Uncooperative
- Those with oropharyngeal structural damage
- Patients with malignancies involving the head and neck region
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 |
|---|---|---|
| Exercises for dysphagia rehabilitationDiet modifications, postural exercises, compensatory exercises, swallowing exercises | Other | Mild dysphagia, Moderate dysphagia, Severe dysphagia |
Primary outcome
Gugging swallowing screening test
Time frame: Change from Baseline Gugging swallowing screening test at 1 months
The gugging test is a validated test in the assessment of bedside swallowing. This test was defined as 20 points (no dysphagia), 15-19 (mild dysphagia), 10-14 (moderate dysphagia) and 9 points or less (severe dysphagia).
Eating assessment tool-10
Time frame: Change from Baseline Gugging swallowing screening test at 1 months
The eating assessment tool-10 is a test that evaluates dysphagia symptoms and severity without any food intake. This test is a test consisting of 10 questions in total and scoring the questions between "no problem" and "serious problem". As the score increases, the severity of dysphagia increases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 16633876Broadley S, Cheek A, Salonikis S, Whitham E, Chong V, Cardone D, Alexander B, Taylor J, Thompson P. Predicting prolonged dysphagia in acute stroke: the Royal Adelaide Prognostic Index for Dysphagic Stroke (RAPIDS). Dysphagia. 2005 Fall;20(4):303-10. doi: 10.1007/s00455-005-0032-y.
- Results publication: PubMed 28122885Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises for dysphagia rehabilitation in people with Stroke, Acute, run by Nazife Kapan 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazife K Kapan, Dr. (03125526000, nazifekapan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gugging swallowing screening test (time frame: Change from Baseline Gugging swallowing screening test at 1 months). The study lists 2 primary outcomes in all. 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 NCT04739514, which also lists 2 linked publications.
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 4 Feb 2021.