StrokeNCT04569968
Expiratory Muscle Training in Stroke
A study testing Expiratory muscle training in people with Stroke and Mastication Disorder, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
Trial summary
Stroke affects the vital activities of daily living such as breathing and swallowing. After stroke excursion of the diaphragm reduces about 50%, and also the maximum expiratory pressure of the individual 50% or higher. Dysphagia occurs in 29% to 45% of the acute stroke cases. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke, Mastication Disorder, Temporomandibular Disorders
- What is being tested?
- Expiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Aug 2020to 3 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mini mental score is 24 or higher
- 55 years of age or higher
- Currently not taking respiratory muscle training
- Fonseca Questionnaire score is 20 or higher
- Onset of stroke is between 3 months and 5 years
Who cannot join
- Developed dysphagia caused by other diseases rather than stroke
- Repetitive stroke story
- Cancer in head and neck region
- Abdominal or thoracic surgery story
- Existence of neurodegenerative disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
Bolu, 14020
Bolu Abant İzzet Baysal University
Bolu, 14280
About this study
Official title: Effect of Expiratory Muscle Training on Stomatognathic System in Patients With Stroke
Stroke affects the vital activities of daily living such as breathing and swallowing. After stroke excursion of the diaphragm reduces about 50%, and also the maximum expiratory pressure of the individual 50% or higher. Dysphagia occurs in 29% to 45% of the acute stroke cases.
Read the detailed description
As a third leading cause of death and one of the major causes of disability, stroke still maintain its bad reputation in worldwide. Stroke owes its fame on wide range of symptoms mostly the musculoskeletal system symptoms such as spasticity, equilibrium and gait problems. Although mentioned symptoms keep their popularity devious two dysfunction caused by stroke; stomatognathic system dysfunction and respiratory dysfunction appears to change this equation. Considering the high incidence of dysphagia and the reduced cardiopulmonary capacity of the stroke patients, it seems inevitable. From this perspective aim of this study is to assess the effect of expiratory muscle training on the stomatognathic system in patients with stroke and as mentioned aid to shatter the mentioned equation.
- Conditions
- Stroke, Mastication Disorder, Temporomandibular Disorders, Dysphagia, Stomatognathic Diseases
- Being tested
- Expiratory muscle training
- Keywords
- Stroke, Mastication, Dysphagia, Temporomandibular joint
- Medical subject headings
- Stroke, Temporomandibular Joint Disorders, Deglutition Disorders, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory muscle trainingOther
For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
| Study group | Role | What they receive |
|---|---|---|
| Expiratory muscle training group | Experimental | Daily expiratory muscle training for four weeks will be applied. Receives: Other: Expiratory muscle training |
| Control group | No intervention | Nothing will be applied except for the hospital conventional physiotherapy program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Masticatory Performance
To assess masticatory performance of the patients, patients will be asked to chew 3 gr of peanuts with 20 chewing stroke and then spit on a sieve with 10 mesh and 1700 µm width. Then the residue will be collected and put into the centrifuge tube. After that residue will be centrifuged for 3 minutes with 1500 rpm. Same procedure will be used for the sieved content. Then this two values will be divided and recorded as a percentage for the calculation masticatory performance index.
Measured: Two measurements: At the beginning and after three weeks
Change in Temporomandibular Range of Motion Measurement
Mandibular depression, protrusion and bilateral lateral deviation of the patients will be performed by a digital caliper. All measurements will be taken while the patients are seated with their head supported. Digital caliper will be positioned in central incisors for the mandibular depression and the protrusion. For lateral deviation first upper central incisor location in relation to the lower central incisor will be drawn by a biocompatible pen then measurement will be performed. After that, a second drawing made. Then the horizontal distance between these two points will be measured for the lateral deviation range of motion. Reference values for mandibular depression, protrusion and the lateral deviation are as follows: 40 mm, 6 mm, and 8 mm.
Measured: Two measurements: At the beginning and after three weeks
Change in General Oral Health Assessment Index
Oral health of the patients will be assessed with general oral health assessment index. Index consists of twelve questions. Answers of these twelve questions makes up the total score. Minimum and maximum scores of the index are 12 and 60 points. Higher total scores mean higher risk of losing the general oral health.
Measured: Two measurements: At the beginning and after three weeks
Change in Eating Assessment Tool (EAT-10)
Swallowing quality of the patients will be assessed with eating assessment tool (EAT-10). the tool has ten questions and the total score of the tool is 40 points. Minimum score is 0 point and the maximum score is 40 point. Higher total scores mean higher risk of losing the general oral health.
Measured: Two measurements: At the beginning and after three weeks
Change in Pain Pressure Threshold of the Masticatory Muscles
Two points in the masseter muscle and two points at the temporalis muscle, in total four points will be measured for the pain pressure threshold assessment. Measurements will be taken four times from every point with two-minute intervals. Due to first measurement values are generally high, average of the last three measurements will be calculated and recorded.
Measured: Two measurements: At the beginning and after three weeks
Change in Craniocervical Angle Measurement
Measurement will be taken while the patients are seated and their head in natural position. After that photos of the patients will be taken and then processus spinosus of the C7 and the tragus of the ear will be marked. After that, the angle between those to marking will be measured by the protractor.
Measured: Two measurements: At the beginning and after three weeks
Change in Repeated Saliva Swallow Test
Patients will be asked to swallow their saliva as much as they can do in thirty seconds.
Measured: Two measurements: At the beginning and after three weeks
Change in Fonseca Questionnaire
Temporomandibular joint dysfunction existence and its severity will be assessed with Fonseca Questionnaire. Questionnaire includes 10 questions with yes, sometimes and no answers matching with 10, 5, and 0 point. Total score of the questionnaire is 100 point. Categorization of dysfunction by the questionnaire as follows; 70-100 point: severe dysfunction, 45-65: moderate dysfunction, 20-40: mild dysfunction and 0-15: has no dysfunction at all.
Measured: Two measurements: At the beginning and after three weeks
Change in Intraoral pH Measurement
Saliva of the patients will be collected between 08:00-12:00 am. After the saliva collected in centrifuge tube reaches 5 ml, collection process will be stopped and immediately pH of the saliva measured with two decimal digital pH meter
Measured: Two measurements: At the beginning and after three weeks
Change in Neck Flexor Endurance Test
Test will be performed while the patients are in supine position. After the position is taken patient will be asked to elevate their head about one inch and keep it that way as much as they can do. The period that passes from starting to the positional alteration will be recorded as the test score.
Measured: Two measurements: At the beginning and after three weeks
Secondary outcomes (2)
Mini Mental State Exame Test
Mini mental state exam test that consist of eleven articles will be used to assess whether the patients' mental state meets for the study enrollment. Total score is maximum 30 point. Lower score characterized with cognitive dysfunction. Cut off point of the test is 24 point or higher which means no cognitive impairment. 18 to 23 point means mild cognitive dysfunction. Total score below the 18 point means severe cognitive dusfunction. Minimum score is zero maximum score is 30.
Measured: At the enrollment process
Change in Labial Commissure Angle
Facial asymmetry of the patients will be assessed with labial commissure angle measurements. Black and white photos of the patients will be taken while the patients are in a seating position. Then photo will be printed in A5 sheet. After that, the angle between bilateral labial commissures, glabella, and the mental protuberance will be measured. Reference value of the labial commissure angle is approximately 90 degrees.
Measured: Two measurements: At the beginning and after three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start18 Aug 2020
- Primary completion9 Sep 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Model description
- Two groups as an intervention and control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ömer Dursun, MSc, Principal investigator, Abant Izzet Baysal UniversityTamer Çankaya, PhD, Principal investigator, Abant Izzet Baysal UniversityErdal Dilekçi, MD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569968
- Sponsor's protocol ID
- BAIBU-FTR-ÖD-01
- Status last verified
- Jun 2022
- First submitted
- 26 Aug 2020
- Last updated
- 31 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Similowski T, Catala M, Rancurel G, Derenne JP. Impairment of central motor conduction to the diaphragm in stroke. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):436-41. doi: 10.1164/ajrccm.154.2.8756819.
PubMed 8756819Finestone HM, Greene-Finestone LS, Wilson ES, Teasell RW. Malnutrition in stroke patients on the rehabilitation service and at follow-up: prevalence and predictors. Arch Phys Med Rehabil. 1995 Apr;76(4):310-6. doi: 10.1016/s0003-9993(95)80655-5.
PubMed 7717830Khedr EM, El Shinawy O, Khedr T, Abdel aziz ali Y, Awad EM. Assessment of corticodiaphragmatic pathway and pulmonary function in acute ischemic stroke patients. Eur J Neurol. 2000 Sep;7(5):509-16. doi: 10.1046/j.1468-1331.2000.00104.x.
PubMed 11054135Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15.
PubMed 26180145Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
PubMed 17132052Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
PubMed 20813995Yelnik AP, Le Breton F, Colle FM, Bonan IV, Hugeron C, Egal V, Lebomin E, Regnaux JP, Perennou D, Vicaut E. Rehabilitation of balance after stroke with multisensorial training: a single-blind randomized controlled study. Neurorehabil Neural Repair. 2008 Sep-Oct;22(5):468-76. doi: 10.1177/1545968308315996.
PubMed 18780882Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
PubMed 14684785Dursun O, Cankaya T. Assessment of Temporomandibular Joint Dysfunction in Patients with Stroke. J Stroke Cerebrovasc Dis. 2018 Aug;27(8):2141-2146. doi: 10.1016/j.jstrokecerebrovasdis.2018.03.007. Epub 2018 Apr 9.
PubMed 29650380
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Expiratory Muscle Training on Stomatognathic System in Patients With Stroke
- ClinicalTrials.gov ID
- NCT04569968
- Acronym / sponsor ID
- BAIBU-FTR-ÖD-01
- Conditions
- Stroke, Mastication Disorder, Temporomandibular Disorders, Dysphagia, Stomatognathic Diseases
- Keywords
- Stroke, Mastication, Dysphagia, Temporomandibular joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Posted 31 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke affects the vital activities of daily living such as breathing and swallowing. After stroke excursion of the diaphragm reduces about 50%, and also the maximum expiratory pressure of the individual 50% or higher. Dysphagia occurs in 29% to 45% of the acute stroke cases.
Detailed description
As a third leading cause of death and one of the major causes of disability, stroke still maintain its bad reputation in worldwide. Stroke owes its fame on wide range of symptoms mostly the musculoskeletal system symptoms such as spasticity, equilibrium and gait problems. Although mentioned symptoms keep their popularity devious two dysfunction caused by stroke; stomatognathic system dysfunction and respiratory dysfunction appears to change this equation. Considering the high incidence of dysphagia and the reduced cardiopulmonary capacity of the stroke patients, it seems inevitable. From this perspective aim of this study is to assess the effect of expiratory muscle training on the stomatognathic system in patients with stroke and as mentioned aid to shatter the mentioned equation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups as an intervention and control.
| Arm | Type | Receives |
|---|---|---|
| Expiratory muscle training group | Experimental | Other: Expiratory muscle trainingDaily expiratory muscle training for four weeks will be applied. |
| Control group | No intervention | –Nothing will be applied except for the hospital conventional physiotherapy program. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mini mental score is 24 or higher
- 55 years of age or higher
- Currently not taking respiratory muscle training
- Fonseca Questionnaire score is 20 or higher
- Onset of stroke is between 3 months and 5 years
Key exclusion criteria (5 listed)
- Developed dysphagia caused by other diseases rather than stroke
- Repetitive stroke story
- Cancer in head and neck region
- Abdominal or thoracic surgery story
- Existence of neurodegenerative disease
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 |
|---|---|---|
| Expiratory muscle trainingFor training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer. | Other | Expiratory muscle training group |
Primary outcome
Change in Masticatory Performance
Time frame: Two measurements: At the beginning and after three weeks
To assess masticatory performance of the patients, patients will be asked to chew 3 gr of peanuts with 20 chewing stroke and then spit on a sieve with 10 mesh and 1700 µm width. Then the residue will be collected and put into the centrifuge tube. After that residue will be centrifuged for 3 minutes with 1500 rpm. Same procedure will be used for the sieved content. Then this two values will be divided and recorded as a percentage for the calculation masticatory performance index.
Change in Temporomandibular Range of Motion Measurement
Time frame: Two measurements: At the beginning and after three weeks
Mandibular depression, protrusion and bilateral lateral deviation of the patients will be performed by a digital caliper. All measurements will be taken while the patients are seated with their head supported. Digital caliper will be positioned in central incisors for the mandibular depression and the protrusion. For lateral deviation first upper central incisor location in relation to the lower central incisor will be drawn by a biocompatible pen then measurement will be performed. After that, a second drawing made. Then the horizontal distance between these two points will be measured for the lateral deviation range of motion. Reference values for mandibular depression, protrusion and the lateral deviation are as follows: 40 mm, 6 mm, and 8 mm.
Change in General Oral Health Assessment Index
Time frame: Two measurements: At the beginning and after three weeks
Oral health of the patients will be assessed with general oral health assessment index. Index consists of twelve questions. Answers of these twelve questions makes up the total score. Minimum and maximum scores of the index are 12 and 60 points. Higher total scores mean higher risk of losing the general oral health.
Change in Eating Assessment Tool (EAT-10)
Time frame: Two measurements: At the beginning and after three weeks
Swallowing quality of the patients will be assessed with eating assessment tool (EAT-10). the tool has ten questions and the total score of the tool is 40 points. Minimum score is 0 point and the maximum score is 40 point. Higher total scores mean higher risk of losing the general oral health.
Change in Pain Pressure Threshold of the Masticatory Muscles
Time frame: Two measurements: At the beginning and after three weeks
Two points in the masseter muscle and two points at the temporalis muscle, in total four points will be measured for the pain pressure threshold assessment. Measurements will be taken four times from every point with two-minute intervals. Due to first measurement values are generally high, average of the last three measurements will be calculated and recorded.
Change in Craniocervical Angle Measurement
Time frame: Two measurements: At the beginning and after three weeks
Measurement will be taken while the patients are seated and their head in natural position. After that photos of the patients will be taken and then processus spinosus of the C7 and the tragus of the ear will be marked. After that, the angle between those to marking will be measured by the protractor.
Change in Repeated Saliva Swallow Test
Time frame: Two measurements: At the beginning and after three weeks
Patients will be asked to swallow their saliva as much as they can do in thirty seconds.
Change in Fonseca Questionnaire
Time frame: Two measurements: At the beginning and after three weeks
Temporomandibular joint dysfunction existence and its severity will be assessed with Fonseca Questionnaire. Questionnaire includes 10 questions with yes, sometimes and no answers matching with 10, 5, and 0 point. Total score of the questionnaire is 100 point. Categorization of dysfunction by the questionnaire as follows; 70-100 point: severe dysfunction, 45-65: moderate dysfunction, 20-40: mild dysfunction and 0-15: has no dysfunction at all.
Change in Intraoral pH Measurement
Time frame: Two measurements: At the beginning and after three weeks
Saliva of the patients will be collected between 08:00-12:00 am. After the saliva collected in centrifuge tube reaches 5 ml, collection process will be stopped and immediately pH of the saliva measured with two decimal digital pH meter
Change in Neck Flexor Endurance Test
Time frame: Two measurements: At the beginning and after three weeks
Test will be performed while the patients are in supine position. After the position is taken patient will be asked to elevate their head about one inch and keep it that way as much as they can do. The period that passes from starting to the positional alteration will be recorded as the test score.
2 secondary outcomes
Mini Mental State Exame Test
Time frame: At the enrollment process
Change in Labial Commissure Angle
Time frame: Two measurements: At the beginning and after three weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8756819Similowski T, Catala M, Rancurel G, Derenne JP. Impairment of central motor conduction to the diaphragm in stroke. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):436-41. doi: 10.1164/ajrccm.154.2.8756819.
- Background: PubMed 7717830Finestone HM, Greene-Finestone LS, Wilson ES, Teasell RW. Malnutrition in stroke patients on the rehabilitation service and at follow-up: prevalence and predictors. Arch Phys Med Rehabil. 1995 Apr;76(4):310-6. doi: 10.1016/s0003-9993(95)80655-5.
- Background: PubMed 11054135Khedr EM, El Shinawy O, Khedr T, Abdel aziz ali Y, Awad EM. Assessment of corticodiaphragmatic pathway and pulmonary function in acute ischemic stroke patients. Eur J Neurol. 2000 Sep;7(5):509-16. doi: 10.1046/j.1468-1331.2000.00104.x.
- Background: PubMed 26180145Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15.
- Background: PubMed 17132052Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
- Background: PubMed 20813995Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
- Background: PubMed 18780882Yelnik AP, Le Breton F, Colle FM, Bonan IV, Hugeron C, Egal V, Lebomin E, Regnaux JP, Perennou D, Vicaut E. Rehabilitation of balance after stroke with multisensorial training: a single-blind randomized controlled study. Neurorehabil Neural Repair. 2008 Sep-Oct;22(5):468-76. doi: 10.1177/1545968308315996.
- Background: PubMed 14684785Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
- Background: PubMed 29650380Dursun O, Cankaya T. Assessment of Temporomandibular Joint Dysfunction in Patients with Stroke. J Stroke Cerebrovasc Dis. 2018 Aug;27(8):2141-2146. doi: 10.1016/j.jstrokecerebrovasdis.2018.03.007. Epub 2018 Apr 9.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
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.
Ömer Dursun, MSc principal investigator
Abant Izzet Baysal University
Tamer Çankaya, PhD principal investigator
Abant Izzet Baysal University
Erdal Dilekçi, MD principal investigator
Abant Izzet Baysal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory muscle training in people with Stroke and Mastication Disorder, run by Abant Izzet Baysal University at 2 sites 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 5 inclusion and 5 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Masticatory Performance (time frame: Two measurements: At the beginning and after three weeks). The study lists 10 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 NCT04569968, which also lists 9 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 31 Mar 2023.