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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expiratory muscle training group | Experimental | Daily expiratory muscle training for four weeks will be applied. |
|
| Control group | No Intervention | Nothing will be applied except for the hospital conventional physiotherapy program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expiratory muscle training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ömer Dursun, MSc | Abant Izzet Baysal University | Principal Investigator |
| Tamer Çankaya, PhD | Abant Izzet Baysal University | Principal Investigator |
| Erdal Dilekçi, MD | Abant Izzet Baysal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital | Bolu | 14020 | Turkey (Türkiye) | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8756819 | Background | 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. | |
| 7717830 | Background | Finestone 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. |
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Patients who had the following situations were excluded from the study; stroke onset of time higher than 3 months, hemorrhagic stroke, cooperation problem, age of 64 or younger, denial of participation to the study, head and/or neck surgery existence, discharge, free of temporomandibular joint dysfunction, existence of infection, incisor and/or canin tooth absence, quarantine, insufficient mastication.
Patients recruited from İzzet Baysal Physical Therapy Education and Research Hospital between 18.08.2020 and 06.09.2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Expiratory Muscle Training Group | Daily expiratory muscle training for three weeks with 50 repetition was applied to the experimental group. |
| FG001 | Control Group | Nothing applied except for the hospital conventional physiotherapy program. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Expiratory Muscle Training Group | Daily expiratory muscle training for three weeks with 50 repetition was applied to the experimental group. |
| BG001 | Control Group | Nothing applied except for the hospital conventional physiotherapy program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of masticated peanuts | Two measurements: At the beginning and after three weeks |
|
During the patient specific time frame which is 3 weeks no adverse event has occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Expiratory Muscle Training Group | Consisted of stroke patients using the expiratory muscle training device. |
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Due to COVID-19 pandemic, portable maximum expiratory pressure measurement device couldn't be used for this reason expiratory muscle device was calibrated based on patients' subjective feedback.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamer ÇANKAYA | Bolu Abant İzzet Baysal University | 5335519171 | +90 | tamercankaya@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2020 | Jun 20, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2020 | Jun 20, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2020 | Jun 20, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D013705 | Temporomandibular Joint Disorders |
| D003680 | Deglutition Disorders |
| D009057 | Stomatognathic Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Two groups as an intervention and control.
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Outcome measures will be performed by an another investigator.
|
| 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. | 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. | 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. | 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. | 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 | 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. | Two measurements: At the beginning and after three weeks |
| 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. | Two measurements: At the beginning and after three weeks |
| Bolu Abant İzzet Baysal University |
| Bolu |
| 14280 |
| Turkey (Türkiye) |
| 11054135 | Background | Khedr 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. |
| 26180145 | Background | Messaggi-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. |
| 17132052 | Background | Mathers 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. |
| 20813995 | Background | Miller 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. |
| 18780882 | Background | Yelnik 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. |
| 14684785 | Background | Sommerfeld 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. |
| 29650380 | Background | Dursun 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. |
| Time of stroke onset |
|
| Type of strokr |
|
| Cooperation |
|
| Age interval |
|
| Denial of participation to the study |
|
| Free of temporomandibular joint dysfunction |
|
| Lack of incisor and/or canin tooth |
|
| Quarantine |
|
| Previous recruitment to the expiratory muscle training |
|
| Repetitive stroke |
|
| Insufficient mastication |
|
| Infection |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Control Group | Nothing will be applied except for the hospital conventional physiotherapy program. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | milimeter | Two measurements: At the beginning and after three weeks |
|
|
|
| Primary | 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. | Posted | Median | Full Range | Score on index | Two measurements: At the beginning and after three weeks |
|
|
|
| Primary | 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. | Posted | Median | Full Range | score on a scale | Two measurements: At the beginning and after three weeks |
|
|
|
| Primary | 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. | Posted | Median | Full Range | kilogram | Two measurements: At the beginning and after three weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | degree | Two measurements: At the beginning and after three weeks |
|
|
|
| Primary | Change in Repeated Saliva Swallow Test | Patients will be asked to swallow their saliva as much as they can do in thirty seconds. | Posted | Median | Full Range | mililiter | Two measurements: At the beginning and after three weeks |
|
|
|
| Primary | 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. | Posted | Median | Full Range | score on a scale | Two measurements: At the beginning and after three weeks |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | pH | Two measurements: At the beginning and after three weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | second | Two measurements: At the beginning and after three weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At the enrollment process |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | degree | Two measurements: At the beginning and after three weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Control Group | Stroke patients that have enrolled to the hospital conventional physiotherapy program. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Left lateral deviation first measurement |
|
| Left lateral deviation last measurement |
|
| Right lateral deviation first measurement |
|
| Right lateral deviation last measurement |
|
| Protrusion first measurement |
|
| Protrusion last measurement |
|
| Left anterior temporalis first measurement |
|
| Left anterior temporalis last measurement |
|
| Right middle temporalis first measurement |
|
| Right middle temporalis last measurement |
|
| Left middle temporalis first measurement |
|
| Left middle temporalis last measurement |
|
| Right anterior masseter first measurement |
|
| Right anterior masseter last measurement |
|
| Left anterior masseter first measurement |
|
| Left anterior masseter last measurement |
|
| Right inferior masseter first measurement |
|
| Right inferior masseter last measurement |
|
| Left inferior masseter first measurement |
|
| Left inferior masseter last measurement |
|