Expiratory Muscle Training in Stroke

Not Applicable

Completed

Conditions: Stomatognathic Diseases
Temporomandibular Disorders
Dysphagia
Stroke
Mastication Disorder

Interventions: Other: Expiratory muscle training

Registration Number: NCT04569968

Lead Sponsor: Abant Izzet Baysal University

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 146

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expiratory muscle training group	Expiratory muscle training	Daily expiratory muscle training for four weeks will be applied.

Primary Outcome Measures

Name	Time	Method
Change in Masticatory Performance	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	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	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)	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	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	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Mini Mental State Exame Test	At the enrollment process	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.
Change in Labial Commissure Angle	Two measurements: At the beginning and after three weeks	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.

Trial Locations

Locations (2): İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
🇹🇷
Bolu, Turkey
Bolu Abant İzzet Baysal University
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Bolu, Turkey