Expiratory Muscle Training in Stroke

Effect of Expiratory Muscle Training on Stomatognathic System in Patients With Stroke

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04569968

Enrollment

146

Registered

2020-09-30

Start date

2020-08-18

Completion date

2021-11-03

Last updated

2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Mastication Disorder, Stomatognathic Diseases, Stroke, Temporomandibular Disorders

Keywords

Stroke, Mastication, Dysphagia, Temporomandibular joint

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.

Interventions

OTHERExpiratory muscle training

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 design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Outcome measures will be performed by an another investigator.

Intervention model description

Two groups as an intervention and control.

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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 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.

Secondary

Measure	Time frame	Description
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.
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.

Countries

Turkey (Türkiye)

Participant flow

Recruitment details

Patients recruited from İzzet Baysal Physical Therapy Education and Research Hospital between 18.08.2020 and 06.09.2021.

Pre-assignment details

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.

Participants by arm

Arm	Count
Expiratory Muscle Training Group Daily expiratory muscle training for three weeks with 50 repetition was applied to the experimental group.	15
Control Group Nothing applied except for the hospital conventional physiotherapy program.	16
Total	31

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Age interval	17	6
Overall Study	Cooperation	8	8
Overall Study	Denial of participation to the study	0	3
Overall Study	Free of temporomandibular joint dysfunction	4	2
Overall Study	Infection	1	0
Overall Study	Insufficient mastication	1	0
Overall Study	Lack of incisor and/or canin tooth	5	3
Overall Study	Lost to Follow-up	2	5
Overall Study	Previous recruitment to the expiratory muscle training	2	0
Overall Study	Quarantine	1	0
Overall Study	Repetitive stroke	8	0
Overall Study	Story of head and/or neck surgery	2	2
Overall Study	Time of stroke onset	8	7
Overall Study	Type of strokr	12	8

Baseline characteristics

Characteristic	Expiratory Muscle Training Group	Control Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	5 Participants	9 Participants	14 Participants
Age, Categorical Between 18 and 65 years	10 Participants	7 Participants	17 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	4 Participants	9 Participants	13 Participants
Sex: Female, Male Male	11 Participants	7 Participants	18 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 15	0 / 16
other Total, other adverse events	0 / 15	0 / 16
serious Total, serious adverse events	0 / 15	0 / 16

Outcome results

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.