Expiratory Muscle Training in Stroke

June 20, 2022 updated by: Abant Izzet Baysal University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bolu, Turkey, 14280
        • Bolu abant Izzet Baysal University
      • Bolu, Turkey, 14020
        • Izzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Expiratory muscle training group
Daily expiratory muscle training for four weeks will be applied.
Other: Expiratory 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.
No Intervention: Control group
Nothing will be applied except for the hospital conventional physiotherapy program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two measurements: At the beginning and after three weeks
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.
Two measurements: At the beginning and after three weeks
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.
Two measurements: At the beginning and after three weeks
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.
Two measurements: At the beginning and after three weeks
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.
Two measurements: At the beginning and after three weeks
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.
Two measurements: At the beginning and after three weeks
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.
Two measurements: At the beginning and after three weeks
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.
Two measurements: At the beginning and after three weeks
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
Two measurements: At the beginning and after three weeks
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.
Two measurements: At the beginning and after three weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Investigators

  • Principal Investigator: Ömer Dursun, MSc, Bolu abant Izzet Baysal University
  • Principal Investigator: Tamer Çankaya, PhD, Bolu abant Izzet Baysal University
  • Principal Investigator: Erdal Dilekçi, MD, Bolu abant Izzet Baysal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2020

Primary Completion (Actual)

September 9, 2021

Study Completion (Actual)

November 3, 2021

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAIBU-FTR-ÖD-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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