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Expiratory Muscle Training in Stroke

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ClinicalTrials.gov Identifier: NCT04569968
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Mastication Disorder Temporomandibular Disorders Dysphagia Stomatognathic Diseases Other: Expiratory muscle training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups as an intervention and control.
Masking: Single (Outcomes Assessor)
Masking Description: Outcome measures will be performed by an another investigator.
Primary Purpose: Treatment
Official Title: Effect of Expiratory Muscle Training on Stomatognathic System in Patients With Stroke
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 1, 2021

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.



Primary Outcome Measures :
  1. Change in masticatory performance index [ Time Frame: Two measurements: At the beginning and after four 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 the masticatory performance index.

  2. Change in temporomandibular range of motion measurement [ Time Frame: Two measurements: At the beginning and after four 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.

  3. Change in general oral health assessment index [ Time Frame: Two measurements: At the beginning and after four 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.

  4. Change in eating assessment tool (EAT-10) [ Time Frame: Two measurements: At the beginning and after four 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.

  5. Change in pain pressure threshold of the masticatory muscles [ Time Frame: Two measurements: At the beginning and after four 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.

  6. Change in craniocervical angle measurement [ Time Frame: Two measurements: At the beginning and after four 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.

  7. Change in repeated saliva swallow test [ Time Frame: Two measurements: At the beginning and after four weeks ]
    Patients will be asked to swallow their saliva as much as they can do in thirty seconds.

  8. Change in Fonseca Questionnaire [ Time Frame: Two measurements: At the beginning and after four 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. 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.

  9. Change in intraoral pH measurement [ Time Frame: Two measurements: At the beginning and after four weeks ]
    Saliva of the patients will be collected between 9:00-11:00 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

  10. Change in neck flexor endurance test [ Time Frame: Two measurements: At the beginning and after four 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 :
  1. Mini mental test [ Time Frame: At the enrollment process ]
    Mini mental test that consist of eleven articles will be used to assess whether the patients' mental state meets for the study enrollment. Cut off point of the test is 24 or higher.

  2. Change in labial commissure angle [ Time Frame: Two measurements: At the beginning and after four 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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569968


Contacts
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Contact: Ömer Dursun, MSc +905426088687 fztomrdrsn@gmail.com
Contact: Tamer Çankaya, PhD +905335519771 tamercankaya@hotmail.com

Locations
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Turkey
İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital Recruiting
Bolu, Turkey, 14020
Contact: Erdal Dilekçi    +905326486161    erdaldilekci@hotmail.com   
Bolu Abant İzzet Baysal University Not yet recruiting
Bolu, Turkey, 14280
Contact: Tamer Çankaya, PhD    +905335519171    tamercankaya@hotmail.com   
Contact: Ömer Dursun, MSc    +905426088687    fztomrdrsn@gmail.com   
Sub-Investigator: Erdal Dilekçi, MD         
Principal Investigator: Ömer Dursun, MSc         
Principal Investigator: Tamer Çankaya, PhD         
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
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Principal Investigator: Ömer Dursun, MSc Bolu Abant İzzet Baysal University
Principal Investigator: Tamer Çankaya, PhD Bolu Abant İzzet Baysal University
Principal Investigator: Erdal Dilekçi, MD Bolu Abant İzzet Baysal University
Publications:

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Responsible Party: Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT04569968    
Other Study ID Numbers: BAIBU-FTR-ÖD-01
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abant Izzet Baysal University:
Stroke
Mastication
Dysphagia
Temporomandibular joint
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Deglutition Disorders
Stomatognathic Diseases
Stroke
Disease
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Myofascial Pain Syndromes