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Expiratory Muscle Training in Stroke

Primary Purpose

Stroke, Mastication Disorder, Temporomandibular Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Expiratory muscle training
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Mastication, Dysphagia, Temporomandibular joint

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
  • Bolu Abant İzzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Expiratory muscle training group

Control group

Arm Description

Daily expiratory muscle training for four weeks will be applied.

Nothing will be applied except for the hospital conventional physiotherapy program.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
Change in Repeated Saliva Swallow Test
Patients will be asked to swallow their saliva as much as they can do in thirty seconds.
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.
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
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 26, 2020
Last Updated
June 20, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04569968
Brief Title
Expiratory Muscle Training in Stroke
Official Title
Effect of Expiratory Muscle Training on Stomatognathic System in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
September 9, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Mastication Disorder, Temporomandibular Disorders, Dysphagia, Stomatognathic Diseases
Keywords
Stroke, Mastication, Dysphagia, Temporomandibular joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups as an intervention and control.
Masking
Outcomes Assessor
Masking Description
Outcome measures will be performed by an another investigator.
Allocation
Non-Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expiratory muscle training group
Arm Type
Experimental
Arm Description
Daily expiratory muscle training for four weeks will be applied.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Nothing will be applied except for the hospital conventional physiotherapy program.
Intervention Type
Other
Intervention Name(s)
Expiratory muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Masticatory Performance
Description
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.
Time Frame
Two measurements: At the beginning and after three weeks
Title
Change in Temporomandibular Range of Motion Measurement
Description
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.
Time Frame
Two measurements: At the beginning and after three weeks
Title
Change in General Oral Health Assessment Index
Description
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.
Time Frame
Two measurements: At the beginning and after three weeks
Title
Change in Eating Assessment Tool (EAT-10)
Description
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.
Time Frame
Two measurements: At the beginning and after three weeks
Title
Change in Pain Pressure Threshold of the Masticatory Muscles
Description
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.
Time Frame
Two measurements: At the beginning and after three weeks
Title
Change in Craniocervical Angle Measurement
Description
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.
Time Frame
Two measurements: At the beginning and after three weeks
Title
Change in Repeated Saliva Swallow Test
Description
Patients will be asked to swallow their saliva as much as they can do in thirty seconds.
Time Frame
Two measurements: At the beginning and after three weeks
Title
Change in Fonseca Questionnaire
Description
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.
Time Frame
Two measurements: At the beginning and after three weeks
Title
Change in Intraoral pH Measurement
Description
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
Time Frame
Two measurements: At the beginning and after three weeks
Title
Change in Neck Flexor Endurance Test
Description
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.
Time Frame
Two measurements: At the beginning and after three weeks
Secondary Outcome Measure Information:
Title
Mini Mental State Exame Test
Description
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.
Time Frame
At the enrollment process
Title
Change in Labial Commissure Angle
Description
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.
Time Frame
Two measurements: At the beginning and after three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer Dursun, MSc
Organizational Affiliation
Bolu Abant İzzet Baysal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamer Çankaya, PhD
Organizational Affiliation
Bolu Abant İzzet Baysal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erdal Dilekçi, MD
Organizational Affiliation
Bolu Abant İzzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
City
Bolu
ZIP/Postal Code
14020
Country
Turkey
Facility Name
Bolu Abant İzzet Baysal University
City
Bolu
ZIP/Postal Code
14280
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8756819
Citation
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.
Results Reference
background
PubMed Identifier
7717830
Citation
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.
Results Reference
background
PubMed Identifier
11054135
Citation
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.
Results Reference
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PubMed Identifier
26180145
Citation
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.
Results Reference
background
PubMed Identifier
17132052
Citation
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.
Results Reference
background
PubMed Identifier
20813995
Citation
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.
Results Reference
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PubMed Identifier
18780882
Citation
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.
Results Reference
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PubMed Identifier
14684785
Citation
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.
Results Reference
background
PubMed Identifier
29650380
Citation
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.
Results Reference
background

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Expiratory Muscle Training in Stroke

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