Expiratory Muscle Training in Stroke

NCT04569968 | Completed Results

• 1 other identifier: BAIBU-FTR-ÖD-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Stroke; Mastication; Dysphagia; Temporomandibular joint

Outcome Measures

Primary Outcomes (10)

• 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.

  Two measurements: At the beginning and after three weeks

• 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.

  Two measurements: At the beginning and after three weeks

• 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.

  Two measurements: At the beginning and after three weeks

• 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.

  Two measurements: At the beginning and after three weeks

• 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.

  Two measurements: At the beginning and after three weeks

• 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.

  Two measurements: At the beginning and after three weeks

• Change in Repeated Saliva Swallow Test

  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

  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

  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

  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 Outcomes (2)

• Mini Mental State Exame Test

  At the enrollment process

• Change in Labial Commissure Angle

  Two measurements: At the beginning and after three weeks

Study Arms (2)

Expiratory muscle training group

EXPERIMENTAL

Daily expiratory muscle training for four weeks will be applied.

Other: Expiratory muscle training

Control group

NO INTERVENTION

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

Interventions

Expiratory muscle training OTHER

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.

Expiratory muscle training group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mini mental score is 24 or higher
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (2)

İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

Bolu, 14020, Turkey (Türkiye)

Location

Bolu Abant İzzet Baysal University

Bolu, 14280, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 8756819 BACKGROUND

• 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.

  PMID: 7717830 BACKGROUND

• 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.

  PMID: 11054135 BACKGROUND

• 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.

  PMID: 26180145 BACKGROUND

• 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.

  PMID: 17132052 BACKGROUND

• 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.

  PMID: 20813995 BACKGROUND

• 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.

  PMID: 18780882 BACKGROUND

• 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.

  PMID: 14684785 BACKGROUND

• 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.

  PMID: 29650380 BACKGROUND

MeSH Terms

Conditions

Stroke; Temporomandibular Joint Disorders; Deglutition Disorders; Stomatognathic Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Limitations and Caveats

Due to COVID-19 pandemic, portable maximum expiratory pressure measurement device couldn't be used for this reason expiratory muscle device was calibrated based on patients' subjective feedback.

Results Point of Contact

• Title: Tamer ÇANKAYA
• Organization: Bolu Abant İzzet Baysal University

tamercankaya@hotmail.com

5335519171

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be performed by an another investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups as an intervention and control.

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 30, 2020
• Study Start: August 18, 2020
• Primary Completion: September 9, 2021
• Study Completion: November 3, 2021
• Last Updated: March 31, 2023
• Results First Posted: March 31, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)