Clinical trial NCT04569968: Expiratory Muscle Training in Stroke
Official title: Effect of Expiratory Muscle Training on Stomatognathic System in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Mastication Disorder
Temporomandibular Disorders
Dysphagia
Stomatognathic Diseases
Keywords: Stroke
Mastication
Dysphagia
Temporomandibular joint
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 146
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups as an intervention and control.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Masticatory Performance
timeFrame: Two measurements: At the beginning and after three weeks
measure: Change in Temporomandibular Range of Motion Measurement
timeFrame: Two measurements: At the beginning and after three weeks
measure: Change in General Oral Health Assessment Index
timeFrame: Two measurements: At the beginning and after three weeks
measure: Change in Eating Assessment Tool (EAT-10)
timeFrame: Two measurements: At the beginning and after three weeks
measure: Change in Pain Pressure Threshold of the Masticatory Muscles
timeFrame: Two measurements: At the beginning and after three weeks
measure: Change in Craniocervical Angle Measurement
timeFrame: Two measurements: At the beginning and after three weeks
measure: Change in Repeated Saliva Swallow Test
timeFrame: Two measurements: At the beginning and after three weeks
measure: Change in Fonseca Questionnaire
timeFrame: Two measurements: At the beginning and after three weeks
measure: Change in Intraoral pH Measurement
timeFrame: Two measurements: At the beginning and after three weeks
measure: Change in Neck Flexor Endurance Test
timeFrame: Two measurements: At the beginning and after three weeks
Secondary outcomes:
measure: Mini Mental State Exame Test
timeFrame: At the enrollment process
measure: Change in Labial Commissure Angle
timeFrame: Two measurements: At the beginning and after three weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University
Study officials:
affiliation: Bolu Abant İzzet Baysal University
name: Ömer Dursun, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant İzzet Baysal University
name: Tamer Çankaya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant İzzet Baysal University
name: Erdal Dilekçi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.