N/A
N=146
Expiratory Muscle Training in Stroke
Stroke · Mastication Disorder · Temporomandibular Disorders · Dysphagia · Stomatognathic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04569968 ↗Enrolled (actual)
146
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Change in Masticatory Performance — 24; 13; 25; 16 percentage of masticated peanuts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Expiratory muscle training (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Abant Izzet Baysal University
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Masticatory Performance |
24; 13; 25; 16 | — |
| PRIMARY Change in Temporomandibular Range of Motion Measurement |
39.55; 41.48; 41.90; 41.09; 7.61; 5.25 | — |
| PRIMARY Change in General Oral Health Assessment Index |
52; 52; 52; 52 | — |
| PRIMARY Change in Eating Assessment Tool (EAT-10) |
0; 0; 0; 0 | — |
| PRIMARY Change in Pain Pressure Threshold of the Masticatory Muscles |
2.3; 1.86; 2.3; 1.86; 2.3; 1.83 | — |
| PRIMARY Change in Craniocervical Angle Measurement |
28.93; 29.09; 27.07; 30.53 | — |
| PRIMARY Change in Repeated Saliva Swallow Test |
3; 2.5; 3; 3 | — |
| PRIMARY Change in Fonseca Questionnaire |
25; 20; 25; 20 | — |
| PRIMARY Change in Intraoral pH Measurement |
6.45; 6.66; 6.54; 6.63 | — |
| PRIMARY Change in Neck Flexor Endurance Test |
24.02; 27.12; 26.97; 27.92 | — |
| SECONDARY Mini Mental State Exame Test |
26.13; 25.06 | — |
| SECONDARY Change in Labial Commissure Angle |
91; 92; 90; 90.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04569968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.