Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients

Stroke Clinical Trial

Official title:

Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05678686
• Other study ID #: KMU-EOZCAN-001
• Status: Completed
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Karamanoglu Mehmetbey University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine the effects of PNF (proprioceptive neuromuscular facilitation) and CTAR (Chin Tuck Against Resistance) exercises on swallowing rehabilitation in stroke patients. In addition another aim is to examine the effects of these exercises on the swallowing function, quality of life, functional independence and functional oral intake of individuals, and to investigate the superiority of the exercises to each other in line with these features.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older,
• Who have been diagnosed with stroke
• At least one month has passed since the diagnosis of stroke
• Voluntarily participated in the research,
• Cooperative, able to take instructions (Mini Mental Test score of 24 and above) and
• Individuals with a score of 2 or higher on the Penetration Aspiration Scale will be included.

Exclusion Criteria:

• Lack of long-term sitting balance, unable to maintain an upright position with or without support,
• Have tumors or neoplastic disease in the head and neck region,
• Radiotherapy applied to the neck, swallowing disorders caused by radiotherapy applied to the head and neck region,
• With additional musculoskeletal disease that may cause swallowing disorders,
• With non-stroke neurological disease (Traumatic Brain Injury, Parkinson's, Dementia, ALS, MS, etc.),
• Individuals who have previously received dysphagia treatment will be excluded from the study.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Stroke
• Swallowing Disorder

Intervention

Other:
• Active Comparator: Routine Exercise Group
Exercises (tongue-palate exercises, tongue base exercises, Masako Maneuver, Mendelson Maneuver, Effortful Swallowing, Supraglottic exercises, thermal tactile stimulation) will be performed 2 days a week for 8 weeks, in total 16 sessions and these exercises applied by the physiotherapist.
• Experimental: PNF Exercise
In addition to the practices in the control group, head-neck PNF(Proprioceptive Neuromuscular Facilitation) movement patterns will be applied to both movement patterns by the physiotherapist using the combined isotonic contraction technique ), 2 days a week for 8 weeks, in total 16 sessions.
• Experimental: CTAR Exercise
In addition to the practices in the control group, CTAR exercises will be applied in the presence of a physiotherapist, 2 days a week for 8 weeks, a total of 16 sessions. In the CTAR exercise, the patient is asked to flexion and extension the neck by pressing a standard size and inflatable rubber ball placed under his chin against his sternum. Patients will be asked to do the exercise protocol, which consists of isometric and isotonic components.

Locations

Country	Name	City	State
Turkey	Selcuk University, Faculty of Medicine, Department of Otolaryngology	Konya	Selcuklu

Sponsors (2)

Lead Sponsor	Collaborator
Karamanoglu Mehmetbey University	Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penetration Aspiration Scale (PAS)	The penetration aspiration scale (PAS) is routinely used to assess penetration and aspiration severity during videofluoroscopic or FEES assessment. It has a scoring system from 0 to 8, depending on whether it is aspirated or penetrated after administration of liquid-consistent and solid foods with oral contrast agent or dye. High scores indicate the presence of aspiration and penetration.	Change from baseline at 8 weeks
Primary	Ultrasound Evaluation	Neck submental muscle cross-sectional thickness measurement (millimeter-mm), sternocleidomastoideus muscle thickness measurement (mm), hyoid bone elevation measurement (millimeter-mm) and tongue base cross-sectional area (square-centimeter-cm2) will be measured by USG before and after therapy. USG measurements will be made by an experienced radiologist. Three measurements will be taken from each muscle group and the results will be averaged to minimize variations in muscle thickness.	Change from baseline at 8 weeks
Secondary	Cognitive Status	Mini Mental Test will be used to evaluate the cognitive status of individuals. It is a short, useful, standardized test that provides the opportunity to evaluate cognitive performance in a short time. A high score indicates a good cognitive status. The maximum possible score is 30. A score of 17 and below is considered severe dementia, a score of 18-23 is considered mild dementia, and a score of 24-30 is considered normal.	a day before the start of treatment
Secondary	The Barthel Index	The Barthel index evaluates physical independence in activities of daily living in 10 items (transfer, ambulation/wheelchair use, stair climbing, feeding, dressing, self-regulation, bathing, toilet use, urinary continence, stool continence). Each item is scored separately as 0, 5, 10 or 15 points. A total score of 0-20 means fully dependent, 21-61 highly dependent, 62-90 moderately dependent, 91-99 mildly dependent and 100 fully independent.	Change from baseline at 8 weeks
Secondary	Eating Assessment Tool (EAT-10)	It is an easy-to-apply scale consisting of ten items, which allows the rapid assessment of dysphagia symptoms in patients with swallowing disorders. It contains ten questions about oropharyngeal dysphagia, each question is scored between 0 and 3. The total score is obtained by summing the scores. High scores indicate severe dysphagia.	Change from baseline at 8 weeks
Secondary	Functional Oral Intake Scale (FOIS)	Oral nutritional status of individuals will be evaluated by using The FOIS is a seven-item scale. It is used to show the level of an individual's feeding tube and oral intake. High scores indicate normal oral intake. The maximum score that can be obtained from the scale is 7.	Change from baseline at 8 weeks
Secondary	Swallowing Quality Of Life Questionnaire (SWAL-QOL)	Quality of life due to swallowing problem will be evaluated with the Swallowing Quality of Life Questionnaire (SWAL-QOL). SWAL-QOL includes 10 concepts: general load, food choice, eating time, desire to eat, fear of eating, sleep, fatigue, communication, mental health, and social function. A high score indicates good quality of life. Since its creation, the SWAL-QOL questionnaire has been used as the gold standard in the assessment of quality of life in studies on swallowing disorders.	Change from baseline at 8 weeks