Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05678686
Enrollment
42
Registered
2023-01-10
Start date
2022-10-03
Completion date
2023-12-31
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Stroke, Swallowing Disorder

Keywords

Dysphagia, Stroke, PNF Exercise, CTAR Exercise, Swallowing Rehabilitation

Brief 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.

Interventions

OTHERActive 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.

OTHERExperimental: 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.

OTHERExperimental: 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.

Sponsors

Ankara Yildirim Beyazıt University
CollaboratorOTHER
Karamanoğlu Mehmetbey University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The physicians who will evaluate imaging methods will not know which arm they are in. In addition patricipants will not know which arm they are in.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Penetration Aspiration Scale (PAS)Change from baseline at 8 weeksThe 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.
Ultrasound EvaluationChange from baseline at 8 weeksNeck 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.

Secondary

MeasureTime frameDescription
Eating Assessment Tool (EAT-10)Change from baseline at 8 weeksIt 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.
Cognitive Statusa day before the start of treatmentMini 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.
Swallowing Quality Of Life Questionnaire (SWAL-QOL)Change from baseline at 8 weeksQuality 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.
Functional Oral Intake Scale (FOIS)Change from baseline at 8 weeksOral 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.
The Barthel IndexChange from baseline at 8 weeksThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026