StrokeNCT05678686
Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients
A study testing Active Comparator: Routine Exercise Group, Experimental: PNF Exercise and Experimental: CTAR Exercise in people with Stroke and Dysphagia, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Dysphagia, Swallowing Disorder
- What is being tested?
- Active Comparator: Routine Exercise Group, Experimental: PNF Exercise and Experimental: CTAR Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Faculty of Medicine, Department of Otolaryngology
Konya, Selcuklu, 42131
About this study
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.
- Conditions
- Stroke, Dysphagia, Swallowing Disorder
- Being tested
- Active Comparator: Routine Exercise Group, Experimental: PNF Exercise, Experimental: CTAR Exercise
- Keywords
- Dysphagia, Stroke, PNF Exercise, CTAR Exercise, Swallowing Rehabilitation
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Routine Exercise GroupOther
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 ExerciseOther
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 ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Exercise Group | Active comparator | Conventional swallowing therapy exercises will be given to the routine exercise group. Receives: Other: Active Comparator: Routine Exercise Group |
| PNF Exercise | Experimental | Head-neck PNF (Proprioceptive Neuromuscular Facilitation) movement patterns will be applied to the participants with the combined isometric contraction technique. Receives: Other: Experimental: PNF Exercise |
| CTAR Exercise | Experimental | CTAR (Chin Tuck Against Resistance) exercises will be applied to the participants. Receives: Other: Experimental: CTAR Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
Secondary outcomes (5)
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.
Measured: a day before the start of treatment
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start3 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Responsible party
- Principal investigator, Esra Nur ÖZCAN, Karamanoğlu Mehmetbey University
- Investigators
- Esra Nur ÖZCAN, MSc, Principal investigator, Karamanoğlu Mehmetbey UniversityNezehat Özgül ÜNLÜER, PhD, Study chair, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678686
- Sponsor's protocol ID
- KMU-EOZCAN-001
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozcan EN, Unluer NO, Ozturk M, Erdur O. Does Proprioceptive Neuromuscular Facilitation Approach Have an Effect on Swallowing Function, Muscle Morphology and Quality of Life in Dysphagic Stroke Patients? A Randomised Controlled Trial. J Oral Rehabil. 2025 Nov;52(11):2044-2058. doi: 10.1111/joor.70000. Epub 2025 Jul 1.
PubMed 40596755
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT05678686
- Acronym / sponsor ID
- KMU-EOZCAN-001
- Conditions
- Stroke, Dysphagia, Swallowing Disorder
- Keywords
- Dysphagia, Stroke, PNF Exercise, CTAR Exercise, Swallowing Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine Exercise Group | Active comparator | Other: Active Comparator: Routine Exercise GroupConventional swallowing therapy exercises will be given to the routine exercise group. |
| PNF Exercise | Experimental | Other: Experimental: PNF ExerciseHead-neck PNF (Proprioceptive Neuromuscular Facilitation) movement patterns will be applied to the participants with the combined isometric contraction technique. |
| CTAR Exercise | Experimental | Other: Experimental: CTAR ExerciseCTAR (Chin Tuck Against Resistance) exercises will be applied to the participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: Routine Exercise GroupExercises (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. | Other | Routine Exercise Group |
| Experimental: PNF ExerciseIn 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. | Other | PNF Exercise |
| Experimental: CTAR ExerciseIn 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. | Other | CTAR Exercise |
Primary outcome
Penetration Aspiration Scale (PAS)
Time frame: Change from baseline at 8 weeks
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.
Ultrasound Evaluation
Time frame: Change from baseline at 8 weeks
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.
5 secondary outcomes
Cognitive Status
Time frame: a day before the start of treatment
The Barthel Index
Time frame: Change from baseline at 8 weeks
Eating Assessment Tool (EAT-10)
Time frame: Change from baseline at 8 weeks
Functional Oral Intake Scale (FOIS)
Time frame: Change from baseline at 8 weeks
Swallowing Quality Of Life Questionnaire (SWAL-QOL)
Time frame: Change from baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 40596755Ozcan EN, Unluer NO, Ozturk M, Erdur O. Does Proprioceptive Neuromuscular Facilitation Approach Have an Effect on Swallowing Function, Muscle Morphology and Quality of Life in Dysphagic Stroke Patients? A Randomised Controlled Trial. J Oral Rehabil. 2025 Nov;52(11):2044-2058. doi: 10.1111/joor.70000. Epub 2025 Jul 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Nur ÖZCAN, MSc principal investigator
Karamanoğlu Mehmetbey University
Nezehat Özgül ÜNLÜER, PhD study chair
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Routine Exercise Group, Experimental: PNF Exercise and Experimental: CTAR Exercise in people with Stroke and Dysphagia, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Scale (PAS) (time frame: Change from baseline at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05678686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.