StrokeNCT06988215
Effect of Kinesiology Taping and Swallowing Exercises on Suprahyoid Muscle Thickness and Swallowing Function in Stroke Patients With Dysphagia
A study testing Kinesiology Taping with Exercise in people with Stroke and Dysphagia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled single-blind study aims to investigate the effect of kinesiology taping combined with resistance exercises on suprahyoid muscle thickness and swallowing function in patients with stroke-related dysphagia. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Stroke, Dysphagia, Cerebrovascular Disorders
- What is being tested?
- Kinesiology Taping with Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2025to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 50 and 80 years
- Diagnosed with stroke
- Mini-Mental State Examination (MMSE) score greater than 22
- Voluntary participation with written informed consent
Who cannot join
- Open wounds or unresolved skin problems in the neck area
- Known allergy to kinesiology tape or its components
- Medically unstable conditions
- Primary esophageal disorders (e.g., achalasia, upper esophageal sphincter dysfunction)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Physical Medicine and Rehabilitation Training Research Hospital
Istanbul, bahçelievler, 34000
Elif Büşra Demirel, MD, 90 554 613 65 32, edemirel2014@gmail.com
elif büsra demirel, md, 905546136532, edemirel2014@gmail.com
About this study
Official title: The Effects of Kinesiology Taping Combined With Swallowing Exercises on Oropharyngeal Muscle Thickness and Swallowing Function in Dysphagia Rehabilitation of Stroke Patients: An Ultrasonographic Assessment in a Single-Blind Randomized Controlled Trial
This randomized controlled single-blind study aims to investigate the effect of kinesiology taping combined with resistance exercises on suprahyoid muscle thickness and swallowing function in patients with stroke-related dysphagia. A total of 36 participants will be randomly assigned to an intervention group receiving real kinesiology taping and a control group receiving placebo taping, both combined with standardized swallowing exercises for 6 weeks. Outcome measures include ultrasonographic evaluation of oropharyngeal muscles (geniohyoid, mylohyoid, anterior digastric, and tongue muscles), swallowing function assessed by the Volume-Viscosity Swallow Test, EAT-10, T-SWAL-QOL, Dysphagia Handicap Index, FOIS, and Functional Ambulation Level. This study will contribute to determining effective rehabilitation methods for improving safe swallowing in post-stroke patients.
Read the detailed description
Dysphagia is a common complication following stroke, associated with serious consequences such as dehydration, malnutrition, and aspiration pneumonia. These complications can prolong hospital stays, impair physical function, and reduce the overall quality of life. The suprahyoid muscle group, which plays a crucial role in the pharyngeal phase of swallowing, is often affected post-stroke. Weakness in these muscles can lead to impaired hyolaryngeal excursion, resulting in incomplete upper esophageal sphincter (UES) opening, residue in the valleculae and piriform sinuses, and increased risk of aspiration and penetration.
The suprahyoid muscles (geniohyoid, mylohyoid, anterior belly of digastric, and stylohyoid) are essential for the anterior-superior movement of the hyolaryngeal complex during swallowing. Rehabilitation targeting this muscle group is clinically important to restore safe and effective swallowing function.
Kinesiology taping (KT) is a non-invasive method widely used in musculoskeletal rehabilitation. KT is believed to support joint alignment, enhance muscle function, and provide mechanical feedback through skin tension. In recent studies, KT has shown promise in enhancing the effects of rehabilitation in conditions such as ankle instability, adhesive capsulitis, and hallux valgus. KT has also been proposed as a novel therapeutic option in the management of neurogenic dysphagia by providing resistance to the hyolaryngeal complex, thereby increasing muscle engagement during swallowing exercises.
This single-blind randomized controlled trial aims to investigate the effects of resistance exercises combined with kinesiology taping on the suprahyoid muscle group in patients with stroke. A total of 36 patients will be randomly assigned into two equal groups: the control group (receiving placebo kinesiology taping plus standard exercises) and the intervention group (receiving real kinesiology taping plus standard exercises).
Ultrasonographic assessment of the suprahyoid muscles (geniohyoid, mylohyoid, anterior digastric, and tongue muscles) will be conducted at baseline and after 6 weeks. Swallowing function will be evaluated using the Volume-Viscosity Swallow Test (VVST), the Eating Assessment Tool (EAT-10), Turkish version of the Swallowing Quality of Life Questionnaire (T-SWAL-QOL), the Dysphagia Handicap Index (DHI), the Functional Oral Intake Scale (FOIS), and the Functional Ambulation Measure (FIM).
Kinesiology tape will be applied in three directions: from the hyoid bone to the clavicle, to the sternum, and horizontally across the hyoid. Participants in both groups will perform effortful swallow and oromotor exercises daily (50 swallows per day, divided into 5 sets of 10 repetitions) for 6 weeks. Tape will be renewed every 3 days.
This study will help determine whether kinesiology taping can enhance the outcomes of dysphagia rehabilitation in post-stroke patients, potentially offering a low-cost and non-invasive adjunctive treatment to traditional therapy.
- Conditions
- Stroke, Dysphagia, Cerebrovascular Disorders
- Being tested
- Kinesiology Taping with Exercise, Placebo Taping with Exercise
- Keywords
- Kinesiology Taping, Dysphagia Rehabilitation, Suprahyoid Muscles, Ultrasound Assessment, Neurogenic Dysphagia
- Medical subject headings
- Stroke, Deglutition Disorders, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiology Taping with ExerciseOther
Real kinesiology taping is applied to the suprahyoid region in three directions (from the hyoid bone to the clavicle, to the sternum, and horizontally). Taping is renewed every three days. Participants also perform effortful swallowing and oromotor exercises daily (5 sets of 10 repetitions) for 6 weeks.
Placebo Taping with ExerciseOther
Non-therapeutic kinesiology taping with no tension is applied to the suprahyoid region to mimic the appearance of the therapeutic tape. Participants perform the same daily swallowing and oromotor exercises as the intervention group for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Kinesiology Taping Group | Experimental | Participants in this group will receive real kinesiology taping applied to the suprahyoid region along with standardized effortful swallowing and oromotor exercises. The taping will be applied in three directions (hyoid to clavicle, hyoid to sternum, and horizontal to hyoid) and renewed every three days over a 6-week period. Exercises will be performed daily, 5 sets of 10 swallows (50 total repetitions). Receives: Other: Kinesiology Taping with Exercise |
| Placebo Taping Group | Placebo comparator | Participants in this group will receive placebo kinesiology taping that mimics the appearance of therapeutic taping, without applying actual tension. The same standardized swallowing and oromotor exercises will be provided daily for 6 weeks, identical to the experimental group. Receives: Other: Placebo Taping with Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Measurement of Oropharyngeal Muscle Thickness Time Frame: Baseline and Week 6 Outcome Description: The thickness of oropharyngeal muscles, including the mylohyoid, geniohyoid, anterior belly of digastric, and tongue muscles, will be measured
The thickness of oropharyngeal muscles, including the mylohyoid, geniohyoid, anterior belly of digastric, and tongue muscles, will be measured using ultrasonography at baseline and after 6 weeks of intervention.
Measured: Baseline and Week 6
Secondary outcomes (5)
Change in Swallowing Safety Assessed by Volume-Viscosity Swallow Test (VVST)
Swallowing function will be evaluated using the Volume-Viscosity Swallow Test to assess changes in safety and efficiency of oral intake before and after the intervention.
Measured: Baseline and Week 6
9Change in Dysphagia Severity Assessed by EAT-10(The Eating Assessment Tool
The Eating Assessment Tool (EAT-10) will be used to quantify self-perceived dysphagia symptoms. Scores will be compared between baseline and the sixth week.
Measured: Baseline and Week 6
Change in Swallowing-Related Quality of Life (T-SWAL-QOL)
Swallowing-related quality of life will be assessed using the Turkish version of the SWAL-QOL questionnaire, administered before and after the intervention.
Measured: Baseline and Week 6
Change in Dysphagia Handicap Index (DHI)
The Dysphagia Handicap Index will be used to evaluate the psychosocial and functional impact of dysphagia on patients, assessed pre- and post-treatment.
Measured: Baseline and Week 6
Change in Functional Independence Measure (FIM)
The Functional Independence Measure will be used to assess changes in overall functional status and mobility in relation to swallowing performance over the 6-week period.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start4 Mar 2025
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive kinesiology taping combined with swallowing exercises, while the control group will receive placebo taping with the same exercises. Both groups will undergo the intervention for 6 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, elifbusrademirel, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Elif Büşra Demirel, MD, Principal investigator, SBÜ Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988215
- Sponsor's protocol ID
- 2025/26
- Other IDs
- 2025/26
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not been finalized. Ethical approval and institutional policies will be reviewed before making a final determination.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Kinesiology Taping Combined With Swallowing Exercises on Oropharyngeal Muscle Thickness and Swallowing Function in Dysphagia Rehabilitation of Stroke Patients: An Ultrasonographic Assessment in a Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06988215
- Acronym / sponsor ID
- 2025/26
- Conditions
- Stroke, Dysphagia, Cerebrovascular Disorders
- Keywords
- Kinesiology Taping, Dysphagia Rehabilitation, Suprahyoid Muscles, Ultrasound Assessment, Neurogenic Dysphagia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 23 May 2025 (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.
This randomized controlled single-blind study aims to investigate the effect of kinesiology taping combined with resistance exercises on suprahyoid muscle thickness and swallowing function in patients with stroke-related dysphagia. A total of 36 participants will be randomly assigned to an intervention group receiving real kinesiology taping and a control group receiving placebo taping, both combined with standardized swallowing exercises for 6 weeks. Outcome measures include ultrasonographic evaluation of oropharyngeal muscles (geniohyoid, mylohyoid, anterior digastric, and tongue muscles), swallowing function assessed by the Volume-Viscosity Swallow Test, EAT-10, T-SWAL-QOL, Dysphagia Handicap Index, FOIS, and Functional Ambulation Level. This study will contribute to determining effective rehabilitation methods for improving safe swallowing in post-stroke patients.
Detailed description
Dysphagia is a common complication following stroke, associated with serious consequences such as dehydration, malnutrition, and aspiration pneumonia. These complications can prolong hospital stays, impair physical function, and reduce the overall quality of life. The suprahyoid muscle group, which plays a crucial role in the pharyngeal phase of swallowing, is often affected post-stroke. Weakness in these muscles can lead to impaired hyolaryngeal excursion, resulting in incomplete upper esophageal sphincter (UES) opening, residue in the valleculae and piriform sinuses, and increased risk of aspiration and penetration.
The suprahyoid muscles (geniohyoid, mylohyoid, anterior belly of digastric, and stylohyoid) are essential for the anterior-superior movement of the hyolaryngeal complex during swallowing. Rehabilitation targeting this muscle group is clinically important to restore safe and effective swallowing function.
Kinesiology taping (KT) is a non-invasive method widely used in musculoskeletal rehabilitation. KT is believed to support joint alignment, enhance muscle function, and provide mechanical feedback through skin tension. In recent studies, KT has shown promise in enhancing the effects of rehabilitation in conditions such as ankle instability, adhesive capsulitis, and hallux valgus. KT has also been proposed as a novel therapeutic option in the management of neurogenic dysphagia by providing resistance to the hyolaryngeal complex, thereby increasing muscle engagement during swallowing exercises.
This single-blind randomized controlled trial aims to investigate the effects of resistance exercises combined with kinesiology taping on the suprahyoid muscle group in patients with stroke. A total of 36 patients will be randomly assigned into two equal groups: the control group (receiving placebo kinesiology taping plus standard exercises) and the intervention group (receiving real kinesiology taping plus standard exercises).
Ultrasonographic assessment of the suprahyoid muscles (geniohyoid, mylohyoid, anterior digastric, and tongue muscles) will be conducted at baseline and after 6 weeks. Swallowing function will be evaluated using the Volume-Viscosity Swallow Test (VVST), the Eating Assessment Tool (EAT-10), Turkish version of the Swallowing Quality of Life Questionnaire (T-SWAL-QOL), the Dysphagia Handicap Index (DHI), the Functional Oral Intake Scale (FOIS), and the Functional Ambulation Measure (FIM).
Kinesiology tape will be applied in three directions: from the hyoid bone to the clavicle, to the sternum, and horizontally across the hyoid. Participants in both groups will perform effortful swallow and oromotor exercises daily (50 swallows per day, divided into 5 sets of 10 repetitions) for 6 weeks. Tape will be renewed every 3 days.
This study will help determine whether kinesiology taping can enhance the outcomes of dysphagia rehabilitation in post-stroke patients, potentially offering a low-cost and non-invasive adjunctive treatment to traditional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive kinesiology taping combined with swallowing exercises, while the control group will receive placebo taping with the same exercises. Both groups will undergo the intervention for 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Kinesiology Taping Group | Experimental | Other: Kinesiology Taping with ExerciseParticipants in this group will receive real kinesiology taping applied to the suprahyoid region along with standardized effortful swallowing and oromotor exercises. The taping will be applied in three directions (hyoid to clavicle, hyoid to sternum, and horizontal to hyoid) and renewed every three days over a 6-week period. Exercises will be performed daily, 5 sets of 10 swallows (50 total repetitions). |
| Placebo Taping Group | Placebo comparator | Other: Placebo Taping with ExerciseParticipants in this group will receive placebo kinesiology taping that mimics the appearance of therapeutic taping, without applying actual tension. The same standardized swallowing and oromotor exercises will be provided daily for 6 weeks, identical to the experimental group. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 50 and 80 years
- Diagnosed with stroke
- Mini-Mental State Examination (MMSE) score greater than 22
- Voluntary participation with written informed consent
Key exclusion criteria (4 listed)
- Open wounds or unresolved skin problems in the neck area
- Known allergy to kinesiology tape or its components
- Medically unstable conditions
- Primary esophageal disorders (e.g., achalasia, upper esophageal sphincter dysfunction)
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 |
|---|---|---|
| Kinesiology Taping with ExerciseReal kinesiology taping is applied to the suprahyoid region in three directions (from the hyoid bone to the clavicle, to the sternum, and horizontally). Taping is renewed every three days. Participants also perform effortful swallowing and oromotor exercises daily (5 sets of 10 repetitions) for 6 weeks. | Other | Kinesiology Taping Group |
| Placebo Taping with ExerciseNon-therapeutic kinesiology taping with no tension is applied to the suprahyoid region to mimic the appearance of the therapeutic tape. Participants perform the same daily swallowing and oromotor exercises as the intervention group for 6 weeks | Other | Placebo Taping Group |
Primary outcome
Ultrasound Measurement of Oropharyngeal Muscle Thickness Time Frame: Baseline and Week 6 Outcome Description: The thickness of oropharyngeal muscles, including the mylohyoid, geniohyoid, anterior belly of digastric, and tongue muscles, will be measured
Time frame: Baseline and Week 6
The thickness of oropharyngeal muscles, including the mylohyoid, geniohyoid, anterior belly of digastric, and tongue muscles, will be measured using ultrasonography at baseline and after 6 weeks of intervention.
5 secondary outcomes
Change in Swallowing Safety Assessed by Volume-Viscosity Swallow Test (VVST)
Time frame: Baseline and Week 6
9Change in Dysphagia Severity Assessed by EAT-10(The Eating Assessment Tool
Time frame: Baseline and Week 6
Change in Swallowing-Related Quality of Life (T-SWAL-QOL)
Time frame: Baseline and Week 6
Change in Dysphagia Handicap Index (DHI)
Time frame: Baseline and Week 6
Change in Functional Independence Measure (FIM)
Time frame: Baseline and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not been finalized. Ethical approval and institutional policies will be reviewed before making a final determination.
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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.
Elif Büşra Demirel, MD principal investigator
SBÜ Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiology Taping with Exercise in people with Stroke and Dysphagia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 May 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Büşra Demirel, medical doctor (+90 554 613 65 32, edemirel2014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Measurement of Oropharyngeal Muscle Thickness Time Frame: Baseline and Week 6 Outcome Description: The thickness of oropharyngeal muscles, including the mylohyoid, geniohyoid, anterior belly of digastric, and tongue muscles, will be measured (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2025.