Clinical trial NCT06988215: Effect of Kinesiology Taping and Swallowing Exercises on Suprahyoid Muscle Thickness and Swallowing Function in Stroke Patients With Dysphagia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Dysphagia
Cerebrovascular Disorders
Keywords: Kinesiology Taping
Dysphagia Rehabilitation
Suprahyoid Muscles
Ultrasound Assessment
Neurogenic Dysphagia
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-23
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
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
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change in Swallowing Safety Assessed by Volume-Viscosity Swallow Test (VVST)
timeFrame: Baseline and Week 6
measure: 9Change in Dysphagia Severity Assessed by EAT-10(The Eating Assessment Tool
timeFrame: Baseline and Week 6
measure: Change in Swallowing-Related Quality of Life (T-SWAL-QOL)
timeFrame: Baseline and Week 6
measure: Change in Dysphagia Handicap Index (DHI)
timeFrame: Baseline and Week 6
measure: Change in Functional Independence Measure (FIM)
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training Research Hospital
state: Bahçelievler
Study officials:
affiliation: SBÜ Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
name: Elif Büşra Demirel, MD
role: PRINCIPAL_INVESTIGATOR
References: