Effect of Kinesiology Taping and Swallowing Exercises on Suprahyoid Muscle Thickness and Swallowing Function in Stroke Patients With Dysphagia

NCT ID: NCT06988215

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2025-10-10

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.

Conditions

Stroke; Dysphagia; Cerebrovascular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Kinesiology Taping Group

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).

Group Type: EXPERIMENTAL

Kinesiology Taping with Exercise

Intervention Type: OTHER

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 Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo Taping with Exercise

Intervention Type: OTHER

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

Interventions

Kinesiology Taping with Exercise

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.

Intervention Type: OTHER

Placebo Taping with Exercise

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

elifbusrademirel

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elif Büşra Demirel, MD

Role: PRINCIPAL_INVESTIGATOR

SBÜ Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Locations

Istanbul Physical Medicine and Rehabilitation Training Research Hospital

Istanbul, bahçelievler, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Elif Büşra Demirel, medical doctor

Role: CONTACT

edemirel2014@gmail.com

+90 554 613 65 32

Facility Contacts

Elif Büşra Demirel, MD

Role: primary

edemirel2014@gmail.com

90 554 613 65 32

elif büsra demirel, md

Role: backup

edemirel2014@gmail.com

905546136532

Other Identifiers

2025/26

Identifier Type: OTHER

Identifier Source: secondary_id

2025/26

Identifier Type: -

Identifier Source: org_study_id