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Идёт набор NCT06988215

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

Без фазы С лечением Stroke Dysphagia Cerebrovascular Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Kinesiology Taping with Exercise, Placebo Taping with Exercise.
Кому может быть актуально
Состояния в реестре: Stroke, Dysphagia, Cerebrovascular Disorders. Базовые параметры: 50 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое 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

Первичные конечные точки

  • 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 [Срок оценки: Baseline and Week 6]
Вторичные конечные точки (5)
  • Change in Swallowing Safety Assessed by Volume-Viscosity Swallow Test (VVST) [Срок оценки: Baseline and Week 6]
  • 9Change in Dysphagia Severity Assessed by EAT-10(The Eating Assessment Tool [Срок оценки: Baseline and Week 6]
  • Change in Swallowing-Related Quality of Life (T-SWAL-QOL) [Срок оценки: Baseline and Week 6]
  • Change in Dysphagia Handicap Index (DHI) [Срок оценки: Baseline and Week 6]
  • Change in Functional Independence Measure (FIM) [Срок оценки: Baseline and Week 6]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul Physical Medicine and Rehabilitation Training Research Hospital — Istanbul

Идентификаторы

NCT: NCT06988215 · 2025/26 · 2025/26

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗