Surface Electromyographic Analysis of Normal Swallowing in Children: An Exploratory Study
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Normal Pediatric Swallowing Physiology, Swallowing Muscle Activation Patterns in Children, Swallowing Function. Базовые параметры: 2 лет — 10 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
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This exploratory clinical trial aims to investigate the mechanism of sequential muscle contractions during normal swallowing processes, including spoon, straw, and cup feeding, in children aged 2 to under 10 years without swallowing disorders. Surface electromyography (sEMG) will be used to evaluate activation patterns of the orbicularis oris, submental, and hyoid muscles during liquid, semi-solid, and solid intake. The study seeks to characterize the timing, duration, amplitude, and coordination of swallowing-related muscle activity in typically developing children. Findings from this study are expected to provide foundational physiological data to inform the development of pediatric-specific neuromuscular electrical stimulation (NMES) protocols for dysphagia treatment.
Подробное описание
Background and Rationale
Swallowing is a complex neuromuscular process requiring coordinated and sequential activation of orofacial and suprahyoid muscles. While neuromuscular electrical stimulation (NMES) has been widely applied in adult dysphagia rehabilitation, pediatric-specific physiological data on swallowing muscle activation patterns remain limited. Current clinical practice often extrapolates adult treatment protocols to pediatric populations, despite developmental differences in anatomy, neuromuscular control, and feeding mechanisms.
Understanding the normative sequential activation patterns of swallowing-related muscles in children is essential for developing age-appropriate therapeutic protocols. This study aims to establish baseline physiological data on muscle activation sequencing during various feeding methods in typically developing children.
Study Design
This is an exploratory, single-center clinical study enrolling 30 children aged 2 to under 10 years without diagnosed swallowing disorders. Participants will undergo non-invasive surface electromyography (sEMG) assessments during standardized feeding tasks.
Study Procedures
1. Spoon Feeding Mechanism Assessment
Participants will consume:
3-5 cc of liquid using a spoon
3-5 cc of yogurt (semi-solid consistency) using a spoon
Solid food using a spoon
Surface EMG electrodes will be placed over the:
Orbicularis oris
Submental muscle group
Hyoid-related musculature
Muscle activation patterns during swallowing will be recorded. 2. Straw Feeding Mechanism Assessment
Participants will consume 5-10 cc of liquid using a straw while sEMG signals are recorded from the same muscle groups. 3. Cup Drinking Mechanism Assessment
Participants will consume 5-10 cc of liquid from a cup with simultaneous sEMG recording.
Data Collection Observational Variables
Name
Age
Birth history (gestational age, birth weight, delivery method)
Sex
Race
Height and weight
Medical history
Surgical history
Medication use
History of pneumonia
Diagnosis of swallowing disorder
Anthropometric Measurements
Distance from mandible midpoint to hyoid bone
Distance between bilateral angles of the mandible
Distance from hyoid bone to clavicle
Bilateral neck width at the level of the thyroid cartilage
Surface Electromyography (sEMG) Outcome Measures
Primary electrophysiological variables include:
Onset latency
Offset latency
Duration of muscle contraction
Первичные конечные точки
- Electromyography-based activation patterns of swallowing-related muscles (orbicularis oris, submental, and hyoid muscles) [Срок оценки: Single assessment at baseline visit]
Критерии участия
Критерии включения
- Children aged 2 to under 10 years
- Children without a diagnosis of dysphagia
- Children without congenital brain lesions or respiratory conditions (e.g., bronchopulmonary dysplasia \[BPD\], respiratory distress syndrome \[RDS\]) that may affect the swallowing process
- Children whose legal guardians provide informed consent for participation
- Participants who meet all of the above inclusion criteria
Критерии исключения
- Refusal to provide consent for participation in the study
- Refusal to undergo the study procedures or assessments
- Determined by the principal investigator to be unsuitable for participation -Meeting any of the above exclusion criteria -
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
South Korea · 1 центр
- Seoul National University Bundang Hospital — Seongnam-si
Идентификаторы
NCT: NCT07455279 · B-2602-1206-302