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Набор скоро начнётся NCT07719582

Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise

Без фазы С лечением Ankyloglossia Impairment of Speech Slurred Speech

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: P1821.
Кому может быть актуально
Состояния в реестре: Ankyloglossia, Impairment of Speech, Slurred Speech. Базовые параметры: Без ограничений · 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The P1821 initiative constitutes an innovative intervention specifically engineered to enhance tongue muscular strength and endurance. The primary objective of this research study is to ascertain whether the integration of a proactive tongue strengthening exercise regimen, utilizing a Non-Significant Risk (NSR) Device, contributes to an observable improvement in speech fluency.

Подробное описание

P1821 specifically targets the muscles in the tongue. These areas are part of the tongue's movable section, known for their great flexibility and ability to perform complex movements.

The tongue plays a crucial role in speech production. Weakness in its muscles can lead to difficulties in speaking clearly and distinctly. The tongue is a highly mobile group of muscles, richly supplied with blood and nerves.

The tongue's remarkable ability to move in all directions stems from the unique arrangement of its muscle fibers, which is unlike any other muscle in the body. These fibers run in three dimensions:

From front to back, from the sides to the middle, and from top to bottom.

This unique structure allows the tongue to perform a variety of movements, including: Getting longer and shorter. The tongue is the only muscle in the body that can be actively lengthened, not just shortened. When the vertical and horizontal fibers contract simultaneously, the tongue becomes narrower and longer, enabling it to be extended. Changing its position: Additional muscles can alter the tongue's overall position by pulling it from the front (from the lower jaw), from below and behind (from the hyoid bone), and from above and behind (from the base of the skull).

Вмешательства

  • Устройство P1821
    The P1821 intervention is distinguished by its independence from pharmaceutical agents and electronic devices. Its foundational mechanism is predicated exclusively on the physiological principles of muscle resistance training, thereby offering a non-pharmacological and non-invasive therapeutic approach.

Первичные конечные точки

  • P1821 [Срок оценки: From enrollment to the end of treatment at 2 weeks.]
  • P1821 [Срок оценки: From enrollment to the end of treatment at 2 weeks.]

Критерии участия

Критерии включения

  • Can read and write
  • Willing and able to follow the requirements of the protocol

Критерии исключения

  • Previously seen and treated by speech and language pathologist for dysphagia or dysarthria for non-head and neck cancer causes
  • Medical instability, restlessness, or other factors that would compromise data acquisition

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • N/A - Remote Study — Naples

Публикации

  • Binger C, Ragsdale J, Bustos A. Language Sampling for Preschoolers With Severe Speech Impairments. Am J Speech Lang Pathol. 2016 Nov 1;25(4):493-507. doi: 10.1044/2016_AJSLP-15-0100. PMID 27552110
  • Potter NL, Nievergelt Y, VanDam M. Tongue Strength in Children With and Without Speech Sound Disorders. Am J Speech Lang Pathol. 2019 May 27;28(2):612-622. doi: 10.1044/2018_AJSLP-18-0023. Epub 2019 Feb 28. PMID 31136240
  • Lalakea ML, Messner AH. Ankyloglossia: the adolescent and adult perspective. Otolaryngol Head Neck Surg. 2003 May;128(5):746-52. doi: 10.1016/S0194-59980300258-4. PMID 12748571
  • Wang J, Yang X, Hao S, Wang Y. The effect of ankyloglossia and tongue-tie division on speech articulation: A systematic review. Int J Paediatr Dent. 2022 Mar;32(2):144-156. doi: 10.1111/ipd.12802. Epub 2021 May 22. PMID 33964037
  • Belmehdi A, Harti KE, Wady WE. Ankyloglossia as an oral functional problem and its surgical management. Dent Med Probl. 2018 Apr-Jun;55(2):213-216. doi: 10.17219/dmp/85708. PMID 30152627
  • Wei EX, Tunkel D, Boss E, Walsh J. Ankyloglossia: Update on Trends in Diagnosis and Management in the United States, 2012-2016. Otolaryngol Head Neck Surg. 2020 Nov;163(5):1029-1031. doi: 10.1177/0194599820925415. Epub 2020 May 19. PMID 32427523
  • Suter VG, Bornstein MM. Ankyloglossia: facts and myths in diagnosis and treatment. J Periodontol. 2009 Aug;80(8):1204-19. doi: 10.1902/jop.2009.090086. PMID 19656020
  • Walsh J, Tunkel D. Diagnosis and Treatment of Ankyloglossia in Newborns and Infants: A Review. JAMA Otolaryngol Head Neck Surg. 2017 Oct 1;143(10):1032-1039. doi: 10.1001/jamaoto.2017.0948. PMID 28715533

Идентификаторы

NCT: NCT07719582 · P1821

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗