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Идёт набор NCT05492266

Expiratory Muscle Strength Training for Hypernasal Speech in Children

Без фазы С лечением Velopharyngeal Insufficiency Velopharyngeal Incompetence Due to Cleft Palate Inadequate Velopharyngeal Closure Palatopharyngeal Incompetence

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: Expiratory Muscle Strength Training, Maintenance Training.
Кому может быть актуально
Состояния в реестре: Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate, Inadequate Velopharyngeal Closure, Palatopharyngeal Incompetence. Базовые параметры: 5 лет — 17 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
США
Следующий шаг
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Официальное название

Expiratory Muscle Strength Training as a Non-surgical Option for Velopharyngeal Dysfunction: A Randomized-controlled Trial

Обзор

When the soft palate does not move enough because of a cleft palate or for unknown reasons, this can lead to a speech difference called velopharyngeal insufficiency. The purpose of this research study is to test if soft palate exercises using a hand help breathing device will help improve the ability of the soft palate to close the area between the throat and nose and help improve speech.

Подробное описание

The objective of this study is to examine the feasibility and efficacy of expiratory muscle strength training to improve velopharyngeal closure in patients with velopharyngeal dysfunction and nasal air emissions. A single-arm trial will be conducted at a cleft craniofacial center at a tertiary children's hospital. Patients will perform Expiratory Muscle Strength Training for 6 to 8 weeks. Patients with reductions in nasal resonance during this time will be further randomized to EMST maintenance training for 6 months or no exercises.

Вмешательства

  • Устройство Expiratory Muscle Strength Training
    At visit 1, participants will be block randomized based on PWSS score (5-6 or 7+) to Expiratory Muscle Strength Training (EMST) for 6 to 8 weeks or no exercises. Participants in the EMST-150 group will perform 5 sets of 5 resistive expirations once a day with a 10-15 second rest between each repetition and a 1-2 minute rest between each set of 5 repetitions.
  • Устройство Maintenance Training
    At visit 2, participants with improved (decreased) CAPS-A hypernasality rating of 1 or more points, for whom the family and/or surgeon is not currently considering surgical intervention for VPI, will be further randomized to continue "maintenance" EMST exercises or no exercises for 6 months. Participants in the "maintenance" group will complete 3-5 sessions exercise sessions each week (rather than daily training), with 2 sets of 5 resistive expirations (rather than 5 sets)

Первичные конечные точки

  • Change in nasalance scores after 6-8 weeks of exercises compared with baseline [Срок оценки: Baseline and 6-8 weeks]
  • Change in perceptual speech symptoms of velopharyngeal dysfunction following 6-8 weeks of exercises compared with baseline [Срок оценки: Baseline and 6-8 weeks]
  • Change in oral pressure following 6-8 weeks of exercises compared with baseline [Срок оценки: Baseline and 6-8 weeks]
  • Change in velopharyngeal flutter following 6-8 weeks of exercises compared with baseline [Срок оценки: Baseline and 6-8 weeks]
  • Change in oral pressure decay following 6-8 weeks of exercises compared with baseline [Срок оценки: Baseline and 6-8 weeks]
Вторичные конечные точки (5)
  • Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline [Срок оценки: Baseline and 6-8 weeks]
  • Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline. [Срок оценки: Baseline and 6-8 weeks]
  • Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline. [Срок оценки: Baseline and 6-8 weeks]
  • Resolution of effusion following 6-8 weeks of exercises compared with baseline. [Срок оценки: Baseline and 6-8 weeks]
  • Resolution of retraction following 6-8 weeks of exercises compared with baseline. [Срок оценки: Baseline and 6-8 weeks]

Критерии участия

Критерии включения

  • Score of 2 or greater on the nasality/resonance domain of the Pittsburgh Weighted Speech Scale
  • Ages 5-17 years

Критерии исключения

  • CAPS-A-AM hypernasality score <2
  • Previous speech surgery (e.g. palatoplasty or pharyngeal flap for speech)
  • Speech surgery scheduled within the next 56 days
  • Unable or unwilling to perform the tests and exercises outlined in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UPMC Children's Hospital of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT05492266 · STUDY21120032 · 5R21DC017553-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗