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Набор скоро начнётся NCT07434375

Speech Intervention Via Telepractice for Children With Repaired Cleft Palate

Без фазы С лечением Cleft Palate Children Speech Sound Disorder

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: Speech therapy via teleprace, Face-to-face speech therapy.
Кому может быть актуально
Состояния в реестре: Cleft Palate Children, Speech Sound Disorder. Базовые параметры: 5 лет — 11 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

Speech Intervention Via Telepractice for Children With Repaired Cleft Palate: Randomized Controlled Trial and Assessment of Speech Production and Perception Skills

Обзор

The goal of this interventional study is to see if online speech therapy works just as well as face-to-face speech therapy in children with cleft palate. The main purposes are: To compare the speech accuracy of target sounds in words produced by children with cleft palate between online and face-to-face speech therapy. To compare the gain in speech accuracy in sentences produced by children with cleft palate between online and face-to-face speech therapy. To assess whether changes in speech intelligibility are perceived by parents. To explore what kinds of factors influence speech accuracy. To explore speech training accuracy and speech understandability training accuracy during speech therapy sessions in children with CP Participants will participate in 30-minute speech intervention sessions twice a week for 10 weeks, either in-person or online.

Вмешательства

  • Поведенческое Speech therapy via teleprace
    Children with cleft palate will participate in 30-minute speech therapy sessions twice a week for 10 weeks
  • Поведенческое Face-to-face speech therapy
    Children with cleft palate will receive treatment maintaining the same frequency as the intervention group.

Первичные конечные точки

  • Change in percent correct for the target sound in words during post-treatment in Face-to-Face and Teletherapy interventions [Срок оценки: Speech accuracy will be measured two times during the study: (1) about 1-2 weeks before therapy begins (this is the starting or baseline visit); (2) about 1 week after therapy ends (this is the final study visit).]
Вторичные конечные точки (1)
  • Change in percent correct for the target sound in sentences post-treatment in Face-to-Face and Teletherapy interventions [Срок оценки: Speech accuracy will be measured two times during the study: (1) about 1-2 weeks before therapy begins (this is the starting or baseline visit); (2) about 1 week after therapy ends (this is the final study visit).]

Критерии участия

Критерии включения

  • Within the ages 5;0 and 11;11 (years; months) at enrollment and for enrollment duration
  • Having normal hearing based on a pure-tone hearing screening at 20 dB HL bilaterally at 500, 1000, 2000 and 4000Hz. Children with a history of hearing loss or children who currently are properly equipped with amplification will be included if they pass the hearing screening
  • Having typical nonverbal IQ, language, and socioemotional function as determined by a T-score with no more than -1.5 SD from the mean on Kauffman Brief Intelligence Test-2 (KBIT-2), receptive language of Clinical Evaluation Language Fundamentals-5 (CELF-5 Core Language), and Childhood Autism Rating Scale-2 (CARS-2)
  • Having a speech sound disorder as determined by a score ≤ 30th percentile on the Goldman-Fristoe Test of Articulation-3 (GFTA-3)
  • Demonstrate a cleft-related or a phonological error on at least one phoneme. For the sound, a cleft-related or a phonological error appears at word-initial phoneme on any two of the following tests; single words on GFTA-3, American English Phrase Samples (AEPS) and Sentence Sample (AESS) on the CAPS-A AM
  • Willing to comply with all study procedures and availability for the study duration.

Критерии исключения

  • Demonstrates a medically diagnosed sensory or neurological disorder based on parents' report
  • Presents with velopharyngeal insufficiency (VPI) due to structural anomalies or an oronasal fistula
  • English is not the primary language spoken at home. Bilingual children will not be excluded.
  • Children who do not demonstrate cleft speech characteristics.

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

США · 1 центр
  • Texas Tech University Health Sciences Center — Lubbock

Идентификаторы

NCT: NCT07434375 · NIDCR Protocol 23-029-E

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗