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Идёт набор NCT05220982

Improving Efficacy of Voice Therapy Concepts Via Telepractice and Mobile App Technology

Без фазы С лечением Voice 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: Conversation Training Therapy, Global Voice Prevention and Therapy Model, Modified Conversation Training Therapy, Modified Global Voice Prevention and Therapy Model.
Кому может быть актуально
Состояния в реестре: Voice Disorders. Базовые параметры: от 18 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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Обзор

Due to the COVID-19 pandemic, telepractice has grown rapidly. To date, synchronous telepractice (i.e., in real-time videoconferencing) has been the focus of most research with asynchronous telepractice (i.e. information stored and accessed later) being used minimally only to record synchronous encounters. Descriptions of voice therapy concepts are minimally available in the literature with no standard reporting framework and no clinical efficacy or effectiveness data. Thus, the proposed study will address these barriers. First, an asynchronous method will be developed that will impact both in-person and telepractice services by offering repeated learning opportunities in the client's environment. The method includes ecological momentary intervention (EMI) through a daily voice therapy practice app, server, and web portal that is flexible in its programming to meet the needs of the client, offers performance feedback, and charts results over time. Second, voice therapy concepts will be tested improving our knowledge about such concepts that facilitate successful client-centered outcomes for both prevention and treatment of voice problems. The participants in the study will be teachers who have a high prevalence of voice problems, impact the healthcare system when treatment is needed, and negatively affect students' learning abilities in the classroom when communicating with a voice problem. Third, the Rehabilitation Treatment Specification System (RTSS) framework will be used to describe the voice therapy concepts. The concepts include: training multiple voices to meet all the clients' vocal needs, defining voice qualities by the anatomy and physiology of the voice production system, generalizing voice targets into hierarchical speech tasks, and using "new" vs "other/old" voice to help the client become their own clinician. Vocally healthy student teachers and professional teachers with voice complaints will be randomized into one of four voice therapy conditions delivered via telepractice. Both groups of teachers are needed to assess the concepts for prevention and treatment. Condition 2, which fully represents the proposed voice therapy concepts, will be superior to the other three conditions, which do not fully represent the concepts, by demonstrating a greater decrease in client-reported primary outcome measures of the Voice Handicap Index-10 and factor 1 and 2 of the Vocal Fatigue Index. Secondary outcomes of acoustic measures, Borg Category Ratio-10 scales for vocal and mental effort, and voice therapy satisfaction surveys will also be investigated. The results will be useful at a practical level by advancing asynchronous telepractice and by improving efficacy of voice therapy concepts. In addition, the results will lay the groundwork for future studies involving development of EMI platforms in other areas of speech-language pathology and testing additional voice therapy concepts that facilitate successful client-centered outcomes.

Вмешательства

  • Поведенческое Conversation Training Therapy
    Training clear speech in conversation with new vs old voice. Training will occur over four weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention. Participants will use the EMI platform to practice voice targets three times a day.
  • Поведенческое Global Voice Prevention and Therapy Model
    Training of four new voices (i.e., resonant voice in connected speech, falsetto for quiet talking, oral twang for talking over noise, and belt for healthy yelling) defined and trained by the anatomy and physiology of the system (i.e., Estill Voice Training's Figures). Training occurs in a bottom-up speech hierarchy with new vs other or old voice at each step. Additional methods are used in asynchronous telepractice to support the new voices during week 1 (e.g., vocal hygiene and education). Trai
  • Поведенческое Modified Conversation Training Therapy
    Training clear speech in conversation with no use of new vs old voice. Training will occur over four weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention. Participants will use the EMI platform to practice voice targets three times a day.
  • Поведенческое Modified Global Voice Prevention and Therapy Model
    Training of a new resonant voice in connected speech defined and trained by the anatomy and physiology of the system (i.e., Estill Voice Training's Figures). Training occurs in a bottom-up speech hierarchy with no use of new vs old voice. Additional methods are used in asynchronous telepractice to support the new voices during week 1 (e.g., vocal hygiene and education). Training will occur over three weekly synchronous telepractice sessions. Each session lasts 45-60 minutes. The ecological momen

Первичные конечные точки

  • Change in Voice Handicap Index 10 [Срок оценки: One time at pre & one time at post condition in fall (4 weeks between pre and post) and once weekly for 15 weeks in spring. Captured on day 4 in the PM for a 5 day period via the VoiceEvalU8 app.]
  • Change in Vocal Fatigue Index (VFI) factor 1 and 2 [Срок оценки: One time at pre & one time at post condition in fall (4 weeks between pre and post) and once weekly for 15 weeks in spring. Captured on day 5 in the PM for a 5 day period via the VoiceEvalU8 app.]
Вторичные конечные точки (10)
  • Change in Fundamental Frequency [Срок оценки: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.]
  • Change in Jitter% [Срок оценки: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.]
  • Change in noise-to-harmonic ratio [Срок оценки: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.]
  • Change in cepstral peak prominence [Срок оценки: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.]
  • Change in smoothed cepstral peak prominence [Срок оценки: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.]
  • Change in acoustic voice quality index [Срок оценки: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.]
  • Change in Borg Category Ratio (CR)10 scale for vocal effort [Срок оценки: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured once a day in PM sessions during a 5 day period via the VoiceEvalU8 app.]
  • Change in Borg Category Ratio (CR)10 scale for mental effort [Срок оценки: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured once a day in PM sessions during a 5 day period via the VoiceEvalU8 app.]
  • Student researcher (SR) voice therapy satisfaction surveys [Срок оценки: Collected immediately after intervention in the fall via Qualtrics online software.]
  • Participant voice therapy satisfaction surveys [Срок оценки: Collected immediately after intervention in the fall via Qualtrics online software.]

Критерии участия

Критерии включения

  • Vocally healthy student in a bachelor of education program with student teaching planned for spring
  • Professional teacher who is currently working as a teacher with voice complaints, but has not sought help for the complaints
  • Owner of either an android or iOS smartphone or tablet.

Критерии исключения

  • Not a student teacher
  • Not a professional teacher.
  • Does not own a smartphone.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Elizabeth Grillo — West Chester

Идентификаторы

NCT: NCT05220982 · R15DC019954

Первоисточники (государственные реестры)

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