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

Voice Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220982
• Other study ID #: R15DC019954
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: May 2023
• Source: West Chester University of Pennsylvania
• Contact: Elizabeth U Grillo, Ph.D.
• Phone: 6104362132
• Email: egrillo[@]wcupa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Not a student teacher

• Not a professional teacher.

• Does not own a smartphone.

Related Conditions & MeSH terms

• Voice Disorders

Intervention

Behavioral:
• 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.
• 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). Training will occur over three 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.
• 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.
• 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 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.

Locations

Country	Name	City	State
United States	Elizabeth Grillo	West Chester	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
West Chester University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Voice Handicap Index 10	The VHI-10 is a client reported outcome measure related to voice impact on quality of life across 10 questions. Each question is rated on a scale from 0-4 with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.	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.
Primary	Change in Vocal Fatigue Index (VFI) factor 1 and 2	The VFI is a client reported outcome measure related to tiredness and avoidance of voice in factor 1 and physical voice discomfort in factor 2. Factor 1 has 11 questions and factor 2 has 5 questions. Each question is rated on a scale from 0-4 with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.	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.
Secondary	Change in Fundamental Frequency	Fundamental frequency will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.	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.
Secondary	Change in Jitter%	Jitter% will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.	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.
Secondary	Change in noise-to-harmonic ratio	Noise-to-harmonic ratio will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.	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.
Secondary	Change in cepstral peak prominence	Cepstral peak prominence will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.	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.
Secondary	Change in smoothed cepstral peak prominence	Smoothed cepstral peak prominence will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.	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.
Secondary	Change in acoustic voice quality index	Acoustic voice quality index will be measured during 1 trial of the 5-sec sustained /a/ and the phrase, "we were away a year ago,"	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.
Secondary	Change in Borg Category Ratio (CR)10 scale for vocal effort	The Borg CR10 scale rates vocal effort on a scale from 0-10 with 0 as no effort and 10 as maximum effort.	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.
Secondary	Change in Borg Category Ratio (CR)10 scale for mental effort	The Borg CR10 scale rates mental effort on a scale from 0-10 with 0 as no effort and 10 as maximum effort.	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.
Secondary	Student researcher (SR) voice therapy satisfaction surveys	The voice therapy satisfaction survey will rate the student researchers' (SR) perceptions after completing the voice therapy conditions. The questions are rated on a scale from 1-5 with 1 as strongly disagree and 5 as strongly agree.; There are also some open ended responses. The SR survey has 17 questions.	Collected immediately after intervention in the fall via Qualtrics online software.
Secondary	Participant voice therapy satisfaction surveys	The voice therapy satisfaction surveys will rate the participants' perceptions after completing the voice therapy conditions. The questions are rated on a scale from 1-5 with1 as strongly disagree and 5 as strongly agree.; There are also some open ended responses. The participant survey has 12 questions.	Collected immediately after intervention in the fall via Qualtrics online software.