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CTRI Number  CTRI/2022/11/047256 [Registered on: 14/11/2022] Trial Registered Prospectively
Last Modified On: 12/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Influence Of Tele Therapy On Individuals With Hyperfunctional Voice Disorders. 
Scientific Title of Study   Influence Of Tele Voice Therapy Program Using Smartphones On Vocal Parameters For Individuals With Hyperfunctional Voice Disorders 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ananya 
Designation  Post Graduate Student 
Affiliation  MCHP, MAHE, Manipal 
Address  Department Of Speech And Hearing, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi District

Udupi
KARNATAKA
576104
India 
Phone  7022737235  
Fax    
Email  ananya.mcoahsma1@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Usha Devadas 
Designation  Associate Professor and Head 
Affiliation  MCHP, MAHE, Manipal 
Address  Department Of Speech And Hearing, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi District.

Udupi
KARNATAKA
576104
India 
Phone  9448930882  
Fax    
Email  usha.d@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ananya 
Designation  Post Graduate Student 
Affiliation  MCHP, MAHE, Manipal 
Address  Department Of Speech And Hearing, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi District.

Udupi
KARNATAKA
576104
India 
Phone  7022737235  
Fax    
Email  ananya.mcoahsma1@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department Of Speech and Hearing, MCHP, MAHE, Manipal  
 
Primary Sponsor  
Name  Ananya 
Address  Department Of Speech And Hearing, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi District. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NA  N/A 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ananya  Kasturba Hospital, Manipal,  Department Of Speech And Hearing, Room Number:416, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi District.
Udupi
KARNATAKA 
7022737235

ananya.mcoahsma1@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R490||Dysphonia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Tele Voice Therapy  The intervention will be provided through smartphones using WhatsApp messenger, for 16 sessions of therapy, 8 sessions being direct intervention sessions- which will be provided for three days in a week in an alternate manner, in which vocal exercises will be provided, and rest 8 sessions being practice sessions where the clinician monitors the exercises passively- which will be for rest three days a week. Therefore, The intervention session will be taken a day, with next day being practice session, the third day being intervention session again. The therapy will be taken in this manner for 16 days. Each session will last for 30 minutes. The outcome measures will be analyzed pre and post intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All the participants referred by Otolaryngologists, who are diagnosed with early vocal nodule and muscle tension dysphonia and are referred for voice therapy, those who cannot attend face-to-face therapy due to distance or occupation related constraints 
 
ExclusionCriteria 
Details  Individuals diagnosed with other vocal pathologies related to hyperfunctional voice disorders(vocal polyps, vocal cysts), Having associated problems like - resonance, articulation, allergic rhinitis, respiratory disorders, hearing loss, psychiatric and neurologic conditions, Participants underwent vocal fold surgery, Have had attended voice therapy previously, Have had no access to smartphones/ internet facility. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Auditory perceptual analysis of voice- GRBAS perceptual scale
2. Acoustic analysis
3. Maximum Phonation Duration
4. Quality of life
 
Outcome measured will be measured at baseline and post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Voice therapy appears to be an effective treatment for various hyper-functional voice disorders, particularly early vocal nodules and muscular tension dysphonia (Holmberg et al., 2003). Vocal nodules have been linked to hyper-functional/phonotraumatic voice usage in literature. Muscle Tension Dysphonia (MTD) is also caused by vocal misuse/abuse, psychiatric illnesses, and underlying organic lesions, Behavioral voice therapy strategies focus on changing certain vocal behaviors and have been shown to help people with vocal nodules improve their voice quality. However, most individuals with voice disorders were reported to drop out and fail to sustain voice therapy sessions at a higher rate. Portone et al. (2008) observed 38% of patients never returned for voice evaluation recommended by the Otolaryngologist, and 47% of patients never reported voice therapy after the voice evaluation. , when these authors studied the reasons for the dropouts, they identified distance to travel for voice therapy, especially individuals who reside in rural areas or remote areas, are not able to take time off from their work, insurance denials, and lack of confidence about voice therapy were the main reasons for the dropout. In recent years telepractice/telerehabilitation has been an effective method in delivering speech therapy for whom face-to-face contact is impossible.The majority of the studies reported positive perceptions of participants about telerehabilitation.  However, this method may not reveal similar results for all types of disability. Hence, there is a need to understand the feasibility and efficacy of voice rehabilitation delivered through telepractice for individuals with voice disorders.

Summary of the review

Different studies were conducted to check the influence and feasibility of telepractice differently. Some of the studies compared pre-and post-therapy assessment measures, and some compared the results of tele practice with conventional mode of therapy. Most of the studies have targeted patients with Parkinson’s diseas/e. Some studies shed light on vocal nodules, muscle tension dysphonia, hyper-functional voice disorders, edema, and unilateral vocal fold paralysis. Most of the studies delivered voice therapy using Skype video calling. However, all the existing studies have reported positive participant perception irrespective of the mode of delivery.

Research gap

Minimal evidence exists regarding the feasibility of tele practice delivered using smartphones. To date, minimal data exists to understand the feasibility and influence of voice therapy delivered through tele practice for individuals with voice disorders in India.

Need for the study

Dysphonia can impact one’s professional and social life. Speech therapy services in India are available in very few centers, and people from rural and remote areas face the challenge of getting such services. Hence, there is a need to explore the influence of telerehabilitation for SLPs for providing therapy services over tele mode, focusing on delivering exceptional care for the medically underserved population.

Purpose/Aim:                  

To investigate the influence of the tele voice therapy program using smartphones on vocal parameters of individuals with hyper-functional voice disorders.

Objectives:

1.      To investigate the changes in vocal parameters pre and post teletherapy.

2.      To investigate the feasibility and participants’ perception of voice therapy delivered through tele practice.     

Statistical analysis

Descriptive statistics will be used to summarise and describe the collected data. For continuous variables, paired t-test will be used to find the change between the mentioned two points. Wilcoxon signed rank will be used for those not following normal distribution to see the shift between the said two points

 

 
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