Back to resultsEfficacy of Kinesio Taping on Mutational Falsetto
Primary Purpose
Mutational Falsetto, Dysphonia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio Tex Gold
Sponsored by
About this trial
This is an interventional treatment trial for Mutational Falsetto focused on measuring kinesio taping, mutational falsetto, therapy, dysphonia
Eligibility Criteria
Inclusion Criteria:
- Patients suffered from Mutational falsetto
- Patients who were accept to consent form
- Patients who have not open wound on neck
Exclusion Criteria:
- Having mental disorders or major physiatric disorders
- Cognitive limitations
- Contact dermatitis
- history of smoking
- Asthma, chronic pulmonary diseases
- history of allergic reactions against to medical tape applied
- having an other organic vocal disorders
- advanced hearing loss
- Out of BMI<18.5 or 30<BMI
- Out of age 16-60 years old patients who were not accept to consent form.
Sites / Locations
- Prof Dr Cemil Tascioglu City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Study group
Sham group
Arm Description
Evaluate of the Kinesio tex gold tape that applied to anterior neck localised.
Evaluate of the Kinesio tex gold tape that applied to different neck localised as no-stretched.
Outcomes
Primary Outcome Measures
The outcomes of voice handicap index - 10
It was assessed by voice handicap index - 10 that a self questionnaire in mutational falsetto patients. The minimum score is 0 and maximum score is 4 per question. The high scores were worst low scores were good.
The outcomes of voice handicap index - 10
It was assessed by voice handicap index - 10 that a self questionnaire in mutational falsetto patients. The minimum score is 0 and maximum score is 4 per question. The high scores were worst low scores were good.
The outcomes of Grade-Roughness-Breathiness-Asthenia-Strain scale
It was assessed by Grade-Roughness-Breathiness-Asthenia-Strain scale that a scale in mutational falsetto patients. The minimum score is 0 and maximum score is 3 per category. The high scores were worst low scores were good.
The outcomes of Grade-Roughness-Breathiness-Asthenia-Strain scale
It was assessed by Grade-Roughness-Breathiness-Asthenia-Strain scale that a scale in mutational falsetto patients. The minimum score is 0 and maximum score is 3 per category. The high scores were worst low scores were good.
The outcomes of fundamental frequency
It was analyzed with noise harmonic ratio, jitter and shimmer that were calculated by computer software. Typical average values for the frequencies are 120 Hz for men and 210 Hz for women. The lower frequencies show masculine voice. The higher frequencies show feminine voices.
The outcomes of fundamental frequency
It was analyzed with noise harmonic ratio, jitter and shimmer that were calculated by computer software. Typical average values for the frequencies are 120 Hz for men and 210 Hz for women. The lower frequencies show masculine voice. The higher frequencies show feminine voices.
The outcomes of maximum phonation times
The subjects tried to say the vowel "a'" for as long as they could than it was assessed as seconds.
Typical average values for the maximum phonation times are between 15-30 seconds. The higher times show healthy phonation.
The outcomes of maximum phonation times
The subjects tried to say the vowel "a'" for as long as they could than it was assessed as seconds.
Typical average values for the maximum phonation times are between 15-30 seconds. The higher times show healthy phonation.
Secondary Outcome Measures
Mean of demographic
Age, gender, history of smoke, history of morbidities, history of treatments, diagnosis, were noted
Full Information
NCT ID
NCT04729660
First Posted
January 21, 2021
Last Updated
February 2, 2021
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1. Study Identification
Unique Protocol Identification Number
NCT04729660
Brief Title
Efficacy of Kinesio Taping on Mutational Falsetto
Official Title
Efficacy of Kinesio Taping on Mutational Falsetto: A Randomized, Double-blind, Sham-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to assess of efficacy of the kinesio-taping on male patients suffering from mutational falsetto
Detailed Description
Mutational falsetto is a functional voice disorder involving a failure to transition from the high-pitched voice of childhood to the lower-pitch ed voice of adolescence and adulthood. In the recent years, kinesio taping has begun to be employed for treating dysphonia patients. We hypothesized that, because the kinesio taping relaxes the suprahyoid muscles and pushes the larynx backward, it could also be used as a therapy of mutational falsetto. This study aimed to assess of efficacy of the kinesio taping on male patients suffering from mutational falsetto.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mutational Falsetto, Dysphonia
Keywords
kinesio taping, mutational falsetto, therapy, dysphonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
Evaluate of the Kinesio tex gold tape that applied to anterior neck localised.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Evaluate of the Kinesio tex gold tape that applied to different neck localised as no-stretched.
Intervention Type
Device
Intervention Name(s)
Kinesio Tex Gold
Intervention Description
The Kinesio Tex Gold is a kinesio tape that had been certified and patented.
Primary Outcome Measure Information:
Title
The outcomes of voice handicap index - 10
Description
It was assessed by voice handicap index - 10 that a self questionnaire in mutational falsetto patients. The minimum score is 0 and maximum score is 4 per question. The high scores were worst low scores were good.
Time Frame
Baseline
Title
The outcomes of voice handicap index - 10
Description
It was assessed by voice handicap index - 10 that a self questionnaire in mutational falsetto patients. The minimum score is 0 and maximum score is 4 per question. The high scores were worst low scores were good.
Time Frame
2 weeks
Title
The outcomes of Grade-Roughness-Breathiness-Asthenia-Strain scale
Description
It was assessed by Grade-Roughness-Breathiness-Asthenia-Strain scale that a scale in mutational falsetto patients. The minimum score is 0 and maximum score is 3 per category. The high scores were worst low scores were good.
Time Frame
Baseline
Title
The outcomes of Grade-Roughness-Breathiness-Asthenia-Strain scale
Description
It was assessed by Grade-Roughness-Breathiness-Asthenia-Strain scale that a scale in mutational falsetto patients. The minimum score is 0 and maximum score is 3 per category. The high scores were worst low scores were good.
Time Frame
2 weeks
Title
The outcomes of fundamental frequency
Description
It was analyzed with noise harmonic ratio, jitter and shimmer that were calculated by computer software. Typical average values for the frequencies are 120 Hz for men and 210 Hz for women. The lower frequencies show masculine voice. The higher frequencies show feminine voices.
Time Frame
Baseline
Title
The outcomes of fundamental frequency
Description
It was analyzed with noise harmonic ratio, jitter and shimmer that were calculated by computer software. Typical average values for the frequencies are 120 Hz for men and 210 Hz for women. The lower frequencies show masculine voice. The higher frequencies show feminine voices.
Time Frame
2 weeks
Title
The outcomes of maximum phonation times
Description
The subjects tried to say the vowel "a'" for as long as they could than it was assessed as seconds.
Typical average values for the maximum phonation times are between 15-30 seconds. The higher times show healthy phonation.
Time Frame
Baseline
Title
The outcomes of maximum phonation times
Description
The subjects tried to say the vowel "a'" for as long as they could than it was assessed as seconds.
Typical average values for the maximum phonation times are between 15-30 seconds. The higher times show healthy phonation.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Mean of demographic
Description
Age, gender, history of smoke, history of morbidities, history of treatments, diagnosis, were noted
Time Frame
Baseline
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
The males show more commonly that findings of mutational falsetto.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suffered from Mutational falsetto
Patients who were accept to consent form
Patients who have not open wound on neck
Exclusion Criteria:
Having mental disorders or major physiatric disorders
Cognitive limitations
Contact dermatitis
history of smoking
Asthma, chronic pulmonary diseases
history of allergic reactions against to medical tape applied
having an other organic vocal disorders
advanced hearing loss
Out of BMI<18.5 or 30<BMI
Out of age 16-60 years old patients who were not accept to consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yavuz Atar, Asso Prof,MD
Organizational Affiliation
University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Prof Dr Cemil Tascioglu City Hospital
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
32222704
Citation
Salturk Z, Doganay T, Ustun O, Tutar B, Akgun MF, Uyar Y. Efficacy of Low Mandible Maneuver on Mutational Falsetto. Folia Phoniatr Logop. 2021;73(5):442-448. doi: 10.1159/000506631. Epub 2020 Mar 27.
Results Reference
background
PubMed Identifier
30528384
Citation
Mezzedimi C, Spinosi M, Mannino V, Ferretti F, Al-Balas H. Kinesio Taping Application in Dysphonic Singers. J Voice. 2020 May;34(3):487.e11-487.e20. doi: 10.1016/j.jvoice.2018.11.001. Epub 2018 Dec 6.
Results Reference
background
Learn more about this trial
Efficacy of Kinesio Taping on Mutational Falsetto
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