Efficacy of Kinesio Taping on Mutational Falsetto

Dysphonia Clinical Trial

Official title:

Efficacy of Kinesio Taping on Mutational Falsetto: A Randomized, Double-blind, Sham-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729660
• Other study ID #: 310
• Status: Completed
• Phase: N/A
• Start date: July 31, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2021
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to assess of efficacy of the kinesio-taping on male patients suffering from mutational falsetto

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysphonia
• Hoarseness
• Mutational Falsetto

Intervention

Device:
• Kinesio Tex Gold
The Kinesio Tex Gold is a kinesio tape that had been certified and patented.

Locations

Country	Name	City	State
Turkey	Prof Dr Cemil Tascioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Saltürk Z, Doganay T, Üstün O, Tutar B, Akgün MF, Uyar Y. Efficacy of Low Mandible Maneuver on Mutational Falsetto. Folia Phoniatr Logop. 2020 Mar 27:1-6. doi: 10.1159/000506631. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	2 weeks
Primary	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.	Baseline
Primary	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.	2 weeks
Primary	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.	Baseline
Primary	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.	2 weeks
Primary	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.	Baseline
Primary	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.	2 weeks
Secondary	Mean of demographic	Age, gender, history of smoke, history of morbidities, history of treatments, diagnosis, were noted	Baseline