Efficacy of Kinesio Taping on Mutational Falsetto

February 2, 2021 updated by: Yavuz Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34384
        • Prof Dr Cemil Tascioglu City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group
Evaluate of the Kinesio tex gold tape that applied to anterior neck localised.
Device: Kinesio Tex Gold
The Kinesio Tex Gold is a kinesio tape that had been certified and patented.
Sham Comparator: Sham group
Evaluate of the Kinesio tex gold tape that applied to different neck localised as no-stretched.
Device: Kinesio Tex Gold
The Kinesio Tex Gold is a kinesio tape that had been certified and patented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The outcomes of voice handicap index - 10
Time Frame: Baseline
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
The outcomes of voice handicap index - 10
Time Frame: 2 weeks
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
The outcomes of Grade-Roughness-Breathiness-Asthenia-Strain scale
Time Frame: Baseline
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
The outcomes of Grade-Roughness-Breathiness-Asthenia-Strain scale
Time Frame: 2 weeks
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
The outcomes of fundamental frequency
Time Frame: Baseline
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
The outcomes of fundamental frequency
Time Frame: 2 weeks
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
The outcomes of maximum phonation times
Time Frame: Baseline

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
The outcomes of maximum phonation times
Time Frame: 2 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of demographic
Time Frame: Baseline
Age, gender, history of smoke, history of morbidities, history of treatments, diagnosis, were noted
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

  • Study Chair: Yavuz Atar, Asso Prof,MD, University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2020

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 310

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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