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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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