Mutational FalsettoNCT04729660

Efficacy of Kinesio Taping on Mutational Falsetto

A study testing Kinesio Tex Gold in people with Mutational Falsetto and Dysphonia, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 60 years, men only
Conditions the study is for: Mutational Falsetto, Dysphonia
What is being tested?: Kinesio Tex Gold
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 31 Jul 2020to 31 Jan 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

Patients suffered from Mutational falsetto
Patients who were accept to consent form
Patients who have not open wound on neck

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Prof Dr Cemil Tascioglu City Hospital
Istanbul, 34384

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the 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.

Conditions: Mutational Falsetto, Dysphonia
Being tested: Kinesio Tex Gold
Keywords: kinesio taping, mutational falsetto, therapy, dysphonia
Medical subject headings: Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Kinesio Tex GoldDevice
The Kinesio Tex Gold is a kinesio tape that had been certified and patented.

Study groups in NCT04729660
Study group	Role	What they receive
Study group	Active comparator	Evaluate of the Kinesio tex gold tape that applied to anterior neck localised. Receives: Device: Kinesio Tex Gold
Sham group	Sham comparator	Evaluate of the Kinesio tex gold tape that applied to different neck localised as no-stretched. Receives: Device: Kinesio Tex Gold

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: Baseline
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.
Measured: 2 weeks

Secondary outcomes (1)

Mean of demographic
Age, gender, history of smoke, history of morbidities, history of treatments, diagnosis, were noted
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 202031 Jan 2021

First posted28 Jan 2021
Study start31 Jul 2020
Primary completion31 Jan 2021
Study completion31 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Mutational FalsettoStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04729660
Sponsor's protocol ID: 310
Status last verified: Feb 2021
First submitted: 21 Jan 2021
Last updated: 4 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 32222704
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.
PubMed 30528384

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Kinesio Taping on Mutational Falsetto: A Randomized, Double-blind, Sham-controlled Clinical Trial
ClinicalTrials.gov ID: NCT04729660
Acronym / sponsor ID: 310
Conditions: Mutational Falsetto, Dysphonia
Keywords: kinesio taping, mutational falsetto, therapy, dysphonia
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
Study start: 31 Jul 2020 (actual)
Primary completion: 31 Jan 2021 (actual)
Study completion: 31 Jan 2021 (actual)
First posted: 28 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Study group	Active comparator	Device: Kinesio Tex GoldEvaluate of the Kinesio tex gold tape that applied to anterior neck localised.
Sham group	Sham comparator	Device: Kinesio Tex GoldEvaluate of the Kinesio tex gold tape that applied to different neck localised as no-stretched.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Patients suffered from Mutational falsetto
Patients who were accept to consent form
Patients who have not open wound on neck

Key exclusion criteria (10 listed)

Having mental disorders or major physiatric disorders
Cognitive limitations
Contact dermatitis
history of smoking
Asthma, chronic pulmonary diseases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Kinesio Tex GoldThe Kinesio Tex Gold is a kinesio tape that had been certified and patented.	Device	Sham group, Study group

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.

1 secondary outcome

Mean of demographic
Time frame: Baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
Background: PubMed 32222704Salturk 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.
Background: PubMed 30528384Mezzedimi 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yavuz Atar, Asso Prof,MD study chair

University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Kinesio Tex Gold in people with Mutational Falsetto and Dysphonia, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The outcomes of voice handicap index - 10 (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04729660, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.