NCT04729660

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

January 21, 2021

Last Update Submit

February 2, 2021

Conditions

Keywords

kinesio tapingmutational falsettotherapydysphonia

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Mean of demographic

    Baseline

Study Arms (2)

Study group

ACTIVE COMPARATOR

Evaluate of the Kinesio tex gold tape that applied to anterior neck localised.

Device: Kinesio Tex Gold

Sham group

SHAM COMPARATOR

Evaluate of the Kinesio tex gold tape that applied to different neck localised as no-stretched.

Device: Kinesio Tex Gold

Interventions

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

Sham groupStudy group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe males show more commonly that findings of mutational falsetto.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 32222704BACKGROUND
  • 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.

    PMID: 30528384BACKGROUND

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yavuz Atar, Asso Prof,MD

    University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D.

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 28, 2021

Study Start

July 31, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations