Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT04729660
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2021-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Kinesio Taping on Mutational Falsetto
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055154', 'term': 'Dysphonia'}], 'ancestors': [{'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-01-26', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The outcomes of voice handicap index - 10', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'The outcomes of voice handicap index - 10', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'The outcomes of Grade-Roughness-Breathiness-Asthenia-Strain scale', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'The outcomes of Grade-Roughness-Breathiness-Asthenia-Strain scale', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'The outcomes of fundamental frequency', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'The outcomes of fundamental frequency', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'The outcomes of maximum phonation times', 'timeFrame': 'Baseline', 'description': 'The subjects tried to say the vowel "a\'" for as long as they could than it was assessed as seconds.\n\nTypical average values for the maximum phonation times are between 15-30 seconds. The higher times show healthy phonation.'}, {'measure': 'The outcomes of maximum phonation times', 'timeFrame': '2 weeks', 'description': 'The subjects tried to say the vowel "a\'" for as long as they could than it was assessed as seconds.\n\nTypical average values for the maximum phonation times are between 15-30 seconds. The higher times show healthy phonation.'}], 'secondaryOutcomes': [{'measure': 'Mean of demographic', 'timeFrame': 'Baseline', 'description': 'Age, gender, history of smoke, history of morbidities, history of treatments, diagnosis, were noted'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['kinesio taping', 'mutational falsetto', 'therapy', 'dysphonia'], 'conditions': ['Mutational Falsetto', 'Dysphonia']}, 'referencesModule': {'references': [{'pmid': '32222704', 'type': 'BACKGROUND', 'citation': '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': '30528384', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to assess of efficacy of the kinesio-taping on male patients suffering from mutational falsetto', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The males show more commonly that findings of mutational falsetto.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffered from Mutational falsetto\n* Patients who were accept to consent form\n* Patients who have not open wound on neck\n\nExclusion Criteria:\n\n* Having mental disorders or major physiatric disorders\n* Cognitive limitations\n* Contact dermatitis\n* history of smoking\n* Asthma, chronic pulmonary diseases\n* history of allergic reactions against to medical tape applied\n* having an other organic vocal disorders\n* advanced hearing loss\n* Out of BMI\\<18.5 or 30\\<BMI\n* Out of age 16-60 years old patients who were not accept to consent form.'}, 'identificationModule': {'nctId': 'NCT04729660', 'briefTitle': 'Efficacy of Kinesio Taping on Mutational Falsetto', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'Efficacy of Kinesio Taping on Mutational Falsetto: A Randomized, Double-blind, Sham-controlled Clinical Trial', 'orgStudyIdInfo': {'id': '310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': 'Evaluate of the Kinesio tex gold tape that applied to anterior neck localised.', 'interventionNames': ['Device: Kinesio Tex Gold']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'description': 'Evaluate of the Kinesio tex gold tape that applied to different neck localised as no-stretched.', 'interventionNames': ['Device: Kinesio Tex Gold']}], 'interventions': [{'name': 'Kinesio Tex Gold', 'type': 'DEVICE', 'description': 'The Kinesio Tex Gold is a kinesio tape that had been certified and patented.', 'armGroupLabels': ['Sham group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34384', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Prof Dr Cemil Tascioglu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yavuz Atar, Asso Prof,MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, M.D.', 'investigatorFullName': 'Yavuz Atar', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}