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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04690166
Other study ID # 462
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 21, 2020
Est. completion date May 21, 2021

Study information

Verified date July 2021
Source Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Purpose of the study is the validation and cultual adaptation of the Turkish translation of the London Speech Evaluation Scale (LSE-T), so that it would be used as an assessment tool for Turkish head and neck cancer patients. There is no validated Turkish version of LSE to measure severity of perceptual speech in head and neck cancer patients.


Description:

The speech function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as voice analysis computer programmes, scales, or well structured questionnaires. There are many scales for assessment of perceptual speech but there is no validated for head and neck patients. The study will assess the construct validity and adaptation of the Turkish translation of Speech Specific Perceptual Speech Evaluation as known as London Speech Evaluation Scale. The investigators developed the Turkish translation of this scale (LSE-T), according to the cross-cultural adaptation guidelines. Two translators translated the LSE into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The LSE scale consisted of 6 parameters and 4 scores related with perceptual speech in head and neck cancer patients.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 21, 2021
Est. primary completion date May 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Able to speak, read, understand and write in Turkish - History of oral, orofarengeal cancer - Volunteers who accept the informed consent Exclusion Criteria: - Mental disorders - Cognitive limitations - Able not to speak, read, understand and write in Turkish - Underwent any surgery last six month - Permanent tracheostomy, total laryngectomy - Pregnancy - Out of age 18-70 years old - Adults who do not accept the informed consent.

Study Design


Intervention

Other:
The speech records related to the reading document
The document consists "bit, bet, but" words and Diyet passage. Volunteers will read the document in front of the microphone and also the speech will recorded by a computer.

Locations

Country Name City State
Turkey Prof Dr Cemil Tascioglu City Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Dwivedi RC, Rose SS, Chisholm EJ, Kerawala CJ, Clarke PM, Nutting CM, Rhys-Evans PH, Harrington KJ, Kazi R. Development and validation of first-ever speech-specific perceptual speech evaluation tool for patients with head and neck cancer: the London speech evaluation (LSE) scale. Head Neck. 2012 Jan;34(1):94-103. doi: 10.1002/hed.21683. Epub 2011 Apr 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Validation of the Turkish Translation of London Speech Evaluation Scale Turkish Translation of London Speech Evaluation Scale consists of 6 parameters and 4 scores. The minimum score is 0 and maximum score is 24. The lower scores mean a better than high scores. Baseline
Primary Validation of the Turkish Translation of London Speech Evaluation Scale Turkish Translation of London Speech Evaluation Scale consists of 6 parameters and 4 scores. The minimum score is 0 and maximum score is 24. The lower scores mean a better than high scores. 6 weeks
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