- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690166
Validation of the Turkish Translation of the London Speech Evaluation Scale
July 28, 2021 updated by: Yavuz Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Validation and Cultural Adaptation of the Turkish Translation of the London Speech Evaluation Scale
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
120
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
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Istanbul, Turkey, 34384
- Prof Dr Cemil Tascioglu City Hospital
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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
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults with oral, oropharyngeal cancer and healthy adults
Description
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 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cancer Patients
In outpatients clinic, the first group consists of 60 head and neck cancer patients who were treated by ours.
The participants will given the document consists that "bit, bet, but" words and also a brief part of "Diyet passage" who written by Omer Seyffettin.
The speech record of patients who read to document, will evaluated by three judges (otorhinolaryngologist).
Three judges will scoring to Turkish translation of London Speech Evaluation Scale (LSE-T), consists of 6 parameters.
After the six weeks, the records were scored again as randomisely.
|
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.
|
Healty Control
In outpatients clinic, the control group consists of 60 patients who have not speech and hear impairments.
The participants will given the document consists that "bit, bet, but" words and also a brief part of "Diyet passage" who written by Omer Seyffettin.
The speech record of patients who read to document, will evaluated by three judges (otorhinolaryngologist).
Three judges will scoring to Turkish translation of London Speech Evaluation Scale (LSE-T), consists of 6 parameters.
After the six weeks, the records were scored again as randomisely.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of the Turkish Translation of London Speech Evaluation Scale
Time Frame: Baseline
|
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
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Validation of the Turkish Translation of London Speech Evaluation Scale
Time Frame: 6 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ziya Salturk, Asso Prof,MD, Anadolu Medical Center, In Affiliation with Johns Hopkins Medicine
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.
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)
December 21, 2020
Primary Completion (ACTUAL)
May 21, 2021
Study Completion (ACTUAL)
May 21, 2021
Study Registration Dates
First Submitted
December 26, 2020
First Submitted That Met QC Criteria
December 26, 2020
First Posted (ACTUAL)
December 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 29, 2021
Last Update Submitted That Met QC Criteria
July 28, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 462 (Alzheimer's Society)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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