Speech IntelligibilityNCT04690166
Validation of the Turkish Translation of the London Speech Evaluation Scale
An observational study of Speech Intelligibility and Speech Disorders, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech Intelligibility, Speech Disorders, Head and Neck Cancer
- What is being tested?
- The speech records related to the reading document
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2020to 21 May 2021
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with oral, oropharyngeal cancer and healthy adults
Who may be able to join
- Able to speak, read, understand and write in Turkish
- History of oral, orofarengeal cancer
- Volunteers who accept the informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof Dr Cemil Tascioglu City Hospital
Istanbul, 34384
About this study
Official title: 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.
Read the 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.
- Conditions
- Speech Intelligibility, Speech Disorders, Head and Neck Cancer, Speech Dysfunction, Speech
- Being tested
- The speech records related to the reading document
- Keywords
- Perceptual, speech, articulation, neck, cancer
- Medical subject headings
- Speech Intelligibility, Speech Disorders, Head and Neck Neoplasms, Speech, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The speech records related to the reading documentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: The speech records related to the reading document | |
| 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. Receives: Other: The speech records related to the reading document |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start21 Dec 2020
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Speech IntelligibilityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Ziya Salturk, Asso Prof,MD, Principal investigator, Anadolu Medical Center, In Affiliation with Johns Hopkins Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690166
- Sponsor's protocol ID
- 462
- Status last verified
- Jul 2021
- First submitted
- 26 Dec 2020
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21469245
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Cultural Adaptation of the Turkish Translation of the London Speech Evaluation Scale
- ClinicalTrials.gov ID
- NCT04690166
- Acronym / sponsor ID
- 462
- Conditions
- Speech Intelligibility, Speech Disorders, Head and Neck Cancer, Speech Dysfunction, Speech
- Keywords
- Perceptual, speech, articulation, neck, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 30 Dec 2020 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients | – | Other: The speech records related to the reading documentIn 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. |
| Healty Control | – | Other: The speech records related to the reading documentIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with oral, oropharyngeal cancer and healthy adults
Key inclusion criteria (3 listed)
- Able to speak, read, understand and write in Turkish
- History of oral, orofarengeal cancer
- Volunteers who accept the informed consent
Key exclusion criteria (8 listed)
- Mental disorders
- Cognitive limitations
- Able not to speak, read, understand and write in Turkish
- Underwent any surgery last six month
- Permanent tracheostomy, total laryngectomy
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 |
|---|---|---|
| The speech records related to the reading documentThe 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. | Other | Cancer Patients, Healty Control |
Primary outcome
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.
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.
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 29 Jul 2021.
- Background: PubMed 21469245Dwivedi 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.
- Individual participant dataSharing planned: No
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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.
Ziya Salturk, Asso Prof,MD principal investigator
Anadolu Medical Center, In Affiliation with Johns Hopkins Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Speech Intelligibility and Speech Disorders, 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 8 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 29 Jul 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. 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?
Validation of the Turkish Translation of London Speech Evaluation Scale (time frame: Baseline). The study lists 2 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 NCT04690166, which also lists 1 linked publication.
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 29 Jul 2021.