Validation of the Turkish Translation of the London Speech Evaluation Scale

NCT ID: NCT04690166

Last Updated: 2021-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-21

Study Completion Date

2021-05-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Speech Intelligibility Speech Disorders Head and Neck Cancer Speech Dysfunction Speech

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 speech records related to the reading document

Intervention Type OTHER

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 speech records related to the reading document

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yavuz Atar

Associate Professor, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ziya Salturk, Asso Prof,MD

Role: PRINCIPAL_INVESTIGATOR

Anadolu Medical Center, In Affiliation with Johns Hopkins Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prof Dr Cemil Tascioglu City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21469245 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

462

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.