Validation of the Turkish Swallowing Disturbance Questionnaire

July 28, 2021 updated by: Sevgi Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Validation and Reliability of the Turkish Translation of the Swallowing Disturbance Questionnaire in Parkinson's Disease Patients

Purpose of the study is the validity and reliability of the Turkish version of the Swallowing Disturbance Questionnaire (SDQ-T), so that it would be used as an assessment tool for Turkish Parkinson Disease's (PD) patients. Despite being translated and validated in many languages, there is no validated Turkish version of SDQ to measure the severity of dysphagia in PD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Parkinson's disease (PD) patients who suffered from dysphagia have reported significantly reduced quality of life. The swallow function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured questionnaires. There are many questionnaire and scales for assessment of dysphagia in PD but very few have been validated. The study will assess the construct validity and reliability of the Turkish version of Swallowing Disturbance Questionnaire. The investigators developed the Turkish version of this questionnaire (SDQ-T), according to the cross-cultural adaptation guidelines. Two translators translated the SDQ 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 SDQ questionnaire consisted of 15 basic questions related with dysphagia symptoms in PD patients.

Study Type

Observational

Enrollment (Actual)

152

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

  • Turkey
      • Istanbul, Turkey, 34384
        • Prof Dr Cemil Tascioglu City Hospital

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Parkinson's disease patients

Description

Inclusion Criteria:

  • Diagnosed with Parkinson's disease
  • Able to speak, read, understand and write in Turkish
  • Taking food orally
  • Malignancy
  • Having an active infection
  • Advanced demans or

Exclusion Criteria:

  • Diagnosed with other neurodegenerative disorders.
  • Able not to speak, read, understand and write in Turkish
  • Advanced demeans or other cognitive limitations
  • Underwent any surgery last six months
  • Pregnancy
  • Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy
  • Out of age 18-80 years old.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
The group consists of Parkinson's disease patients with dysphagia complaints. The participants will be given the Turkish version of the Swallow Disturbance Questionnaire (SDQ-T), which consisted of 15 questions and two scales evaluated with the fiberoptic endoscopic evaluation of swallowing. After two weeks, all participants will be given the SDQ-T for sampling.
Other: Turkish Version of Swallowing Disturbance Questionnaire
The Turkish Version of Swallowing Disturbance Questionnaire consists of 15 questions related with dysphagia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penetration and aspiration scale
Time Frame: Baseline
The scale consists of 8 levels for assessment of penetration and aspiration. The scores are from 0 to 8. Low score is better, higher score is worse.
Baseline
Turkish Version of Swallow Disturbance Questionnaire
Time Frame: Baseline
Turkish version of the questionnaire consists of 15 questions about dysphagia and swallowing complaints. The minimum score is 0 and maximum score is 44,5. The lower scores mean a normal swallowing function, higher scores mean worst swallowing functions.
Baseline
Turkish Version of Swallow Disturbance Questionnaire
Time Frame: 2 weeks
Turkish version of the questionnaire consists of 15 questions about dysphagia and swallowing complaints. The minimum score is 0 and maximum score is 44,5. The lower scores mean a normal swallowing function, higher scores mean worst swallowing functions.
2 weeks
Yale Pharyngeal Residue Severity Rating Scale
Time Frame: Baseline
The scale consists of 5 assessment units and two localisations for pharyngeal residue. The scores are from 1 to 5 each localisation. Low score is better, higher score is worse.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject demographics
Time Frame: Baseline
The median values of age and ratio of gender in all groups
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

  • Study Chair: Yavuz Atar, Asso Prof,MD, University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City Hospital
  • Study Director: Sevgi Atar, Special.,MD, University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City Hospital
  • Principal Investigator: Onur Akan, Special.,MD, University of Health Sciences, Department of Neurology, Prof Dr Cemil Tascioglu City Hospital

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.

General Publications

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 7, 2020

Primary Completion (Actual)

March 7, 2021

Study Completion (Actual)

March 7, 2021

Study Registration Dates

First Submitted

January 30, 2021

First Submitted That Met QC Criteria

January 30, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 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

  • 440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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