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Completed

NCT Number: NCT04737811

Validation of the Turkish Swallowing Disturbance Questionnaire

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Otorhinolaryngologic Diseases Parkinsonian Disorders Pharyngeal Diseases Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Turkish Version of Swallowing Disturbance Questionnaire

Other

The Turkish Version of Swallowing Disturbance Questionnaire consists of 15 questions related with dysphagia.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Subject demographics

    Time frame: Baseline

    The median values of age and ratio of gender in all groups

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 4, 2021
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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