Validation of the Turkish Swallowing Disturbance Questionnaire

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04737811
• Other study ID #: 440
• Status: Completed
• Start date: December 7, 2020
• Est. completion date: March 7, 2021

Study information

• Verified date: July 2021
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 7, 2021
• Est. primary completion date: March 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Turkey	Prof Dr Cemil Tascioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Cohen JT, Manor Y. Swallowing disturbance questionnaire for detecting dysphagia. Laryngoscope. 2011 Jul;121(7):1383-7. doi: 10.1002/lary.21839. Epub 2011 Jun 10. — View Citation

Manor Y, Giladi N, Cohen A, Fliss DM, Cohen JT. Validation of a swallowing disturbance questionnaire for detecting dysphagia in patients with Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1917-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Turkish Version of Swallow Disturbance Questionnaire	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
Primary	Turkish Version of Swallow Disturbance Questionnaire	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
Primary	Penetration and aspiration scale	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
Primary	Yale Pharyngeal Residue Severity Rating Scale	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	Subject demographics	The median values of age and ratio of gender in all groups	Baseline