Clinical trial NCT04737811: Validation of the Turkish Swallowing Disturbance Questionnaire
Official title: Validation and Reliability of the Turkish Translation of the Swallowing Disturbance Questionnaire in Parkinson's Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Dysphagia
Keywords: Parkinson's disease
dysphagia
questionnaire
swallowing
validation
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parkinson's disease patients

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Turkish Version of Swallow Disturbance Questionnaire
timeFrame: Baseline
measure: Turkish Version of Swallow Disturbance Questionnaire
timeFrame: 2 weeks
measure: Penetration and aspiration scale
timeFrame: Baseline
measure: Yale Pharyngeal Residue Severity Rating Scale
timeFrame: Baseline
Secondary outcomes:
measure: Subject demographics
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof Dr Cemil Tascioglu City Hospital
Study officials:
affiliation: University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City Hospital
name: Yavuz Atar, Asso Prof,MD
role: STUDY_CHAIR
affiliation: University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City Hospital
name: Sevgi Atar, Special.,MD
role: STUDY_DIRECTOR
affiliation: University of Health Sciences, Department of Neurology, Prof Dr Cemil Tascioglu City Hospital
name: Onur Akan, Special.,MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1002/mds.21625.
citation: 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.