Parkinson DiseaseNCT04737811
Validation of the Turkish Swallowing Disturbance Questionnaire
An observational study of Parkinson Disease and Dysphagia, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, Dysphagia
- What is being tested?
- Turkish Version of Swallowing Disturbance Questionnaire
- How many people
- 152 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2020to 7 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease patients
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof Dr Cemil Tascioglu City Hospital
Istanbul, 34384
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Dysphagia
- Being tested
- Turkish Version of Swallowing Disturbance Questionnaire
- Keywords
- Parkinson's disease, dysphagia, questionnaire, swallowing, validation
- Medical subject headings
- Parkinson Disease, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Version of Swallowing Disturbance QuestionnaireOther
The Turkish Version of Swallowing Disturbance Questionnaire consists of 15 questions related with dysphagia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Turkish Version of Swallowing Disturbance Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: Baseline
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.
Measured: Baseline
Secondary outcomes (1)
Subject demographics
The median values of age and ratio of gender in all groups
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start7 Dec 2020
- Primary completion7 Mar 2021
- Study completion7 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Yavuz Atar, Asso Prof,MD, Study chair, University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City HospitalSevgi Atar, Special.,MD, Study director, University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City HospitalOnur Akan, Special.,MD, Principal investigator, University of Health Sciences, Department of Neurology, Prof Dr Cemil Tascioglu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737811
- Sponsor's protocol ID
- 440
- Status last verified
- Jul 2021
- First submitted
- 30 Jan 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17588237Cohen 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.
PubMed 21671239
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Reliability of the Turkish Translation of the Swallowing Disturbance Questionnaire in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT04737811
- Acronym / sponsor ID
- 440
- Conditions
- Parkinson Disease, Dysphagia
- Keywords
- Parkinson's disease, dysphagia, questionnaire, swallowing, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 7 Mar 2021 (actual)
- Study completion
- 7 Mar 2021 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Turkish Version of Swallowing Disturbance QuestionnaireThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients
Key inclusion criteria (6 listed)
- Diagnosed with Parkinson's disease
- Able to speak, read, understand and write in Turkish
- Taking food orally
- Malignancy
- Having an active infection
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish Version of Swallowing Disturbance QuestionnaireThe Turkish Version of Swallowing Disturbance Questionnaire consists of 15 questions related with dysphagia. | Other | Study group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Subject demographics
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 17588237Manor 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.
- Background: PubMed 21671239Cohen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yavuz Atar, Asso Prof,MD study chair
University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City Hospital
Sevgi Atar, Special.,MD study director
University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City Hospital
Onur Akan, Special.,MD principal investigator
University of Health Sciences, Department of Neurology, Prof Dr Cemil Tascioglu City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Dysphagia, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish Version of Swallow Disturbance Questionnaire (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737811, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.