NCT04737811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2021

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

January 30, 2021

Last Update Submit

July 28, 2021

Conditions

Keywords

Parkinson's diseasedysphagiaquestionnaireswallowingvalidation

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Subject demographics

    Baseline

Study Arms (1)

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

Interventions

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

Study group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Parkinson's disease patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 17588237BACKGROUND
  • 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.

    PMID: 21671239BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseDeglutition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Yavuz Atar, Asso Prof,MD

    University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City Hospital

    STUDY CHAIR
  • Sevgi Atar, Special.,MD

    University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City Hospital

    STUDY DIRECTOR
  • Onur Akan, Special.,MD

    University of Health Sciences, Department of Neurology, Prof Dr Cemil Tascioglu City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist, MD

Study Record Dates

First Submitted

January 30, 2021

First Posted

February 4, 2021

Study Start

December 7, 2020

Primary Completion

March 7, 2021

Study Completion

March 7, 2021

Last Updated

August 3, 2021

Record last verified: 2021-07

Locations