Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases

April 11, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Measurements of dysphagia severity are important when making management decisions and in the objective evaluation of swallowing impairments. The Sydney Swallow Questionnaire (SSQ) is a validated self-report inventory using a visual analogue scale. This questionnaire permits a quantitative, sensitive, specific, repeatable and easily responsive evaluation of dysphagia in different pathology. Opposed to largely used videofluoroscopy swallowing study and endoscopy examinations, the SSQ is noninvasive, less expensive, avoids radiation exposure and enables a readily available assessment. Validated French version is not yet available. In the first phase of the study the investigators will validated this translation in dysphagic patients and control. Secondly, the investigators will validate the SSQ in Neuromuscular patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Phase 1:

Group 1:

  • Healthy participants
  • Able to speak, read and write in French
  • Aged at least 18 years old

Group 2:

  • Patients, with symptoms indicative of a deglutition disorder, referred for a videofluoroscopic study to the Otolaryngology, Head and Neck Surgery Department, Voice and Swallowing Clinic
  • Able to speak, read and write in French
  • Aged at least 18 years old

Phase 2:

  • Clinical diagnosis of neuromuscular diseases
  • Able to understand French

Exclusion Criteria:

Phase 1:

Group 1:

  • History of neurological or neuromuscular disease
  • History of any diagnosticated swallowing disorder

Group 2:

  • Patients who could not be cataloged as dysphagic or non-dysphagic after the videofluoroscopic study evaluation
  • Patients unable to answer the questionnaire

Phase 2:

  • Patients who could not be cataloged as dysphagic or non-dysphagic
  • Patients unable to answer the questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dysphagia assessment
Other: Sydney Swallow Questionnaire
The Sydney Swallow Questionnaire (SSQ) is a validated self-report symptom questionnaire, it contains 17 items recorded as visual analogue scales and is a tool specifically designed for evaluation of swallowing difficulties.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sydney Swallow Questionnaire
Time Frame: 10 minutes
The participants were asked to fill out these questionnaires during the outpatient visit.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Nicolas Audag, PT, Cliniques Universitaires Saint-Luc, Brussels, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSQVAL
  • 2016/18MAI/215 (Other Identifier: CEHF)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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