The Test of Mastication and Swallowing Solids and the Timed Water Swallow Test

November 12, 2021 updated by: Oshrat Sella, University of Haifa

The Test of Mastication and Swallowing Solids and the Timed Water Swallow Test: Reliability, Associations, Age and Gender Effects, and Normative Data

This study aimed to gather more information regarding two clinically relevant tests: The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST). Both tests can be used clinically as part of swallowing disorders evaluation.

The aims of the study were to assess the reliability of the two tests, to document the effects of age and gender on the outcome measures of the TOMASS and TWST and to explore the relationship between participants' function in the two tests. To do that, 298 healthy participants were included. All of them did not have dysphagia. Most of them were elderly.

Study Overview

Detailed Description

Background: Quantitative measures of swallowing function can increase accuracy, reliability, and improve clinical decision making. The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST) are functional tests of swallowing that provide quantitative results.

Objectives: To explore the relationship between TOMASS and TWST; evaluate test-retest and interrater reliability; explore age and gender effects; and to gather normative data.

Methods: Healthy community dwelling participants (n = 298, ≥20 years old) were recruited. Of those, 126 were included in the reliability study. Participants completed the TWST and TOMASS.

Study Type

Observational

Enrollment (Actual)

298

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy subjects living in the community

Description

Inclusion Criteria:

  • all participants were eligible to participate if they were over 20 years of age, with no known medical history of dysphagia, had an SDQ score of less than 11, indicating no suspicion for dysphagia, were able to give a written informed consent, and could follow simple verbal instructions. In addition, all participants indicated that they do not avoid eating crackers due to swallowing disorders or allergies.

Exclusion Criteria:

  • SDQ over 11 or medically reported dysphagia not eating crackers due to swallowing difficulty allergy to gluten

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adults living in the community
Healthy community dwelling participants, aged 20 year old and above, without dysphagia.
Participants swallowed one cracker for the TOMASS. They swallowed 150 mL of water for the TWST.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration
Time Frame: one-off assessment
length of time required to complete the task
one-off assessment
swallows
Time Frame: one-off assessment
number of swallows required to complete the task
one-off assessment
bites
Time Frame: one-off assessment
number of bites required to eat the cracker
one-off assessment
masticatory cycles
Time Frame: one-off assessment
number of masticatory cycles required to eat the cracker
one-off assessment
volume
Time Frame: one-off assessment
the amount of water swallowed
one-off assessment

Collaborators and Investigators

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

Investigators

  • Principal Investigator: oshrat sella, PhD, University of Haifa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

February 1, 2016

Primary Completion (Actual)

December 23, 2018

Study Completion (Actual)

December 23, 2018

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 1012 (Registry Identifier: NNGYK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

there is no plan to make individual participant data (IPD) available to other researchers.

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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