- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05132452
The Test of Mastication and Swallowing Solids and the Timed Water Swallow Test
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
Status
Conditions
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: oshrat sella, PhD, University of Haifa
Publications and helpful links
General Publications
- Sarve AR, Krishnamurthy R, Balasubramanium RK. The timed water test of swallowing: Reliability, validity, and normative data from Indian population. Int J Health Sci (Qassim). 2021 Mar-Apr;15(2):14-20.
- Athukorala RP, Jones RD, Sella O, Huckabee ML. Skill training for swallowing rehabilitation in patients with Parkinson's disease. Arch Phys Med Rehabil. 2014 Jul;95(7):1374-82. doi: 10.1016/j.apmr.2014.03.001. Epub 2014 May 9.
- Huckabee ML, McIntosh T, Fuller L, Curry M, Thomas P, Walshe M, McCague E, Battel I, Nogueira D, Frank U, van den Engel-Hoek L, Sella-Weiss O. The Test of Masticating and Swallowing Solids (TOMASS): reliability, validity and international normative data. Int J Lang Commun Disord. 2018 Jan;53(1):144-156. doi: 10.1111/1460-6984.12332. Epub 2017 Jul 5.
- Krishnamurthy R, Kothari S, Balasubramanium RK, Huckabee ML. The Test of Masticating and Swallowing Solids (TOMASS): Normative data for the adult Indian population. Data Brief. 2021 Mar 18;35:106958. doi: 10.1016/j.dib.2021.106958. eCollection 2021 Apr.
- Hughes TA, Wiles CM. Clinical measurement of swallowing in health and in neurogenic dysphagia. QJM. 1996 Feb;89(2):109-16. doi: 10.1093/qjmed/89.2.109.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1012 (Registry Identifier: NNGYK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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