Clinical trial NCT05132452: The Test of Mastication and Swallowing Solids and the Timed Water Swallow Test
Official title: The Test of Mastication and Swallowing Solids and the Timed Water Swallow Test: Reliability, Associations, Age and Gender Effects, and Normative Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Aging
Gender
Swallowing Disorder
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 298
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy subjects living in the community

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: duration
timeFrame: one-off assessment
measure: swallows
timeFrame: one-off assessment
measure: bites
timeFrame: one-off assessment
measure: masticatory cycles
timeFrame: one-off assessment
measure: volume
timeFrame: one-off assessment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Haifa
name: oshrat sella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.