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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05132452
Other study ID # 1012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2016
Est. completion date December 23, 2018

Study information

Verified date November 2021
Source University of Haifa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 298
Est. completion date December 23, 2018
Est. primary completion date December 23, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST)
Participants swallowed one cracker for the TOMASS. They swallowed 150 mL of water for the TWST.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Haifa

References & Publications (5)

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. — View 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. — View Citation

Hughes TA, Wiles CM. Clinical measurement of swallowing in health and in neurogenic dysphagia. QJM. 1996 Feb;89(2):109-16. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary duration length of time required to complete the task one-off assessment
Primary swallows number of swallows required to complete the task one-off assessment
Primary bites number of bites required to eat the cracker one-off assessment
Primary masticatory cycles number of masticatory cycles required to eat the cracker one-off assessment
Primary volume the amount of water swallowed one-off assessment
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