Healthy Aging Clinical Trial
Official title:
The Test of Mastication and Swallowing Solids and the Timed Water Swallow Test: Reliability, Associations, Age and Gender Effects, and Normative 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 |
Verified date | November 2021 |
Source | University of Haifa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Haifa |
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
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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