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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04658316
Other study ID # 202010017RINB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date April 30, 2021

Study information

Verified date November 2020
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main topic of the research is to investigate the tongue's strength when swallowing. There has been much foreign literature on tongue strength. Iowa Oral Performance Instrument also has norms for reference, but the data are all taken from non-Asian people such as Caucasians. In this case, the credibility of the norms are decreased in domestic, and we also lack norm data of tongue strength when swallowing. Through the research, we can establish normative data belonging to the domestics, provide usable data for domestic researchers and clinical staff, and explore whether there are differences in age and gender in data between Taiwanese and foreigners.


Description:

Swallowing refers to the process by which food enters the stomach from the mouth. It is the physiological mechanism by which humans take in water and nutrients. It is a vital activity for individual survival. The physiological mechanism of swallowing has four major stages, oral preparation, oral cavity, pharynx, and esophagus. Each stage has its physiological mechanism, which depends on the different nerve and muscle structures. In the oral stage, our tongue plays an important role. Whether in the formation or transition of the food bolus, it must rely on the tongue to perform its normal functions. The main topic of the research is to explore the strength of the tongue when swallowing. The purpose is to discuss the influence of gender and age on swallowing tongue pressure. We expect to recruit 80 subjects and divide them into three groups according to their age: 20 to 39 years old, 40 to 59 years old, and 60 to 79 years old, with 13 to 14 males and females in each group, using Iowa Oral Performance Instrument measures the subject's maximum tongue pressure, average swallowing tongue pressure, and the ratio of the maximum tongue pressure used when swallowing, to explore whether age and gender affect tongue strength when swallowing.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date April 30, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria: - Aged twenty and above. Exclusion Criteria: - Based on self-representation, has the disease of the nervous system, included stroke, brain trauma, Parkinson's disease, dementia, etc. - Based on self-representation, has head and neck cancers. - Based on self-representation, had any history of swallowing disorders. - Based on self-representation, has obvious cognition impairment or language disorder that will affect measure procedure.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Iowa Oral Performance Instrument
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure

Locations

Country Name City State
Taiwan National Taiwan University hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (12)

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Adams V, Mathisen B, Baines S, Lazarus C, Callister R. A systematic review and meta-analysis of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument (IOPI). Dysphagia. 2013 Sep;28(3):350-69. doi: 10.1007/s00455-013-9451-3. Epub 2013 Mar 7. Review. — View Citation

Alsanei, W. A. S. (2015). Tongue Pressure-A Key Limiting Aspect in Bolus Swallowing (Doctoral dissertation, University of Leeds).

Crow HC, Ship JA. Tongue strength and endurance in different aged individuals. J Gerontol A Biol Sci Med Sci. 1996 Sep;51(5):M247-50. — View Citation

Logemann, J. A. (1998). Evaluation and Treatment of Swallowing Disorders (2nd ed.). Austin, TX: Pro-Ed.

Park JS, You SJ, Kim JY, Yeo SG, Lee JH. Differences in orofacial muscle strength according to age and sex in East Asian healthy adults. Am J Phys Med Rehabil. 2015 Sep;94(9):677-86. doi: 10.1097/PHM.0000000000000230. — View Citation

Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8. — View Citation

Robinovitch SN, Hershler C, Romilly DP. A tongue force measurement system for the assessment of oral-phase swallowing disorders. Arch Phys Med Rehabil. 1991 Jan;72(1):38-42. — View Citation

Stierwalt JA, Youmans SR. Tongue measures in individuals with normal and impaired swallowing. Am J Speech Lang Pathol. 2007 May;16(2):148-56. — View Citation

Vanderwegen J, Guns C, Van Nuffelen G, Elen R, De Bodt M. The influence of age, sex, bulb position, visual feedback, and the order of testing on maximum anterior and posterior tongue strength and endurance in healthy belgian adults. Dysphagia. 2013 Jun;28(2):159-66. doi: 10.1007/s00455-012-9425-x. Epub 2012 Sep 16. — View Citation

Vitorino J. Effect of age on tongue strength and endurance scores of healthy Portuguese speakers. Int J Speech Lang Pathol. 2010 Jun;12(3):237-43. doi: 10.3109/17549501003746160. — View Citation

Youmans SR, Youmans GL, Stierwalt JA. Differences in tongue strength across age and gender: is there a diminished strength reserve? Dysphagia. 2009 Mar;24(1):57-65. doi: 10.1007/s00455-008-9171-2. Epub 2008 Aug 9. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Iowa Oral Performance Instrument Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure of subject, in order to establish Taiwan's data. immediately after the intervention/procedure/surgery
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