NCT04658316

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

August 8, 2022

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 30, 2020

Last Update Submit

August 4, 2022

Conditions

Swallowing Disorder

Keywords

Swallowing functionAgeGender

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

20-39Years-old Male

Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.

Behavioral: Iowa Oral Performance Instrument

40-59Years-old Male

Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.

Behavioral: Iowa Oral Performance Instrument

60-79Years-old Male

Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.

Behavioral: Iowa Oral Performance Instrument

20-39Years-old Female

Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.

Behavioral: Iowa Oral Performance Instrument

40-59Years-old Female

Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.

Behavioral: Iowa Oral Performance Instrument

60-79Years-old Female

Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.

Behavioral: Iowa Oral Performance Instrument

Interventions

Iowa Oral Performance InstrumentBEHAVIORAL

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

20-39Years-old Female20-39Years-old Male40-59Years-old Female40-59Years-old Male60-79Years-old Female60-79Years-old Male

Eligibility Criteria

Age20 Years - 79 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBased on gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adult.

You may qualify if:

  • Aged twenty and above.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University hospital

Taipei, +886, Taiwan

Location

Related Publications (12)

  • 張家臻, 陳惠櫻, 李蕙蓉, 林宗豪, 謝佩君, 張雁雲, & 邱麗玲. (2018). 國 際吞嚥困難飲食標準中文繁體版本. 亞東學報, (38), 1-18.

    BACKGROUND

  • 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.

    PMID: 23468283BACKGROUND

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

    BACKGROUND

  • 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. doi: 10.1093/gerona/51a.5.m247.

    PMID: 8808997BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 25415391BACKGROUND

  • 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.

    PMID: 1985622BACKGROUND

  • 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. doi: 10.1016/j.apmr.2006.11.002.

    PMID: 17270511BACKGROUND

  • Stierwalt JA, Youmans SR. Tongue measures in individuals with normal and impaired swallowing. Am J Speech Lang Pathol. 2007 May;16(2):148-56. doi: 10.1044/1058-0360(2007/019).

    PMID: 17456893BACKGROUND

  • 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.

    PMID: 22983359BACKGROUND

  • 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.

    PMID: 20433342BACKGROUND

  • 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.

    PMID: 18690406BACKGROUND

MeSH Terms

Conditions

Deglutition DisordersCoitus

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesSexual BehaviorBehavior

Study Officials

  • Yu-Chun Chih, Doctoral

    Chung Shan Medical University, Taiwan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 8, 2020

Study Start

December 1, 2020

Primary Completion

February 28, 2021

Study Completion

April 30, 2021

Last Updated

August 8, 2022

Record last verified: 2020-11

Locations

TW(1)