Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2021-06-01
2022-08-15
Brief Summary
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Detailed Description
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To determine an optimal delivery method for tongue resistance training in healthy older persons by examining how intensity progression and biofeedback impacts tongue strength, participant motivation, and program adherence. The data collected in this initial study will inform future studies designed to develop a framework for guiding clinical practice with SLPs prescribing tongue strengthening exercise to patients with swallowing issues.
Primary Research Questions:
* Is tongue strength impacted by exercise resistance intensity when comparing progressive resistance to maximum resistance?
* Is tongue strength impacted by visual biofeedback during tongue resistance training?
Secondary Research Questions:
* Is participant motivation impacted by progressive intensity exercise when compared to maximum intensity exercise?
* Is participant motivation impacted by the use of biofeedback when compared to no visual biofeedback?
* Is participant adherence to the exercise program impacted by progressive intensity exercise when compared to maximum intensity exercise?
* Is participant adherence to the exercise program impacted by the use of biofeedback when compared to no visual biofeedback?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Max intensity with no visual biofeedback
Tongue resistance exercises completed at maximum intensity with no visual biofeedback.
Tongue resistance exercise
Participant will complete tongue resistance exercises.
Progressive intensity with no visual biofeedback.
Tongue resistance exercises completed at a progressive intensity with no visual biofeedback.
Tongue resistance exercise
Participant will complete tongue resistance exercises.
Max intensity with visual biofeedback
Tongue resistance exercises completed at maximum intensity with visual biofeedback of performance.
Tongue resistance exercise
Participant will complete tongue resistance exercises.
Progressive intensity with visual biofeedback.
Tongue resistance exercises completed at a progressive intensity with visual biofeedback of performance.
Tongue resistance exercise
Participant will complete tongue resistance exercises.
Interventions
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Tongue resistance exercise
Participant will complete tongue resistance exercises.
Eligibility Criteria
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Inclusion Criteria
* \< 3 score on Eating Assessment Tool-10 (screening tool for swallowing difficulty)
* \> 24 score on Mini Mental State Examination (screening tool for cognitive impairment)
* Have a normal oral structure as assessed with an oral mechanism screener
Exclusion Criteria
* Past or present pain disorders involving the jaw or mandible (e.g., TMJ disorder, myofascial pain disorder) (contraindication for Tongueometerâ„¢ use)
* A history of oral surgery (routine dental surgery acceptable)
* A history of neurogenic disorder (e.g., Parkinson's disease)
* A history of swallowing difficulty
* Not being able to complete an 8-week study protocol
55 Years
ALL
Yes
Sponsors
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Case Western Reserve University
OTHER
Emerson College
OTHER
James Madison University
OTHER
Texas Christian University
OTHER
Samford University
OTHER
Responsible Party
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Principal Investigators
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Sarah H Szynkiewicz, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Samford University
Erin Kamarunas, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
James Madison University
Teresa Drulia, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Texas Christian University
Lindsay Griffin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Emerson College
Rachel Mulheren, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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Samford University
Birmingham, Alabama, United States
Countries
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References
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Rhea MR, Alvar BA, Burkett LN, Ball SD. A meta-analysis to determine the dose response for strength development. Med Sci Sports Exerc. 2003 Mar;35(3):456-64. doi: 10.1249/01.MSS.0000053727.63505.D4.
Kamarunas E, Murray K, Drulia T, Szynkiewicz S, Griffin L, Mulheren R. Biofeedback and Exercise Load Affect Accuracy of Tongue Strength Exercise Performance. Dysphagia. 2025 Apr;40(2):489-500. doi: 10.1007/s00455-024-10751-w. Epub 2024 Aug 18.
Other Identifiers
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EXPD-HP-20-F-5
Identifier Type: -
Identifier Source: org_study_id