Recruiting

Motor Imagery & Tongue Strength

Sponsor:

University of South Florida

Code:

NCT03423095

Conditions

Dysphagia

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Active Jaw Exercise with Relaxation

Active Tongue Exercise

Active Tongue Exercise + Mental Practice

Mental Practice Tongue Exercise

Study Details

Brief summary:

This research study is a six-week treatment pilot study to compare the effects of different exercise types on measures of tongue strength and swallowing pressure in typically aging older adults. Typically-aging older adults represent a group "at risk" for dysphagia secondary to sarcopenia of striated musculature important to swallowing. Participants at all study sites will be randomly selected into one of four study exercise groups. At some study sites, the investigators will also determine cortical activation patterns differences during motor execution and motor imagery of tongue exercises between the groups using near-infrared spectroscopy. The results of this study will inform refinement/further development of the mental practice protocol to use with patients with dysphagia in future studies.

Conditions

Dysphagia

Study ID

NCT03423095

Start date

Dec 19, 2017

Status verified date

Oct, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults aged 60-89
  • < 3 on EAT-10 (Eating Assessment Tool-10) (part of health questionnaire)
  • Mean of ≥2.5 on the KVIQ-10 questions (Kinesthetic and Visual Imagery Questionnaire, short version), a screening questionnaire that assesses a person's motor imagery abilities
  • > 24 on MMSE (Mini Mental State Examination), a screening questionnaire that assesses cognitive abilities
  • Availability to complete a consecutive 6-week exercise regimen
  • Access to reliable transportation to and from study site for in-person experimental sessions
  • There are certain conditions that are common to the aging study population we are recruiting which will be acceptable: controlled hypertension and controlled diabetes mellitus

Exclusion Criteria:

  • History of diagnosed dysphagia (swallowing disorder)
  • History of a seizure(s)
  • Current or past problem with pain disorders involving the jaw muscles or joint of the mandible (e.g., TMJ (temporomandibular) disorder or myofacial pain disorder) - these are contraindicated for tongue strengthening exercises
  • Presence of oral piercings/oral apparatus that may interfere with tongue exercises
  • Medical conditions that would affect oral motor performance (e.g., history of acute or degenerative neurological condition, head/neck cancer), as determined by investigator
  • History of a diagnosed dementia or other cognitive impairment
  • Uncontrolled high blood pressure

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Active Jaw Exercise with Relaxation

Participants randomized to this arm will complete active jaw exercises and visualization relaxation exercise (control group).

active comparator: Active Tongue Exercise

Participants randomized to this arm will complete active tongue exercises only.

experimental: Active Tongue Exercise + Mental Practice

Participants randomized to this arm will complete active tongue exercises and mental practice of tongue exercise via motor imagery.

experimental: Mental Practice Tongue Exercise

Participants randomized to this arm will complete mental practice of tongue exercise via motor imagery only.

Interventions

Active Jaw Exercise with Relaxation

This is the control group that will complete exercises unrelated to the primary outcome measures.

Active Tongue Exercise

This is the active comparator group that will complete exercises already shown to increase tongue strength measures.

Active Tongue Exercise + Mental Practice

This is an experimental group that will complete active tongue and mental tongue exercises to assess effect on tongue strength measures.

Mental Practice Tongue Exercise

This is an experimental group that will complete mental tongue exercises only to assess effect on tongue strength measures.

Primary outcome measure

  • Tongue strength change [ Time Frame: Change from baseline tongue strength at 6 weeks ]

Central Contacts and Locations

Central contacts

Sarah Hegyi Szynkiewicz, PhD

941-359-4383sehegyi@usf.edu

Locations

Sarah Hegyi Szynkiewicz, PhD, CCC-SLP

Recruiting

Sarasota, Florida, United States, 34243

Contacts

Sarah Hegyi Szynkiewicz, PhD

941-359-4383sehegyi@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Apr 17, 2019

Last verified

Oct, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2019-04-17.