Acute Effects of Motor Imagery and Physical Exercise on Tongue Strength and Pain Threshold in Healthy Adults

March 29, 2021 updated by: Turhan Kahraman, Dokuz Eylul University

Comparison of Acute Effects of Motor Imagery and Physical Exercise on Tongue Strength and Pain Threshold in Healthy Adults

Motor imagery is the feeling and thinking that the movement is done by imagination without physically occurring. In addition to its use in various fields, its use in the field of physiotherapy is also increasing. Especially in situations where real movement is difficult or contraindicated, motor visualization is very advantageous when there is no physical contact.

Swallowing function is one of the vital functions that ensure human independence. Like many components in swallowing, tongue muscle is also important. It has been shown that the strength of the tongue decreases with age, disease or other reasons. In the development of the strength of the tongue, while physiological principles are taken as basis, a different procedure from normal procedures is performed. However, language is a part of the body where one can study on his own.

Such situations lead to research on whether language reinforcement can occur with motor imagery. Considering that in addition to long-term effects, acute effects may also affect the functions of individuals, the starting point of the study is formed. Studies have investigated the acute change in tongue strength and pain perception after motor imagery.

The primary aim of this study is compare the acute effects of different motor imagery methods and physical exercise on tongue strength and pain in heatlhy adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Dokuz Eylül University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants age between 18-65
  • Symmetrical chewing function, fluent mouth and tongue movements

Exclusion Criteria:

  • Participants with systemic, cardiorespiratuar, central nerve system and romatologic diseases or musculoskeletal pain or craniocervical pathology
  • A history of orofacial pain or temporomandibular diseases.
  • Over-reacting for touching or tooth-pain
  • Pregnancy or possibility of pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Kinesthetic Motor Imagery
They will be asked to imagine the exercises kinesthetically from a first person perspective (as if they were doing it themselves).
Behavioral: Kinesthetic Motor Imagery Exercises
Seven exercises designated as "jaw shifting, tongue pushing forward, jaw opening, jaw shifting with tongue, jaw opening with tongue, jaw shifting by pressing the tongue on the palate, and chin shifting with one's own resistance", the videos prepared by the researchers and containing these exercises Once viewed, it will be applied as "kinesthetic imagery". Each exercise will be applied as 2 sets x 10 repetitions. There will be a 30-second break between sets.
Experimental: Visual Motor Imagery
They will be asked to imagine the exercises visually from a third person perspective (as if they were watching from the mirror / from the mirror while doing it themselves).
Behavioral: Visual Motor Imagery Exercises
Seven exercises designated as "jaw shifting, tongue pushing forward, jaw opening, jaw shifting with tongue, jaw opening with tongue, jaw shifting by pressing the tongue on the palate, and chin shifting with one's own resistance", the videos prepared by the researchers and containing these exercises Once viewed, it will be applied as "visual imagery". Each exercise will be applied as 2 sets x 10 repetitions. There will be a 30-second break between sets.
Active Comparator: Real Physical Movements
They will be asked to actually do the exercises shown in the video.
Behavioral: Physical Exercise
The videos will be prepared by the researchers and will be watched by the physical exercise group, which includes exercises such as "shifting the jaw to the side, pushing the tongue forward, jaw opening, sliding the jaw with the tongue, opening the chin with the tongue, opening the chin by pressing the tongue against the palate and shifting the chin with the person's own resistance". Then they will be asked to do the exercises physically. Each exercise will be applied as 2 sets x 10 repetitions. There will be a 30-second break between sets.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Tongue Strength
Time Frame: The outcome will be assessed at baseline and immediately after intervention.
Tongue strength will be measured by the tongue pressure measuring device. The measurement will be in the form of placing a bulb filled with air and designed to transmit pressure, just behind the anterior teeth, on the hard palate, and the tongue compresses this bulb and transmits the pressure to the device. People will be asked to lift their tongue and press the bulbous for about three seconds. 3 measurements will be made in front and back of the tongue separately. In the anterior tongue evaluation, the bulb is placed in the palate just behind the teeth, and in the posterior tongue evaluation, the bulb is placed in the hard palate. It has been shown that it is valid and safe to measure the strength of the front and back regions of the tongue by this method.Measurements are recorded in kPa. The value of change in tongue strength expresses the effect of intervention on tongue strength. Higher kPa values mean strong tongue. Increasing in change implies that more force is being generated.
The outcome will be assessed at baseline and immediately after intervention.
Change in Pain Threshold
Time Frame: The outcome will be assessed at baseline and immediately after intervention.
Pain threshold will be measured with an algometer. The areas to be measured in this study were determined as masseter muscle (2.5 cm in front of the tragus, 1.5 cm below) and temporalis (3 cm above the lateral edge of the eye). Measurements from each region will be made 3 times at 30 second intervals and the average of the measurements will be included for analysis. During the measurement, the algometer will be held perpendicular to the skin. Measurement is terminated at the first value at which discomfort is felt. Measurements from each region will be made 3 times at 30 second intervals and the average of the measurements will be included for analysis. The change in pain threshold will be used as a measurement tool to determine how the intervention is affecting the pain threshold. Higher values in the pain threshold indicate that the person is more susceptible to pain.
The outcome will be assessed at baseline and immediately after intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Perceived Exertion
Time Frame: The outcome will be assessed at baseline and immediately after intervention.
After the actual and motor imagery exercises, the perceived exertion of the participants will be evaluated with the Borg scale. On this scale, individuals rate their perceived difficulty between 6 (I did not feel any difficulty) and 20 (very, very difficult). High score means more perceived exertion.
The outcome will be assessed at baseline and immediately after intervention.
Movement Imagery Questionnaire-Revised
Time Frame: At baseline
It is a questionnaire used for administration in healthy adults and athletic populations and includes movements that require a high degree of skill and coordination. The visual and kinesthetic motor imagery skills of the person are measured with the scale consisting of 8 items. Items related to visual imagery are evaluated with a Likert type scale between 1 (very difficult to see) and 7 (very easy to see). Items related to kinesthetic imagery are likewise evaluated using a Likert-type scale that is graded between 1 (very difficult to feel) and 7 (very easy to feel). High scores indicate high visual and kinesthetic imagery skills. The Turkish validation study of the questionnaire has been conducted and it has been shown to be valid and reliable.
At baseline
Mental Chronometer Time Ratio for Jaw Movement Task
Time Frame: At baseline
The participants will actually execute and imagine a motor task: jaw movements. The duration of actual and imagined movements will be recorded by means of an electronic stopwatch. During the execution of the actual and imagined movements subjects will hold the electronic stopwatch in their non-dominant hand. They will start the stopwatch when they started to move (actual or imagined movement) and they will stop it when they completed their movement (actual or imagined). The ratio between real and imagined time will be calculated. A ratio close to 1 means that motor imagery is close to physical motion.
At baseline
Mental Chronometer Time Ratio for Tongue Movement Task
Time Frame: At baseline
The participants will actually execute and imagine a motor task: tongue movements. The duration of actual and imagined movements will be recorded by means of an electronic stopwatch. During the execution of the actual and imagined movements subjects will hold the electronic stopwatch in their non-dominant hand. They will start the stopwatch when they started to move (actual or imagined movement) and they will stop it when they completed their movement (actual or imagined). The ratio between real and imagined time will be calculated. A ratio close to 1 means that motor imagery is close to physical motion.
At baseline
Mental Chronometer Time Ratio for Writing Task
Time Frame: At baseline
The participants will actually execute and imagine a motor task: writing the following sentence: "Ankara is the capital of Turkey". The duration of actual and imagined movements will be recorded by means of an electronic stopwatch. During the execution of the actual and imagined movements subjects will hold the electronic stopwatch in their non-dominant hand. They will start the stopwatch when they started to move (actual or imagined movement) and they will stop it when they completed their movement (actual or imagined). A ratio close to 1 means that motor imagery is close to physical motion.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Izmir Katip Celebi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5857-GOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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