NCT04822896

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 21, 2021

Last Update Submit

March 29, 2021

Conditions

Keywords

motor imagerytongue strengthorofacial exercises

Outcome Measures

Primary Outcomes (2)

  • Change in Tongue Strength

    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

    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 Outcomes (5)

  • Change in Perceived Exertion

    The outcome will be assessed at baseline and immediately after intervention.

  • Movement Imagery Questionnaire-Revised

    At baseline

  • Mental Chronometer Time Ratio for Jaw Movement Task

    At baseline

  • Mental Chronometer Time Ratio for Tongue Movement Task

    At baseline

  • Mental Chronometer Time Ratio for Writing Task

    At baseline

Study Arms (3)

Kinesthetic Motor Imagery

EXPERIMENTAL

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

Visual Motor Imagery

EXPERIMENTAL

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

Real Physical Movements

ACTIVE COMPARATOR

They will be asked to actually do the exercises shown in the video.

Behavioral: Physical Exercise

Interventions

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.

Real Physical Movements

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.

Kinesthetic Motor Imagery

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.

Visual Motor Imagery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Turhan Kahraman, PhD

CONTACT

Tayfun Işık, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2021

First Posted

March 30, 2021

Study Start

March 1, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations