Effects of Action Observation and Motor Imagery on Orofacial Sensorimotor Variables

July 19, 2019 updated by: Roy La Touche Arbizu, Universidad Autonoma de Madrid
The main objective of the present study was to evaluate the effects of different dosages of action observation (AO) and motor imagery (MI) combined with an orofacial exercise program on pain pressure thresholds, lingual endurance and perceived exertion in asymptomatic subjects.

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.
50

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 Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28023
        • CSEU La Salle

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:

  1. healthy individuals with no pain
  2. aged between 18 and 65 years
  3. subjects with correct masticatory function and labial and lingual mobility

Exclusion Criteria:

  1. individuals who presented systemic, cardiorespiratory, central nervous system or rheumatic diseases, or those who presented any musculoskeletal or craniocervical pathology
  2. underage individuals
  3. individuals with orofacial pain or temporomandibular disorders at the time of the study
  4. subjects' complaint of toothache or tenderness to percussion.

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: Parallel Assignment
  • Masking: Quadruple

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: Moderate dosage training
Behavioral: Moderate dosage training of action Observation and Motor imagery
Motor imagery and action observation of orofacial exercises with moderate dosage
Behavioral: Moderate dosage orofacial exercises
Orofacial exercises with moderate intensity
Experimental: Intensive dosage training
Behavioral: Intensive dosage training of action observation and motor imagery
Motor imagery and action observation of the orofacial exercises with intensive dosage
Biological: Intensive dosage orofacial exercises
Orofacial exercises with high intensity

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
Pain pressure thresholds (PPTs)
Time Frame: Change from baseline and immediately post-intervention
PPT is defined as the minimal amount of pressure where a sense of pressure first changes to pain. The mechanical pressure algometer (Force Ten TM FDX Digital Force Gage) used in this study consisted of a round rubber disk (area, 1 cm2) attached to a pressure (force) gauge. The gauge displays values in kilograms but, because the surface of the rubber tip is 1 cm2, the readings are expressed in kg/cm2. The range of values of the pressure algometer is 0 to 10 kg, with 0.1-kg divisions. The pressure was applied at a rate of 0.31 kg/second (Chesterton et al. 2007).
Change from baseline and immediately post-intervention
Lingual muscle endurance
Time Frame: Change from baseline and immediately post-intervention
Lingual muscle endurance is assessed using the Iowa Oral Performance Instrument (IOPI) (Adams et al. 2015). The measurement of muscular endurance was carried out by placing a plastic bulb with oblong air content on the hard palate, posterior to the central incisor teeth. The participants were asked to elevate the lingual (through anterior and posterior lingual region) to press the instrument with the maximum possible force for 3 seconds, while monitoring the force exerted, quantified in Newtons Adams et al. (2015) found moderate to strong reliability for anterior (ICC: 0.58-0.77) and posterior (ICC 0.77-0.84) tongue strength.
Change from baseline and immediately post-intervention
Perceived exertion
Time Frame: Change from baseline and immediately post-intervention
The Borg scale of perceived effort measures the entire range of effort that the individual perceives when exercising. This scale gives criteria to make adjustments to the intensity of exercise, that is. To the workload, and thus predict and dictate the different intensities of exercise in sports and in medical rehabilitation (BORG, 1982). It can also be used in athletics, astronautics, industry and military environments, as well as in everyday situations. The concept of perceived effort is a subjective evaluation that indicates the subject's opinion regarding the intensity of the work carried out (MORGAN, 1973). The subject doing the exercise must designate a number, from 1 to 20, to represent the subjective sensation of the amount of work performed and higher values represent more perceived exertion
Change from baseline and immediately post-intervention

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.
Universidad Autonoma de Madrid

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.
July 12, 2019

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.
August 12, 2019

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.
August 15, 2019

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).
July 8, 2019

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.
July 14, 2019

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.
July 16, 2019

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.
July 22, 2019

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.
July 19, 2019

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.
July 1, 2019

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.
  • uammadrid10

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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