- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04022174
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
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- 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 Locations
-
-
-
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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy individuals with no pain
- aged between 18 and 65 years
- subjects with correct masticatory function and labial and lingual mobility
Exclusion Criteria:
- individuals who presented systemic, cardiorespiratory, central nervous system or rheumatic diseases, or those who presented any musculoskeletal or craniocervical pathology
- underage individuals
- individuals with orofacial pain or temporomandibular disorders at the time of the study
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: Moderate dosage training
|
Motor imagery and action observation of orofacial exercises with moderate dosage
Orofacial exercises with moderate intensity
|
|
Experimental: Intensive dosage training
|
Motor imagery and action observation of the orofacial exercises with intensive dosage
Orofacial exercises with high intensity
|
What is the study measuring?
Primary Outcome Measures
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
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)
July 12, 2019
Primary Completion (Anticipated)
August 12, 2019
Study Completion (Anticipated)
August 15, 2019
Study Registration Dates
First Submitted
July 8, 2019
First Submitted That Met QC Criteria
July 14, 2019
First Posted (Actual)
July 16, 2019
Study Record Updates
Last Update Posted (Actual)
July 22, 2019
Last Update Submitted That Met QC Criteria
July 19, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID 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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