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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04022174
Other study ID # uammadrid10
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 12, 2019
Est. completion date August 15, 2019

Study information

Verified date July 2019
Source Universidad Autonoma de Madrid
Contact Roy La Touche
Phone +349174019803
Email roylatouche@yahoo.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date August 15, 2019
Est. primary completion date August 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Moderate dosage training of action Observation and Motor imagery
Motor imagery and action observation of orofacial exercises with moderate dosage
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
Behavioral:
Moderate dosage orofacial exercises
Orofacial exercises with moderate intensity

Locations

Country Name City State
Spain CSEU La Salle Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain pressure thresholds (PPTs) 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
Primary Lingual muscle endurance 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
Primary Perceived exertion 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
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