Effect of Brain Training Through Visual Mirror Feedback, Action Observation Training and Motor Imagery on Orofacial Sensorimotor Variables in Asymptomatic Subjects: A Single-blind Randomized Controlled Trial.

Pain Clinical Trial

Official title:

Effect of Brain Training Through Visual Mirror Feedback, Action Observation Training and Motor Imagery on Orofacial Sensorimotor Variables in Asymptomatic Subjects: A Single-blind Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04021147
• Other study ID #: uammadrid9
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 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
• Study type: Interventional

Clinical Trial Summary

The main objective of the present study was to evaluate the effects of action observation (AO), visual mirror feedback (VMF), motor imagery (MI) combined with an orofacial exercise program in asymptomatic subjects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: August 15, 2019
• Est. primary completion date: August 10, 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; (d) subjects' complaint of toothache or tenderness to percussion.

Related Conditions & MeSH terms

• Exercise
• Pain

Intervention

Behavioral:
• Exercise plus action observation
Orofacial exercise plus action observation (video) of the same exercise
• Exercise plus motor imagery
Orofacial exercise plus motor imagery of the same exercise
• Exercise plus visual mirror feedback
Exercise plus visual mirror feedback
• Exercise
Orofacial exercises

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). Chesterton et al. (2007) have shown that the reliability of pressure algometry is as high as [ICC=0.91 (95% confidence interval, CI 0.82-0.97)].	Change from baseline and immediately post-intervention
Primary	Lingual muscle endurance	Lingual muscle endurance was 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
Secondary	Maximal mouth opening (MMO)	The craniomandibular scale was used to assess the MMO. It was held with the right hand and the left hand was placed on the forehead to maintain the participant's neutral position. The following verbal command was given: "open your mouth as wide as you can without moving your head". The assessor placed the scale on the incisal edge of the maxillary central incisor that was most vertically oriented, measured vertically to the labioincisal edge of the opposing mandibular incisor, and recorded this as the MMO measurement. Beltran-Alacreu et al. (2014) showed that reliability for MMO was good (inter-rater, ICC= 0.95-0.96; intra-rater, ICC= 0.95-0.96). Zawawi et al. (2003) found that the normal range of mouth opening in women is 40-57 mm and 42-68 mm in men	Change from baseline and immediately post-intervention
Secondary	Lingual extensibility	This variable consists of measuring the tongue in centimeters, from the chin to the lingual vertex. Through the use of a lingual depressor, located in the midface sagittal axis at the height of the chin, the subject was asked for a maximum lingual protrusion, extending his tongue as far as possible, indicating that route on the lingual depressor and then measuring that distance. The mean obtained from two measurements was recorded.	Change from baseline and immediately post-intervention
Secondary	Ability to generate mental motor images	Movement imagery questionnaire-revised (MIQ-R) is an 8-item self-report inventory and was used to assess visual and kinesthetic motor imagery ability. Four different movements are included in MIQ-R and it is comprised of four visual and four kinesthetic items. For each item, participants read a description of the movement. They then physically perform the movement and were instructed to re-assume the starting position after finishing the movement and before performing the mental task, imaging the movement visually or kinesthetically. Then, each participant rated the ease or difficulty of generating that image on a 7-point scale in which 7 indicates "very easy to see/feel" and 1 "very difficult to see/feel. The internal consistencies of the MIQ-R have been consistently adequate with Cronbach's a coefficients ranging above 0.84 for the total scale, 0.80 for de visual subscale and 0.84 for the kinesthetic subscale (Campos and González 2010).	Change from baseline and immediately post-intervention