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.

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Exercise
• Intervention / Treatment: Behavioral: Exercise plus action observation; Behavioral: Exercise plus motor imagery; Behavioral: Exercise plus visual mirror feedback; Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Action Observation	Behavioral: Exercise plus action observation; Orofacial exercise plus action observation (video) of the same exercise
Experimental: Motor Imagery	Behavioral: Exercise plus motor imagery; Orofacial exercise plus motor imagery of the same exercise
Experimental: Visual mirror feedback	Behavioral: Exercise plus visual mirror feedback; Exercise plus visual mirror feedback
Active Comparator: Orofacial exercise	Behavioral: Exercise; Orofacial exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 α 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

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2019
• Primary Completion (Anticipated): August 10, 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: Motor Imagery; Action observation; Visual mirror feedback; Pain pressure thresholds
• Other Study ID Numbers: uammadrid9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No