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.
1 other identifier
interventional
55
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2019
CompletedStudy Start
First participant enrolled
July 15, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2019
CompletedJuly 22, 2019
July 1, 2019
26 days
July 8, 2019
July 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Maximal mouth opening (MMO)
Change from baseline and immediately post-intervention
Lingual extensibility
Change from baseline and immediately post-intervention
Ability to generate mental motor images
Change from baseline and immediately post-intervention
Study Arms (4)
Action Observation
EXPERIMENTALMotor Imagery
EXPERIMENTALVisual mirror feedback
EXPERIMENTALOrofacial exercise
ACTIVE COMPARATORInterventions
Orofacial exercise plus action observation (video) of the same exercise
Orofacial exercise plus motor imagery of the same exercise
Exercise plus visual mirror feedback
Eligibility Criteria
You may qualify if:
- healthy individuals with no pain
- aged between 18 and 65 years
- subjects with correct masticatory function and labial and lingual mobility
You may not qualify if:
- 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; (d) subjects' complaint of toothache or tenderness to percussion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CSEU La Salle
Madrid, 28023, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 8, 2019
First Posted
July 16, 2019
Study Start
July 15, 2019
Primary Completion
August 10, 2019
Study Completion
August 15, 2019
Last Updated
July 22, 2019
Record last verified: 2019-07