ExerciseNCT04021147
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.
A study testing Exercise plus action observation, Exercise plus motor imagery and Exercise plus visual mirror feedback in people with Exercise and Pain, run by Universidad Autonoma de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Exercise plus action observation, Exercise plus motor imagery and Exercise plus visual mirror feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2019to 15 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy individuals with no pain
- aged between 18 and 65 years
- subjects with correct masticatory function and labial and lingual mobility
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Exercise plus action observation, Exercise plus motor imagery, Exercise plus visual mirror feedback, Exercise
- Keywords
- Motor Imagery, Action observation, Visual mirror feedback, Pain pressure thresholds
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise plus action observationBehavioural
Orofacial exercise plus action observation (video) of the same exercise
Exercise plus motor imageryBehavioural
Orofacial exercise plus motor imagery of the same exercise
Exercise plus visual mirror feedbackBehavioural
Exercise plus visual mirror feedback
ExerciseBehavioural
Orofacial exercises
| Study group | Role | What they receive |
|---|---|---|
| Action Observation | Experimental | Not described Receives: Behavioral: Exercise plus action observation |
| Motor Imagery | Experimental | Not described Receives: Behavioral: Exercise plus motor imagery |
| Visual mirror feedback | Experimental | Not described Receives: Behavioral: Exercise plus visual mirror feedback |
| Orofacial exercise | Active comparator | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)].
Measured: 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.
Measured: Change from baseline and immediately post-intervention
Secondary outcomes (3)
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
Measured: 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.
Measured: 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).
Measured: Change from baseline and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start15 Jul 2019 (estimated)
- Primary completion10 Aug 2019 (estimated)
- Study completion15 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy La Touche Arbizu, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021147
- Sponsor's protocol ID
- uammadrid9
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04021147
- Acronym / sponsor ID
- uammadrid9
- Keywords
- Motor Imagery, Action observation, Visual mirror feedback, Pain pressure thresholds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 15 Jul 2019 (estimated)
- Primary completion
- 10 Aug 2019 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Action Observation | Experimental | Behavioral: Exercise plus action observation |
| Motor Imagery | Experimental | Behavioral: Exercise plus motor imagery |
| Visual mirror feedback | Experimental | Behavioral: Exercise plus visual mirror feedback |
| Orofacial exercise | Active comparator | Behavioral: Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy individuals with no pain
- aged between 18 and 65 years
- subjects with correct masticatory function and labial and lingual mobility
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise plus action observationOrofacial exercise plus action observation (video) of the same exercise | Behavioural | Action Observation |
| Exercise plus motor imageryOrofacial exercise plus motor imagery of the same exercise | Behavioural | Motor Imagery |
| Exercise plus visual mirror feedbackExercise plus visual mirror feedback | Behavioural | Visual mirror feedback |
| ExerciseOrofacial exercises | Behavioural | Orofacial exercise |
Primary outcome
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). 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)].
Lingual muscle endurance
Time frame: Change from baseline and immediately post-intervention
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.
3 secondary outcomes
Maximal mouth opening (MMO)
Time frame: Change from baseline and immediately post-intervention
Lingual extensibility
Time frame: Change from baseline and immediately post-intervention
Ability to generate mental motor images
Time frame: Change from baseline and immediately post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise plus action observation, Exercise plus motor imagery and Exercise plus visual mirror feedback in people with Exercise and Pain, run by Universidad Autonoma de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roy La Touche (+349174019803, roylatouche@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure thresholds (PPTs) (time frame: Change from baseline and immediately post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.