AzTrials
AzTrials

ElectromyographyNCT06949332

Investigation of the Instant Effect of Rocabado Exercise

An observational study of Electromyography and Exercise, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The temporomandibular joint (TMJ) or jaw joint is a bilateral hinge joint formed by the fusion of the temporal bone and mandible, which provides complex movements necessary for basic functions such as eating, swallowing, speaking and yawning. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
What is being tested?
electromyography
How many people
35 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Dec 2024to 8 Apr 2025
Phase
Observational
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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: healthy sedentary individuals

Who may be able to join

  • Age between 18 and 40 years.
  • No engagement in any regular sports activities (sedentary lifestyle).
  • Voluntary participation in the study.

Who cannot join

  • A history of teeth grinding or bruxism.
  • Clinical signs of increased muscle tone in the masticatory muscles upon physical examination by a physiotherapist.
  • A masseter pressure pain threshold measurement below a predetermined cutoff point, as assessed by an algometer (Baseline, USA). This criterion is included to ensure participants do not have underlying muscle sensitivity that could influence EMG readings.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gülhane Health Sciences Faculty

    Ankara, Keçiören, 06300

Other trials in Turkey (Türkiye)

About this study

Official title: Electromyographic Investigation of the Instant Effect of Rocabado Exercise Approaches on Masseter Muscle Activity

The temporomandibular joint (TMJ) or jaw joint is a bilateral hinge joint formed by the fusion of the temporal bone and mandible, which provides complex movements necessary for basic functions such as eating, swallowing, speaking and yawning. This joint, which can perform rotation and translation movements, functions with the coordinated work of the masticatory muscles (masseter, temporalis, pterygoideus medialis and lateralis, digastricus). The masseter muscle in particular plays an important role in closing the jaw and generating chewing force.

Rocabado exercises are a special exercise program that requires the active participation of the patient to restore the normal movement of the TMJ, reduce pain, maintain body balance and correct postural disorders. This program includes six different exercises: tongue relaxation position, shoulder retraction, head position stabilization, chin tuck, TMJ rotation control and rhythmic stabilization technique.

There are a limited number of studies on the effectiveness of Rocabado exercises in the literature and there is no study specifically examining the effects of these exercises on the masseter muscle. Therefore, this study will investigate the effects of Rocabado exercises on masseter muscle activity in sedentary individuals. The findings may provide a new perspective in the physiotherapy processes of individuals with masseter muscle problems and may contribute to the selection of appropriate exercises to increase the activation of this muscle by determining which Rocabado exercise activates the masseter muscle more.

Read the detailed description

This study aims to investigate the effect of different Rocabado exercises on masseter muscle activity in healthy, sedentary individuals. The study will be conducted at the Faculty of Physiotherapy and Rehabilitation, Health Sciences University Gülhane, Ankara, Türkiye.

Participants and Recruitment

A total of 35 healthy, sedentary individuals aged between 18 and 40 years will be recruited for this study. Participants will be included based on the following criteria:

Age between 18 and 40 years. No engagement in any regular sports activities (sedentary lifestyle). Voluntary participation in the study.

Individuals will be excluded if they have:

A history of teeth grinding or bruxism. Clinical signs of increased muscle tone in the masticatory muscles upon physical examination by a physiotherapist.

A masseter pressure pain threshold measurement below a predetermined cutoff point, as assessed by an algometer (Baseline, USA). This criterion is included to ensure participants do not have underlying muscle sensitivity that could influence EMG readings.

Recruitment will be conducted through online announcements on social media platforms and messaging applications. Interested individuals who meet the inclusion criteria will be selected for participation. Prior to their involvement, all participants will provide written informed consent after receiving a detailed explanation of the study's purpose, procedures, potential risks, and benefits, both orally and in written form. The study schedule will be determined, and willing participants will be invited to the research facility. A physiotherapist will assess the participants for any signs of increased masticatory muscle tone and will include them in the study based on this assessment.

Data Collection

The following data will be collected from each participant:

Demographic and Health Data: Information such as name, age, education level, and relevant medical history will be recorded.

Masseter Muscle Activity Assessment via Electromyography (EMG): Surface EMG (Noraxon USA Inc., Scottsdale, AZ, USA) will be used to measure the electrical activity of the masseter muscles. Participants will be tested individually in a quiet environment. They will be seated comfortably, and their demographic information (height, weight, etc.) will be recorded in the EMG device. Before the test, participants will be instructed on how to perform each of the six Rocabado exercises. The physiotherapist will demonstrate each exercise. The exercises will be performed in a randomized order for each participant to minimize any potential order effects on the EMG data. Non-invasive surface electrodes will be placed bilaterally over the masseter muscles in a manner that does not cause discomfort . EMG data will be recorded during the performance of each exercise.

The Noraxon USA Inc. surface EMG device, along with its electrodes and signal processing units , is a validated and reliable instrument for assessing muscle activation. Surface EMG detects muscle activity through non-invasive electrodes applied to the skin surface . During each exercise, the real-time EMG signal will be monitored on the device screen and recorded for subsequent analysis .

Tragus-to-Wall Distance Measurement: This measurement will be taken to assess the participants' cervical and upper thoracic posture . Participants will stand with their feet shoulder-width apart, heels, buttocks, and shoulders against a wall. They will be instructed to maintain a "good posture," looking straight ahead, and to hold this position during the measurement. The distance between the tragus of the ear and the wall will be measured using a ruler.

Maximum Active Mouth Opening (MAMO) Measurement: Participants will be asked to open their mouths as wide as possible without causing pain. The distance between the upper and lower incisal edges will be measured in millimeters using a ruler. Three trials will be performed, and the average value will be recorded .

Lateral Mandibular Mobility Measurement: This measurement assesses the distance of lateral movement between the upper and lower central incisors. The mandible should move symmetrically in a specific plane during lateral excursions, with movement typically being equal on both sides and less than 8 mm.

Oral Habits Checklist (OBC): The "Oral Behaviour Checklist (OBC)," a 21-item questionnaire, will be administered to identify parafunctional habits such as day and night teeth clenching, teeth grinding, nail biting, lip or cheek biting, pen biting, and gum chewing, which are known to play a significant role in the pathogenesis of Temporomandibular Disorders (TMD).

Neck Disability Index (NDI): The Turkish version of the Neck Disability Index, a 10-item questionnaire developed by Dr. Howard Vernon and validated for Turkish population by Telci et al. , will be used to assess the participants' neck pain levels and the impact of neck pain on their daily activities. Each question has a score ranging from 0 to 5, with a maximum total score of 50. If participants do not drive or work, those specific questions will be excluded from the scoring.

Rocabado Exercise Protocol

Participants will perform each of the following six Rocabado exercises with 6 repetitions each, as described below:

Tongue Relaxation Position: With teeth apart and lips closed, the anterior one-third of the tongue rests on the palate, without touching the teeth. Diaphragmatic breathing is performed through the nose.

Shoulder Retraction: The shoulders are simultaneously moved downwards and backwards, bringing the shoulder blades together.

Cervical Retraction (Head Positioning): With hands clasped behind the neck to stabilize it, the head is gently moved forward (chin tuck) and then returned to the starting position (distraction movement).

Chin Tucks (Jaw Movement): The chin is moved towards the neck and then away, maintaining a straight horizontal movement.

Controlled TMJ Rotation: In the tongue relaxation position, the index finger is placed on the TMJ while controlled mouth opening and closing movements are performed. Lateral deviation of the jaw is avoided. Participants will be encouraged to perform this exercise in front of a mirror to ensure proper control and to learn controlled chewing patterns.

Rhythmic Stabilization Technique: In the tongue resting position, the index finger is placed on the chin to stabilize the jaw. The participant is asked to apply a slight resistance while performing small opening, closing, and lateral deviation movements of the TMJ.

Statistical Analysis Demographic data obtained from the participants will be presented using descriptive statistics (e.g., mean, standard deviation, frequency, percentage). The normality of the data for the outcome measures (EMG activity during each exercise, tragus-to-wall distance, MAMO, lateral mandibular mobility) will be assessed using the One-Sample Kolmogorov-Smirnov test. If the data are normally distributed, a one-way repeated measures analysis of variance (ANOVA) will be used to compare the masseter muscle activity during the six different Rocabado exercises. In case of non-normal distribution, the non-parametric Friedman test will be used for the same comparison. The level of statistical significance will be set at p < 0.05 for all analyses.

Being tested
electromyography
Keywords
rocabado exercise, Temporomandibular Joint Disc, electromyography, superficial electromyography, emg, exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electromyographyDevice

    In this study, surface Electromyography (EMG) was employed to assess the electrical activity of the masseter muscles. Surface EMG is a physiological measurement technique that allows for the recording of electrical potentials generated by muscle fiber depolarization through non-invasive electrodes placed on the skin. This method is widely accepted for objectively determining muscle activation levels and timing, enabling the quantitative analysis of changes in masseter muscle activity during the performance of various Rocabado exercises in this study. The validity and reliability of the EMG device utilized (Noraxon USA Inc., Scottsdale, AZ, USA) have been established in the literature.

Study groups in NCT06949332
Study groupRoleWhat they receive
healthy sedentary groupHealthy, sedentary individuals aged 18-40. No history of bruxism or increased masticatory muscle tone. Protocol: EMG: Masseter muscle activity during 6 Rocabado exercises. Tragus-to-Wall Distance: Cervical/upper thoracic posture. Maximum active mouth opening. Lateral Mandibular Mobility: Sideways jaw movement. Oral parafunctional habits. Neck pain and disability level.
Receives: Device: electromyography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Masseter Muscle Activition

    Masseter muscle activation, refers to the summation of electrical potentials generated by the motor units of the masseter muscle fibers upon stimulation by motor nerves. This physiological process enables muscle contraction and consequently, the elevation of the mandible (upward movement of the jaw) and the execution of masticatory function. The intensity and duration of activation vary according to the applied force and the phase of the chewing cycle, and it can be non-invasively measured using methods such as surface EMG.

    Measured: immediate effect during exercise

Secondary outcomes (2)
  1. Neck Disability Index (NDI)

    his is a self-report questionnaire consisting of 10 items that assess the impact of neck pain on a person's daily activities and their perceived level of disability. It covers areas such as pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Higher scores indicate a greater level of disability due to neck pain.

    Measured: before exercise

  2. Oral Habits Checklist

    This is a self-report questionnaire comprising 21 items designed to evaluate the frequency and nature of various parafunctional oral behaviors that the individual has engaged in over the past month. These behaviors include teeth grinding and clenching (during sleep and wakefulness), nail biting, lip or cheek biting, tongue thrusting, gum chewing, and others. The checklist aims to quantify the occurrence of these habits, which are often associated with temporomandibular disorders (TMD).

    Measured: before exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start3 Dec 2024
  3. Primary completion4 Mar 2025
  4. Study completion8 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06949332
Sponsor's protocol ID
2024-456
Status last verified
Apr 2025
First submitted
8 Apr 2025
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Electromyography and Exercise, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).

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: finished, as of the sponsor's last update on 29 Apr 2025. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Masseter Muscle Activition (time frame: immediate effect during exercise). 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 29 Apr 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in