NCT06949332

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 8, 2025

Last Update Submit

April 21, 2025

Conditions

Keywords

rocabado exerciseTemporomandibular Joint Discelectromyographysuperficial electromyographyemgexercise

Outcome Measures

Primary Outcomes (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.

    immediate effect during exercise

Secondary Outcomes (2)

  • Neck Disability Index (NDI)

    before exercise

  • Oral Habits Checklist

    before exercise

Other Outcomes (4)

  • demographic information

    before exercise

  • Tragus Wall Distance Measurement

    before exercise

  • Maximum Active Mouth Opening Measurement

    before exercise

  • +1 more other outcomes

Study Arms (1)

healthy sedentary group

Healthy, 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.

Device: electromyography

Interventions

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.

healthy sedentary group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy sedentary individuals

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gülhane Health Sciences Faculty

Ankara, Keçiören, 06300, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctoral faculty member

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 29, 2025

Study Start

December 3, 2024

Primary Completion

March 4, 2025

Study Completion

April 8, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations