- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556510
Telerehabilitation Dual-Task Training in Temporomandibular Joint Dysfunction
April 29, 2026 updated by: Miray Baser, Ege University
Effect of Telerehabilitation-Based Dual-Task Training on Clinical Outcomes in Temporomandibular Joint Dysfunction
This randomized controlled trial will be conducted among 18-25-year-old participants who present with temporomandibular joint dysfunction symptoms, including pain, limited range of motion, and joint crepitation.
Participants will be randomly allocated into control and intervention groups using block randomization.
The control group will receive a standard physiotherapy program, while the intervention group will additionally perform telerehabilitation-based dual-task exercises.
The intervention will last for six weeks, with progressive increases in exercise and cognitive task difficulty.
Outcomes will be assessed at baseline and at the end of the 6th week.
Primary and secondary outcome measures include pain intensity (Visual Analog Scale), jaw functional limitation (Jaw Functional Limitation Scale-20), oral habits, static balance (Tetrax system), and dynamic balance (Timed Up and Go Test).
Within-group and between-group comparisons will be performed.
The sample size was calculated using power analysis, resulting in 30 participants in total (15 per group), accounting for potential dropouts.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Serkan Bakırhan, Professor
- Phone Number: +90 505 663 18 40
- Email: serkan.bakirhan@ege.edu.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of temporomandibular joint dysfunction according to the
- Temporomandibular Disorders Research Diagnostic Criteria and Diagnostic
- Criteria for Temporomandibular Disorders
- No neurological, orthopedic, or systemic condition that may affect balance
- Ability to comply with a telerehabilitation program
- Willingness to provide written informed consent
- No prior physiotherapy treatment for temporomandibular joint dysfunction
Exclusion Criteria:
- Inability to participate in regular exercise or telerehabilitation programs
- Presence of severe systemic diseases (cardiac, rheumatologic, neurological) or other severe chronic conditions
- Presence of psychiatric disorders or cognitive impairment
- Use of medications that may affect balance (such as sedatives)
- History of jaw or dental surgery within the last 6 months
- Receipt of physiotherapy, splint therapy, or similar treatment for temporomandibular joint dysfunction within the last 3-6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Physiotherapy and TMJ Exercise Program
Standard Physiotherapy Program
|
Cervical range of motion exercises, cervical lateral flexion stretching, upper trapezius stretching, pectoral stretching, breathing exercises, seated cervical postural correction exercises, supine and prone cervical postural exercises, postural training exercises, temporomandibular joint (TMJ) rotation control exercises, TMJ opening, closing, protrusion, and retrusion exercises, tongue resting position training, isometric TMJ elevation, depression, and lateral deviation exercises in sitting position, post-isometric relaxation techniques, abdominal strengthening exercises, and back extensor strengthening exercises.
|
|
Experimental: Telerehabilitation-Based Dual-Task Training
Standard Physiotherapy Program plus Telerehabilitation-Based Dual-Task Training
|
Cervical range of motion exercises, cervical lateral flexion stretching, upper trapezius stretching, pectoral stretching, breathing exercises, seated cervical postural correction exercises, supine and prone cervical postural exercises, postural training exercises, temporomandibular joint (TMJ) rotation control exercises, TMJ opening, closing, protrusion, and retrusion exercises, tongue resting position training, isometric TMJ elevation, depression, and lateral deviation exercises in sitting position, post-isometric relaxation techniques, abdominal strengthening exercises, and back extensor strengthening exercises.
Backward counting from 200 by threes during cervical range of motion exercises and pectoral stretching, naming cities starting with the letter "A" during supine cervical postural exercises, naming animals starting with the letter "A" during TMJ rotation control exercises, simple arithmetic tasks (addition and subtraction) during isometric TMJ elevation and depression exercises, and more complex arithmetic tasks during lateral deviation exercises in sitting position.
Cognitive task difficulty will be progressively increased over time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Measurements will be recorded at baseline and at week 6. Change in pain intensity will be analyzed.
|
Pain intensity will be assessed using a 10-cm Visual Analog Scale.
Participants will rate their pain at rest, during chewing, and at night.
Scores range from 0 (no pain) to 10 (worst imaginable pain).
|
Measurements will be recorded at baseline and at week 6. Change in pain intensity will be analyzed.
|
|
Jaw Functional Limitation
Time Frame: Assessments will be performed at baseline and week 6.
|
(Jaw Functional Limitation Scale - JFLS-20): Jaw function will be evaluated using the JFLS-20, a 20-item self-report scale assessing functional limitations in mastication, speech, and jaw movement.
Each item is scored from 0 (no limitation) to 10 (severe limitation).
Higher scores indicate greater functional impairment.
|
Assessments will be performed at baseline and week 6.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Temporomandibular Disorder Classification
Time Frame: Assessment will be performed at baseline.
|
Temporomandibular joint dysfunction diagnosis and classification will be determined using the Temporomandibular Disorders Research Diagnostic Criteria and Diagnostic Criteria for Temporomandibular Disorders questionnaire, which provides a standardized multidimensional assessment of temporomandibular disorders.
This assessment includes evaluation of muscle-related disorders, disc displacement conditions, and degenerative joint diseases, and enables a comprehensive clinical and psychosocial classification of temporomandibular dysfunction.
|
Assessment will be performed at baseline.
|
|
Oral Habits
Time Frame: Assessments will be performed at baseline and week 6.
|
Oral Habits Questionnaire: Oral parafunctional habits will be assessed using a 21-item questionnaire evaluating behaviors such as bruxism, nail biting, and gum chewing.
Each item is rated on a 0-4 Likert scale, with total scores ranging from 0 to 84.
Higher scores indicate more frequent parafunctional habits.
|
Assessments will be performed at baseline and week 6.
|
|
Dynamic Balance
Time Frame: Assessments will be performed at baseline and week 6.
|
Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test.
The time (in seconds) required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded.
Shorter times indicate better mobility and balance.
|
Assessments will be performed at baseline and week 6.
|
|
Stability Index (SI)
Time Frame: Baseline and after 6 weeks
|
Static balance will be assessed using the Tetrax system (Sunlight Medical Ltd., Israel).
The Stability Index reflects overall postural sway and stability performance.
Higher scores indicate poorer stability.
Unit of measure: index score.
|
Baseline and after 6 weeks
|
|
Weight Distribution Index (WDI)
Time Frame: Baseline and after 6 weeks
|
Measured using the Tetrax system, the WDI evaluates the distribution of body weight across four force plates.
Higher values indicate asymmetry in weight distribution.
Unit of measure: index score.
|
Baseline and after 6 weeks
|
|
Fourier Harmonic Index (FHI)
Time Frame: Baseline and after 6 weeks
|
The FHI is derived from frequency analysis of postural sway signals obtained via the Tetrax system.
It provides information about postural control mechanisms.
Unit of measure: index score.
|
Baseline and after 6 weeks
|
|
Fall Index
Time Frame: Baseline and after 6 weeks
|
The Fall Index estimates the risk of falling based on postural stability parameters measured by the Tetrax system.
Higher scores indicate greater fall risk.
Unit of measure: index score.
|
Baseline and after 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 16, 2026
Primary Completion (Estimated)
October 16, 2026
Study Completion (Estimated)
February 16, 2027
Study Registration Dates
First Submitted
April 16, 2026
First Submitted That Met QC Criteria
April 22, 2026
First Posted (Actual)
April 29, 2026
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
April 29, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMJ2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data will be shared upon reasonable request after publication of the main study results.
De-identified data may be provided to qualified researchers for academic and non-commercial purposes.
Data sharing will be subject to ethical approval and data use agreements.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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