- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05966103
Efficacy of Scapulothoracic Exercises on Postural Stability, Proprioception, Muscular Features and Mandibular Functions
The Effects of Scapulothoracic Exercises on Postural Stability, Muscle Strength, Muscular Endurance and Proprioception in Sedentary Individuals With Cranio-Servico-Mandibular Malalignment
The goal of this Randomized, Double-Blind, Clinical Trial is to investigate the effects of scapulothoracic exercises on postural stability, muscle strength, muscular endurance, mandibular functions and proprioception in sedentary individuals aged 18-45 years with head forward posture and temporomandibular joint dysfunction (Cranio-Cervico-Mandibular Malalignment). The main questions it aims to answer are:
• Do Scapulothoracic exercises given in addition to cervical posture exercises have an effect on postural stability, proprioception, muscle strength, muscular endurance and mandibular functions in individuals with Cranio-Cervico-Mandibular malalignment?
Researchers will compare conventional neck exercises (control group) and scapulothoracic exercises applied in addition to conventional neck exercises (treatment group) to see the effects of scapulothoracic exercises on the neck and jaw area.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lefkosa
-
Mersin, Lefkosa, Turkey, 99040
- Cyprus International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female students and employees between the ages of 18-45,
- Individuals with a craniovertabral angle (CVA) <50° and a Fonseca questionnaire score between 20-100,
- Individuals with a Helkimo clinical dysfunction index score between 1-25,
- Individuals with a low level of physical activity according to the International Physical Activity Questionnaire.
Exclusion Criteria:
- Serious problems of the musculoskeletal system, including the cervical and thoracic spine,
- Presence of serious chronic diseases such as hypertension, diabetes, cancer,
- Presence of neurological disease at a level that will affect balance and postural control,
- Being pregnant,
- Tooth and jaw problems in the last 6 months,
- Individuals with a total denture or prosthesis on the anterior teeth.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Exercise Group (Control Group)
Conventional neck exercises were applied to the control group.
|
For control group; Cervical conventional exercises.
For treatment group; scapulothoracic exercises including strengthening, proprioceptive and stabilization exercises in addition to cervical conventional exercises
|
|
Experimental: Scapulothoracic Exercise (Treatment Group)
In the treatment group, scapulothoracic exercises were applied in addition to conventional neck exercises.
|
For control group; Cervical conventional exercises.
For treatment group; scapulothoracic exercises including strengthening, proprioceptive and stabilization exercises in addition to cervical conventional exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint Position Sense
Time Frame: Proprioception measurements were made at 3 different times (before treatment, 8 weeks after treatment, 12 weeks follow up). The mean measurement time for mandibular position sense for each participant was 8 min. Cervical joint position sense measure
|
Mandibular and cervical joint position sense measurements were made.
|
Proprioception measurements were made at 3 different times (before treatment, 8 weeks after treatment, 12 weeks follow up). The mean measurement time for mandibular position sense for each participant was 8 min. Cervical joint position sense measure
|
|
Postural Stability
Time Frame: Postural stability was measured at 3 different times (before treatment, 8 weeks after treatment, 12 weeks follow up). The average measurement time for each participant was 5 min.
|
Five different data were obtained: the peripheral length value of the total sway degree (°) made on the device during balance, the percentile value of the area gap (%) showing the percentage of the area drawn according to the reference circle, the sway velocity value (°/sec), the average values (°) reached in the sway in the antero-posterior (AP) and medio-lateral (ML) directions.
|
Postural stability was measured at 3 different times (before treatment, 8 weeks after treatment, 12 weeks follow up). The average measurement time for each participant was 5 min.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength
Time Frame: Muscle strength measurements were made at 3 different times (pre-treatment, 8th week post-treatment, 12th-week follow-up). The temporomandibular joint depressor muscle strength measurement time for each participant lasted 3 minutes. The st
|
Isometric muscle strength test will be performed on TMJ depressor muscles and cervical region muscles.
|
Muscle strength measurements were made at 3 different times (pre-treatment, 8th week post-treatment, 12th-week follow-up). The temporomandibular joint depressor muscle strength measurement time for each participant lasted 3 minutes. The st
|
|
Endurance Measurement of Deep Neck Flexor Muscles
Time Frame: Muscular endurance of deep neck flexors was measured at 3 different times (pre-treatment, 8th week post-treatment, 12th week post-treatment follow-up). It took an average of 15 minutes for each participant.
|
The muscular endurance measurement of the deep neck flexors will be made using the "craniocervical flexion test" and a stabilizer device.
|
Muscular endurance of deep neck flexors was measured at 3 different times (pre-treatment, 8th week post-treatment, 12th week post-treatment follow-up). It took an average of 15 minutes for each participant.
|
|
Mandibular Function Disorder Questionnaire (MFBA)
Time Frame: Mandibular Function Disorder Questionnaire (MFBA) was measured at 3 different times (pre-treatment, 8th week post-treatment, 12th week post-treatment follow-up). It took an average of 2 minutes for each participant.
|
It is used to evaluate the level of impairment in jaw functions in patients with TMED.
|
Mandibular Function Disorder Questionnaire (MFBA) was measured at 3 different times (pre-treatment, 8th week post-treatment, 12th week post-treatment follow-up). It took an average of 2 minutes for each participant.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index
Time Frame: Body Mass Index was measured at pre-treatment period.
|
Height and body weights were measured to measure the body mass index of the participants.
|
Body Mass Index was measured at pre-treatment period.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mehmet Micoogullari, MSc, Cyprus International University
Publications and helpful links
General Publications
- Chaves TC, Turci AM, Pinheiro CF, Sousa LM, Grossi DB. Static body postural misalignment in individuals with temporomandibular disorders: a systematic review. Braz J Phys Ther. 2014 Nov-Dec;18(6):481-501. doi: 10.1590/bjpt-rbf.2014.0061. Epub 2014 Oct 31.
- Saito ET, Akashi PM, Sacco Ide C. Global body posture evaluation in patients with temporomandibular joint disorder. Clinics (Sao Paulo). 2009;64(1):35-9. doi: 10.1590/s1807-59322009000100007.
- Sajjadi, E., Olyaei, G. R., Talebian, S., Hadian, M. R., & Jalaie, S. (2014). The effect of forward head posture on cervical joint position sense. Archives of Advances in Biosciences, 5(4).
- Ryan, J., Akhter, R., Hassan, N., Hilton, G., Wickham, J., & Ibaragi, S. (2019). Epidemiology of temporomandibular disorder in the general population: A systematic review. Adv Dent Oral Health, 10(3), 1-13.
- Weber, P., Corrêa, E. C. R., de Paula Bolzan, G., dos Santos Ferreira, F., Soares, J. C., & da Silva, A. M. T. (2012). Relationship between craniocervical posture, mandible and hyoid bone and influence on alimentary functions. Brazilian Journal of Oral Sciences, 11(2), 141-147.
- Ries LG, Berzin F. Analysis of the postural stability in individuals with or without signs and symptoms of temporomandibular disorder. Braz Oral Res. 2008 Oct-Dec;22(4):378-83. doi: 10.1590/s1806-83242008000400016.
- Gadotti I, Hicks K, Koscs E, Lynn B, Estrazulas J, Civitella F. Electromyography of the masticatory muscles during chewing in different head and neck postures - A pilot study. J Oral Biol Craniofac Res. 2020 Apr-Jun;10(2):23-27. doi: 10.1016/j.jobcr.2020.02.002. Epub 2020 Feb 5.
- Moustafa IM, Youssef A, Ahbouch A, Tamim M, Harrison DE. Is forward head posture relevant to autonomic nervous system function and cervical sensorimotor control? Cross sectional study. Gait Posture. 2020 Mar;77:29-35. doi: 10.1016/j.gaitpost.2020.01.004. Epub 2020 Jan 7.
- de Albuquerque Vieira, M., de Araújo, M. D. G. R., Antonino, G. B., da Silva Tenório, A., das Graças Paiva, M., & de Lima Ferreira, A. P. (2018). Cervical and scapular instability in subjects with temporomandibular disorder. Manual Therapy, Posturology & Rehabilitation Journal, 1-5.
- Safwat͘, Y. M., Wadee, A. N., Lasheen, Y. R., & Kamel, R. M. (2019). Influence of Scapular Stabilization Exercises on Asymptomatic Forward Head Posture; A Randomized Controlled Trial. Indian Journal of Public Health Research & Development, 10(12).
- Dickerson SM, Weaver JM, Boyson AN, Thacker JA, Junak AA, Ritzline PD, Donaldson MB. The effectiveness of exercise therapy for temporomandibular dysfunction: a systematic review and meta-analysis. Clin Rehabil. 2017 Aug;31(8):1039-1048. doi: 10.1177/0269215516672275. Epub 2016 Oct 3.
- Zhao W, You H, Jiang S, Zhang H, Yang Y, Zhang M. Effect of Pro-kin visual feedback balance training system on gait stability in patients with cerebral small vessel disease. Medicine (Baltimore). 2019 Feb;98(7):e14503. doi: 10.1097/MD.0000000000014503.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0232
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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