xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05966103</url>
    </required_header>
    <id_info>
      <org_study_id>2022-0232</org_study_id>
      <nct_id>NCT05966103</nct_id>
    </id_info>
    <brief_title>Efficacy of Scapulothoracic Exercises on Postural Stability, Proprioception, Muscular Features and Mandibular Functions</brief_title>
    <official_title>The Effects of Scapulothoracic Exercises on Postural Stability, Muscle Strength, Muscular Endurance and Proprioception in Sedentary Individuals With Cranio-Servico-Mandibular Malalignment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cyprus International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Eastern Mediterranean University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cyprus International University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this Randomized, Double-Blind, Clinical Trial is to investigate the effects of&#xD;
        scapulothoracic exercises on postural stability, muscle strength, muscular endurance,&#xD;
        mandibular functions and proprioception in sedentary individuals aged 18-45 years with head&#xD;
        forward posture and temporomandibular joint dysfunction (Cranio-Cervico-Mandibular&#xD;
        Malalignment). The main questions it aims to answer are:&#xD;
  &#xD;
        • Do Scapulothoracic exercises given in addition to cervical posture exercises have an effect&#xD;
        on postural stability, proprioception, muscle strength, muscular endurance and mandibular&#xD;
        functions in individuals with Cranio-Cervico-Mandibular malalignment?&#xD;
  &#xD;
        Researchers will compare conventional neck exercises (control group) and scapulothoracic&#xD;
        exercises applied in addition to conventional neck exercises (treatment group) to see the&#xD;
        effects of scapulothoracic exercises on the neck and jaw area.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators aimed to investigate the effects of scapulothoracic exercises on postural&#xD;
        stability, muscle strength, muscular endurance, mandibular functions and proprioception in&#xD;
        sedentary individuals aged 18-45 years with cranio-cervico-mandibular malalignment including&#xD;
        head-first posture and temporomandibular joint dysfunction problems.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 5, 2022</start_date>
    <completion_date type="Actual">July 5, 2023</completion_date>
    <primary_completion_date type="Actual">April 10, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized Comparative Double-Blind Study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Evaluations were done by a different physical therapist. The physiotherapist who administered the treatment was different. In addition, the participants did not know which group they were in.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Postural Stability</measure>
      <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.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Joint Position Sense</measure>
      <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</time_frame>
      <description>Mandibular and cervical joint position sense measurements were made.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Muscle Strength</measure>
      <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</time_frame>
      <description>Isometric muscle strength test will be performed on TMJ depressor muscles and cervical region muscles.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Endurance Measurement of Deep Neck Flexor Muscles</measure>
      <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.</time_frame>
      <description>The muscular endurance measurement of the deep neck flexors will be made using the &quot;craniocervical flexion test&quot; and a stabilizer device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mandibular Function Disorder Questionnaire (MFBA)</measure>
      <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.</time_frame>
      <description>It is used to evaluate the level of impairment in jaw functions in patients with TMED.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>Body Mass Index was measured at pre-treatment period.</time_frame>
      <description>Height and body weights were measured to measure the body mass index of the participants.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">49</enrollment>
    <condition>Temporomandibular Joint Dysfunction Syndrome</condition>
    <condition>Forward Head Posture</condition>
    <arm_group>
      <arm_group_label>Conventional Exercise Group (Control Group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Conventional neck exercises were applied to the control group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Scapulothoracic Exercise (Treatment Group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the treatment group, scapulothoracic exercises were applied in addition to conventional neck exercises.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercises</intervention_name>
      <description>For control group; Cervical conventional exercises. For treatment group; scapulothoracic exercises including strengthening, proprioceptive and stabilization exercises in addition to cervical conventional exercises</description>
      <arm_group_label>Conventional Exercise Group (Control Group)</arm_group_label>
      <arm_group_label>Scapulothoracic Exercise (Treatment Group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female students and employees between the ages of 18-45,&#xD;
  &#xD;
            -  Individuals with a craniovertabral angle (CVA) &lt;50° and a Fonseca questionnaire score&#xD;
               between 20-100,&#xD;
  &#xD;
            -  Individuals with a Helkimo clinical dysfunction index score between 1-25,&#xD;
  &#xD;
            -  Individuals with a low level of physical activity according to the International&#xD;
               Physical Activity Questionnaire.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Serious problems of the musculoskeletal system, including the cervical and thoracic&#xD;
               spine,&#xD;
  &#xD;
            -  Presence of serious chronic diseases such as hypertension, diabetes, cancer,&#xD;
  &#xD;
            -  Presence of neurological disease at a level that will affect balance and postural&#xD;
               control,&#xD;
  &#xD;
            -  Being pregnant,&#xD;
  &#xD;
            -  Tooth and jaw problems in the last 6 months,&#xD;
  &#xD;
            -  Individuals with a total denture or prosthesis on the anterior teeth.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mehmet Micoogullari, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cyprus International University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Cyprus International University</name>
        <address>
          <city>Mersin</city>
          <state>Lefkosa</state>
          <zip>99040</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Sajjadi, E., Olyaei, G. R., Talebian, S., Hadian, M. R., &amp; Jalaie, S. (2014). The effect of forward head posture on cervical joint position sense. Archives of Advances in Biosciences, 5(4).</citation>
    </reference>
    <reference>
      <citation>Ryan, J., Akhter, R., Hassan, N., Hilton, G., Wickham, J., &amp; Ibaragi, S. (2019). Epidemiology of temporomandibular disorder in the general population: A systematic review. Adv Dent Oral Health, 10(3), 1-13.</citation>
    </reference>
    <reference>
      <citation>Weber, P., Corrêa, E. C. R., de Paula Bolzan, G., dos Santos Ferreira, F., Soares, J. C., &amp; 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.</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>19148396</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32071851</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31955048</PMID>
    </reference>
    <reference>
      <citation>de Albuquerque Vieira, M., de Araújo, M. D. G. R., Antonino, G. B., da Silva Tenório, A., das Graças Paiva, M., &amp; de Lima Ferreira, A. P. (2018). Cervical and scapular instability in subjects with temporomandibular disorder. Manual Therapy, Posturology &amp; Rehabilitation Journal, 1-5.</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>25590441</PMID>
    </reference>
    <reference>
      <citation>Safwat͘, Y. M., Wadee, A. N., Lasheen, Y. R., &amp; Kamel, R. M. (2019). Influence of Scapular Stabilization Exercises on Asymptomatic Forward Head Posture; A Randomized Controlled Trial. Indian Journal of Public Health Research &amp; Development, 10(12).</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>27697824</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>19142549</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30762779</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Musculoskeletal Rehabilitation</keyword>
    <keyword>Temporomandibular Joint Treatment</keyword>
    <keyword>Scapulothoracic Exercises</keyword>
    <keyword>Cranio-Cervico-Mandibular Malalignment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Diseases</mesh_term>
      <mesh_term>Temporomandibular Joint Disorders</mesh_term>
      <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05966103
  org study id: 2022-0232
  nct id: NCT05966103
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  The investigators aimed 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 cranio-cervico-mandibular malalignment including
        head-first posture and temporomandibular joint dysfunction problems.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Comparative Double-Blind Study
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Evaluations were done by a different physical therapist. The physiotherapist who administered the treatment was different. In addition, the participants did not know which group they were in.
  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.
  description: 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.
  measure: 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
  description: Mandibular and cervical joint position sense measurements were made.
  measure: 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
  description: Isometric muscle strength test will be performed on TMJ depressor muscles and cervical region muscles.
  measure: 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.
  description: The muscular endurance measurement of the deep neck flexors will be made using the "craniocervical flexion test" and a stabilizer device.
  measure: 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.
  description: It is used to evaluate the level of impairment in jaw functions in patients with TMED.
  measure: Body Mass Index
  time frame: Body Mass Index was measured at pre-treatment period.
  description: Height and body weights were measured to measure the body mass index of the participants.
  arm group label: Conventional Exercise Group (Control Group)
  arm group type: Active Comparator
  description: Conventional neck exercises were applied to the control group.
  arm group label: Scapulothoracic Exercise (Treatment Group)
  arm group type: Experimental
  description: In the treatment group, scapulothoracic exercises were applied in addition to conventional neck exercises.
  intervention type: Other
  intervention name: Exercises
  description: For control group; Cervical conventional exercises. For treatment group; scapulothoracic exercises including strengthening, proprioceptive and stabilization exercises in addition to cervical conventional exercises
  arm group label: Conventional Exercise Group (Control Group)
  arm group label: Scapulothoracic Exercise (Treatment Group)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Mehmet Micoogullari, MSc
  role: Principal Investigator
  affiliation: Cyprus International University
  facility: 
  country: Turkey
  citation: 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).
  citation: 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.
  citation: 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.
  citation: 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.
  PMID: 19148396
  citation: 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.
  PMID: 32071851
  citation: 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.
  PMID: 31955048
  citation: 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.
  citation: 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.
  PMID: 25590441
  citation: 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).
  citation: 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.
  PMID: 27697824
  citation: 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.
  PMID: 19142549
  citation: 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.
  PMID: 30762779
  responsible party type: Sponsor
  mesh term: Joint Diseases
  mesh term: Temporomandibular Joint Disorders
  mesh term: Temporomandibular Joint Dysfunction Syndrome
  sharing ipd: No