<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/NCT03778034</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/001886</org_study_id>
    <nct_id>NCT03778034</nct_id>
  </id_info>
  <brief_title>Effect of Forward Head Posture(FHP)on Temopromandibular Joint (TMJ) Proprioception in Post-pubertal Females</brief_title>
  <official_title>Effect of Forward Head Posture(FHP) on Temopromandibular Joint (TMJ) Proprioception in Post-pubertal Females</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HAhmed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      No studies up to date has been evaluated the effect of FHP on TMJ proprioception.Therefore,&#xD;
      this study will be the first one which aims to investigate the effect of FHP on TMJ&#xD;
      proprioception in post-pubertal females&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forward head posture and temporomandibular disorder are two common problems in post-pubertal&#xD;
      females. They are closely related to each other. Previous studies showed influences of head&#xD;
      posture on the mandibular rest position, range of functional movements and the jaw and neck&#xD;
      muscles work together during rhythmic movements. They affirm that patients with TMD present&#xD;
      more alterations in head positioning than patients with no dysfunction .&#xD;
&#xD;
      However, no studies up to date has been evaluated the effect of FHP on TMJ proprioception.&#xD;
      The proprioceptors in the human TMJ play important key role in identification of mandibular&#xD;
      position when the teeth are not occluded. TMJ receptors provide the greater afferent activity&#xD;
      regarding perceptual awareness of joint position and movement . Proper assessment of TMJ&#xD;
      proprioception may be critical for designing not only rehabilitation but also&#xD;
      pre-habilitation interventions for patients with FHP aiming to prevent TMD. Therefore, this&#xD;
      study will be the first one which aims to investigate the effect of FHP on TMJ proprioception&#xD;
      in post-pubertal females. This study may expand the role of physiotherapy in woman's health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2019</start_date>
  <completion_date type="Anticipated">December 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Testing TMJ proprioception</measure>
    <time_frame>one month</time_frame>
    <description>TMJ proprioception will be tested through a digital vernier caliper for each female in both groups. Each female will be asked to sit on a stool, feet will be rested on the floor, arms will be supported on armrests, knees and elbow joints will assume right angles, and the chair's back will not exceed suprascapular border. With closed eyes, the female's mouth will be opened passively by 3 cm measured by adigital Vernier caliper, which is considered as functional position of jaw for eating and speech. The procedures will be repeated 3 times and maintained for 3 seconds. Then, each female will be asked to open her mouth actively for the target distance and the distance will bemeasured by the caliper.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>measuring the shoulder angle</measure>
    <time_frame>one month</time_frame>
    <description>The angle formed at the intersection of the line between the midpoint of the humerus and spinous process of C7 and the horizontal line through the midpoint of the humerus. The investigators considered 52° as the reference angle and will be measure like CVA</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Forward Head Posture</condition>
  <arm_group>
    <arm_group_label>Female with forward head posture</arm_group_label>
    <description>post-pubertal females suffering from (FHP) with Craniovertebral angle (CVA) less than 49 degrees(study group)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy female without (FHP)</arm_group_label>
    <description>post-pubertal females expected to exhibit an average normal CVA within 10degrees range from 49 to 59 (control group)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>female with Forward head posture</intervention_name>
    <description>measuring tmj proprioception with open eyes and closed eyes for mouth opening,right deviation,left deviation and protrusion,cranio vertebral angle and shoulder angle</description>
    <arm_group_label>Female with forward head posture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>healthy female without (FHP)</intervention_name>
    <description>measuring tmj proprioception with open eyes and closed eyes for mouth opening,right deviation,left deviation and protrusion,cranio vertebral angle and shoulder angle</description>
    <arm_group_label>healthy female without (FHP)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Proper assessment of TMJ proprioception may be critical for designing not only&#xD;
        rehabilitation but also pre-habilitation interventions for patients with FHP aiming to&#xD;
        prevent TMD. Therefore, this study will be the first one which aims to investigate the&#xD;
        effect of FHP on TMJ proprioception in post-pubertal females. This study may expand the&#xD;
        role of physiotherapy in woman's health.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. They should be at least 1 year post-puberty.&#xD;
&#xD;
          2. Their age will range from 14 to 19 years old.&#xD;
&#xD;
          3. Their body mass index (BMI) will range from 18-25 kg/m2.&#xD;
&#xD;
          4. They should spend long period of time with bad posture on computer, laptop or smart&#xD;
             phones.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  They shouldn't have headache, migraine, vertebra-basilar insufficiency,temporo&#xD;
             mandibular disorders (TMD) ,uncorrected impairment of vision or audition, neck pain,&#xD;
             fixed or mobile spinal deformity or history of fracture or surgery of the upper&#xD;
             quadrant of the body&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Forward head posture and temporomandibular disorder are two common problems in post-pubertal females.Females exhibit more incidence of FHP after puberty than males. This posture of greater flexion in females can be attributable to psychosocial issues, such as stress, or partly associated with the development of secondary sex characteristics in females.Temporomandibular disorders (TMD) are common pain conditions that have the highest prevalence among females of reproductive age.the male to female ratio of TMD patients is estimated at around 1:3 and The pattern of onset after puberty and lowered prevalence rates in the postmenopausal years suggest that female reproductive hormones may play an etiologic role in TMD</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>amel youssef, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nehal gamal, bachleor</last_name>
    <phone>01096691802</phone>
    <email>nehalgamal616@gmail.com</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>HAhmed</investigator_full_name>
    <investigator_title>lecturer at biomechanics department</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03778034
org study id: P.T.REC/012/001886
nct id: NCT03778034
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
No studies up to date has been evaluated the effect of FHP on TMJ proprioception.Therefore,
      this study will be the first one which aims to investigate the effect of FHP on TMJ
      proprioception in post-pubertal females
Forward head posture and temporomandibular disorder are two common problems in post-pubertal
      females. They are closely related to each other. Previous studies showed influences of head
      posture on the mandibular rest position, range of functional movements and the jaw and neck
      muscles work together during rhythmic movements. They affirm that patients with TMD present
      more alterations in head positioning than patients with no dysfunction .

      However, no studies up to date has been evaluated the effect of FHP on TMJ proprioception.
      The proprioceptors in the human TMJ play important key role in identification of mandibular
      position when the teeth are not occluded. TMJ receptors provide the greater afferent activity
      regarding perceptual awareness of joint position and movement . Proper assessment of TMJ
      proprioception may be critical for designing not only rehabilitation but also
      pre-habilitation interventions for patients with FHP aiming to prevent TMD. Therefore, this
      study will be the first one which aims to investigate the effect of FHP on TMJ proprioception
      in post-pubertal females. This study may expand the role of physiotherapy in woman's health.
observational model: Other
time perspective: Cross-Sectional
measure: Testing TMJ proprioception
time frame: one month
description: TMJ proprioception will be tested through a digital vernier caliper for each female in both groups. Each female will be asked to sit on a stool, feet will be rested on the floor, arms will be supported on armrests, knees and elbow joints will assume right angles, and the chair's back will not exceed suprascapular border. With closed eyes, the female's mouth will be opened passively by 3 cm measured by adigital Vernier caliper, which is considered as functional position of jaw for eating and speech. The procedures will be repeated 3 times and maintained for 3 seconds. Then, each female will be asked to open her mouth actively for the target distance and the distance will bemeasured by the caliper.
measure: measuring the shoulder angle
time frame: one month
description: The angle formed at the intersection of the line between the midpoint of the humerus and spinous process of C7 and the horizontal line through the midpoint of the humerus. The investigators considered 52° as the reference angle and will be measure like CVA
arm group label: Female with forward head posture
description: post-pubertal females suffering from (FHP) with Craniovertebral angle (CVA) less than 49 degrees(study group)
arm group label: healthy female without (FHP)
description: post-pubertal females expected to exhibit an average normal CVA within 10degrees range from 49 to 59 (control group)
intervention type: Other
intervention name: female with Forward head posture
description: measuring tmj proprioception with open eyes and closed eyes for mouth opening,right deviation,left deviation and protrusion,cranio vertebral angle and shoulder angle
arm group label: Female with forward head posture
intervention type: Other
intervention name: healthy female without (FHP)
description: measuring tmj proprioception with open eyes and closed eyes for mouth opening,right deviation,left deviation and protrusion,cranio vertebral angle and shoulder angle
arm group label: healthy female without (FHP)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Forward head posture and temporomandibular disorder are two common problems in post-pubertal females.Females exhibit more incidence of FHP after puberty than males. This posture of greater flexion in females can be attributable to psychosocial issues, such as stress, or partly associated with the development of secondary sex characteristics in females.Temporomandibular disorders (TMD) are common pain conditions that have the highest prevalence among females of reproductive age.the male to female ratio of TMD patients is estimated at around 1:3 and The pattern of onset after puberty and lowered prevalence rates in the postmenopausal years suggest that female reproductive hormones may play an etiologic role in TMD
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: amel youssef, phd
role: Principal Investigator
affiliation: Cairo University
last name: Nehal gamal, bachleor
phone: 01096691802
email: nehalgamal616@gmail.com
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: HAhmed
investigator title: lecturer at biomechanics department