<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/NCT03038139</url>
  </required_header>
  <id_info>
    <org_study_id>IRB- pGS- 2016-03- 144</org_study_id>
    <nct_id>NCT03038139</nct_id>
  </id_info>
  <brief_title>Postural Correction Exercises for Forward Head Posture</brief_title>
  <official_title>Changes in Spinal Muscular Activation and Creaniovertebral Angle After Postural Correction Program for Forward Head Posture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imam Abdulrahman Bin Faisal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imam Abdulrahman Bin Faisal University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the changes of spinal muscle activation in&#xD;
      cervical, thoracic and lumbar segments for subjects with forward head posture (FHP) after&#xD;
      application of two correction programs; a conventional one including cervical and thoracic&#xD;
      spine, and a second program involving lumbosacral segment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of Craniovertebral angle</measure>
    <time_frame>4 weeks</time_frame>
    <description>The craniovertebral angle will be measure before and after 4 weeks of applying an exercise program.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electromyography</measure>
    <time_frame>4 weeks</time_frame>
    <description>The Electromyography will be measure before and after 4 weeks of applying an exercise program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck Disability Index</measure>
    <time_frame>4 weeks</time_frame>
    <description>The neck disability index will be measure before and after 4 weeks of applying an exercise program.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Forward Head Posture</condition>
  <arm_group>
    <arm_group_label>Cervical exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A= Cervical correction program The cervical exercise program consist of 3 strengthening exercises and 2 stretching exercises.&#xD;
Applying exercises 3 times per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lumbosacral exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B= Cervical + Lumbosacral correction program The cervical exercise program consist of 3 strengthening exercises and 2 stretching exercises.&#xD;
The lumbosacral exercise program consist of 2 strengthening exercises and 4 stretching exercises.&#xD;
Applying exercises 3 times per week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervical exercises</intervention_name>
    <description>Cervical correction program consist of 3 strengthening and 2 stretching exercises for neck and scapula Lumbosacral correction program consist of strengthening and stretching exercises for lumbar and sacral regions</description>
    <arm_group_label>Cervical exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lumosacral exercises</intervention_name>
    <description>Cervical and Lumbosacral correction program Lumbosacral program consist of 2 strengthening and 4 stretching exercises</description>
    <arm_group_label>Lumbosacral exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults with craniovertebral angle less than 50◦&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded if they have&#xD;
&#xD;
          -  congenital spinal deformity such as scoliosis&#xD;
&#xD;
          -  spinal conditions such as cervical trauma, fracture, instability of cervical spine,&#xD;
             inflammation, infection, or neurological deficit&#xD;
&#xD;
          -  a history of surgery at cervical spine or shoulder&#xD;
&#xD;
          -  pregnant woman&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>28 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dammam University</name>
      <address>
        <city>Dammam</city>
        <state>Eastern Province</state>
        <zip>31952</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dammam University</name>
      <address>
        <city>Dammam</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <link>
    <url>http://by7nn3rg6h.search.serialssolutions.com/?ctx_ver=Z39.88-2004&amp;ctx_enc=info%3Aofi%2Fenc%3AUTF-8&amp;rfr_id=info%3Asid%2Fsummon.serialssolutions.com&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=article&amp;rft.atitle=The+effect+of+forward+head+posture+on+muscle+activity+during+neck+protraction+and+retraction&amp;rft.jtitle=Journal+of+Physical+Therapy+Science&amp;rft.au=Lee%2C+Kyeong-Jin&amp;rft.au=Han%2C+Hee-Young&amp;rft.au=Cheon%2C+Song-Hee&amp;rft.au=Park%2C+So-Hyun&amp;rft.date=2015&amp;rft.issn=0915-5287&amp;rft.eissn=2187-5626&amp;rft.volume=27&amp;rft.issue=3&amp;rft.spage=977&amp;rft.epage=979&amp;rft_id=info:doi/10.1589%2Fjpts.27.977&amp;rft.externalDBID=n%2Fa&amp;rft.externalDocID=10_1589_jpts_27_977&amp;paramdict=en-US</url>
    <description>The effect of forward head posture on muscle activity during neck protraction and retraction</description>
  </link>
  <link>
    <url>http://by7nn3rg6h.search.serialssolutions.com/?ctx_ver=Z39.88-2004&amp;ctx_enc=info%3Aofi%2Fenc%3AUTF-8&amp;rfr_id=info%3Asid%2Fsummon.serialssolutions.com&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=article&amp;rft.atitle=Changes+in+the+activity+of+the+muscles+surrounding+the+neck+according+to+the+angles+of+movement+of+the+neck+in+adults+in+their+20s&amp;rft.jtitle=Journal+of+Physical+Therapy+Science&amp;rft.au=Lee%2C+Tae-Ho&amp;rft.au=Lee%2C+Joon-Hyuk&amp;rft.au=Lee%2C+Yun-Seob&amp;rft.au=Kim%2C+Myoung-Kwon&amp;rft.date=2015&amp;rft.issn=0915-5287&amp;rft.eissn=2187-5626&amp;rft.volume=27&amp;rft.issue=3&amp;rft.spage=973&amp;rft.epage=975&amp;rft_id=info:doi/10.1589%2Fjpts.27.973&amp;rft.externalDBID=n%2Fa&amp;rft.externalDocID=10_1589_jpts_27_973&amp;paramdict=en-US</url>
    <description>Changes in the activity of the muscles surrounding the neck according to the angles of movement of the neck in adults in their 20s</description>
  </link>
  <link>
    <url>http://by7nn3rg6h.search.serialssolutions.com/?ctx_ver=Z39.88-2004&amp;ctx_enc=info%3Aofi%2Fenc%3AUTF-8&amp;rfr_id=info%3Asid%2Fsummon.serialssolutions.com&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=article&amp;rft.atitle=Effect+of+an+exercise+program+for+posture+correction+on+musculoskeletal+pain&amp;rft.jtitle=Journal+of+Physical+Therapy+Science&amp;rft.au=Kim%2C+DeokJu&amp;rft.au=Cho%2C+MiLim&amp;rft.au=Park%2C+YunHee&amp;rft.au=Yang%2C+YeongAe&amp;rft.date=2015&amp;rft.issn=0915-5287&amp;rft.eissn=2187-5626&amp;rft.volume=27&amp;rft.issue=6&amp;rft.spage=1791&amp;rft.epage=1794&amp;rft_id=info:doi/10.1589%2Fjpts.27.1791&amp;rft.externalDBID=n%2Fa&amp;rft.externalDocID=10_1589_jpts_27_1791&amp;paramdict=en-US</url>
    <description>Effect of an exercise program for posture correction on musculoskeletal pain</description>
  </link>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>forward head posture</keyword>
  <keyword>postural correction</keyword>
  <keyword>spinal muscles</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>only coded data (descriptive)</ipd_description>
  </patient_data>
  <!-- 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/NCT03038139
org study id: IRB- pGS- 2016-03- 144
nct id: NCT03038139
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the changes of spinal muscle activation in
      cervical, thoracic and lumbar segments for subjects with forward head posture (FHP) after
      application of two correction programs; a conventional one including cervical and thoracic
      spine, and a second program involving lumbosacral segment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes of Craniovertebral angle
time frame: 4 weeks
description: The craniovertebral angle will be measure before and after 4 weeks of applying an exercise program.
measure: Electromyography
time frame: 4 weeks
description: The Electromyography will be measure before and after 4 weeks of applying an exercise program.
measure: Neck Disability Index
time frame: 4 weeks
description: The neck disability index will be measure before and after 4 weeks of applying an exercise program.
arm group label: Cervical exercises
arm group type: Experimental
description: Group A= Cervical correction program The cervical exercise program consist of 3 strengthening exercises and 2 stretching exercises.
Applying exercises 3 times per week.
arm group label: Lumbosacral exercises
arm group type: Experimental
description: Group B= Cervical + Lumbosacral correction program The cervical exercise program consist of 3 strengthening exercises and 2 stretching exercises.
The lumbosacral exercise program consist of 2 strengthening exercises and 4 stretching exercises.
Applying exercises 3 times per week.
intervention type: Other
intervention name: Cervical exercises
description: Cervical correction program consist of 3 strengthening and 2 stretching exercises for neck and scapula Lumbosacral correction program consist of strengthening and stretching exercises for lumbar and sacral regions
arm group label: Cervical exercises
intervention type: Other
intervention name: Lumosacral exercises
description: Cervical and Lumbosacral correction program Lumbosacral program consist of 2 strengthening and 4 stretching exercises
arm group label: Lumbosacral exercises
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 28 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Saudi Arabia
url: http://by7nn3rg6h.search.serialssolutions.com/?ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+effect+of+forward+head+posture+on+muscle+activity+during+neck+protraction+and+retraction&rft.jtitle=Journal+of+Physical+Therapy+Science&rft.au=Lee%2C+Kyeong-Jin&rft.au=Han%2C+Hee-Young&rft.au=Cheon%2C+Song-Hee&rft.au=Park%2C+So-Hyun&rft.date=2015&rft.issn=0915-5287&rft.eissn=2187-5626&rft.volume=27&rft.issue=3&rft.spage=977&rft.epage=979&rft_id=info:doi/10.1589%2Fjpts.27.977&rft.externalDBID=n%2Fa&rft.externalDocID=10_1589_jpts_27_977&paramdict=en-US
description: The effect of forward head posture on muscle activity during neck protraction and retraction
url: http://by7nn3rg6h.search.serialssolutions.com/?ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Changes+in+the+activity+of+the+muscles+surrounding+the+neck+according+to+the+angles+of+movement+of+the+neck+in+adults+in+their+20s&rft.jtitle=Journal+of+Physical+Therapy+Science&rft.au=Lee%2C+Tae-Ho&rft.au=Lee%2C+Joon-Hyuk&rft.au=Lee%2C+Yun-Seob&rft.au=Kim%2C+Myoung-Kwon&rft.date=2015&rft.issn=0915-5287&rft.eissn=2187-5626&rft.volume=27&rft.issue=3&rft.spage=973&rft.epage=975&rft_id=info:doi/10.1589%2Fjpts.27.973&rft.externalDBID=n%2Fa&rft.externalDocID=10_1589_jpts_27_973&paramdict=en-US
description: Changes in the activity of the muscles surrounding the neck according to the angles of movement of the neck in adults in their 20s
url: http://by7nn3rg6h.search.serialssolutions.com/?ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Effect+of+an+exercise+program+for+posture+correction+on+musculoskeletal+pain&rft.jtitle=Journal+of+Physical+Therapy+Science&rft.au=Kim%2C+DeokJu&rft.au=Cho%2C+MiLim&rft.au=Park%2C+YunHee&rft.au=Yang%2C+YeongAe&rft.date=2015&rft.issn=0915-5287&rft.eissn=2187-5626&rft.volume=27&rft.issue=6&rft.spage=1791&rft.epage=1794&rft_id=info:doi/10.1589%2Fjpts.27.1791&rft.externalDBID=n%2Fa&rft.externalDocID=10_1589_jpts_27_1791&paramdict=en-US
description: Effect of an exercise program for posture correction on musculoskeletal pain
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: only coded data (descriptive)