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/NCT06019819</url>
    </required_header>
    <id_info>
      <org_study_id>RiphahIU Sidrah Sufian</org_study_id>
      <nct_id>NCT06019819</nct_id>
    </id_info>
    <brief_title>Effects of Postural Correction Exercises in Reducing Forward Head Posture in Children Carrying Heavy Bag Packs</brief_title>
    <official_title>Effects of 4 Weeks Postural Correction Exercises in Reducing Forward Head Posture in Children Carrying Heavy Bag Packs</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah 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>
        : This study aims to investigate the effectiveness of a 4-week postural correction exercise&#xD;
        program in reducing FHP in children carrying heavy backpacks to school. This study's findings&#xD;
        could have significant implications for preventing musculoskeletal problems associated with&#xD;
        FHP. Furthermore, the study's findings could inform healthcare professionals and educators&#xD;
        about the importance of promoting healthy postures among children and adolescents to prevent&#xD;
        long-term musculoskeletal problems. This is an experimental study. Subjects will be divided&#xD;
        into two groups. Group A (control group) and group B (experimental group).fun activities will&#xD;
        be performed by experimental group under the supervision of the therapist.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Regular use of heavy school bags and inappropriate carrying methods can put children at the&#xD;
        risk of musculoskeletal problems and changes the body posture. It is imperative to note that&#xD;
        carrying a backpack more than the recommended weight limit poses a twofold hazard,&#xD;
        particularly to children and adolescents who are undergoing neuromusculoskeletal development&#xD;
        and growth. Hence, it is crucial to ensure that the backpack's weight does not exceed 10-15%&#xD;
        of the child or adolescent's body weight. Overreaching this weight limit may result in&#xD;
        posterior displacement of the center of gravity, thereby engendering augmented strain on the&#xD;
        neck and back muscles. Such effects are commonly linked with spinal column pathologies and&#xD;
        reduced lung volume.One of the most prevalent types of postural anomaly is called &quot;forward&#xD;
        head posture&quot; (FHP), and it is typically characterized by the head being anterior to the&#xD;
        body's vertical line gravity point. Chronic FHP issues develop from an excessive load being&#xD;
        placed on the joint and muscle when cervical muscular imbalances brought on by postural&#xD;
        misalignment are left untreated. Both an upper cervical extension and a lower cervical&#xD;
        flexion define forward head position. These modifications in the cervical region could result&#xD;
        in long-term bad head posture, which could cause &quot;upper crossed syndrome&quot; or other&#xD;
        musculoskeletal disorders. Additionally, neck and shoulder pain are common complaints among&#xD;
        FHPs patients . Numerous studies have shown that carrying a backpack that is 7.5% of or more&#xD;
        of your body weight (BW) causes postural compensations. The increased weight of the backpack&#xD;
        correlates with higher FHP, trunk flexion, spinal asymmetry, and tensile forces in the&#xD;
        intervertebral discs under static settings&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">February 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 30, 2024</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>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Forward head posture analysis app</measure>
      <time_frame>4 weeks</time_frame>
      <description>Changes form the Baseline will be measured. This Forward head posture analysis app can be used to assess the forward head posture using visual analysis through camera. the angle of the cervical spine was measured in the side view through pictures.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>numeric pain rating scale</measure>
      <time_frame>4th week</time_frame>
      <description>Changes form the Baseline will be measured. It measured the neck pain with 11 points, 0 showing min and 10 showing max pain</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">86</enrollment>
    <condition>Postural Kyphosis</condition>
    <arm_group>
      <arm_group_label>control group A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Postural correction exercises group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>strengthening exercise</intervention_name>
      <description>Perform general physical training activities conducted in schools including upper limb forward elevation, lateral elevation, touching toes in standing and cervical range of motion, strengthening exercise will be performed for 3days a week for 4 weeks.</description>
      <arm_group_label>control group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Postural correction exercises</intervention_name>
      <description>Chin Tuck, Strengthening shoulder retractors, Stretching sternocleidomastoiD, Pectorals stretch For strengthening exercises 3 sets of 10 repetitions were performed with 6 seconds rest period between each set and a hold of 6 seconds. Stretching exercises will be performed in 3 sets of 10 repetitions ,30 seconds hold and 30 seconds rest period between each exercise. The exercises were performed 3days a week for 4 weeks.</description>
      <arm_group_label>Postural correction exercises group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Both gender&#xD;
  &#xD;
            -  Children who carry heavy backpacks to school (more than 10% of their body weight)&#xD;
  &#xD;
            -  Forward head posture, defined as a craniovertebral angle of less than 50 degrees.&#xD;
  &#xD;
            -  Willing to participate in the study.&#xD;
  &#xD;
            -  Consent obtained from parents or legal guardians&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cervical spine fracture or neurological disorder.&#xD;
  &#xD;
            -  Scoliosis or torticollis.&#xD;
  &#xD;
            -  Joint hypermobility or recent surgery . Prior history of physical therapy treatment&#xD;
               for forward head posture in the past six months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>13 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aisha Razzaq, MSPT-OMPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Imran Amjad, PHD</last_name>
      <phone>03324390125</phone>
      <email>imran.amjad@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Private and Public Schools</name>
        <address>
          <city>Rawalpindi</city>
          <state>Punjab</state>
          <zip>46000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Aisha Razzaq, MSPT-OMPT</last_name>
        <phone>03015030784</phone>
        <email>aisha.razzaq@riphah.edu.pk</email>
      </contact>
      <investigator>
        <last_name>sidra sufian, MSPT-OMPT*</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>forward head posture</keyword>
    <keyword>posture correction exercises</keyword>
    <keyword>strength training</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kyphosis</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/NCT06019819
  org study id: RiphahIU Sidrah Sufian
  nct id: NCT06019819
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  : This study aims to investigate the effectiveness of a 4-week postural correction exercise
        program in reducing FHP in children carrying heavy backpacks to school. This study's findings
        could have significant implications for preventing musculoskeletal problems associated with
        FHP. Furthermore, the study's findings could inform healthcare professionals and educators
        about the importance of promoting healthy postures among children and adolescents to prevent
        long-term musculoskeletal problems. This is an experimental study. Subjects will be divided
        into two groups. Group A (control group) and group B (experimental group).fun activities will
        be performed by experimental group under the supervision of the therapist.
  Regular use of heavy school bags and inappropriate carrying methods can put children at the
        risk of musculoskeletal problems and changes the body posture. It is imperative to note that
        carrying a backpack more than the recommended weight limit poses a twofold hazard,
        particularly to children and adolescents who are undergoing neuromusculoskeletal development
        and growth. Hence, it is crucial to ensure that the backpack's weight does not exceed 10-15%
        of the child or adolescent's body weight. Overreaching this weight limit may result in
        posterior displacement of the center of gravity, thereby engendering augmented strain on the
        neck and back muscles. Such effects are commonly linked with spinal column pathologies and
        reduced lung volume.One of the most prevalent types of postural anomaly is called "forward
        head posture" (FHP), and it is typically characterized by the head being anterior to the
        body's vertical line gravity point. Chronic FHP issues develop from an excessive load being
        placed on the joint and muscle when cervical muscular imbalances brought on by postural
        misalignment are left untreated. Both an upper cervical extension and a lower cervical
        flexion define forward head position. These modifications in the cervical region could result
        in long-term bad head posture, which could cause "upper crossed syndrome" or other
        musculoskeletal disorders. Additionally, neck and shoulder pain are common complaints among
        FHPs patients . Numerous studies have shown that carrying a backpack that is 7.5% of or more
        of your body weight (BW) causes postural compensations. The increased weight of the backpack
        correlates with higher FHP, trunk flexion, spinal asymmetry, and tensile forces in the
        intervertebral discs under static settings
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Forward head posture analysis app
  time frame: 4 weeks
  description: Changes form the Baseline will be measured. This Forward head posture analysis app can be used to assess the forward head posture using visual analysis through camera. the angle of the cervical spine was measured in the side view through pictures.
  measure: numeric pain rating scale
  time frame: 4th week
  description: Changes form the Baseline will be measured. It measured the neck pain with 11 points, 0 showing min and 10 showing max pain
  arm group label: control group A
  arm group type: Active Comparator
  arm group label: Postural correction exercises group B
  arm group type: Experimental
  intervention type: Other
  intervention name: strengthening exercise
  description: Perform general physical training activities conducted in schools including upper limb forward elevation, lateral elevation, touching toes in standing and cervical range of motion, strengthening exercise will be performed for 3days a week for 4 weeks.
  arm group label: control group A
  intervention type: Other
  intervention name: Postural correction exercises
  description: Chin Tuck, Strengthening shoulder retractors, Stretching sternocleidomastoiD, Pectorals stretch For strengthening exercises 3 sets of 10 repetitions were performed with 6 seconds rest period between each set and a hold of 6 seconds. Stretching exercises will be performed in 3 sets of 10 repetitions ,30 seconds hold and 30 seconds rest period between each exercise. The exercises were performed 3days a week for 4 weeks.
  arm group label: Postural correction exercises group B
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 13 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Aisha Razzaq, MSPT-OMPT
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Imran Amjad, PHD
  phone: 03324390125
  email: imran.amjad@riphah.edu.pk
  facility: 
  contact: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Kyphosis
  sharing ipd: No