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/NCT06019806</url>
    </required_header>
    <id_info>
      <org_study_id>RiphahIU Shabi ul Hassan</org_study_id>
      <nct_id>NCT06019806</nct_id>
    </id_info>
    <brief_title>Effects of Forward Head Posture Correction on Visual Acuity in Low Level Visually Impaired University Students</brief_title>
    <official_title>Effects of Forward Head Posture Correction on Visual Acuity and Fatigue in Low Level Visually Impaired University Students</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>
        The aim of this research is to find the effect of forward head posture correction on visual&#xD;
        acuity and fatigue in low level visually impaired university students. Randomized controlled&#xD;
        trials at Cecos University of IT and Emerging Sciences would be done. The sample size would&#xD;
        be 48. The subjects would be divided in two groups, 24 subjects Intervention group and 24 in&#xD;
        control group. Study duration would be 6 months. Sampling technique applied would be a&#xD;
        non-probability convenience sampling technique. Only 18-25 years low level visually impaired&#xD;
        university students with forward head posture would be included. Tools used in the study&#xD;
        would be asthenopia questionnaire, Snellen chart and CVA angle photogrammetry&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In recent years, the increasing use of modern technology has raised concerns about its&#xD;
        potential impact on our visual health. However, research suggests that in addition to these&#xD;
        factors environmental factors such as near work, visual stress, educational stress and&#xD;
        acquired false head posture may have a greater impact on visual health of young adult&#xD;
        population. Prolonged use of digital devices can cause digital eye strain, leading to&#xD;
        symptoms such as headaches and blurred vision. However, poor posture can also cause strain on&#xD;
        the eyes, leading to decreased visual acuity and compromised performance. It is essential to&#xD;
        consider factors such as posture when assessing visual performance in university students, in&#xD;
        addition to the impact of modern technology. The forward head posture (FHP) is the head&#xD;
        movement that occurs from poor postural awareness and frequently leads to muscle imbalance&#xD;
        and discomfort.&#xD;
  &#xD;
        University students frequently experience a forward head position, especially those who spend&#xD;
        a lot of time studying or using computers. Both forward head posture and visual impairment&#xD;
        are more prevalent among university students. It has been found that 63.96% of university&#xD;
        students, including both genders, exhibit a prevalence of forward head posture. . A 2019&#xD;
        study in America found that 67.8% of university students experience visual fatigue, with&#xD;
        blurred vision being the most commonly reported symptom (27%). This suggests many students&#xD;
        may have mild visual impairments, impacting their academic performance and quality of life.&#xD;
        The existing research has mainly concentrated on studying visual impairment by defining&#xD;
        specific levels of impairment such as 'moderate' and 'severe.' However, it is plausible that&#xD;
        even a minor reduction in visual acuity, also known as 'mild' visual impairment (ranging from&#xD;
        20/30 to 20/70), could have a subtle but significant impact on an individual's ability to&#xD;
        cope with activities of daily life. The position and movement of the head play a crucial role&#xD;
        in visual perception, as the somatosensory system of the neck is intricately connected to the&#xD;
        visual system. Spending most of the time using computers, mobile phones and reading can cause&#xD;
        biomechanical alterations that make it difficult to keep a neutral head position and&#xD;
        compromise the structural integrity .The Centre of Gravity (COG) of the head moves in&#xD;
        anterosuperior direction as a result of this structural integrity compromise, increasing the&#xD;
        stress on the neck. Each inch that the head is moved forward or anteriorly from its neutral&#xD;
        position adds approximately 10 pounds (4.5 kilograms) of extra weight to the cervical spine.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 6, 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>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Snellen Chart</measure>
      <time_frame>4 weeks</time_frame>
      <description>Universally used for measuring visual acuity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Asthenopia Questionnaire</measure>
      <time_frame>4 weeks</time_frame>
      <description>Used for measuring Visual fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Craniovertebral Angle</measure>
      <time_frame>4 weeks</time_frame>
      <description>Craniovertebral angle is measured by taking 2 lateral photographs of the subject in a relaxed seated position without a back support. Spinous process of C7 and the tragus of ear are marked with a body marker. A horizontal line is drawn passing through C7 making a right angle with the vertical.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Visual Acuity</condition>
    <arm_group>
      <arm_group_label>postural correction group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Chin tuck (deep cervical flexor)&#xD;
  Strengthening shoulder retractors&#xD;
  Sternocleidomastoid muscle stretch&#xD;
  Pectoralis stretch</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>postural Correction education</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>POSTURAL CORRECTION four exercises</intervention_name>
      <description>The program will involve four exercises, including two strengthening exercises and two stretching exercises.&#xD;
  Chin tuck (deep cervical flexor)&#xD;
  Strengthening shoulder retractors&#xD;
  Sternocleidomastoid muscle stretch&#xD;
  Pectoralis stretch Participants will be instructed to perform three sets of 12 repetitions for the strengthening exercises, with a 30-second rest period allotted between each set. For the stretching exercises, participants will be instructed to hold each stretch for 30 seconds, with a 30-second rest period allotted between each exercise The experimental group will also receive postural Correction education</description>
      <arm_group_label>postural correction group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>postural Correction education with a manuscript</intervention_name>
      <description>The control group would receive postural Correction education and they would be provided with a manuscript. They would be then guided to follow these guidelines as a home plan for four weeks. At the end of the Fourth week, they would be assessed.</description>
      <arm_group_label>Control group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Both male and female&#xD;
  &#xD;
            -  Mild visual impairment, visual acuity of 20/30 to 20/70 and with symptoms of visual&#xD;
               fatigue&#xD;
  &#xD;
            -  Forward head posture (FHP)&#xD;
  &#xD;
            -  Craniovertebral Angle less than 48-50&#xD;
  &#xD;
            -  Able to understand and provide informed consent&#xD;
  &#xD;
            -  Able to participate in the intervention and attend all the required&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Visual impairment other than mild visual impairment (e.g., legal blindness)&#xD;
  &#xD;
            -  Pre-existing medical conditions or injuries that may affect the posture or visual&#xD;
               function&#xD;
  &#xD;
            -  Any previous neck and Eye surgery.&#xD;
  &#xD;
            -  Previous history of treatment for FHP or visual impairment in the past six months(23)&#xD;
  &#xD;
            -  Any physical, neurological or cognitive disability that may affect the ability to&#xD;
               participate in the intervention or the assessments&#xD;
  &#xD;
            -  Use of medication or treatments that may affect the posture or visual function&#xD;
  &#xD;
            -  Psychological conditions&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>28 Years</maximum_age>
      <healthy_volunteers>No</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>Cecos University of IT and Emerging Scienecs</name>
        <address>
          <city>Peshawar</city>
          <state>KPK</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aisha Razzaq, MSPT-OMPT</last_name>
        <phone>03015030784</phone>
        <email>aisha.razzaq@riphah.edu.pk</email>
      </contact>
      <investigator>
        <last_name>shabi ul hassan, 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 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>forward head posture</keyword>
    <keyword>visual fatigue</keyword>
    <keyword>craniovertebral angle</keyword>
    <keyword>postural correction exercises</keyword>
    <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/NCT06019806
  org study id: RiphahIU Shabi ul Hassan
  nct id: NCT06019806
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this research is to find the effect of forward head posture correction on visual
        acuity and fatigue in low level visually impaired university students. Randomized controlled
        trials at Cecos University of IT and Emerging Sciences would be done. The sample size would
        be 48. The subjects would be divided in two groups, 24 subjects Intervention group and 24 in
        control group. Study duration would be 6 months. Sampling technique applied would be a
        non-probability convenience sampling technique. Only 18-25 years low level visually impaired
        university students with forward head posture would be included. Tools used in the study
        would be asthenopia questionnaire, Snellen chart and CVA angle photogrammetry
  In recent years, the increasing use of modern technology has raised concerns about its
        potential impact on our visual health. However, research suggests that in addition to these
        factors environmental factors such as near work, visual stress, educational stress and
        acquired false head posture may have a greater impact on visual health of young adult
        population. Prolonged use of digital devices can cause digital eye strain, leading to
        symptoms such as headaches and blurred vision. However, poor posture can also cause strain on
        the eyes, leading to decreased visual acuity and compromised performance. It is essential to
        consider factors such as posture when assessing visual performance in university students, in
        addition to the impact of modern technology. The forward head posture (FHP) is the head
        movement that occurs from poor postural awareness and frequently leads to muscle imbalance
        and discomfort.
  
        University students frequently experience a forward head position, especially those who spend
        a lot of time studying or using computers. Both forward head posture and visual impairment
        are more prevalent among university students. It has been found that 63.96% of university
        students, including both genders, exhibit a prevalence of forward head posture. . A 2019
        study in America found that 67.8% of university students experience visual fatigue, with
        blurred vision being the most commonly reported symptom (27%). This suggests many students
        may have mild visual impairments, impacting their academic performance and quality of life.
        The existing research has mainly concentrated on studying visual impairment by defining
        specific levels of impairment such as 'moderate' and 'severe.' However, it is plausible that
        even a minor reduction in visual acuity, also known as 'mild' visual impairment (ranging from
        20/30 to 20/70), could have a subtle but significant impact on an individual's ability to
        cope with activities of daily life. The position and movement of the head play a crucial role
        in visual perception, as the somatosensory system of the neck is intricately connected to the
        visual system. Spending most of the time using computers, mobile phones and reading can cause
        biomechanical alterations that make it difficult to keep a neutral head position and
        compromise the structural integrity .The Centre of Gravity (COG) of the head moves in
        anterosuperior direction as a result of this structural integrity compromise, increasing the
        stress on the neck. Each inch that the head is moved forward or anteriorly from its neutral
        position adds approximately 10 pounds (4.5 kilograms) of extra weight to the cervical spine.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Snellen Chart
  time frame: 4 weeks
  description: Universally used for measuring visual acuity.
  measure: Asthenopia Questionnaire
  time frame: 4 weeks
  description: Used for measuring Visual fatigue.
  measure: Craniovertebral Angle
  time frame: 4 weeks
  description: Craniovertebral angle is measured by taking 2 lateral photographs of the subject in a relaxed seated position without a back support. Spinous process of C7 and the tragus of ear are marked with a body marker. A horizontal line is drawn passing through C7 making a right angle with the vertical.
  arm group label: postural correction group A
  arm group type: Experimental
  description: Chin tuck (deep cervical flexor)
  Strengthening shoulder retractors
  Sternocleidomastoid muscle stretch
  Pectoralis stretch
  arm group label: Control group B
  arm group type: Active Comparator
  description: postural Correction education
  intervention type: Other
  intervention name: POSTURAL CORRECTION four exercises
  description: The program will involve four exercises, including two strengthening exercises and two stretching exercises.
  Chin tuck (deep cervical flexor)
  Strengthening shoulder retractors
  Sternocleidomastoid muscle stretch
  Pectoralis stretch Participants will be instructed to perform three sets of 12 repetitions for the strengthening exercises, with a 30-second rest period allotted between each set. For the stretching exercises, participants will be instructed to hold each stretch for 30 seconds, with a 30-second rest period allotted between each exercise The experimental group will also receive postural Correction education
  arm group label: postural correction group A
  intervention type: Other
  intervention name: postural Correction education with a manuscript
  description: The control group would receive postural Correction education and they would be provided with a manuscript. They would be then guided to follow these guidelines as a home plan for four weeks. At the end of the Fourth week, they would be assessed.
  arm group label: Control group B
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 28 Years
  healthy volunteers: No
  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: 
  status: Recruiting
  contact: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  sharing ipd: No