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/NCT06030960</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-PGS-2023-03-097</org_study_id>
      <nct_id>NCT06030960</nct_id>
    </id_info>
    <brief_title>Effects of Virtual Reality Stabilization Training in Patients With Low Back Pain</brief_title>
    <acronym>VR</acronym>
    <official_title>The Effects of Virtual Reality Stabilization Training on Postural Stability and Proprioception in Patients With Low Back Pain</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The reversibility of LBP proprioceptive mechanism effects may give an insight into a&#xD;
        treatment approach for postural stability. To our knowledge, no studies have better&#xD;
        investigated the effect of Core Stabilization Exercises using VR on ankle and trunk&#xD;
        proprioception in patients with CLBP and in turn on postural stability.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Low Back Pain (LBP), one of the most critical disability causatives, has been&#xD;
        associated with neuromuscular and biomechanical manifestations related to the deficiency of&#xD;
        postural control and stability. Virtual reality (VR) core stabilization exercises (CSE) has&#xD;
        proven previously to be effective in improving postural control among conditions with&#xD;
        different proprioceptive damage mechanisms other than those affected with LBP. The Aim of&#xD;
        this study is to explore the differing effects of this treatment regimen on postural&#xD;
        stability in relation to lumbar and ankle proprioception among in a population of&#xD;
        participants with LBP. Design and Methods: a randomized clinical trial encompassing 44&#xD;
        participants of both genders. Participants with Chronic Low Back Pain (CLBP) will be&#xD;
        randomized to one of two treatment groups: an Experimental group receiving VR stabilization&#xD;
        exercises and a Control group receiving CSE only without VR simulations inaddition to patient&#xD;
        instructions and education of both groups. Parameters of postural stability, ankle and trunk&#xD;
        proprioception, pain intensity, balance interference with activity and psychological aspects&#xD;
        of pain interference with activity will be measured by a force plate, iPhone applications,&#xD;
        visual analog scale (VAS), the Activities-specific Balance Confidence (ABC) scale, Pain&#xD;
        Catastrophizing Scale (PCS) and the Pain Self-Efficacy Questionnaire (PSEQ-Ar) respectively.&#xD;
        Outcome measures will be collected at baseline, immediately after 1st treatment and after the&#xD;
        last treatment session. Treatment regimens will consist of 12 sessions in 3 weeks using&#xD;
        virtual reality glasses. Statistical Analysis: A mixed-model repeated-measures analysis of&#xD;
        variance will be used to analyze within- and between-group differences at the baseline, 6th&#xD;
        session and twelfth sessions (repeated measures will be set as GROUP with two levels and TIME&#xD;
        with three levels). Bonferroni post-hoc procedures will be used for multiple comparisons of&#xD;
        the differences over time. Intention-to-treat analysis shall be utilized. Statistical&#xD;
        significance was set at P &lt; 0.05.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">December 13, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 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 (Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postural stability</measure>
      <time_frame>12 weeks</time_frame>
      <description>Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proprioception</measure>
      <time_frame>12 weeks</time_frame>
      <description>Ankle and Trunk Joint Position Sense (JPS)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain Intensity</measure>
      <time_frame>12 weeks</time_frame>
      <description>Visual Analog Scale (VAS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Self-Efficacy Questionnaire (PSEQ-Ar)</measure>
      <time_frame>12 weeks</time_frame>
      <description>to examine one's beliefs, level of Pain intensity and actual achievements contributions to performance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Activities-specific Balance Confidence (ABC)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Active clinical assessment measures of balance and function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Catastrophizing Scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>Overstressed undesirable perceptions of pain and the ambiance surrounding its involvement</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Low Back Pain</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Virtual Reality (VR)</intervention_name>
      <description>Virtual Reality (VR) Stabilization Exercises</description>
      <arm_group_label>Group 1</arm_group_label>
      <other_name>Exergames</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Regular Exercises</intervention_name>
      <description>Regular Stabilization Exercises</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>patient instructions and education</intervention_name>
      <description>a unified form of patient instructions and education in regards of LBP</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients in Group 1 and Group 2 will be included if they:&#xD;
  &#xD;
            1. Are adults between 25 and 59 years of age.&#xD;
  &#xD;
            2. Have LBP for longer than 3 months.&#xD;
  &#xD;
            3. Are not currently undergoing medication or conservative treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients in these two groups will be excluded if they have:&#xD;
  &#xD;
            1. Nerve root manifestations (such as referred symptoms of radiating pain below the knee&#xD;
               or paresthesia during the straight leg raise test),&#xD;
  &#xD;
            2. Systematic or visceral disease,&#xD;
  &#xD;
            3. Ankylosing spondylitis, Spondylolysis and Spondylolisthesis,&#xD;
  &#xD;
            4. Vestibular dysfunctions,&#xD;
  &#xD;
            5. Body mass index (BMI) ≥ 30 kg/m2,&#xD;
  &#xD;
            6. Lower extremity injury within the past month,&#xD;
  &#xD;
            7. Concussion,&#xD;
  &#xD;
            8. Psychiatric, cardiovascular or musculoskeletal disorders,&#xD;
  &#xD;
            9. Vision problems,&#xD;
  &#xD;
           10. Vertebral fracture,&#xD;
  &#xD;
           11. Spinal Stenosis,&#xD;
  &#xD;
           12. Previous spinal surgery,&#xD;
  &#xD;
           13. Present pregnancy,&#xD;
  &#xD;
           14. Scoliosis,&#xD;
  &#xD;
           15. Inability to understand instructions, read or write (Li et al., 2021).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>59 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ali AlShami, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>alshami@iau.edu.sa</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abrar AlSadiq, MSC</last_name>
      <phone>00966565455689</phone>
      <email>221070000@iau.edu.sa</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Imam Abdulrahman Bin Faisal University</investigator_affiliation>
      <investigator_full_name>Abrar AlSadiq</investigator_full_name>
      <investigator_title>Rehabilitation Sciences PhD Student</investigator_title>
    </responsible_party>
    <keyword>LBP</keyword>
    <keyword>Psychological effects</keyword>
    <keyword>Intervention</keyword>
    <keyword>Virtual Reality</keyword>
    <keyword>postural stability</keyword>
    <keyword>balance</keyword>
    <keyword>pain</keyword>
    <keyword>COP</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Back Pain</mesh_term>
      <mesh_term>Low Back Pain</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/NCT06030960
  org study id: IRB-PGS-2023-03-097
  nct id: NCT06030960
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The reversibility of LBP proprioceptive mechanism effects may give an insight into a
        treatment approach for postural stability. To our knowledge, no studies have better
        investigated the effect of Core Stabilization Exercises using VR on ankle and trunk
        proprioception in patients with CLBP and in turn on postural stability.
  Background: Low Back Pain (LBP), one of the most critical disability causatives, has been
        associated with neuromuscular and biomechanical manifestations related to the deficiency of
        postural control and stability. Virtual reality (VR) core stabilization exercises (CSE) has
        proven previously to be effective in improving postural control among conditions with
        different proprioceptive damage mechanisms other than those affected with LBP. The Aim of
        this study is to explore the differing effects of this treatment regimen on postural
        stability in relation to lumbar and ankle proprioception among in a population of
        participants with LBP. Design and Methods: a randomized clinical trial encompassing 44
        participants of both genders. Participants with Chronic Low Back Pain (CLBP) will be
        randomized to one of two treatment groups: an Experimental group receiving VR stabilization
        exercises and a Control group receiving CSE only without VR simulations inaddition to patient
        instructions and education of both groups. Parameters of postural stability, ankle and trunk
        proprioception, pain intensity, balance interference with activity and psychological aspects
        of pain interference with activity will be measured by a force plate, iPhone applications,
        visual analog scale (VAS), the Activities-specific Balance Confidence (ABC) scale, Pain
        Catastrophizing Scale (PCS) and the Pain Self-Efficacy Questionnaire (PSEQ-Ar) respectively.
        Outcome measures will be collected at baseline, immediately after 1st treatment and after the
        last treatment session. Treatment regimens will consist of 12 sessions in 3 weeks using
        virtual reality glasses. Statistical Analysis: A mixed-model repeated-measures analysis of
        variance will be used to analyze within- and between-group differences at the baseline, 6th
        session and twelfth sessions (repeated measures will be set as GROUP with two levels and TIME
        with three levels). Bonferroni post-hoc procedures will be used for multiple comparisons of
        the differences over time. Intention-to-treat analysis shall be utilized. Statistical
        significance was set at P < 0.05.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Care Provider, Outcomes Assessor)
  measure: Postural stability
  time frame: 12 weeks
  description: Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):
  measure: Proprioception
  time frame: 12 weeks
  description: Ankle and Trunk Joint Position Sense (JPS)
  measure: Pain Intensity
  time frame: 12 weeks
  description: Visual Analog Scale (VAS)
  measure: Pain Self-Efficacy Questionnaire (PSEQ-Ar)
  time frame: 12 weeks
  description: to examine one's beliefs, level of Pain intensity and actual achievements contributions to performance
  measure: Activities-specific Balance Confidence (ABC)
  time frame: 12 weeks
  description: Active clinical assessment measures of balance and function
  measure: Pain Catastrophizing Scale
  time frame: 12 weeks
  description: Overstressed undesirable perceptions of pain and the ambiance surrounding its involvement
  arm group label: Group 1
  arm group type: Experimental
  description: Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education
  arm group label: Group 2
  arm group type: Active Comparator
  description: Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education
  intervention type: Device
  intervention name: Virtual Reality (VR)
  description: Virtual Reality (VR) Stabilization Exercises
  arm group label: Group 1
  other name: Exergames
  intervention type: Other
  intervention name: Regular Exercises
  description: Regular Stabilization Exercises
  arm group label: Group 1
  arm group label: Group 2
  intervention type: Other
  intervention name: patient instructions and education
  description: a unified form of patient instructions and education in regards of LBP
  arm group label: Group 1
  arm group label: Group 2
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 59 Years
  healthy volunteers: No
  last name: Ali AlShami, PhD
  role: Study Chair
  affiliation: alshami@iau.edu.sa
  last name: Abrar AlSadiq, MSC
  phone: 00966565455689
  email: 221070000@iau.edu.sa
  responsible party type: Principal Investigator
  investigator affiliation: Imam Abdulrahman Bin Faisal University
  investigator full name: Abrar AlSadiq
  investigator title: Rehabilitation Sciences PhD Student
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No