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/NCT05971966</url>
    </required_header>
    <id_info>
      <org_study_id>REC/01652 Nayab Mehmood</org_study_id>
      <nct_id>NCT05971966</nct_id>
    </id_info>
    <brief_title>Effects of Virtual Reality Rehabilitation and Muscle Energy Technique in Patients With Patellofemoral Pain Syndrome.</brief_title>
    <official_title>Effect of Virtual Reality Rehabilitation and Muscle Energy Technique in Patients With Patellofemoral Pain Syndrome.</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>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 aim of this randomized controlled trial is to determine the effects of Virtual reality&#xD;
        rehabilitation and muscle energy techniques in patients with patellofemoral pain syndrome for&#xD;
        reducing pain, enhancing knee range of motion and improve functional activities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Muscle energy technique is defined as a manual treatment in which patient produces a&#xD;
        contraction in a precisely controlled position and direction against the counterforce applied&#xD;
        by a manual therapist. Applications of MET to stretch and increase myofascial tissue&#xD;
        extensibility seem to affect viscoelastic and plastic tissue property.&#xD;
  &#xD;
        Virtual reality generates a virtual world in three dimensional space through a computer&#xD;
        simulation that stimulates user senses, such as sight and hearing, making users feel as if&#xD;
        they are immersed in it. VRBR is effective in improving knee pain, ROM, strength and&#xD;
        functions. immersive VR is more appropriate for pain reduction, improving range of motion and&#xD;
        functional activities. It distracts the patient and allows to perform active and&#xD;
        rehabilitation exercises to reduce cognitive attention in pain and avoidance behavior.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">April 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 28, 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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Kujala questionnaire</measure>
      <time_frame>4 weeks</time_frame>
      <description>It is a self administered questionnaire for patients with PFPS that consists of 13 questions that relate to specified activities, pain severity, and clinical symptoms. The scores range from a maximum of 100 to a minimum of 0, with lower scores indicating greater pain and disability.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale (VAS)</measure>
      <time_frame>4 weeks</time_frame>
      <description>VAS is a qualitative pain measurement tool that assigns integer numbers between zero and 10 to different pain levels, where zero means no pain and 10 means excruciating pain. VAS is a reliable scale to measure knee pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Goniometer</measure>
      <time_frame>4 weeks</time_frame>
      <description>It is an instrument that measures the available range of motion at a joint.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Patellofemoral Pain Syndrome</condition>
    <condition>Knee Pain Chronic</condition>
    <arm_group>
      <arm_group_label>Virtual Reality technique</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Virtual reality technique+ Conventional PT</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Muscle energy technique</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Muscle energy technique + Conventional PT</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Virtual Reality technique</intervention_name>
      <description>They would be receiving treatment as follow:&#xD;
  Specific exercises by using virtual reality with conventional treatment. The VR game included holopoint,hot squat and portal stories that will target the hamstring, quadriceps and gluteas muscles.Frequency: 3 times/week for 4 weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: virtual reality gaming exercises Conventional PT including patellar mobilization+ ultrasound on anterior knee in supine lying + stretching of ITB . Frequency: 10 reps with 5 sec hold for 3 times/week for 4 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins</description>
      <arm_group_label>Virtual Reality technique</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Muscle energy technique</intervention_name>
      <description>They would be receiving treatment as follow:&#xD;
  Muscle energy technique of quadriceps and hamstring muscles. Frequency: 3 times/week for 4 weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: Muscle energy technique to improve range of motion.&#xD;
  Conventional PT including patellar mobilization + ultrasound on anterior knee in supine lying + stretching of ITB. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins</description>
      <arm_group_label>Muscle energy technique</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age group 18-40&#xD;
  &#xD;
            -  Both males and females&#xD;
  &#xD;
            -  Retropatellar or anterior knee pain for atleast past 3 months&#xD;
  &#xD;
            -  Having knee pain in atleast 2 activities among stair ascent and descent,squatting over&#xD;
               90 degrees, running,jumping,kneeling and prolong sitting with knees flexed.&#xD;
  &#xD;
            -  Experience pain in one of the following knee tests; a) pain on patellar grinding test,&#xD;
               b) pain on apprehension test, c) pain during resisted extension of the knee during 90&#xD;
               degree flexion&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cervical radiculopathy&#xD;
  &#xD;
            -  Neurological disorder&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Rheumatoid arthritis&#xD;
  &#xD;
            -  Hip or ankle injuries&#xD;
  &#xD;
            -  Patellar instabilities&#xD;
  &#xD;
            -  Meniscal or ligament tear&#xD;
  &#xD;
            -  Who have visual or auditory problems&#xD;
  &#xD;
            -  With cognitive issues&#xD;
  &#xD;
            -  Previous surgery related to lower limbs/ radiculopathy&#xD;
  &#xD;
            -  having received knee injections of corticosteroids or hyaluronic acid&#xD;
  &#xD;
            -  knee osteoarthritis&#xD;
  &#xD;
            -  drug use that affects the balance during the past 72 h.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kinza Anwar, MS-OMPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kinza Anwar, MS-OMPT</last_name>
      <phone>+92-3239735427</phone>
      <email>kinza.anwar@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dr.z pain &amp; brain physiotherapy center</name>
        <address>
          <city>Islamabad</city>
          <state>Punjab</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>KINZA ANWAR, MS-OMPT</last_name>
        <phone>+92-3239735427</phone>
        <email>kinza.anwar@riphah.edu.pk</email>
      </contact>
      <contact_backup>
        <last_name>Nayab Mehmood, MS-OMPT*</last_name>
      </contact_backup>
      <investigator>
        <last_name>Nayab Mehmood, MS-OMPT*</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>muscle energy technique</keyword>
    <keyword>virtual reality technique</keyword>
    <keyword>knee pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Somatoform Disorders</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/NCT05971966
  org study id: REC/01652 Nayab Mehmood
  nct id: NCT05971966
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this randomized controlled trial is to determine the effects of Virtual reality
        rehabilitation and muscle energy techniques in patients with patellofemoral pain syndrome for
        reducing pain, enhancing knee range of motion and improve functional activities.
  Muscle energy technique is defined as a manual treatment in which patient produces a
        contraction in a precisely controlled position and direction against the counterforce applied
        by a manual therapist. Applications of MET to stretch and increase myofascial tissue
        extensibility seem to affect viscoelastic and plastic tissue property.
  
        Virtual reality generates a virtual world in three dimensional space through a computer
        simulation that stimulates user senses, such as sight and hearing, making users feel as if
        they are immersed in it. VRBR is effective in improving knee pain, ROM, strength and
        functions. immersive VR is more appropriate for pain reduction, improving range of motion and
        functional activities. It distracts the patient and allows to perform active and
        rehabilitation exercises to reduce cognitive attention in pain and avoidance behavior.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Kujala questionnaire
  time frame: 4 weeks
  description: It is a self administered questionnaire for patients with PFPS that consists of 13 questions that relate to specified activities, pain severity, and clinical symptoms. The scores range from a maximum of 100 to a minimum of 0, with lower scores indicating greater pain and disability.
  measure: Visual analogue scale (VAS)
  time frame: 4 weeks
  description: VAS is a qualitative pain measurement tool that assigns integer numbers between zero and 10 to different pain levels, where zero means no pain and 10 means excruciating pain. VAS is a reliable scale to measure knee pain
  measure: Goniometer
  time frame: 4 weeks
  description: It is an instrument that measures the available range of motion at a joint.
  arm group label: Virtual Reality technique
  arm group type: Active Comparator
  description: Virtual reality technique+ Conventional PT
  arm group label: Muscle energy technique
  arm group type: Experimental
  description: Muscle energy technique + Conventional PT
  intervention type: Other
  intervention name: Virtual Reality technique
  description: They would be receiving treatment as follow:
  Specific exercises by using virtual reality with conventional treatment. The VR game included holopoint,hot squat and portal stories that will target the hamstring, quadriceps and gluteas muscles.Frequency: 3 times/week for 4 weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: virtual reality gaming exercises Conventional PT including patellar mobilization+ ultrasound on anterior knee in supine lying + stretching of ITB . Frequency: 10 reps with 5 sec hold for 3 times/week for 4 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins
  arm group label: Virtual Reality technique
  intervention type: Other
  intervention name: Muscle energy technique
  description: They would be receiving treatment as follow:
  Muscle energy technique of quadriceps and hamstring muscles. Frequency: 3 times/week for 4 weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: Muscle energy technique to improve range of motion.
  Conventional PT including patellar mobilization + ultrasound on anterior knee in supine lying + stretching of ITB. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins
  arm group label: Muscle energy technique
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Kinza Anwar, MS-OMPT
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Kinza Anwar, MS-OMPT
  phone: +92-3239735427
  email: kinza.anwar@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Patellofemoral Pain Syndrome
  mesh term: Syndrome
  mesh term: Somatoform Disorders
  sharing ipd: No