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/NCT06017778</url>
    </required_header>
    <id_info>
      <org_study_id>012/004572</org_study_id>
      <nct_id>NCT06017778</nct_id>
    </id_info>
    <brief_title>Impact Of Whole Body Vibration on Planter /Dorsi Flexor Ratio, Pain and Functional Activities in Patellofemoral Pain Syndrome</brief_title>
    <official_title>Impact Of Whole Body Vibration on Planter /Dorsi Flexor Ratio, Pain and Functional Activities in Patellofemoral Pain Syndrome: Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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>
        Patellofemoral pain syndrome (PFPS) can significantly affect an individual's ability perform&#xD;
        to functional activities, such as walking, running, climbing stairs, and sitting for&#xD;
        prolonged periods.&#xD;
  &#xD;
        PFPS is often associated with pain and discomfort in the front of the knee, which can limit&#xD;
        an individual's range of motion and cause difficulty with weight-bearing activities. The pain&#xD;
        may also be exacerbated by activities that involve bending the knee, such as squatting or&#xD;
        kneeling.&#xD;
  &#xD;
        Whole body vibration (WBV) has been suggested as a potential intervention for patellofemoral&#xD;
        pain syndrome (PFPS). Some studies have shown that WBV can improve muscle strength, balance,&#xD;
        and proprioception, which are all factors that may contribute to PFPS. Additionally, WBV may&#xD;
        help reduce pain and improve functional abilities in individuals with PFPS However, the&#xD;
        evidence for the effectiveness of WBV as an intervention for PFPS is still limited, and more&#xD;
        research is needed to fully understand its potential benefits and limitations. It is&#xD;
        important to note that WBV may not be suitable for all individuals with PFPS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patellofemoral pain syndrome (PFPS) can significantly affect an individual's ability perform&#xD;
        to functional activities, such as walking, running, climbing stairs, and sitting for&#xD;
        prolonged periods.&#xD;
  &#xD;
        PFPS is often associated with pain and discomfort in the front of the knee, which can limit&#xD;
        an individual's range of motion and cause difficulty with weight-bearing activities. The pain&#xD;
        may also be exacerbated by activities that involve bending the knee, such as squatting or&#xD;
        kneeling.&#xD;
  &#xD;
        Whole body vibration (WBV) has been suggested as a potential intervention for patellofemoral&#xD;
        pain syndrome (PFPS). Some studies have shown that WBV can improve muscle strength, balance,&#xD;
        and proprioception, which are all factors that may contribute to PFPS. Additionally, WBV may&#xD;
        help reduce pain and improve functional abilities in individuals with PFPS.&#xD;
  &#xD;
        However, the evidence for the effectiveness of WBV as an intervention for PFPS is still&#xD;
        limited, and more research is needed to fully understand its potential benefits and&#xD;
        limitations. It is important to note that WBV may not be suitable for all individuals with&#xD;
        PFPS.&#xD;
  &#xD;
        HYPOTHESES:&#xD;
  &#xD;
        There will be no significant difference on dorsi/planter flexor ratio , functional activities&#xD;
        and pain level after adding the whole body vibration to traditional treatment of PFPS&#xD;
  &#xD;
        RESEARCH QUESTION:&#xD;
  &#xD;
        What is the impact of whole-body vibration on dorsi/planter flexor ratio, functional&#xD;
        activities and pain levels in individuals with PFPS?&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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 (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dorsi/planter torque ratio</measure>
      <time_frame>one month</time_frame>
      <description>dorsi/planter torque ratio will be measured through the Biodex System 4-Pro Isokinetic Strength Dynamometer for assessment of muscle torque</description>
    </primary_outcome>
    <primary_outcome>
      <measure>functional activities</measure>
      <time_frame>one month</time_frame>
      <description>Kujala Anterior Knee Pain Scale, which includes questions related to functional activities.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>one month</time_frame>
      <description>10 cm Visual Analogue Scale (VAS) was used to assess pain intensity during activity in patients with patellofemoral pain (PFP). The scale ranged from 0, indicating &quot;no pain,&quot; to 100, representing the &quot;worst pain imaginable.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Patellofemoral Pain Syndrome</condition>
    <arm_group>
      <arm_group_label>whole body viberation group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>whole body vibration</intervention_name>
      <description>patients will receive WBV training in addition to traditional training will be performed on a tri-planar (mostly vertical, Z axis) oscillating vibration platform (Power PlateR pro5™; Power Plate North America, Inc., Northbrook, IL,USA) for 20-30 minutes per session. WBV training will be supervised and performed in a clinic three days a week with at least one day between each session for four weeks (total of 12 sessions).</description>
      <arm_group_label>whole body viberation group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>traditional exercise group</intervention_name>
      <description>10 minutes warm-up (lower extremity stretching exercises), 20-30 minutes period of strength exercises with three sets of 10-15 repetitions (isometric quadriceps setting, knee extensions, double-legged wall squat), and 5 minutes cool-down (lower extremity stretching exercises). Lower extremity stretching exercises consisted of quadriceps, hamstring, gastrocnemius and iliotibial band stretching with 3 repetitions for 30 s each muscle.</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>whole body viberation group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: Adults aged 18 -35 years&#xD;
  &#xD;
            2. Symptoms: Pain in the anterior or retro patellar knee region during activities such as&#xD;
               running, jumping, squatting, or prolonged sitting&#xD;
  &#xD;
            3. Duration: Pain lasting at least 6 weeks&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Presence of other knee conditions: Individuals with PFPS who also have other knee&#xD;
               conditions such as ligament or meniscal injuries, osteoarthritis, or patellar&#xD;
               tendinopathy may be excluded.&#xD;
  &#xD;
            2. History of knee surgery: Patients who have undergone any knee surgery may be excluded&#xD;
               as this may affect the outcomes of the study.&#xD;
  &#xD;
            3. Systemic conditions: Patients with systemic conditions that may affect the&#xD;
               musculoskeletal system such as rheumatoid arthritis or lupus may be excluded.&#xD;
  &#xD;
            4. Pregnancy: Pregnant women with PFPS may be excluded as pregnancy may affect the&#xD;
               outcomes of the study.&#xD;
  &#xD;
            5. Inability to comply with study requirements: Patients who are unable to comply with&#xD;
               the study requirements such as attending follow-up appointments or completing&#xD;
               questionnaires may be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Radwa Elshorbagy</last_name>
      <phone>00966500920691</phone>
      <email>Rtelshorbagy@ju.edu.sa</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of physical therapy , cairo university</name>
        <address>
          <city>Giza</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Radwa</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Radwa T. Elshorbagy</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <keyword>Patellofemoral pain syndrome</keyword>
    <keyword>vibration</keyword>
    <keyword>Planter/Dorsi ratio</keyword>
    <keyword>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>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>6 months after publication</ipd_time_frame>
      <ipd_access_criteria>study protocol</ipd_access_criteria>
    </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/NCT06017778
  org study id: 012/004572
  nct id: NCT06017778
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Patellofemoral pain syndrome (PFPS) can significantly affect an individual's ability perform
        to functional activities, such as walking, running, climbing stairs, and sitting for
        prolonged periods.
  
        PFPS is often associated with pain and discomfort in the front of the knee, which can limit
        an individual's range of motion and cause difficulty with weight-bearing activities. The pain
        may also be exacerbated by activities that involve bending the knee, such as squatting or
        kneeling.
  
        Whole body vibration (WBV) has been suggested as a potential intervention for patellofemoral
        pain syndrome (PFPS). Some studies have shown that WBV can improve muscle strength, balance,
        and proprioception, which are all factors that may contribute to PFPS. Additionally, WBV may
        help reduce pain and improve functional abilities in individuals with PFPS However, the
        evidence for the effectiveness of WBV as an intervention for PFPS is still limited, and more
        research is needed to fully understand its potential benefits and limitations. It is
        important to note that WBV may not be suitable for all individuals with PFPS.
  Patellofemoral pain syndrome (PFPS) can significantly affect an individual's ability perform
        to functional activities, such as walking, running, climbing stairs, and sitting for
        prolonged periods.
  
        PFPS is often associated with pain and discomfort in the front of the knee, which can limit
        an individual's range of motion and cause difficulty with weight-bearing activities. The pain
        may also be exacerbated by activities that involve bending the knee, such as squatting or
        kneeling.
  
        Whole body vibration (WBV) has been suggested as a potential intervention for patellofemoral
        pain syndrome (PFPS). Some studies have shown that WBV can improve muscle strength, balance,
        and proprioception, which are all factors that may contribute to PFPS. Additionally, WBV may
        help reduce pain and improve functional abilities in individuals with PFPS.
  
        However, the evidence for the effectiveness of WBV as an intervention for PFPS is still
        limited, and more research is needed to fully understand its potential benefits and
        limitations. It is important to note that WBV may not be suitable for all individuals with
        PFPS.
  
        HYPOTHESES:
  
        There will be no significant difference on dorsi/planter flexor ratio , functional activities
        and pain level after adding the whole body vibration to traditional treatment of PFPS
  
        RESEARCH QUESTION:
  
        What is the impact of whole-body vibration on dorsi/planter flexor ratio, functional
        activities and pain levels in individuals with PFPS?
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Dorsi/planter torque ratio
  time frame: one month
  description: dorsi/planter torque ratio will be measured through the Biodex System 4-Pro Isokinetic Strength Dynamometer for assessment of muscle torque
  measure: functional activities
  time frame: one month
  description: Kujala Anterior Knee Pain Scale, which includes questions related to functional activities.
  measure: Pain intensity
  time frame: one month
  description: 10 cm Visual Analogue Scale (VAS) was used to assess pain intensity during activity in patients with patellofemoral pain (PFP). The scale ranged from 0, indicating "no pain," to 100, representing the "worst pain imaginable.
  arm group label: whole body viberation group
  arm group type: Experimental
  arm group label: control group
  arm group type: Active Comparator
  intervention type: Device
  intervention name: whole body vibration
  description: patients will receive WBV training in addition to traditional training will be performed on a tri-planar (mostly vertical, Z axis) oscillating vibration platform (Power PlateR pro5™; Power Plate North America, Inc., Northbrook, IL,USA) for 20-30 minutes per session. WBV training will be supervised and performed in a clinic three days a week with at least one day between each session for four weeks (total of 12 sessions).
  arm group label: whole body viberation group
  intervention type: Other
  intervention name: traditional exercise group
  description: 10 minutes warm-up (lower extremity stretching exercises), 20-30 minutes period of strength exercises with three sets of 10-15 repetitions (isometric quadriceps setting, knee extensions, double-legged wall squat), and 5 minutes cool-down (lower extremity stretching exercises). Lower extremity stretching exercises consisted of quadriceps, hamstring, gastrocnemius and iliotibial band stretching with 3 repetitions for 30 s each muscle.
  arm group label: control group
  arm group label: whole body viberation group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: No
  last name: Radwa Elshorbagy
  phone: 00966500920691
  email: Rtelshorbagy@ju.edu.sa
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Radwa T. Elshorbagy
  investigator title: assistant professor
  mesh term: Patellofemoral Pain Syndrome
  mesh term: Syndrome
  mesh term: Somatoform Disorders
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 6 months after publication
  ipd access criteria: study protocol