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/NCT05967637</url>
    </required_header>
    <id_info>
      <org_study_id>2023-874</org_study_id>
      <nct_id>NCT05967637</nct_id>
    </id_info>
    <brief_title>The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty</brief_title>
    <official_title>The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Gulhane Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Gazi 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 study's objective is to investigate the effects of whole-body vibration therapy&#xD;
        administered before surgery on various factors related to patients who undergo total knee&#xD;
        arthroplasty. These factors include pain, swelling, skin temperature, normal joint movement,&#xD;
        knee joint position sense, knee extensor muscle strength, functional status, and patient&#xD;
        satisfaction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will include participants aged 50-80 who are planning to undergo total knee&#xD;
        arthroplasty. According to the sample size analysis, a total of 40 people will be included in&#xD;
        this study. The enrolled participants will be randomly assigned to one of two parallel&#xD;
        groups: the whole-body vibration group or the sham whole-body vibration group. Both groups&#xD;
        will receive standard patient education and exercise training.The experimental group will&#xD;
        receive whole-body vibration along with exercise on the whole-body vibration device, while&#xD;
        the control group (sham group) will receive sham vibration on the same device. All&#xD;
        participants will receive treatment for a total of 5 days, one session per day.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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>Baseline pain severity</measure>
      <time_frame>baseline</time_frame>
      <description>The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in pain severity from baseline to day 5 after interventions</measure>
      <time_frame>up to 5 days after baseline</time_frame>
      <description>The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.pain and 10 representing maximal pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the preoperative pain severity on the 7th day of surgery</measure>
      <time_frame>up to 7 days after surgery</time_frame>
      <description>The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in pain severity from day 7 to day 14 post-surgery</measure>
      <time_frame>up to 14 days after surgery</time_frame>
      <description>The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in pain severity from day 14 to day 21 post-surgery</measure>
      <time_frame>up to 21 days after surgery</time_frame>
      <description>The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline leg circumference</measure>
      <time_frame>baseline</time_frame>
      <description>Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in leg circumference from baseline to day 5 after interventions</measure>
      <time_frame>up to 5 days after baseline</time_frame>
      <description>Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the preoperative leg circumference on the 7th day of surgery</measure>
      <time_frame>up to 7 days after surgery</time_frame>
      <description>Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in leg circumference from day 7 to day 14 post-surgery</measure>
      <time_frame>up to 14 days after surgery</time_frame>
      <description>Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in leg circumference from day 14 to day 21 post-surgery</measure>
      <time_frame>up to 21 days after surgery</time_frame>
      <description>Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline range of motion</measure>
      <time_frame>baseline</time_frame>
      <description>The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in range of motion from baseline to day 5 after interventions</measure>
      <time_frame>up to 5 days after baseline</time_frame>
      <description>The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the preoperative range of motion on the 7th day of surgery</measure>
      <time_frame>up to 7 days after surgery</time_frame>
      <description>The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in range of motion from day 7 to day 14 post-surgery</measure>
      <time_frame>up to 14 days after surgery</time_frame>
      <description>The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in range of motion from day 14 to day 21 post-surgery</measure>
      <time_frame>up to 21 days after surgery</time_frame>
      <description>The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline muscle strength</measure>
      <time_frame>baseline</time_frame>
      <description>Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in muscle strength from baseline to day 5 after interventions</measure>
      <time_frame>up to 5 days after baseline</time_frame>
      <description>Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the preoperative muscle strength on the 7th day of surgery</measure>
      <time_frame>up to 7 days after surgery</time_frame>
      <description>Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in muscle strength from day 7 to day 14 post-surgery</measure>
      <time_frame>up to 14 days after surgery</time_frame>
      <description>Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in muscle strength from day 14 to day 21 post-surgery</measure>
      <time_frame>up to 21 days after surgery</time_frame>
      <description>Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline skin temperature</measure>
      <time_frame>baseline</time_frame>
      <description>A portable infrared thermometer will be used to measure knee skin temperature.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in skin temperature from baseline to day 5 after interventions</measure>
      <time_frame>up to 5 days after baseline</time_frame>
      <description>A portable infrared thermometer will be used to measure knee skin temperature.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the preoperative skin temperature on the 7th day of surgery</measure>
      <time_frame>up to 7 days after surgery</time_frame>
      <description>A portable infrared thermometer will be used to measure knee skin temperature.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in skin temperature from day 7 to day 14 post-surgery</measure>
      <time_frame>up to 14 days after surgery</time_frame>
      <description>A portable infrared thermometer will be used to measure knee skin temperature.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in skin temperature from day 14 to day 21 post-surgery</measure>
      <time_frame>up to 21 days after surgery</time_frame>
      <description>A portable infrared thermometer will be used to measure knee skin temperature.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline knee proprioception</measure>
      <time_frame>baseline</time_frame>
      <description>Active reposition test will be measured using a digital inclinometer device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in knee proprioception from baseline to day 5 after interventions</measure>
      <time_frame>up to 5 days after baseline</time_frame>
      <description>Active reposition test will be measured using a digital inclinometer device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the preoperative knee proprioception on the 7th day of surgery</measure>
      <time_frame>up to 7 days after surgery</time_frame>
      <description>Active reposition test will be measured using a digital inclinometer device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in knee proprioception from day 7 to day 14 post-surgery</measure>
      <time_frame>up to 14 days after surgery</time_frame>
      <description>Active reposition test will be measured using a digital inclinometer device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in knee proprioception from day 14 to day 21 post-surgery</measure>
      <time_frame>up to 21 days after surgery</time_frame>
      <description>Active reposition test will be measured using a digital inclinometer device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline Time Up and Go</measure>
      <time_frame>baseline</time_frame>
      <description>functional performance test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Time Up and Go from baseline to day 5 after interventions</measure>
      <time_frame>up to 5 days after baseline</time_frame>
      <description>functional performance test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the preoperative Time Up and Go on the 7th day of surgery</measure>
      <time_frame>up to 7 days after surgery</time_frame>
      <description>functional performance test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Time Up and Go from day 7 to day 14 post-surgery</measure>
      <time_frame>up to 14 days after surgery</time_frame>
      <description>functional performance test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Time Up and Go from day 14 to day 21 post-surgery</measure>
      <time_frame>up to 21 days after surgery</time_frame>
      <description>functional performance test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SF-36</measure>
      <time_frame>baseline</time_frame>
      <description>The 36-Item Short-Form Health Survey (SF-36) is a general scoring instrument used to provide a health profile comprised of eight scaled scores. Each scale is instantly turned into a 0-100 scale, allowing identification of the patient's physical and mental status. A higher score means a better result.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the preoperative SF-36 on the 21st day of surgery</measure>
      <time_frame>up to 21 days after surgery</time_frame>
      <description>The 36-Item Short-Form Health Survey (SF-36) is a general scoring instrument used to provide a health profile comprised of eight scaled scores. Each scale is instantly turned into a 0-100 scale, allowing identification of the patient's physical and mental status. A higher score means a better result.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>WOMAC</measure>
      <time_frame>before interventions, 21st day after surgery</time_frame>
      <description>The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-report multidimensional questionnaire that assesses pain, stiffness, and physical functional disability. A higher score means a better result.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the preoperative WOMAC on the 21st day of surgery</measure>
      <time_frame>up to 21 days after surgery</time_frame>
      <description>The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-report multidimensional questionnaire that assesses pain, stiffness, and physical functional disability. A higher score means a better result.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global Rating of Change Scales (GROC)</measure>
      <time_frame>up to 21st day after surgery</time_frame>
      <description>The GROC score, which has seven response options ranging from 'much worse' (a score of 0) to 'much better' (a score of six), will be used to determine the subject's perception of overall improvement.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Whole-body Vibration</condition>
    <condition>Arthropathy of Knee</condition>
    <condition>Swelling/ Edema</condition>
    <arm_group>
      <arm_group_label>Whole-body vibration</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Standard patient education and exercise training + whole body vibration</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham-whole-body vibration</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Standard patient education and exercise training + sham whole body vibration</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Whole body vibration</intervention_name>
      <description>The vibration will be applied for 10 minutes (30 seconds rest, 30 seconds training, 10 reps) in total with a low frequency (20 HZ) and low amplitude (2mm). Participants will be asked to stand in a squatting position by semi-flexing (30°) their knees during the 30-second vibration period.</description>
      <arm_group_label>Whole-body vibration</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sham-Whole body vibration</intervention_name>
      <description>The sham-whole body vibration treatment will follow the same procedures with the vibration machine off.</description>
      <arm_group_label>Sham-whole-body vibration</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with advanced idiopathic knee OA and scheduled for unilateral total knee&#xD;
               arthroplasty will be considered candidates for the present study and will be asked to&#xD;
               participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  if they had undergone another hip or knee joint replacement in the previous year&#xD;
  &#xD;
            -  if they had any medical condition in which exercise was contraindicated&#xD;
  &#xD;
            -  if they had any disease that affected functional performance&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zeynep Hazar</last_name>
      <role>Study Director</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Cemil Yıldız</last_name>
      <role>Study Chair</role>
      <affiliation>Gulhane Training and Research Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sevim Beyza Ölmez</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Beyza Yazgan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>İnci Ayaş</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sevim Beyza Olmez</last_name>
      <phone>+90 312 216 26 21</phone>
      <email>sevimbeyzaolmez@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Gazi University</name>
        <address>
          <city>Ankara</city>
          <zip>06490</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Department of Physiotherapy and Rehabilitation, Prof</last_name>
        <phone>+90 312 2162601</phone>
        <email>sbfogrenciisleri@gazi.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gazi University</investigator_affiliation>
      <investigator_full_name>Sevim Beyza Ölmez</investigator_full_name>
      <investigator_title>Principal Investigator, PhD</investigator_title>
    </responsible_party>
    <keyword>whole-body vibration</keyword>
    <keyword>total knee arthroplasty</keyword>
    <keyword>swelling</keyword>
    <keyword>edema</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Diseases</mesh_term>
      <mesh_term>Edema</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/NCT05967637
  org study id: 2023-874
  nct id: NCT05967637
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study's objective is to investigate the effects of whole-body vibration therapy
        administered before surgery on various factors related to patients who undergo total knee
        arthroplasty. These factors include pain, swelling, skin temperature, normal joint movement,
        knee joint position sense, knee extensor muscle strength, functional status, and patient
        satisfaction.
  The study will include participants aged 50-80 who are planning to undergo total knee
        arthroplasty. According to the sample size analysis, a total of 40 people will be included in
        this study. The enrolled participants will be randomly assigned to one of two parallel
        groups: the whole-body vibration group or the sham whole-body vibration group. Both groups
        will receive standard patient education and exercise training.The experimental group will
        receive whole-body vibration along with exercise on the whole-body vibration device, while
        the control group (sham group) will receive sham vibration on the same device. All
        participants will receive treatment for a total of 5 days, one session per day.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Baseline pain severity
  time frame: baseline
  description: The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
  measure: Change in pain severity from baseline to day 5 after interventions
  time frame: up to 5 days after baseline
  description: The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.pain and 10 representing maximal pain.
  measure: Change in the preoperative pain severity on the 7th day of surgery
  time frame: up to 7 days after surgery
  description: The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
  measure: Change in pain severity from day 7 to day 14 post-surgery
  time frame: up to 14 days after surgery
  description: The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
  measure: Change in pain severity from day 14 to day 21 post-surgery
  time frame: up to 21 days after surgery
  description: The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
  measure: Baseline leg circumference
  time frame: baseline
  description: Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
  measure: Change in leg circumference from baseline to day 5 after interventions
  time frame: up to 5 days after baseline
  description: Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
  measure: Change in the preoperative leg circumference on the 7th day of surgery
  time frame: up to 7 days after surgery
  description: Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
  measure: Change in leg circumference from day 7 to day 14 post-surgery
  time frame: up to 14 days after surgery
  description: Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
  measure: Change in leg circumference from day 14 to day 21 post-surgery
  time frame: up to 21 days after surgery
  description: Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
  measure: Baseline range of motion
  time frame: baseline
  description: The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
  measure: Change in range of motion from baseline to day 5 after interventions
  time frame: up to 5 days after baseline
  description: The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
  measure: Change in the preoperative range of motion on the 7th day of surgery
  time frame: up to 7 days after surgery
  description: The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
  measure: Change in range of motion from day 7 to day 14 post-surgery
  time frame: up to 14 days after surgery
  description: The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
  measure: Change in range of motion from day 14 to day 21 post-surgery
  time frame: up to 21 days after surgery
  description: The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
  measure: Baseline muscle strength
  time frame: baseline
  description: Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
  measure: Change in muscle strength from baseline to day 5 after interventions
  time frame: up to 5 days after baseline
  description: Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
  measure: Change in the preoperative muscle strength on the 7th day of surgery
  time frame: up to 7 days after surgery
  description: Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
  measure: Change in muscle strength from day 7 to day 14 post-surgery
  time frame: up to 14 days after surgery
  description: Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
  measure: Change in muscle strength from day 14 to day 21 post-surgery
  time frame: up to 21 days after surgery
  description: Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
  measure: Baseline skin temperature
  time frame: baseline
  description: A portable infrared thermometer will be used to measure knee skin temperature.
  measure: Change in skin temperature from baseline to day 5 after interventions
  time frame: up to 5 days after baseline
  description: A portable infrared thermometer will be used to measure knee skin temperature.
  measure: Change in the preoperative skin temperature on the 7th day of surgery
  time frame: up to 7 days after surgery
  description: A portable infrared thermometer will be used to measure knee skin temperature.
  measure: Change in skin temperature from day 7 to day 14 post-surgery
  time frame: up to 14 days after surgery
  description: A portable infrared thermometer will be used to measure knee skin temperature.
  measure: Change in skin temperature from day 14 to day 21 post-surgery
  time frame: up to 21 days after surgery
  description: A portable infrared thermometer will be used to measure knee skin temperature.
  measure: Baseline knee proprioception
  time frame: baseline
  description: Active reposition test will be measured using a digital inclinometer device.
  measure: Change in knee proprioception from baseline to day 5 after interventions
  time frame: up to 5 days after baseline
  description: Active reposition test will be measured using a digital inclinometer device.
  measure: Change in the preoperative knee proprioception on the 7th day of surgery
  time frame: up to 7 days after surgery
  description: Active reposition test will be measured using a digital inclinometer device.
  measure: Change in knee proprioception from day 7 to day 14 post-surgery
  time frame: up to 14 days after surgery
  description: Active reposition test will be measured using a digital inclinometer device.
  measure: Change in knee proprioception from day 14 to day 21 post-surgery
  time frame: up to 21 days after surgery
  description: Active reposition test will be measured using a digital inclinometer device.
  measure: Baseline Time Up and Go
  time frame: baseline
  description: functional performance test
  measure: Change in Time Up and Go from baseline to day 5 after interventions
  time frame: up to 5 days after baseline
  description: functional performance test
  measure: Change in the preoperative Time Up and Go on the 7th day of surgery
  time frame: up to 7 days after surgery
  description: functional performance test
  measure: Change in Time Up and Go from day 7 to day 14 post-surgery
  time frame: up to 14 days after surgery
  description: functional performance test
  measure: Change in Time Up and Go from day 14 to day 21 post-surgery
  time frame: up to 21 days after surgery
  description: functional performance test
  measure: SF-36
  time frame: baseline
  description: The 36-Item Short-Form Health Survey (SF-36) is a general scoring instrument used to provide a health profile comprised of eight scaled scores. Each scale is instantly turned into a 0-100 scale, allowing identification of the patient's physical and mental status. A higher score means a better result.
  measure: Change in the preoperative SF-36 on the 21st day of surgery
  time frame: up to 21 days after surgery
  description: The 36-Item Short-Form Health Survey (SF-36) is a general scoring instrument used to provide a health profile comprised of eight scaled scores. Each scale is instantly turned into a 0-100 scale, allowing identification of the patient's physical and mental status. A higher score means a better result.
  measure: WOMAC
  time frame: before interventions, 21st day after surgery
  description: The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-report multidimensional questionnaire that assesses pain, stiffness, and physical functional disability. A higher score means a better result.
  measure: Change in the preoperative WOMAC on the 21st day of surgery
  time frame: up to 21 days after surgery
  description: The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-report multidimensional questionnaire that assesses pain, stiffness, and physical functional disability. A higher score means a better result.
  measure: Global Rating of Change Scales (GROC)
  time frame: up to 21st day after surgery
  description: The GROC score, which has seven response options ranging from 'much worse' (a score of 0) to 'much better' (a score of six), will be used to determine the subject's perception of overall improvement.
  arm group label: Whole-body vibration
  arm group type: Experimental
  description: Standard patient education and exercise training + whole body vibration
  arm group label: Sham-whole-body vibration
  arm group type: Sham Comparator
  description: Standard patient education and exercise training + sham whole body vibration
  intervention type: Other
  intervention name: Whole body vibration
  description: The vibration will be applied for 10 minutes (30 seconds rest, 30 seconds training, 10 reps) in total with a low frequency (20 HZ) and low amplitude (2mm). Participants will be asked to stand in a squatting position by semi-flexing (30°) their knees during the 30-second vibration period.
  arm group label: Whole-body vibration
  intervention type: Other
  intervention name: Sham-Whole body vibration
  description: The sham-whole body vibration treatment will follow the same procedures with the vibration machine off.
  arm group label: Sham-whole-body vibration
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zeynep Hazar
  role: Study Director
  affiliation: Gazi University
  last name: Cemil Yıldız
  role: Study Chair
  affiliation: Gulhane Training and Research Hospital
  last name: Sevim Beyza Ölmez
  role: Principal Investigator
  affiliation: Gazi University
  last name: Beyza Yazgan
  role: Principal Investigator
  affiliation: Gazi University
  last name: İnci Ayaş
  role: Principal Investigator
  affiliation: Gazi University
  last name: Sevim Beyza Olmez
  phone: +90 312 216 26 21
  email: sevimbeyzaolmez@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Gazi University
  investigator full name: Sevim Beyza Ölmez
  investigator title: Principal Investigator, PhD
  mesh term: Joint Diseases
  mesh term: Edema
  sharing ipd: No