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/NCT05999864</url>
    </required_header>
    <id_info>
      <org_study_id>FethiyeTDAPNF</org_study_id>
      <nct_id>NCT05999864</nct_id>
    </id_info>
    <brief_title>Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Programme in Patients With Total Knee Arthroplasty</brief_title>
    <official_title>Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Programme Versus Usual Care in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Muğla Sıtkı Koçman University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Muğla Sıtkı Koçman 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>
        This study was planned to investigate the effectiveness of usual care and proprioceptive&#xD;
        neuromuscular facilitation exercise program in patients undergoing total knee arthroplasty&#xD;
        surgery. It is aimed to evaluate pain intensity, disability level, proprioception,&#xD;
        kinesiophobia, balance, range of motion and functional status of the patients. The study will&#xD;
        be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology&#xD;
        outpatient clinic of Fethiye State Hospital and who have undergone total knee arthroplasty&#xD;
        surgery. The evaluations will be performed in the Orthopedics and Traumatology outpatient&#xD;
        clinic of Fethiye State Hospital. It is aimed to evaluate at least 32 patients for the study.&#xD;
        The first evaluation will be performed 6 weeks post-operatively and the second evaluation&#xD;
        will be performed 2 months after the treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 8, 2023</start_date>
    <completion_date type="Anticipated">June 7, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 8, 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale (VAS)</measure>
      <time_frame>Change from Baseline VAS at 8 weeks</time_frame>
      <description>On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Western-Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</measure>
      <time_frame>Change from Baseline WOMAC at 8 weeks</time_frame>
      <description>Functionality level in the patient group with knee OA was measured using WOMAC. WOMAC consists of 3 main headings: pain intensity, stiffness and physical function. The individuals included in the study are asked to score each item between 0 (no pain, stiffness, difficulty) and 5 (very severe pain, stiffness, difficulty). The total score ranges from 0 (no disability) to 96 (complete disability).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knee Joint Proprioception Measurement</measure>
      <time_frame>Change from Baseline Knee Joint Proprioception Measurement at 8 weeks</time_frame>
      <description>The inclinometer is placed distal to the tibial tuberosity. In full knee extension, the patient is asked to perform a single leg squat with eyes closed or unable to see the leg being tested. He/she is allowed to support with his/her hands to prevent loss of balance. When the knee flexion angle of 30° is reached, the patient is asked to stop and stay at this point for 5 seconds. Then return to full knee extension. This movement is repeated 3 times. This time, without any stop command, the patient is asked to reach the same 30° knee flexion angle as in the previous exercises. This application is also repeated 3 times. The &quot;absolute angle difference&quot;, which is the difference between the targeted angle in each repetition and the angle realized by the patient, is recorded. The arithmetic mean of the 3 repetitions' absolute angle difference is recorded as the result data.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified Four Square Step Test (mFSST)</measure>
      <time_frame>Change from Baseline mFSST at 8 weeks</time_frame>
      <description>A suitable background is divided into four identical squares with a &quot;+&quot; shaped line using tape. The squares are numbered with numbers between 1-4 in a clockwise direction and this sequence is explained to the participant. The patient steps from the starting point to squares 1,2,3 and 4 in a way that the direction remains the same and without stepping on the lines. The test is terminated when the last foot contact is interrupted at square 4. The time elapsed during the main measurement is recorded with a stopwatch.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Figure 8 Walking Test (F8WT)</measure>
      <time_frame>Change from Baseline F8WT at 8 weeks</time_frame>
      <description>Participants are instructed to stand at the midpoint between two cones (1.52 m apart) and look at one of the cones. Participants are asked to walk in a circle of 8 around the cones at a comfortable speed and direction of their choice. The stopwatch is stopped while returning to the starting point. The elapsed time and the number of steps taken are recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berg Balance Scale (BBS)</measure>
      <time_frame>Change from Baseline BBS at 8 weeks</time_frame>
      <description>The 14 items in the scale assess static sitting and standing balance as well as expected balance during activities. Scoring is done on a 5-point scale that takes into account whether the patient can perform the task safely and independently and is usually based on a specific time interval. Normal performances are rated from 0 (unable to perform) to 4 points (normal performance). Scores on individual items are summed for a total score, with a maximum score of 56 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activity Specific Balance Confidence Scale (ABC)</measure>
      <time_frame>Change from Baseline ABC at 8 weeks</time_frame>
      <description>This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tampa Scale for Kinesiophobia (TSK)</measure>
      <time_frame>Change from Baseline TSK at 8 weeks</time_frame>
      <description>The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Knee Arthroplasty</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the program given to the control group, proprioceptive neuromuscular facilitation exercise will be given to the study group as previously described (Gstoettner et al., 2011). These applications will be applied to the patients for 8 weeks, 2 days a week in the clinical environment after the initial evaluation. In addition, both groups will be told that they can contact the researcher when requested.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises activities of daily living recommendations.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rehabilitation</intervention_name>
      <description>Proprioceptive neuromuscular facilitation exercise will be given to the study group as previously described (Gstoettner et al., 2011). These applications will be applied to the patients for 8 weeks, 2 days a week in the clinical environment after the initial evaluation. In addition, both groups will be told that they can contact the researcher when requested.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having undergone unilateral total knee arthroplasty surgery and being 6 weeks&#xD;
               postoperative&#xD;
  &#xD;
            -  Participate in all necessary follow-up assessments&#xD;
  &#xD;
            -  60 years of age or older&#xD;
  &#xD;
            -  Understand simple commands&#xD;
  &#xD;
            -  Signing the consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A previous history of total knee arthroplasty&#xD;
  &#xD;
            -  Presence of revision surgery&#xD;
  &#xD;
            -  Presence of severe osteoarthritis in the contralateral knee&#xD;
  &#xD;
            -  Severe acute metabolic neuromuscular and cardiovascular diseases&#xD;
  &#xD;
            -  Extreme obesity (bki&gt;35)&#xD;
  &#xD;
            -  Presence of malignancy&#xD;
  &#xD;
            -  Have any other orthopedic or neurological problem that may affect treatment and&#xD;
               assessments&#xD;
  &#xD;
            -  Situations that prevent communication&#xD;
  &#xD;
            -  Lack of cooperation during the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fatih Özden, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>İsmet Tümtürk, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Süleyman Demirel University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>İsmail Uysal, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fatih Özyer, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fethiye State Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nazan Tuğay, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sanko University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fatih Özden, PhD</last_name>
      <phone>543 433 4593</phone>
      <phone_ext>+90</phone_ext>
      <email>fatihozden@mu.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fethiye State Hospital</name>
        <address>
          <city>Muğla</city>
          <state>Fethiye</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fatih Özyer, MD</last_name>
        <phone>532 271 5411</phone>
        <phone_ext>+90</phone_ext>
        <email>fatihozyer@yahoo.com</email>
      </contact>
      <investigator>
        <last_name>Fatih Özden, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>İsmet Tümtürk, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Fatih Özyer, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>İsmail Uysal, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nazan Tuğay, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation>
      <investigator_full_name>Fatih Ozden</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <!-- 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/NCT05999864
  org study id: FethiyeTDAPNF
  nct id: NCT05999864
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was planned to investigate the effectiveness of usual care and proprioceptive
        neuromuscular facilitation exercise program in patients undergoing total knee arthroplasty
        surgery. It is aimed to evaluate pain intensity, disability level, proprioception,
        kinesiophobia, balance, range of motion and functional status of the patients. The study will
        be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology
        outpatient clinic of Fethiye State Hospital and who have undergone total knee arthroplasty
        surgery. The evaluations will be performed in the Orthopedics and Traumatology outpatient
        clinic of Fethiye State Hospital. It is aimed to evaluate at least 32 patients for the study.
        The first evaluation will be performed 6 weeks post-operatively and the second evaluation
        will be performed 2 months after the treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Visual Analog Scale (VAS)
  time frame: Change from Baseline VAS at 8 weeks
  description: On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
  measure: Western-Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
  time frame: Change from Baseline WOMAC at 8 weeks
  description: Functionality level in the patient group with knee OA was measured using WOMAC. WOMAC consists of 3 main headings: pain intensity, stiffness and physical function. The individuals included in the study are asked to score each item between 0 (no pain, stiffness, difficulty) and 5 (very severe pain, stiffness, difficulty). The total score ranges from 0 (no disability) to 96 (complete disability).
  measure: Knee Joint Proprioception Measurement
  time frame: Change from Baseline Knee Joint Proprioception Measurement at 8 weeks
  description: The inclinometer is placed distal to the tibial tuberosity. In full knee extension, the patient is asked to perform a single leg squat with eyes closed or unable to see the leg being tested. He/she is allowed to support with his/her hands to prevent loss of balance. When the knee flexion angle of 30° is reached, the patient is asked to stop and stay at this point for 5 seconds. Then return to full knee extension. This movement is repeated 3 times. This time, without any stop command, the patient is asked to reach the same 30° knee flexion angle as in the previous exercises. This application is also repeated 3 times. The "absolute angle difference", which is the difference between the targeted angle in each repetition and the angle realized by the patient, is recorded. The arithmetic mean of the 3 repetitions' absolute angle difference is recorded as the result data.
  measure: Modified Four Square Step Test (mFSST)
  time frame: Change from Baseline mFSST at 8 weeks
  description: A suitable background is divided into four identical squares with a "+" shaped line using tape. The squares are numbered with numbers between 1-4 in a clockwise direction and this sequence is explained to the participant. The patient steps from the starting point to squares 1,2,3 and 4 in a way that the direction remains the same and without stepping on the lines. The test is terminated when the last foot contact is interrupted at square 4. The time elapsed during the main measurement is recorded with a stopwatch.
  measure: Figure 8 Walking Test (F8WT)
  time frame: Change from Baseline F8WT at 8 weeks
  description: Participants are instructed to stand at the midpoint between two cones (1.52 m apart) and look at one of the cones. Participants are asked to walk in a circle of 8 around the cones at a comfortable speed and direction of their choice. The stopwatch is stopped while returning to the starting point. The elapsed time and the number of steps taken are recorded.
  measure: Berg Balance Scale (BBS)
  time frame: Change from Baseline BBS at 8 weeks
  description: The 14 items in the scale assess static sitting and standing balance as well as expected balance during activities. Scoring is done on a 5-point scale that takes into account whether the patient can perform the task safely and independently and is usually based on a specific time interval. Normal performances are rated from 0 (unable to perform) to 4 points (normal performance). Scores on individual items are summed for a total score, with a maximum score of 56 points.
  measure: Activity Specific Balance Confidence Scale (ABC)
  time frame: Change from Baseline ABC at 8 weeks
  description: This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.
  measure: Tampa Scale for Kinesiophobia (TSK)
  time frame: Change from Baseline TSK at 8 weeks
  description: The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
  arm group label: Intervention Group
  arm group type: Experimental
  description: In addition to the program given to the control group, proprioceptive neuromuscular facilitation exercise will be given to the study group as previously described (Gstoettner et al., 2011). These applications will be applied to the patients for 8 weeks, 2 days a week in the clinical environment after the initial evaluation. In addition, both groups will be told that they can contact the researcher when requested.
  arm group label: Control Group
  arm group type: Active Comparator
  description: The control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises activities of daily living recommendations.
  intervention type: Other
  intervention name: Rehabilitation
  description: Proprioceptive neuromuscular facilitation exercise will be given to the study group as previously described (Gstoettner et al., 2011). These applications will be applied to the patients for 8 weeks, 2 days a week in the clinical environment after the initial evaluation. In addition, both groups will be told that they can contact the researcher when requested.
  arm group label: Control Group
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Fatih Özden, PhD
  role: Study Director
  affiliation: Muğla Sıtkı Koçman University
  last name: İsmet Tümtürk, MSc
  role: Principal Investigator
  affiliation: Süleyman Demirel University
  last name: İsmail Uysal, PhD
  role: Principal Investigator
  affiliation: Muğla Sıtkı Koçman University
  last name: Fatih Özyer, MD
  role: Principal Investigator
  affiliation: Fethiye State Hospital
  last name: Nazan Tuğay, PhD
  role: Principal Investigator
  affiliation: Sanko University
  last name: Fatih Özden, PhD
  phone: 543 433 4593
  phone ext: +90
  email: fatihozden@mu.edu.tr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Muğla Sıtkı Koçman University
  investigator full name: Fatih Ozden
  investigator title: Assistant Professor