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/NCT06009432</url>
    </required_header>
    <id_info>
      <org_study_id>kalça artroplasti pnf rkç</org_study_id>
      <nct_id>NCT06009432</nct_id>
    </id_info>
    <brief_title>Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Program in Total Hip Arthroplasty</brief_title>
    <official_title>Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Program Versus Usual Care in Patients With Total Hip Arthroplasty: A Randomized 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 additional&#xD;
        proprioceptive neuromuscular facilitation exercise program in patients undergoing total hip&#xD;
        arthroplasty surgery. It is aimed to evaluate pain intensity, disability level,&#xD;
        proprioception, kinesiophobia, balance 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 hip 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 42 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 treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">September 27, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 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>3 Meter Backward Walk Test (3MBWT)</measure>
      <time_frame>Change from Baseline 3MBWT at 8 weeks</time_frame>
      <description>A distance of 3 meters is measured and marked. Children are asked to walk backwards safely when the signal is given and stop when they reach the marked point. They are allowed to look behind them if necessary. Measurements are repeated 3 times and the average time is recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>One Leg Standing Test (OLST)</measure>
      <time_frame>Change from Baseline OLST at 8 weeks</time_frame>
      <description>The subject is tested standing on one leg using the right and left legs respectively. The test is repeated on a hard surface with eyes open and closed. The subject is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The subject is asked to stand with one leg in a 90 degree flexion position and the other leg in a standing position. A stopwatch is used to record the time the subject can maintain the test position. If the subject can hold the position for more than 30 seconds, the test is terminated and the elapsed time is recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Five Times Sit to Stand Test (5TSST)</measure>
      <time_frame>Change from Baseline 5TSST at 8 weeks</time_frame>
      <description>A chair without armrests, with a 28.5 cm deep seat and backrest and adjustable height is used for the tests. Subjects start in a seated position, with their arms in the desired position and their backs against the chair backrest. The following verbal instructions are given: &quot;Please stand up and sit down 5 times as quickly as possible. Straighten your knees when standing up and lean your back against the backrest when sitting down.&quot; Timing with the digital stopwatch is started manually with the instruction &quot;Start&quot; and stopped when the subject's back touches the backrest after the fifth standing up.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fear-Avoidance Beliefs Questionnaire (FABQ)</measure>
      <time_frame>Change from Baseline FABQ at 8 weeks</time_frame>
      <description>The FABQ consists of 16 items and is divided into 2 subscales. The items are scored on a 7-point Likert scale (from strongly disagree to strongly agree). The score of each subscale is used independently. Higher scores represent more fear avoidance beliefs.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Falls Efficacy Scale International (FES-I)</measure>
      <time_frame>Change from Baseline FES-I at 8 weeks</time_frame>
      <description>The FES-I is a self-report questionnaire, providing information on level of concern about falls during activities of daily living. The questionnaire contains 16 items scored on a four-point scale (1 = not at all concerned to 4 = very concerned) providing a total score ranging from 16 (absence of concern) to 64 (extreme concern).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hip joint proprioception measurement</measure>
      <time_frame>Change from Baseline proprioception measurement at 8 weeks</time_frame>
      <description>Patients were placed in a supine position and blindfolded to eliminate visual cues. The test started at neutral position (0°) and patient actively fexed the hip toward the fexion target position of 45°, which was indicated by a mechanical obstruction. After holding that position for 5 s, patient focused and remembered the angle, and brought the joint actively back to the neutral starting position. Then, patient was asked to actively reproduce the target position without the mechanical obstruction and hold at where he/she felt it was the just position. Five repetitions were performed for each leg and &quot;absolute angular error&quot; values were obtained from the start and stop angles.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Hip 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, the study group will be given proprioceptive neuromuscular facilitation exercise as previously described (Smedes et. al., 2021). 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>The control group will receive the usual post-operative care of stretching, lower extremity strengthening, balance exercises, activities of daily living recommendations. The study group will be given proprioceptive neuromuscular facilitation exercise in addition to the program given to the control group.</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 hip 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 hip arthroplasty&#xD;
  &#xD;
            -  Presence of revision surgery&#xD;
  &#xD;
            -  Presence of severe osteoarthritis in the contralateral hip&#xD;
  &#xD;
            -  Severe acute metabolic neuromuscular and cardiovascular diseases&#xD;
  &#xD;
            -  Severe 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_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>
      <contact>
        <last_name>Fatih Özden, PhD</last_name>
        <phone>543 433 4593</phone>
        <phone_ext>+90</phone_ext>
        <email>fatihozden90@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 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>
    <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/NCT06009432
  org study id: kalça artroplasti pnf rkç
  nct id: NCT06009432
  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 additional
        proprioceptive neuromuscular facilitation exercise program in patients undergoing total hip
        arthroplasty surgery. It is aimed to evaluate pain intensity, disability level,
        proprioception, kinesiophobia, balance 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 hip 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 42 patients for the study.
        The first evaluation will be performed 6 weeks post-operatively and the second evaluation
        will be performed 2 months after 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: 3 Meter Backward Walk Test (3MBWT)
  time frame: Change from Baseline 3MBWT at 8 weeks
  description: A distance of 3 meters is measured and marked. Children are asked to walk backwards safely when the signal is given and stop when they reach the marked point. They are allowed to look behind them if necessary. Measurements are repeated 3 times and the average time is recorded.
  measure: One Leg Standing Test (OLST)
  time frame: Change from Baseline OLST at 8 weeks
  description: The subject is tested standing on one leg using the right and left legs respectively. The test is repeated on a hard surface with eyes open and closed. The subject is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The subject is asked to stand with one leg in a 90 degree flexion position and the other leg in a standing position. A stopwatch is used to record the time the subject can maintain the test position. If the subject can hold the position for more than 30 seconds, the test is terminated and the elapsed time is recorded.
  measure: Five Times Sit to Stand Test (5TSST)
  time frame: Change from Baseline 5TSST at 8 weeks
  description: A chair without armrests, with a 28.5 cm deep seat and backrest and adjustable height is used for the tests. Subjects start in a seated position, with their arms in the desired position and their backs against the chair backrest. The following verbal instructions are given: "Please stand up and sit down 5 times as quickly as possible. Straighten your knees when standing up and lean your back against the backrest when sitting down." Timing with the digital stopwatch is started manually with the instruction "Start" and stopped when the subject's back touches the backrest after the fifth standing up.
  measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
  time frame: Change from Baseline FABQ at 8 weeks
  description: The FABQ consists of 16 items and is divided into 2 subscales. The items are scored on a 7-point Likert scale (from strongly disagree to strongly agree). The score of each subscale is used independently. Higher scores represent more fear avoidance beliefs.
  measure: Falls Efficacy Scale International (FES-I)
  time frame: Change from Baseline FES-I at 8 weeks
  description: The FES-I is a self-report questionnaire, providing information on level of concern about falls during activities of daily living. The questionnaire contains 16 items scored on a four-point scale (1 = not at all concerned to 4 = very concerned) providing a total score ranging from 16 (absence of concern) to 64 (extreme concern).
  measure: Hip joint proprioception measurement
  time frame: Change from Baseline proprioception measurement at 8 weeks
  description: Patients were placed in a supine position and blindfolded to eliminate visual cues. The test started at neutral position (0°) and patient actively fexed the hip toward the fexion target position of 45°, which was indicated by a mechanical obstruction. After holding that position for 5 s, patient focused and remembered the angle, and brought the joint actively back to the neutral starting position. Then, patient was asked to actively reproduce the target position without the mechanical obstruction and hold at where he/she felt it was the just position. Five repetitions were performed for each leg and "absolute angular error" values were obtained from the start and stop angles.
  arm group label: Intervention Group
  arm group type: Experimental
  description: In addition to the program given to the control group, the study group will be given proprioceptive neuromuscular facilitation exercise as previously described (Smedes et. al., 2021). 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: The control group will receive the usual post-operative care of stretching, lower extremity strengthening, balance exercises, activities of daily living recommendations. The study group will be given proprioceptive neuromuscular facilitation exercise in addition to the program given to the control group.
  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: Fatih Özden, PhD
  phone: 543 433 4593
  phone ext: +90
  email: fatihozden@mu.edu.tr
  facility: 
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Muğla Sıtkı Koçman University
  investigator full name: Fatih Ozden
  investigator title: Assistant Professor
  sharing ipd: No