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/NCT06018610</url>
    </required_header>
    <id_info>
      <org_study_id>Kalça kırığı</org_study_id>
      <nct_id>NCT06018610</nct_id>
    </id_info>
    <brief_title>Effectiveness of Relaxation and Massage Methods in Proximal Femur Fractures</brief_title>
    <official_title>Mid-term Efficacy and Results of Postoperative Relaxation and Underfloor Classical Massage Methods and Training in Proximal Femur Fractures</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>
        The study will be conducted with volunteer patients who are followed up by the Orthopedics&#xD;
        and Traumatology Service of Muğla Sıtkı Koçman University Training and Research Hospital and&#xD;
        who have undergone proximal femur fracture surgery and meet the study criteria. It is aimed&#xD;
        to investigate the mid-term efficacy of relaxation exercises and classical massage of the&#xD;
        sole of the foot applied in addition to the conventional physiotherapy program in the&#xD;
        postoperative in-hospital period in patients with proximal femur fracture.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 18, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale (VAS)</measure>
      <time_frame>Change from Baseline VAS at 3 days</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>Barthel Index (BI)</measure>
      <time_frame>Change from Baseline BI at 3 days</time_frame>
      <description>The Barthel Index was developed as a measure to assess disability in patients with neuromuscular and musculoskeletal disorders undergoing inpatient rehabilitation. A maximum total score of 100 can be obtained. Higher score indicates better condition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EQ-5D-3L Quality of Life Scale</measure>
      <time_frame>Change from Baseline EQ-5D-3L at 3 days</time_frame>
      <description>The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning &quot;worst imaginable health&quot; and 100 meaning &quot;best imaginable health&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
      <time_frame>Change from Baseline HADS at 3 days</time_frame>
      <description>The HADS consists of two subscales, one with seven items measuring anxiety and the other with seven items measuring depression, which are scored separately. Each item is answered by the patient on a 4-point response category (0 to 3), so that possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. 0 to 7 is considered &quot;normal&quot;, 8 to 10 &quot;mild&quot;, 11 to 14 &quot;moderate&quot; and 15 to 21 &quot;severe&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tampa Scale for Kinesiophobia (TSK)</measure>
      <time_frame>Change from Baseline TSK at 3 days</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>
    <primary_outcome>
      <measure>Nottingham Hip Fracture Score (NHFS)</measure>
      <time_frame>Change from Baseline NHFS at 3 days</time_frame>
      <description>The Nottingham Hip Fracture Score is an aggregate score of seven preoperative variables that gives an estimated risk of 30-day postoperative mortality using a standard logistic regression. This score is calculated based on age, gender, comorbidities, place of residence (i.e. home or institutional care), abbreviated mental test score (AMTS) and hemoglobin level at admission. Higher scores indicate better condition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sole sensory testing with Semmes-Weinstein Monofilament</measure>
      <time_frame>Change from Baseline Semmes-Weinstein Monofilament Test at 3 days</time_frame>
      <description>The filament is imposed horizontally against the skin until there is a visible bending of the fiber. The patient then verbally assesses whether the sensation is perceived. Starting with the thinnest filament, thick filament is used sequentially until the patient feels it.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Fracture of Femur</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group. Patients will be re-evaluated 3 days after the completion of the interventions.</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 conventional rehabilitation practices (in and out of bed strengthening exercises, for 3 days).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rehabilitation</intervention_name>
      <description>In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>Conventional rehabilitation will be applied to the control group.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female patients aged 50 years and older who were diagnosed with proximal&#xD;
               femur fracture and underwent surgery&#xD;
  &#xD;
            -  No medical contraindications that would limit the ability to exercise&#xD;
  &#xD;
            -  Having a caregiver who can supervise the exercise program after discharge&#xD;
  &#xD;
            -  To be able to understand simple commands and to have signed the consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with pathological fractures and/or multiple fractures&#xD;
  &#xD;
            -  Those with serious early complications&#xD;
  &#xD;
            -  Terminally ill patients&#xD;
  &#xD;
            -  Circumstances that would interfere with conducting assessments or communicating&#xD;
  &#xD;
            -  Lack of cooperation during the study&#xD;
  &#xD;
            -  Scoring ≤14 on the Mini Mental State Examinatio&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmet İmerci, MD</last_name>
      <role>Study Director</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fatih Özden, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Serkan Bakırhan, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ege 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>Fatih Özyer, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fethiye State Hospital</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 Özden, PhD</last_name>
        <phone>543 433 4593</phone>
        <phone_ext>+90</phone_ext>
        <email>fatihozden90@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Muğla Sıtkı Koçman Training and Research Hospital</name>
        <address>
          <city>Muğla</city>
          <state>Menteşe</state>
          <zip>48000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ahmet İmerci, MD</last_name>
        <phone>506 893 5276</phone>
        <phone_ext>+90</phone_ext>
        <email>ahmetimerci@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 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>Muğla Sıtkı Koçman University</investigator_affiliation>
      <investigator_full_name>Fatih Ozden</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Femoral Fractures</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/NCT06018610
  org study id: Kalça kırığı
  nct id: NCT06018610
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study will be conducted with volunteer patients who are followed up by the Orthopedics
        and Traumatology Service of Muğla Sıtkı Koçman University Training and Research Hospital and
        who have undergone proximal femur fracture surgery and meet the study criteria. It is aimed
        to investigate the mid-term efficacy of relaxation exercises and classical massage of the
        sole of the foot applied in addition to the conventional physiotherapy program in the
        postoperative in-hospital period in patients with proximal femur fracture.
  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 3 days
  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: Barthel Index (BI)
  time frame: Change from Baseline BI at 3 days
  description: The Barthel Index was developed as a measure to assess disability in patients with neuromuscular and musculoskeletal disorders undergoing inpatient rehabilitation. A maximum total score of 100 can be obtained. Higher score indicates better condition.
  measure: EQ-5D-3L Quality of Life Scale
  time frame: Change from Baseline EQ-5D-3L at 3 days
  description: The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".
  measure: Hospital Anxiety and Depression Scale (HADS)
  time frame: Change from Baseline HADS at 3 days
  description: The HADS consists of two subscales, one with seven items measuring anxiety and the other with seven items measuring depression, which are scored separately. Each item is answered by the patient on a 4-point response category (0 to 3), so that possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. 0 to 7 is considered "normal", 8 to 10 "mild", 11 to 14 "moderate" and 15 to 21 "severe".
  measure: Tampa Scale for Kinesiophobia (TSK)
  time frame: Change from Baseline TSK at 3 days
  description: The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
  measure: Nottingham Hip Fracture Score (NHFS)
  time frame: Change from Baseline NHFS at 3 days
  description: The Nottingham Hip Fracture Score is an aggregate score of seven preoperative variables that gives an estimated risk of 30-day postoperative mortality using a standard logistic regression. This score is calculated based on age, gender, comorbidities, place of residence (i.e. home or institutional care), abbreviated mental test score (AMTS) and hemoglobin level at admission. Higher scores indicate better condition.
  measure: Sole sensory testing with Semmes-Weinstein Monofilament
  time frame: Change from Baseline Semmes-Weinstein Monofilament Test at 3 days
  description: The filament is imposed horizontally against the skin until there is a visible bending of the fiber. The patient then verbally assesses whether the sensation is perceived. Starting with the thinnest filament, thick filament is used sequentially until the patient feels it.
  arm group label: Intervention Group
  arm group type: Experimental
  description: In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group. Patients will be re-evaluated 3 days after the completion of the interventions.
  arm group label: Control Group
  arm group type: Active Comparator
  description: The control group will receive conventional rehabilitation practices (in and out of bed strengthening exercises, for 3 days).
  intervention type: Other
  intervention name: Rehabilitation
  description: In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group.
  arm group label: Intervention Group
  intervention type: Other
  intervention name: Control
  description: Conventional rehabilitation will be applied to the control group.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ahmet İmerci, MD
  role: Study Director
  affiliation: Muğla Sıtkı Koçman University
  last name: Fatih Özden, PhD
  role: Principal Investigator
  affiliation: Muğla Sıtkı Koçman University
  last name: Serkan Bakırhan, PhD
  role: Principal Investigator
  affiliation: Ege University
  last name: İsmet Tümtürk, MSc
  role: Principal Investigator
  affiliation: Süleyman Demirel University
  last name: Fatih Özyer, MD
  role: Principal Investigator
  affiliation: Fethiye State Hospital
  last name: Fatih Özden, PhD
  phone: 543 433 4593
  phone ext: +90
  email: fatihozden@mu.edu.tr
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Muğla Sıtkı Koçman University
  investigator full name: Fatih Ozden
  investigator title: Assistant Professor
  mesh term: Fractures, Bone
  mesh term: Femoral Fractures
  sharing ipd: No