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/NCT06009419</url>
    </required_header>
    <id_info>
      <org_study_id>kalça artroplasti dualtask</org_study_id>
      <nct_id>NCT06009419</nct_id>
    </id_info>
    <brief_title>Effectiveness of Dual Task Training in Total Hip Arthroplasty</brief_title>
    <official_title>Effectiveness of Dual Task Training 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 dual task program&#xD;
        in patients who underwent total hip arthroplasty surgery. It is aimed to evaluate pain&#xD;
        intensity, disability level, mini mental status, coordination, balance and functional status&#xD;
        of the patients. The study will be conducted with volunteer patients who are followed up by&#xD;
        the Orthopedics and Traumatology outpatient clinic of Muğla Training and Research Hospital&#xD;
        and who have undergone total hip arthroplasty surgery. The evaluations will be performed in&#xD;
        the Orthopedics and Traumatology outpatient clinic of Muğla Training and Research Hospital.&#xD;
        It is aimed to evaluate at least 24 patients for the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 3, 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>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>Cognitive Timed Up and Go Test (CTUG)</measure>
      <time_frame>Change from Baseline CTUG at 8 weeks</time_frame>
      <description>Patients are first asked to stand up from a sitting position, walk 3 m at their normal speed, turn around, walk back to the chair and sit down. Walking aids are allowed. Patients are asked to perform this test while performing a cognitive dual task (subtract 2 continuously starting from 100).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dual-Task Questionnaire (DTQ)</measure>
      <time_frame>Change from Baseline DTQ at 8 weeks</time_frame>
      <description>The questionnaire consists of 10 items and each question is rated out of 5 points (ranging from 0 &quot;never&quot; to 4 &quot;very often&quot; or N/A &quot;not applicable&quot;). The score obtained is the average score per question (i.e. total score/10 for the questionnaire).</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>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>Harris Hip Score (HHS)</measure>
      <time_frame>Change from Baseline HHS at 8 weeks</time_frame>
      <description>The HHS contains 12 questions covering four domains: pain (44 points); function (47 points); deformity; and range of motion (9 points). This questionnaire was developed to assess the outcomes of young and middle-aged patients following hip arthroscopic debridement. Each question is answered using a Likert scale with an overall score ranging from 0 (extreme symptoms) to 100 (no symptoms).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mini-Mental State Examination (MMSE)</measure>
      <time_frame>Change from Baseline MMSE at 8 weeks</time_frame>
      <description>The mini mental test is categorized under five main headings: orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). The scale is scored out of a total of 30 points and has two different variants for educated and uneducated people. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment. 18-23 is considered as mild dementia, 12-17 as moderate dementia and below 12 as severe dementia.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower-Extremity Motor Coordination Test (LEMOCOT)</measure>
      <time_frame>Change from Baseline LEMOCOT at 8 weeks</time_frame>
      <description>The test requires subjects seated in a chair to alternately touch a proximal and distal target placed 30 cm apart on the floor with their feet within a 20-second period. A higher score indicates better motor coordination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>4-Meter Gait Speed (4MGS)</measure>
      <time_frame>Change from Baseline 4MGS at 8 weeks</time_frame>
      <description>Walking speed is assessed over two trials using a stopwatch in a long corridor over a distance of 4 meters during a single testing session, with one trial performed immediately after the other. Participants start ambulating approximately two meters before the start of the timed 4-meter walk and stop ambulating approximately two meters after completing the 4-meter walk. Timing begins and ends when the participants' lead foot crosses the start and end points of the 4-meter walk, respectively. Participants are instructed to walk at their normal safe walking speed and are allowed to use an assistive device if needed. The time taken to complete the two ambulation trials is recorded for analysis. Walking speed is calculated as the distance walked (4 meters) divided by the time taken to complete the 4-meter walk. The average walking speed for the two trials is calculated.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</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 dual task program will be progressively given to the study group as previously described (Silsupadol et al., 2006). These applications will be explained to the patients or their relatives face-to-face in the clinical environment after the initial evaluation and then sent and followed up by telerehabilitation method and patients will always have access to programs and education. In addition, both groups will be told that they can contact the researcher upon request.</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 a dual task program 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>Muğla Sıtkı Koçman Training and Research Hospital</name>
        <address>
          <city>Muğla</city>
          <state>Menteşe</state>
          <zip>48000</zip>
          <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/NCT06009419
  org study id: kalça artroplasti dualtask
  nct id: NCT06009419
  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 dual task program
        in patients who underwent total hip arthroplasty surgery. It is aimed to evaluate pain
        intensity, disability level, mini mental status, coordination, 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 Muğla Training and Research Hospital
        and who have undergone total hip arthroplasty surgery. The evaluations will be performed in
        the Orthopedics and Traumatology outpatient clinic of Muğla Training and Research Hospital.
        It is aimed to evaluate at least 24 patients for the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  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: Cognitive Timed Up and Go Test (CTUG)
  time frame: Change from Baseline CTUG at 8 weeks
  description: Patients are first asked to stand up from a sitting position, walk 3 m at their normal speed, turn around, walk back to the chair and sit down. Walking aids are allowed. Patients are asked to perform this test while performing a cognitive dual task (subtract 2 continuously starting from 100).
  measure: Dual-Task Questionnaire (DTQ)
  time frame: Change from Baseline DTQ at 8 weeks
  description: The questionnaire consists of 10 items and each question is rated out of 5 points (ranging from 0 "never" to 4 "very often" or N/A "not applicable"). The score obtained is the average score per question (i.e. total score/10 for the questionnaire).
  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: 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: Harris Hip Score (HHS)
  time frame: Change from Baseline HHS at 8 weeks
  description: The HHS contains 12 questions covering four domains: pain (44 points); function (47 points); deformity; and range of motion (9 points). This questionnaire was developed to assess the outcomes of young and middle-aged patients following hip arthroscopic debridement. Each question is answered using a Likert scale with an overall score ranging from 0 (extreme symptoms) to 100 (no symptoms).
  measure: Mini-Mental State Examination (MMSE)
  time frame: Change from Baseline MMSE at 8 weeks
  description: The mini mental test is categorized under five main headings: orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). The scale is scored out of a total of 30 points and has two different variants for educated and uneducated people. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment. 18-23 is considered as mild dementia, 12-17 as moderate dementia and below 12 as severe dementia.
  measure: Lower-Extremity Motor Coordination Test (LEMOCOT)
  time frame: Change from Baseline LEMOCOT at 8 weeks
  description: The test requires subjects seated in a chair to alternately touch a proximal and distal target placed 30 cm apart on the floor with their feet within a 20-second period. A higher score indicates better motor coordination.
  measure: 4-Meter Gait Speed (4MGS)
  time frame: Change from Baseline 4MGS at 8 weeks
  description: Walking speed is assessed over two trials using a stopwatch in a long corridor over a distance of 4 meters during a single testing session, with one trial performed immediately after the other. Participants start ambulating approximately two meters before the start of the timed 4-meter walk and stop ambulating approximately two meters after completing the 4-meter walk. Timing begins and ends when the participants' lead foot crosses the start and end points of the 4-meter walk, respectively. Participants are instructed to walk at their normal safe walking speed and are allowed to use an assistive device if needed. The time taken to complete the two ambulation trials is recorded for analysis. Walking speed is calculated as the distance walked (4 meters) divided by the time taken to complete the 4-meter walk. The average walking speed for the two trials is calculated.
  arm group label: Intervention Group
  arm group type: Experimental
  description: In addition to the program given to the control group, the dual task program will be progressively given to the study group as previously described (Silsupadol et al., 2006). These applications will be explained to the patients or their relatives face-to-face in the clinical environment after the initial evaluation and then sent and followed up by telerehabilitation method and patients will always have access to programs and education. In addition, both groups will be told that they can contact the researcher upon request.
  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 a dual task program 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