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/NCT06014632</url>
    </required_header>
    <id_info>
      <org_study_id>Fethiye NRŞ RKÇ</org_study_id>
      <nct_id>NCT06014632</nct_id>
    </id_info>
    <brief_title>Efficacy of Motor Control Exercise Program After Lumbar Spinal Decompression Surgery</brief_title>
    <official_title>The Effect of Supervised Motor Control Exercise Program on Pain, Disability, Kinesiophobia, Proprioception and Function After Lumbar Spinal Decompression Surgery</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 have undergone lumbar decompression&#xD;
        surgery and who are followed up by the Neurosurgery outpatient clinic of Fethiye State&#xD;
        Hospital. The cases will be divided into 2 groups by randomization software. The control&#xD;
        group will receive stretching, strengthening, core stabilization and educational content as&#xD;
        usual care 3 months post-operatively. The study group will be given motion control exercises&#xD;
        in addition to the program given to the control group 3 months post-operatively. These&#xD;
        applications will be applied to the patients face-to-face in the clinical environment 2 days&#xD;
        a week for 12 weeks. The first evaluation will be performed 3 months post-operatively before&#xD;
        the treatment and the second evaluation will be performed 3 months after the treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 12, 2023</start_date>
    <completion_date type="Anticipated">August 23, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 13, 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>12-item Örebro Musculoskeletal Screening Questionnaire (ÖMSQ-12)</measure>
      <time_frame>Change from Baseline ÖMSQ-12 at 12 weeks</time_frame>
      <description>ÖMSQ-12 is a 12-item self-report questionnaire. Each item is scored on an 11-point Likert scale (0-10) based on the response to the question asked. Items 8, 11 and 12 are reverse scored items. The maximum score that can be obtained from the questionnaire is 120. A high score means a high risk of absenteeism, high cost, chronicity or delayed recovery, and severity of the problem due to the individual's problematic musculoskeletal condition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fear-Avoidance Beliefs Questionnaire (FABQ)</measure>
      <time_frame>Change from Baseline FABQ at 12 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>Oswestry Disability Index (ODI)</measure>
      <time_frame>Change from Baseline ODI at 12 weeks</time_frame>
      <description>The Oswestry Disability Index consists of 10 questions measuring functional status. Each question is evaluated between 0 and 5 points and the total maximum score is 50. Higher score indicates more disability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lumbar region proprioception measurement</measure>
      <time_frame>Change from Baseline proprioception measurement at 12 weeks</time_frame>
      <description>Subjects are asked to stand in a neutral position, with knees straight and weight equal to both feet. To measure lumbar repositioning errors in flexion, the first inclinometer is placed on the lateral chest (T12 level) and the second inclinometer on the hemipelvis (S1 level). The primary inclinometer (T12) and the secondary inclinometer (sacral midpoint) are used in the frontal plane to record the lateral bending angle error. Velcro straps are used to secure the digital inclinometer. The inclinometer is calibrated by the examiner to a starting position (0 degrees). Subjects memorize this neutral position for a few seconds, perform active full flexion and then return to the neutral position. Displacement accuracy is measured in degrees.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Five Times Sit to Stand Test (5TSST)</measure>
      <time_frame>Change from Baseline 5TSST at 12 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>Timed Up and Go Test (TUG)</measure>
      <time_frame>Change from Baseline TUG at 12 weeks</time_frame>
      <description>Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the &quot;ready, go&quot; signal and ends when the participants are seated in the chair and the movement is finished.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Lumbar Spine Disease</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The study group will be given motor control exercises in addition to the program given to the control group. It will include exercise therapy aimed at improving the motor control of the lumbar spine. These applications will be applied to the patients face-to-face in a clinical setting 2 days a week for 12 weeks. 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 stretching, strengthening, core stabilization and educational content as usual care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rehabilitation</intervention_name>
      <description>The study group will be given motor control exercises in addition to the program given to the control group.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>The control group will receive stretching, strengthening, core stabilization and educational content as usual care.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To have undergone lumbar decompression surgery without fusion and 3 months have&#xD;
               passed, to participate in all necessary follow-up evaluations and treatment sessions&#xD;
  &#xD;
            -  To be between the ages of 18-65, to be able to understand simple commands and to have&#xD;
               signed the consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of a previous spinal fusion surgery, presence of malignancy&#xD;
  &#xD;
            -  Having undergone spine surgery before&#xD;
  &#xD;
            -  Have any other orthopedic or neurological problem that may affect treatment and&#xD;
               assessments&#xD;
  &#xD;
            -  Situations that may interfere with communication&#xD;
  &#xD;
            -  Lack of cooperation during the study and refusal to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>İsmail Uysal, PhD</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>İsmet Tümtürk, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Süleyman Demirel University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ferdi Başkurt, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Süleyman Demirel University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mehmet Şimşek, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fethiye State Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Baki Umut Tuğay, PhD</last_name>
      <role>Principal Investigator</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>
      <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_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 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>Spinal Diseases</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/NCT06014632
  org study id: Fethiye NRŞ RKÇ
  nct id: NCT06014632
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study will be conducted with volunteer patients who have undergone lumbar decompression
        surgery and who are followed up by the Neurosurgery outpatient clinic of Fethiye State
        Hospital. The cases will be divided into 2 groups by randomization software. The control
        group will receive stretching, strengthening, core stabilization and educational content as
        usual care 3 months post-operatively. The study group will be given motion control exercises
        in addition to the program given to the control group 3 months post-operatively. These
        applications will be applied to the patients face-to-face in the clinical environment 2 days
        a week for 12 weeks. The first evaluation will be performed 3 months post-operatively before
        the treatment and the second evaluation will be performed 3 months after the treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 12-item Örebro Musculoskeletal Screening Questionnaire (ÖMSQ-12)
  time frame: Change from Baseline ÖMSQ-12 at 12 weeks
  description: ÖMSQ-12 is a 12-item self-report questionnaire. Each item is scored on an 11-point Likert scale (0-10) based on the response to the question asked. Items 8, 11 and 12 are reverse scored items. The maximum score that can be obtained from the questionnaire is 120. A high score means a high risk of absenteeism, high cost, chronicity or delayed recovery, and severity of the problem due to the individual's problematic musculoskeletal condition.
  measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
  time frame: Change from Baseline FABQ at 12 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: Oswestry Disability Index (ODI)
  time frame: Change from Baseline ODI at 12 weeks
  description: The Oswestry Disability Index consists of 10 questions measuring functional status. Each question is evaluated between 0 and 5 points and the total maximum score is 50. Higher score indicates more disability.
  measure: Lumbar region proprioception measurement
  time frame: Change from Baseline proprioception measurement at 12 weeks
  description: Subjects are asked to stand in a neutral position, with knees straight and weight equal to both feet. To measure lumbar repositioning errors in flexion, the first inclinometer is placed on the lateral chest (T12 level) and the second inclinometer on the hemipelvis (S1 level). The primary inclinometer (T12) and the secondary inclinometer (sacral midpoint) are used in the frontal plane to record the lateral bending angle error. Velcro straps are used to secure the digital inclinometer. The inclinometer is calibrated by the examiner to a starting position (0 degrees). Subjects memorize this neutral position for a few seconds, perform active full flexion and then return to the neutral position. Displacement accuracy is measured in degrees.
  measure: Five Times Sit to Stand Test (5TSST)
  time frame: Change from Baseline 5TSST at 12 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: Timed Up and Go Test (TUG)
  time frame: Change from Baseline TUG at 12 weeks
  description: Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.
  arm group label: Intervention Group
  arm group type: Experimental
  description: The study group will be given motor control exercises in addition to the program given to the control group. It will include exercise therapy aimed at improving the motor control of the lumbar spine. These applications will be applied to the patients face-to-face in a clinical setting 2 days a week for 12 weeks. 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 stretching, strengthening, core stabilization and educational content as usual care.
  intervention type: Other
  intervention name: Rehabilitation
  description: The study group will be given motor control exercises in addition to the program given to the control group.
  arm group label: Intervention Group
  intervention type: Other
  intervention name: Control
  description: The control group will receive stretching, strengthening, core stabilization and educational content as usual care.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: İsmail Uysal, PhD
  role: Study Director
  affiliation: Muğla Sıtkı Koçman University
  last name: Fatih Özden, PhD
  role: Principal Investigator
  affiliation: Muğla Sıtkı Koçman University
  last name: İsmet Tümtürk, MSc
  role: Principal Investigator
  affiliation: Süleyman Demirel University
  last name: Ferdi Başkurt, PhD
  role: Principal Investigator
  affiliation: Süleyman Demirel University
  last name: Mehmet Şimşek, MD
  role: Principal Investigator
  affiliation: Fethiye State Hospital
  last name: Baki Umut Tuğay, PhD
  role: Principal Investigator
  affiliation: Muğla Sıtkı Koçman University
  last name: Fatih Özden, PhD
  phone: 543 433 4593
  phone ext: +90
  email: fatihozden@mu.edu.tr
  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: Spinal Diseases
  sharing ipd: No