<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/NCT04409548</url>
  </required_header>
  <id_info>
    <org_study_id>Bahçeşehir University</org_study_id>
    <nct_id>NCT04409548</nct_id>
  </id_info>
  <brief_title>The Spatiotemporal Gait Parameters in LDH Patient</brief_title>
  <official_title>Preoperative and Postoperative Spatiotemporal Gait Parameters and Gait Asymmetry in Patients With Lumbar Disc Herniation: a Prospective, Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bahçeşehir University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to assessment on the interaction of spatial and temporal gait&#xD;
      parameters and gait asymmetry in patients with Lumbar Disc Herniation (LDH) before and 15&#xD;
      days after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants were divided into LDH and healthy control groups. The analysis of the&#xD;
      spatiotemporal gait parameters was performed using the &quot;Win-Track&quot; gait analysis platform&#xD;
      system for two groups. In addition, the analysis of spatiotemporal gait parameters of 60&#xD;
      participants who had the planned lumbar discectomy surgery, was tested before and 15 days&#xD;
      after surgery. The pain intensity of the patients was recorded by the Visual Analog Scale&#xD;
      (VAS) immediately before performing the analysis. After then participants completed ten&#xD;
      passes on the &quot;Win-Track&quot; Gait Analysis Platform at their self-selected walking speed. The&#xD;
      arithmetic mean of the three flawless walking data was used for analysis. The gait symmetry&#xD;
      index was used to calculate the walking asymmetry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2016</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 29, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>The pain intensity of the patients was recorded immediately before performing the analysis.</time_frame>
    <description>Pain intensity was obtained using a Visual Analog Scale (VAS). VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with &quot;No Pain&quot; (score of zero) on the left side up to &quot;pain as bad as it could be&quot; or the &quot;worst imaginable pain&quot; (Score of 100 [100-mm scale]) on the right side. The patient was asked to mark the line point that represented his or her current pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Step length (cm)</measure>
    <time_frame>Changes from the step length at 2 weeks</time_frame>
    <description>Step length is the distance between the heel contact point of one foot and that of the other foot. The step length (cm) was recorded separately for both extremities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait cycle length (cm)</measure>
    <time_frame>Changes from the gait cycle length at 2 weeks</time_frame>
    <description>Gait cycle length is the distance between successive foot contacts of the same limbs. The gait cycle length (cm) was recorded separately for both extremities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cadence (step/min)</measure>
    <time_frame>Changes from the cadence at 2 weeks</time_frame>
    <description>Cadence is the number of steps per minute.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Velocity (cm/s)</measure>
    <time_frame>Changes from the velocity at 2 weeks</time_frame>
    <description>Velocity is the distance covered in a given period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait cycle duration (seconds)</measure>
    <time_frame>Changes from the gait cycle duration at 2 weeks</time_frame>
    <description>Gait cycle duration is the time between successive foot contacts of the same limbs. The gait cycle duration (seconds) was recorded separately for both extremities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Step duration (seconds)</measure>
    <time_frame>Changes from the step duration at 2 weeks</time_frame>
    <description>Step duration is the time between two consecutive heel strikes. The step duration (seconds) was recorded separately for both extremities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Double stance duration (seconds)</measure>
    <time_frame>Changes from the double stance duration at 2 weeks</time_frame>
    <description>Double stance duration is the time over which the body is supported by both legs. The double stance duration (seconds) was recorded separately for both extremities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Swing duration (seconds)</measure>
    <time_frame>Changes from the swing duration at 2 weeks</time_frame>
    <description>Swing duration is the time taken for the leg to swing through while the body is in single support on the other leg. The swing duration (seconds) was recorded separately for both extremities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait symmetry</measure>
    <time_frame>Changes from the gait asymmetry at 2 weeks (preoperative and postoperative).</time_frame>
    <description>Gait symmetry is a coordinated and consistent activity of locomotion between left and right limb during walking.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Lumbar Disc Herniation</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Lumbar Disc Hernaition Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The number of participants in this group is anticipated to be 153. The pain intensity of the patients was recorded by a Visual Analog Scale (VAS) immediately before performing the analysis. The patients were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The number of participants in this group is anticipated to be 54. The participants were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preoperative and Postoperative Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The number of participants in this group is anticipated to be 59. The patients were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day, before and 15 days after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>All of the spatial and Temporal Gait parameters</intervention_name>
    <arm_group_label>Healthy Control Group</arm_group_label>
    <arm_group_label>Lumbar Disc Hernaition Group</arm_group_label>
    <arm_group_label>Preoperative and Postoperative Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals who were diagnosed with LDH by a specialist;&#xD;
&#xD;
          -  Patients had a medical history and proven by MRI with more or less evidence of&#xD;
             degenerative lumbar disc;&#xD;
&#xD;
          -  Aged between 25-80 years old;&#xD;
&#xD;
          -  Pain symptom on the lumbal area or lower extremity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have previously received surgery or physical therapy treatment;&#xD;
&#xD;
          -  Having congenital deformity in the spine or lower extremity;&#xD;
&#xD;
          -  History of spinal surgery or other diseases affecting gait;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Situations that may cause gait balance problems;&#xD;
&#xD;
          -  Using assistive gait appliance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TUGBA KURU COLAK, Assoc. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Marmara University</affiliation>
  </overall_official>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/25921552</url>
    <description>Gait behaviors as an objective surgical outcome in low back disorders: A systematic review.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Decompression+surgery+improves+gait+quality+in+patients+with+symptomatic+lumbar+spinal+stenosis.</url>
    <description>Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis.</description>
  </link>
  <reference>
    <citation>Toosizadeh N, Yen TC, Howe C, Dohm M, Mohler J, Najafi B. Gait behaviors as an objective surgical outcome in low back disorders: A systematic review. Clin Biomech (Bristol, Avon). 2015 Jul;30(6):528-36. doi: 10.1016/j.clinbiomech.2015.04.005. Epub 2015 Apr 17.</citation>
    <PMID>25921552</PMID>
  </reference>
  <reference>
    <citation>Loske S, Nuesch C, Byrnes KS, Fiebig O, Scharen S, Mundermann A, Netzer C. Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis. Spine J. 2018 Dec;18(12):2195-2204. doi: 10.1016/j.spinee.2018.04.016. Epub 2018 Apr 27.</citation>
    <PMID>29709554</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>September 23, 2022</last_update_submitted>
  <last_update_submitted_qc>September 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Gait analysis</keyword>
  <keyword>Lumbar Disc Herniation</keyword>
  <keyword>Spatiotemporal gait parameters</keyword>
  <keyword>Gait asymmetry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT04409548/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT04409548/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04409548
org study id: Bahçeşehir University
nct id: NCT04409548
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to assessment on the interaction of spatial and temporal gait
      parameters and gait asymmetry in patients with Lumbar Disc Herniation (LDH) before and 15
      days after surgery.
The participants were divided into LDH and healthy control groups. The analysis of the
      spatiotemporal gait parameters was performed using the "Win-Track" gait analysis platform
      system for two groups. In addition, the analysis of spatiotemporal gait parameters of 60
      participants who had the planned lumbar discectomy surgery, was tested before and 15 days
      after surgery. The pain intensity of the patients was recorded by the Visual Analog Scale
      (VAS) immediately before performing the analysis. After then participants completed ten
      passes on the "Win-Track" Gait Analysis Platform at their self-selected walking speed. The
      arithmetic mean of the three flawless walking data was used for analysis. The gait symmetry
      index was used to calculate the walking asymmetry.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Analog Scale (VAS)
time frame: The pain intensity of the patients was recorded immediately before performing the analysis.
description: Pain intensity was obtained using a Visual Analog Scale (VAS). VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "pain as bad as it could be" or the "worst imaginable pain" (Score of 100 [100-mm scale]) on the right side. The patient was asked to mark the line point that represented his or her current pain.
measure: Step length (cm)
time frame: Changes from the step length at 2 weeks
description: Step length is the distance between the heel contact point of one foot and that of the other foot. The step length (cm) was recorded separately for both extremities.
measure: Gait cycle length (cm)
time frame: Changes from the gait cycle length at 2 weeks
description: Gait cycle length is the distance between successive foot contacts of the same limbs. The gait cycle length (cm) was recorded separately for both extremities.
measure: Cadence (step/min)
time frame: Changes from the cadence at 2 weeks
description: Cadence is the number of steps per minute.
measure: Velocity (cm/s)
time frame: Changes from the velocity at 2 weeks
description: Velocity is the distance covered in a given period.
measure: Gait cycle duration (seconds)
time frame: Changes from the gait cycle duration at 2 weeks
description: Gait cycle duration is the time between successive foot contacts of the same limbs. The gait cycle duration (seconds) was recorded separately for both extremities.
measure: Step duration (seconds)
time frame: Changes from the step duration at 2 weeks
description: Step duration is the time between two consecutive heel strikes. The step duration (seconds) was recorded separately for both extremities.
measure: Double stance duration (seconds)
time frame: Changes from the double stance duration at 2 weeks
description: Double stance duration is the time over which the body is supported by both legs. The double stance duration (seconds) was recorded separately for both extremities.
measure: Swing duration (seconds)
time frame: Changes from the swing duration at 2 weeks
description: Swing duration is the time taken for the leg to swing through while the body is in single support on the other leg. The swing duration (seconds) was recorded separately for both extremities.
measure: Gait symmetry
time frame: Changes from the gait asymmetry at 2 weeks (preoperative and postoperative).
description: Gait symmetry is a coordinated and consistent activity of locomotion between left and right limb during walking.
arm group label: Lumbar Disc Hernaition Group
arm group type: Active Comparator
description: The number of participants in this group is anticipated to be 153. The pain intensity of the patients was recorded by a Visual Analog Scale (VAS) immediately before performing the analysis. The patients were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day.
arm group label: Healthy Control Group
arm group type: Active Comparator
description: The number of participants in this group is anticipated to be 54. The participants were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day.
arm group label: Preoperative and Postoperative Group
arm group type: Active Comparator
description: The number of participants in this group is anticipated to be 59. The patients were asked to continuously walk barefoot for ten times as straight as possible without any assistance on the Win-Track platform within the same day, before and 15 days after surgery.
intervention type: Other
intervention name: All of the spatial and Temporal Gait parameters
arm group label: Healthy Control Group
arm group label: Lumbar Disc Hernaition Group
arm group label: Preoperative and Postoperative Group
criteria: 
gender: All
minimum age: 25 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: TUGBA KURU COLAK, Assoc. Prof.
role: Study Director
affiliation: Marmara University
url: https://www.ncbi.nlm.nih.gov/pubmed/25921552
description: Gait behaviors as an objective surgical outcome in low back disorders: A systematic review.
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Decompression+surgery+improves+gait+quality+in+patients+with+symptomatic+lumbar+spinal+stenosis.
description: Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis.
citation: Toosizadeh N, Yen TC, Howe C, Dohm M, Mohler J, Najafi B. Gait behaviors as an objective surgical outcome in low back disorders: A systematic review. Clin Biomech (Bristol, Avon). 2015 Jul;30(6):528-36. doi: 10.1016/j.clinbiomech.2015.04.005. Epub 2015 Apr 17.
PMID: 25921552
citation: Loske S, Nuesch C, Byrnes KS, Fiebig O, Scharen S, Mundermann A, Netzer C. Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis. Spine J. 2018 Dec;18(12):2195-2204. doi: 10.1016/j.spinee.2018.04.016. Epub 2018 Apr 27.
PMID: 29709554
responsible party type: Sponsor
mesh term: Intervertebral Disc Displacement
mesh term: Hernia
provided document: 
provided document: 