<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/NCT03759613</url>
  </required_header>
  <id_info>
    <org_study_id>GO 18/785</org_study_id>
    <nct_id>NCT03759613</nct_id>
  </id_info>
  <brief_title>Evaluation of Gait Symmetry in Upper Extremity Burn Injuries</brief_title>
  <official_title>Evaluation of Gait Symmetry in Patients With Unilateral Upper Extremity Burn Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ankara Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hacettepe 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>
      Thirty patients with unilateral burn injury, and 60 healthy subjects will be included in this&#xD;
      study. Participants with burn injury will evaluate with the following assessment tools:&#xD;
      Demographic data; age, gender, height, body mass index; burn characteristics; type of burn&#xD;
      injury, degree of burn injury, localization of burn injury and total burn surface area will&#xD;
      be recorded. Gait parameters (step length, stride length, base support, step time, cycle&#xD;
      time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance&#xD;
      (% of gait cycle). will be recorded via computerized system. And gait symmetry will be&#xD;
      calculated via formule. Participants' kinesiophobia level will be evaluated with Tampa&#xD;
      kinesiophobia scale. Their pain will be assessed by visual analog scale. Their arm swing will&#xD;
      be evaluated by a scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty individuals with lower extremity burn injury and sixty healthy subjects will be&#xD;
      included in this study. Participants with burn injury will be included if they are aged of&#xD;
      18-50, able to walk independently at least 10 meters. Healthy subjects will be included if&#xD;
      there are no orthopedic, neurological or musculoskeletal disorders that affect gait.&#xD;
&#xD;
        1. Group: 30 Patients with burn injury&#xD;
&#xD;
        2. Group: 30 healthy subjects (When evaluating the gait analysis, their arm will not be&#xD;
           restricted (Their natural walking)&#xD;
&#xD;
        3. Group : 30 healthy subject (When evaluating the gait analysis, their arm will be&#xD;
           restricted )&#xD;
&#xD;
      Participants will evaluate with the following assessment tools: Demographic data; age,&#xD;
      gender, height, body mass index; burn characteristics; type of burn injury, degree of burn&#xD;
      injury, localization of burn injury and total burn surface area will be recorded.&#xD;
&#xD;
      All subjects' gait analysis will be conducted via GAITRite (computerized) system.&#xD;
&#xD;
      GAITRite system for gait parameters (step length, stride length, base support, step time,&#xD;
      cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and&#xD;
      stance (% of gait cycle), Tampa Kinesiophobia scale for kinesiophobia level, visual analog&#xD;
      scale for pain, a scale that developed by us for arm swing will be used.&#xD;
&#xD;
      These evaluations will be applied one time for participants. These evaluations will be made&#xD;
      within 5 days following burn injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</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>Screening</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gait Speed</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>It is measured by computerized gait analysis system. Speed is the distance walked per unit of time. It is determined in centimeters per second (cm/sec)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>step length</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>It is measured by computerized gait analysis system. Difference in position between the feet at heel strike, in the direction of forward motion. The unit of measure is centimeters. It is calculated both right and left foot.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Swing phase</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>It is measured by computerized gait analysis system. Swing Phase,which accounts for 40% of a single gait cycle, the phase during which the foot is not in contact with the ground. It is expressed in seconds (sec) and as a percentage of the gait cycle of the same foot. It is calculated both right and left foot.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stance Phase</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>It is measured by computerized gait analysis system.The gait phase that lasts from heel strike to toe off, which accounts for 60% of a single gait cycle. It is expressed in seconds (sec) and as a percentage of the gait cycle of the same foot. It is calculated both right and left foot.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Single Support</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>It is measured by computerized gait analysis system. Only one foot in contact with the floor. It is expressed as a percentage of the gait cycle. It is calculated both right and left foot.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Double Support</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>It is measured by computerized gait analysis system. Boot feet in contact with the floor. It is expressed as a percentage of the gait cycle. It is calculated both right and left foot.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait symmetry index</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>It's calculated in order to evaluate symmetry for bilateral parameters of gait. The value of symmetry index =0 equals full symmetry. Minimum score is 0 indicates perfect symmetry. Maximum score is endless. The higher score is indicated the more asymmetrica gait pattern.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cadence</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>It is measured by computerized gait analysis system. Rhythm expressed in steps per second.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Base support</measure>
    <time_frame>through study completion, an average of 5 months.</time_frame>
    <description>It is measured by computerized gait analysis system. It is the distance between two linescutting feet equal halves. The unit of measure is centimeters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tampa Kinesiophobia Scale</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>This scale consists of a 17-item self-report questionnaire that measures the fear of re-injury because of movement. Items are scored on a 4-point Likert scale ranging from 1 &quot;strongly disagree&quot; to 4 &quot;strongly agree&quot;. The total scores for scale range from 17 to 68. Maximum score means higher level of kinesiophobia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain severity</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>Pain severity was assessed by visual analogue scale. This scale score range from &quot;no pain=0 point &quot; to &quot;worst imaginable pain=10 points&quot; for intensity. Maximum point means worst pain severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm swing</measure>
    <time_frame>through study completion, an average of 5 months</time_frame>
    <description>Arm swing will be evaluated with an arm swing scale. Arm swing scale consists of a 5 item questions for each side (left arm-right arm). Totally, scale consist of 10 questions. Scale score range from &quot;10 points: indicates normal arm swing&quot; to &quot;0 points: indicates totally restricted arm swing. Maximum score means best arm swing.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Burn Injury</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thirty subjects with unilateral upper burn injury will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. Their evaluations will be made within 5 days following burn injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thirty healthy subjects will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. When their gait analysis made, they will be asked to walk their natural walking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Grup (Restricted arm swing)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Thirty healthy subjects will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. When their gait analysis made, their arms will be fixed with a bandage on their bodies. Their arm swing will be restricted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gait Analysis</intervention_name>
    <description>Gait Analysis: Gait analysis is not a routine assessment tool for upper extremity burn injuries. This analysis is an assessment method to estimate gait symmetry.&#xD;
Restriction arm swing: Participants in group will be restricted for arm swing using a bandage. Thus, the reciprocal arm swing will be prevented.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Control Grup (Restricted arm swing)</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
    <other_name>Arm Restriction</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of upper extremity burn injury&#xD;
&#xD;
          -  must be able to walk independently&#xD;
&#xD;
          -  Control group consists of healthy adults with the similar demographic characteristics&#xD;
             as experimental group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Walking with assist device&#xD;
&#xD;
          -  Having a visual deficits&#xD;
&#xD;
          -  Having an orthopedic problems that affect gait&#xD;
&#xD;
          -  Having a neurological disorders&#xD;
&#xD;
          -  Having a musculoskeletal disorders that affect gait&#xD;
&#xD;
          -  Having an undergone orthopedic surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ozden Ozkal, PhD, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ozden Ozkal</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>June 13, 2019</last_update_submitted>
  <last_update_submitted_qc>June 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Ozden Ozkal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Burn Injury</keyword>
  <keyword>Gait Symmetry</keyword>
  <keyword>Arm Swing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <!-- 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/NCT03759613
org study id: GO 18/785
nct id: NCT03759613
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thirty patients with unilateral burn injury, and 60 healthy subjects will be included in this
      study. Participants with burn injury will evaluate with the following assessment tools:
      Demographic data; age, gender, height, body mass index; burn characteristics; type of burn
      injury, degree of burn injury, localization of burn injury and total burn surface area will
      be recorded. Gait parameters (step length, stride length, base support, step time, cycle
      time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance
      (% of gait cycle). will be recorded via computerized system. And gait symmetry will be
      calculated via formule. Participants' kinesiophobia level will be evaluated with Tampa
      kinesiophobia scale. Their pain will be assessed by visual analog scale. Their arm swing will
      be evaluated by a scale.
Thirty individuals with lower extremity burn injury and sixty healthy subjects will be
      included in this study. Participants with burn injury will be included if they are aged of
      18-50, able to walk independently at least 10 meters. Healthy subjects will be included if
      there are no orthopedic, neurological or musculoskeletal disorders that affect gait.

        1. Group: 30 Patients with burn injury

        2. Group: 30 healthy subjects (When evaluating the gait analysis, their arm will not be
           restricted (Their natural walking)

        3. Group : 30 healthy subject (When evaluating the gait analysis, their arm will be
           restricted )

      Participants will evaluate with the following assessment tools: Demographic data; age,
      gender, height, body mass index; burn characteristics; type of burn injury, degree of burn
      injury, localization of burn injury and total burn surface area will be recorded.

      All subjects' gait analysis will be conducted via GAITRite (computerized) system.

      GAITRite system for gait parameters (step length, stride length, base support, step time,
      cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and
      stance (% of gait cycle), Tampa Kinesiophobia scale for kinesiophobia level, visual analog
      scale for pain, a scale that developed by us for arm swing will be used.

      These evaluations will be applied one time for participants. These evaluations will be made
      within 5 days following burn injury.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Outcomes Assessor)
measure: Gait Speed
time frame: through study completion, an average of 5 months
description: It is measured by computerized gait analysis system. Speed is the distance walked per unit of time. It is determined in centimeters per second (cm/sec)
measure: step length
time frame: through study completion, an average of 5 months
description: It is measured by computerized gait analysis system. Difference in position between the feet at heel strike, in the direction of forward motion. The unit of measure is centimeters. It is calculated both right and left foot.
measure: Swing phase
time frame: through study completion, an average of 5 months
description: It is measured by computerized gait analysis system. Swing Phase,which accounts for 40% of a single gait cycle, the phase during which the foot is not in contact with the ground. It is expressed in seconds (sec) and as a percentage of the gait cycle of the same foot. It is calculated both right and left foot.
measure: Stance Phase
time frame: through study completion, an average of 5 months
description: It is measured by computerized gait analysis system.The gait phase that lasts from heel strike to toe off, which accounts for 60% of a single gait cycle. It is expressed in seconds (sec) and as a percentage of the gait cycle of the same foot. It is calculated both right and left foot.
measure: Single Support
time frame: through study completion, an average of 5 months
description: It is measured by computerized gait analysis system. Only one foot in contact with the floor. It is expressed as a percentage of the gait cycle. It is calculated both right and left foot.
measure: Double Support
time frame: through study completion, an average of 5 months
description: It is measured by computerized gait analysis system. Boot feet in contact with the floor. It is expressed as a percentage of the gait cycle. It is calculated both right and left foot.
measure: Gait symmetry index
time frame: through study completion, an average of 5 months
description: It's calculated in order to evaluate symmetry for bilateral parameters of gait. The value of symmetry index =0 equals full symmetry. Minimum score is 0 indicates perfect symmetry. Maximum score is endless. The higher score is indicated the more asymmetrica gait pattern.
measure: Cadence
time frame: through study completion, an average of 5 months
description: It is measured by computerized gait analysis system. Rhythm expressed in steps per second.
measure: Base support
time frame: through study completion, an average of 5 months.
description: It is measured by computerized gait analysis system. It is the distance between two linescutting feet equal halves. The unit of measure is centimeters.
measure: Tampa Kinesiophobia Scale
time frame: through study completion, an average of 5 months
description: This scale consists of a 17-item self-report questionnaire that measures the fear of re-injury because of movement. Items are scored on a 4-point Likert scale ranging from 1 "strongly disagree" to 4 "strongly agree". The total scores for scale range from 17 to 68. Maximum score means higher level of kinesiophobia.
measure: Pain severity
time frame: through study completion, an average of 5 months
description: Pain severity was assessed by visual analogue scale. This scale score range from "no pain=0 point " to "worst imaginable pain=10 points" for intensity. Maximum point means worst pain severity.
measure: Arm swing
time frame: through study completion, an average of 5 months
description: Arm swing will be evaluated with an arm swing scale. Arm swing scale consists of a 5 item questions for each side (left arm-right arm). Totally, scale consist of 10 questions. Scale score range from "10 points: indicates normal arm swing" to "0 points: indicates totally restricted arm swing. Maximum score means best arm swing.
arm group label: Experimental Group
arm group type: Experimental
description: Thirty subjects with unilateral upper burn injury will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. Their evaluations will be made within 5 days following burn injury.
arm group label: Control Group
arm group type: Active Comparator
description: Thirty healthy subjects will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. When their gait analysis made, they will be asked to walk their natural walking.
arm group label: Control Grup (Restricted arm swing)
arm group type: Sham Comparator
description: Thirty healthy subjects will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. When their gait analysis made, their arms will be fixed with a bandage on their bodies. Their arm swing will be restricted.
intervention type: Other
intervention name: Gait Analysis
description: Gait Analysis: Gait analysis is not a routine assessment tool for upper extremity burn injuries. This analysis is an assessment method to estimate gait symmetry.
Restriction arm swing: Participants in group will be restricted for arm swing using a bandage. Thus, the reciprocal arm swing will be prevented.
arm group label: Control Group
arm group label: Control Grup (Restricted arm swing)
arm group label: Experimental Group
other name: Arm Restriction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ozden Ozkal, PhD, PT
role: Principal Investigator
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Ozden Ozkal
investigator title: Principal Investigator
mesh term: Wounds and Injuries
mesh term: Burns