<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/NCT02988310</url>
  </required_header>
  <id_info>
    <org_study_id>G10</org_study_id>
    <nct_id>NCT02988310</nct_id>
  </id_info>
  <brief_title>Comparison of Gait Characteristics in Individuals With Above and Below Knee Limb Loss</brief_title>
  <official_title>Comparison of Gait Characteristics in Individuals With Trans Femaoral and Trans Tibial Limb Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15&#xD;
      healthy individuals will be participants of the study. Participants with lower limb loss will&#xD;
      evaluate with the following assessment tools: Demographic datas; age, gender, height, body&#xD;
      mass will be recorded. Gait parameters (step length, variation of step length, time on each&#xD;
      foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's preferred&#xD;
      speed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15&#xD;
      healthy individuals who were referred to receive amputee rehabilitation at Hacettepe&#xD;
      University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation,&#xD;
      Prosthetics and Biomechanics unit, and healthy individuals will be the subjects of this&#xD;
      study.&#xD;
&#xD;
      Participants will evaluate with the following assessment tools: Demographic datas; age,&#xD;
      gender, height, body mass will be recorded. Gait parameters (step length, variation of step&#xD;
      length, time on each foot, ambulation index, gait speed) will evaluate with Gait Trainer&#xD;
      Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants&#xD;
      practiced at treadmill to determine appropriate gait speed. Once participants implied the&#xD;
      preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was&#xD;
      recorded between the 4nd and 6th minutes at walk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Step length assesment while walking.</measure>
    <time_frame>Initially evaluation at first minute</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ambulation index assessment while walking.</measure>
    <time_frame>Initially evaluation at first minute</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">39</enrollment>
  <condition>Amputation</condition>
  <arm_group>
    <arm_group_label>Individuals with below knee limb loss</arm_group_label>
    <description>Individuals with below knee limb loss will be participants of the group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individuals with above knee limb loss</arm_group_label>
    <description>Individuals with above knee limb loss will be participants of the group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy individuals</arm_group_label>
    <description>Healthy individuals will be participants of the group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <arm_group_label>Healthy individuals</arm_group_label>
    <arm_group_label>Individuals with above knee limb loss</arm_group_label>
    <arm_group_label>Individuals with below knee limb loss</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals with unilateral below or above knee limb loss&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with unilateral above knee lower limb loss and below knee limb loss&#xD;
&#xD;
          -  Age between 20-55 years&#xD;
&#xD;
          -  Using conventional type socket design Dynamic foot using&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have passive joint limitation at extremities&#xD;
&#xD;
          -  Surgery at last 1 year&#xD;
&#xD;
          -  Systemic problems such as neurological disorders, rheumatoid disorders&#xD;
&#xD;
          -  Another orthopedic anomalies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>hhotaman</investigator_full_name>
    <investigator_title>Research Assistant, PhD,PT</investigator_title>
  </responsible_party>
  <keyword>Limb Loss</keyword>
  <keyword>Gait Characteristics</keyword>
  <!-- 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/NCT02988310
org study id: G10
nct id: NCT02988310
lead sponsor: 
has dmc: Yes
Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15
      healthy individuals will be participants of the study. Participants with lower limb loss will
      evaluate with the following assessment tools: Demographic datas; age, gender, height, body
      mass will be recorded. Gait parameters (step length, variation of step length, time on each
      foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's preferred
      speed.
Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15
      healthy individuals who were referred to receive amputee rehabilitation at Hacettepe
      University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation,
      Prosthetics and Biomechanics unit, and healthy individuals will be the subjects of this
      study.

      Participants will evaluate with the following assessment tools: Demographic datas; age,
      gender, height, body mass will be recorded. Gait parameters (step length, variation of step
      length, time on each foot, ambulation index, gait speed) will evaluate with Gait Trainer
      Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants
      practiced at treadmill to determine appropriate gait speed. Once participants implied the
      preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was
      recorded between the 4nd and 6th minutes at walk.
time perspective: Cross-Sectional
measure: Step length assesment while walking.
time frame: Initially evaluation at first minute
measure: Ambulation index assessment while walking.
time frame: Initially evaluation at first minute
arm group label: Individuals with below knee limb loss
description: Individuals with below knee limb loss will be participants of the group.
arm group label: Individuals with above knee limb loss
description: Individuals with above knee limb loss will be participants of the group.
arm group label: Healthy individuals
description: Healthy individuals will be participants of the group.
intervention type: Other
intervention name: No intervention
arm group label: Healthy individuals
arm group label: Individuals with above knee limb loss
arm group label: Individuals with below knee limb loss
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: hhotaman
investigator title: Research Assistant, PhD,PT