<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/NCT04456244</url>
  </required_header>
  <id_info>
    <org_study_id>19/164</org_study_id>
    <nct_id>NCT04456244</nct_id>
  </id_info>
  <brief_title>Comparison of Transtibial and Transfemoral Amputees' Posture Parameters</brief_title>
  <official_title>Comparison of Transtibial and Transfemoral Amputees' Posture Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Istanbul Saglik Bilimleri University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</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>
      With the onset of prosthesis use following lower extremity amputations, body shows&#xD;
      biomechanical changes according to the amputation level and consequently develops adaptation&#xD;
      mechanisms both on the healthy and ampute side. The aim of this study is to determine the&#xD;
      static postural adaptations that appear at different amputation levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2021</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">January 23, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the static posture-1</measure>
    <time_frame>Changes from baseline static posture adaptations before and following Six Minutes Walking Test</time_frame>
    <description>Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in free standing position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the static posture-2</measure>
    <time_frame>Changes from baseline static posture adaptations before and following Six Minutes Walking Test</time_frame>
    <description>Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in equal weighting on platform (3D L.A.S.A.R. Posture, 743L500, Ottobock)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the back pain</measure>
    <time_frame>Changes from baseline static posture adaptations before and following Six Minutes Walking Test</time_frame>
    <description>Pain will be evaluated by using Visual Analog Scale ranging 0(no pain)-10(worst pain)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Amputation; Traumatic, Limb</condition>
  <condition>Postural; Defect</condition>
  <arm_group>
    <arm_group_label>Group 1:Transtibial Amputation</arm_group_label>
    <description>Photographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2:Transfemoral Amputation</arm_group_label>
    <description>Photographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of the static posture</intervention_name>
    <description>Photographing from the back, front and side with ADIBAS posturography in standing position</description>
    <arm_group_label>Group 1:Transtibial Amputation</arm_group_label>
    <arm_group_label>Group 2:Transfemoral Amputation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        With Unilateral Transfemoral and Transtibial Amputation Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being between the ages of 18-65&#xD;
&#xD;
          -  Having had an amputation at least 6 months ago&#xD;
&#xD;
          -  Have had transfemoral amputation or transtibial amputation&#xD;
&#xD;
          -  To be able to perform ambulation independently&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mental inability to understand commands&#xD;
&#xD;
          -  have a neurological, orthopedic and systemic problem that will negatively affect&#xD;
             posture or gait.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>With Unilateral Transfemoral and Transtibial Amputation Patients</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nilüfer Kablan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul Sağlık Bilimleri Üniversitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Saglık Bilimleri University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Silverman AK, Fey NP, Portillo A, Walden JG, Bosker G, Neptune RR. Compensatory mechanisms in below-knee amputee gait in response to increasing steady-state walking speeds. Gait Posture. 2008 Nov;28(4):602-9. doi: 10.1016/j.gaitpost.2008.04.005. Epub 2008 Jun 2.</citation>
    <PMID>18514526</PMID>
  </results_reference>
  <results_reference>
    <citation>Hendershot BD, Nussbaum MA. Persons with lower-limb amputation have impaired trunk postural control while maintaining seated balance. Gait Posture. 2013 Jul;38(3):438-42. doi: 10.1016/j.gaitpost.2013.01.008. Epub 2013 Feb 4.</citation>
    <PMID>23391751</PMID>
  </results_reference>
  <results_reference>
    <citation>Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev. 2008;45(1):15-29. doi: 10.1682/jrrd.2006.11.0147.</citation>
    <PMID>18566923</PMID>
  </results_reference>
  <results_reference>
    <citation>Molina-Rueda F, Alguacil-Diego IM, Cuesta-Gomez A, Iglesias-Gimenez J, Martin-Vivaldi A, Miangolarra-Page JC. Thorax, pelvis and hip pattern in the frontal plane during walking in unilateral transtibial amputees: biomechanical analysis. Braz J Phys Ther. 2014 May-Jun;18(3):252-8. doi: 10.1590/bjpt-rbf.2014.0032.</citation>
    <PMID>25003278</PMID>
  </results_reference>
  <results_reference>
    <citation>Kulkarni J, Gaine WJ, Buckley JG, Rankine JJ, Adams J. Chronic low back pain in traumatic lower limb amputees. Clin Rehabil. 2005 Jan;19(1):81-6. doi: 10.1191/0269215505cr819oa.</citation>
    <PMID>15704512</PMID>
  </results_reference>
  <results_reference>
    <citation>Soares AS, Yamaguti EY, Mochizuki L, Amadio AC, Serrao JC. Biomechanical parameters of gait among transtibial amputees: a review. Sao Paulo Med J. 2009 Sep;127(5):302-9. doi: 10.1590/s1516-31802009000500010.</citation>
    <PMID>20169280</PMID>
  </results_reference>
  <results_reference>
    <citation>Lloyd CH, Stanhope SJ, Davis IS, Royer TD. Strength asymmetry and osteoarthritis risk factors in unilateral trans-tibial, amputee gait. Gait Posture. 2010 Jul;32(3):296-300. doi: 10.1016/j.gaitpost.2010.05.003. Epub 2010 Aug 1.</citation>
    <PMID>20678938</PMID>
  </results_reference>
  <results_reference>
    <citation>Khamis S, Carmeli E. The effect of simulated leg length discrepancy on lower limb biomechanics during gait. Gait Posture. 2018 Mar;61:73-80. doi: 10.1016/j.gaitpost.2017.12.024. Epub 2017 Dec 28.</citation>
    <PMID>29306147</PMID>
  </results_reference>
  <results_reference>
    <citation>Carmona GA, Hoffmeyer P, Herrmann FR, Vaucher J, Tschopp O, Lacraz A, Vischer UM. Major lower limb amputations in the elderly observed over ten years: the role of diabetes and peripheral arterial disease. Diabetes Metab. 2005 Nov;31(5):449-54. doi: 10.1016/s1262-3636(07)70215-x.</citation>
    <PMID>16357788</PMID>
  </results_reference>
  <results_reference>
    <citation>Gaffney BM, Murray AM, Christiansen CL, Davidson BS. Identification of trunk and pelvis movement compensations in patients with transtibial amputation using angular momentum separation. Gait Posture. 2016 Mar;45:151-6. doi: 10.1016/j.gaitpost.2016.01.015. Epub 2016 Jan 25.</citation>
    <PMID>26979898</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>January 19, 2022</last_update_submitted>
  <last_update_submitted_qc>January 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>amputation, postural adaptations, transtibial, transfemoral</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amputation, Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04456244
org study id: 19/164
nct id: NCT04456244
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With the onset of prosthesis use following lower extremity amputations, body shows
      biomechanical changes according to the amputation level and consequently develops adaptation
      mechanisms both on the healthy and ampute side. The aim of this study is to determine the
      static postural adaptations that appear at different amputation levels.
observational model: Other
time perspective: Cross-Sectional
measure: Evaluation of the static posture-1
time frame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
description: Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in free standing position
measure: Evaluation of the static posture-2
time frame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
description: Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in equal weighting on platform (3D L.A.S.A.R. Posture, 743L500, Ottobock)
measure: Evaluation of the back pain
time frame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
description: Pain will be evaluated by using Visual Analog Scale ranging 0(no pain)-10(worst pain)
arm group label: Group 1:Transtibial Amputation
description: Photographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis.
arm group label: Group 2:Transfemoral Amputation
description: Photographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis.
intervention type: Other
intervention name: Evaluation of the static posture
description: Photographing from the back, front and side with ADIBAS posturography in standing position
arm group label: Group 1:Transtibial Amputation
arm group label: Group 2:Transfemoral Amputation
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: With Unilateral Transfemoral and Transtibial Amputation Patients
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nilüfer Kablan, PhD
role: Principal Investigator
affiliation: Istanbul Sağlık Bilimleri Üniversitesi
facility: 
country: Turkey
citation: Silverman AK, Fey NP, Portillo A, Walden JG, Bosker G, Neptune RR. Compensatory mechanisms in below-knee amputee gait in response to increasing steady-state walking speeds. Gait Posture. 2008 Nov;28(4):602-9. doi: 10.1016/j.gaitpost.2008.04.005. Epub 2008 Jun 2.
PMID: 18514526
citation: Hendershot BD, Nussbaum MA. Persons with lower-limb amputation have impaired trunk postural control while maintaining seated balance. Gait Posture. 2013 Jul;38(3):438-42. doi: 10.1016/j.gaitpost.2013.01.008. Epub 2013 Feb 4.
PMID: 23391751
citation: Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev. 2008;45(1):15-29. doi: 10.1682/jrrd.2006.11.0147.
PMID: 18566923
citation: Molina-Rueda F, Alguacil-Diego IM, Cuesta-Gomez A, Iglesias-Gimenez J, Martin-Vivaldi A, Miangolarra-Page JC. Thorax, pelvis and hip pattern in the frontal plane during walking in unilateral transtibial amputees: biomechanical analysis. Braz J Phys Ther. 2014 May-Jun;18(3):252-8. doi: 10.1590/bjpt-rbf.2014.0032.
PMID: 25003278
citation: Kulkarni J, Gaine WJ, Buckley JG, Rankine JJ, Adams J. Chronic low back pain in traumatic lower limb amputees. Clin Rehabil. 2005 Jan;19(1):81-6. doi: 10.1191/0269215505cr819oa.
PMID: 15704512
citation: Soares AS, Yamaguti EY, Mochizuki L, Amadio AC, Serrao JC. Biomechanical parameters of gait among transtibial amputees: a review. Sao Paulo Med J. 2009 Sep;127(5):302-9. doi: 10.1590/s1516-31802009000500010.
PMID: 20169280
citation: Lloyd CH, Stanhope SJ, Davis IS, Royer TD. Strength asymmetry and osteoarthritis risk factors in unilateral trans-tibial, amputee gait. Gait Posture. 2010 Jul;32(3):296-300. doi: 10.1016/j.gaitpost.2010.05.003. Epub 2010 Aug 1.
PMID: 20678938
citation: Khamis S, Carmeli E. The effect of simulated leg length discrepancy on lower limb biomechanics during gait. Gait Posture. 2018 Mar;61:73-80. doi: 10.1016/j.gaitpost.2017.12.024. Epub 2017 Dec 28.
PMID: 29306147
citation: Carmona GA, Hoffmeyer P, Herrmann FR, Vaucher J, Tschopp O, Lacraz A, Vischer UM. Major lower limb amputations in the elderly observed over ten years: the role of diabetes and peripheral arterial disease. Diabetes Metab. 2005 Nov;31(5):449-54. doi: 10.1016/s1262-3636(07)70215-x.
PMID: 16357788
citation: Gaffney BM, Murray AM, Christiansen CL, Davidson BS. Identification of trunk and pelvis movement compensations in patients with transtibial amputation using angular momentum separation. Gait Posture. 2016 Mar;45:151-6. doi: 10.1016/j.gaitpost.2016.01.015. Epub 2016 Jan 25.
PMID: 26979898
responsible party type: Sponsor
mesh term: Amputation, Traumatic
sharing ipd: Undecided