<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/NCT03304405</url>
  </required_header>
  <id_info>
    <org_study_id>UW 16-294</org_study_id>
    <nct_id>NCT03304405</nct_id>
  </id_info>
  <brief_title>Influence of Sagittal Imbalance of the Spine on Gait Pattern in Adult Spinal Deformity</brief_title>
  <official_title>Influence of Sagittal Imbalance of the Spine on Gait Pattern in Adult Spinal Deformity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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>
      This study intends to investigate the changes in gait pattern in adult spinal deformity (ASD)&#xD;
      patients with sagittal imbalance. It will investigate the gait kinematics in patients who&#xD;
      have a mismatch of their spinopelvic parameters, and a positive sagittal balance. The&#xD;
      investigators hypothesise that patients with abnormal spinopelvic parameters may demonstrate&#xD;
      a pathological gait pattern.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With an ageing population, ASD presents as a significant health issue with increasing&#xD;
      incidence. Most of the earlier literature concentrated on radiographic measurements of the&#xD;
      deformity in the coronal plane, and its surgical correction. However, recent publications&#xD;
      have demonstrated that sagittal spinopelvic alignment plays a critical role in pain and&#xD;
      disability in patients with ASD, and is a primary determinant of health related quality of&#xD;
      life measures. There is substantial evidence that restoration of these parameters after&#xD;
      spinal reconstructive surgery is correlated with good clinical outcome.&#xD;
&#xD;
      Maintenance of the ideal sagittal alignment allows an individual to maintain an erect posture&#xD;
      with minimal energy expenditure. When there is progressive loss of lumbar lordosis,&#xD;
      compensatory mechanisms involving the pelvis, hips and knees occur to extend adjacent&#xD;
      segments of the kyphotic spine to allow for compensation of anterior translation of the axis&#xD;
      of gravity. However, this compensatory mechanism may potentially result in adverse effect.&#xD;
      One of the main disabilities in ASD patients with sagittal imbalance is their decreased&#xD;
      walking tolerance. The change in the spinal alignment along with these compensatory&#xD;
      mechanisms may result in an inefficient gait worsening their walking tolerance.&#xD;
&#xD;
      Few studies in the literature have investigated the changes in gait pattern in patients with&#xD;
      sagittal imbalance. Of those, the patient group was heterogeneous, and the only criterion of&#xD;
      sagittal imbalance was a positive sagittal vertical axis (SVA), which the investigators now&#xD;
      know is not a complete assessment of the sagittal alignment. The investigators propose to&#xD;
      study the change in gait pattern in individuals with abnormal spinopelvic parameters, and how&#xD;
      this may affect their quality of lives.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the effect of sagittal imbalance on the gait cycle using reflective surface markers</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate the effect of sagittal imbalance on the gait cycle using reflective surface markers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigate the difference in gait kinematics between normal and abnormal sagittal balance using reflective surface markers</measure>
    <time_frame>1 year</time_frame>
    <description>To investigate the difference in gait kinematics between normal and abnormal sagittal balance using reflective surface markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigate the efficiency in gait differences between normal and abnormal sagittal balance using reflective surface markers</measure>
    <time_frame>1 year</time_frame>
    <description>To investigate the efficiency in gait differences between normal and abnormal sagittal balance using reflective surface markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigate different muscle recruitment in gait cycles between normal and abnormal sagittal balance using a submaximal graded exercise test</measure>
    <time_frame>1 year</time_frame>
    <description>To investigate different muscle recruitment in gait cycles between normal and abnormal sagittal balance using a submaximal graded exercise test</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Adult Spinal Deformity</condition>
  <arm_group>
    <arm_group_label>Gait Analysis</arm_group_label>
    <description>All patients will undergo gait analysis using reflective surface markers placed at different locations on the head, trunk, upper and lower extremities, and pelvis. All patients will complete an analog pain scale, Oswestry, and SRS-22 questionnaires. These are health-related quality of life questionnaires that provide subjective assessment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Gait Analysis</intervention_name>
    <description>All patients will undergo gait analysis using reflective surface markers placed at different locations on the head, trunk, upper and lower extremities, and pelvis. All patients will complete an analog pain scale, Oswestry, and SRS-22 questionnaires. These are health-related quality of life questionnaires that provide subjective assessment.</description>
    <arm_group_label>Gait Analysis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diagnosis of ADS will be recruited in this study conducted by the Department&#xD;
        of Orthopaedics and Traumatology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients diagnosed with ASD, fulfilling the following radiographic criteria based on&#xD;
        whole spine lateral film are eligible for recruitment:&#xD;
&#xD;
          -  SVA bigger than 47mm&#xD;
&#xD;
          -  Pelvic tilt (PT) bigger than 22deg&#xD;
&#xD;
          -  Pelvic incidence (PI) - lumbar lordosis (LL) bigger than 11deg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If the aetiology of the ASD of the patient is neuromuscular origin&#xD;
&#xD;
          -  other pathologies that may affect their gait such as previous trauma or surgeries to&#xD;
             the pelvis or the lower limbs and joint replacements&#xD;
&#xD;
          -  inability to walk without aids for short distances&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Kenny Kwan, BMBCh(Oxon)</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duchess of Kent Children's Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Cho KJ, Suk SI, Park SR, Kim JH, Kang SB, Kim HS, Oh SJ. Risk factors of sagittal decompensation after long posterior instrumentation and fusion for degenerative lumbar scoliosis. Spine (Phila Pa 1976). 2010 Aug 1;35(17):1595-601. doi: 10.1097/BRS.0b013e3181bdad89.</citation>
    <PMID>20386505</PMID>
  </reference>
  <reference>
    <citation>Glassman SD, Berven S, Bridwell K, Horton W, Dimar JR. Correlation of radiographic parameters and clinical symptoms in adult scoliosis. Spine (Phila Pa 1976). 2005 Mar 15;30(6):682-8. doi: 10.1097/01.brs.0000155425.04536.f7.</citation>
    <PMID>15770185</PMID>
  </reference>
  <reference>
    <citation>Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S, Schwab F. The impact of positive sagittal balance in adult spinal deformity. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2024-9. doi: 10.1097/01.brs.0000179086.30449.96.</citation>
    <PMID>16166889</PMID>
  </reference>
  <reference>
    <citation>Smith JS, Bess S, Shaffrey CI, Burton DC, Hart RA, Hostin R, Klineberg E; International Spine Study Group. Dynamic changes of the pelvis and spine are key to predicting postoperative sagittal alignment after pedicle subtraction osteotomy: a critical analysis of preoperative planning techniques. Spine (Phila Pa 1976). 2012 May 1;37(10):845-53. doi: 10.1097/BRS.0b013e31823b0892.</citation>
    <PMID>22024904</PMID>
  </reference>
  <reference>
    <citation>Le Huec JC, Faundez A, Dominguez D, Hoffmeyer P, Aunoble S. Evidence showing the relationship between sagittal balance and clinical outcomes in surgical treatment of degenerative spinal diseases: a literature review. Int Orthop. 2015 Jan;39(1):87-95. doi: 10.1007/s00264-014-2516-6. Epub 2014 Sep 6.</citation>
    <PMID>25192690</PMID>
  </reference>
  <reference>
    <citation>Barrey C, Roussouly P, Le Huec JC, D'Acunzi G, Perrin G. Compensatory mechanisms contributing to keep the sagittal balance of the spine. Eur Spine J. 2013 Nov;22 Suppl 6(Suppl 6):S834-41. doi: 10.1007/s00586-013-3030-z. Epub 2013 Sep 20.</citation>
    <PMID>24052406</PMID>
  </reference>
  <reference>
    <citation>Engsberg JR, Bridwell KH, Reitenbach AK, Uhrich ML, Baldus C, Blanke K, Lenke LG. Preoperative gait comparisons between adults undergoing long spinal deformity fusion surgery (thoracic to L4, L5, or sacrum) and controls. Spine (Phila Pa 1976). 2001 Sep 15;26(18):2020-8. doi: 10.1097/00007632-200109150-00016.</citation>
    <PMID>11547203</PMID>
  </reference>
  <reference>
    <citation>Sarwahi V, Boachie-Adjei O, Backus SI, Taira G. Characterization of gait function in patients with postsurgical sagittal (flatback) deformity: a prospective study of 21 patients. Spine (Phila Pa 1976). 2002 Nov 1;27(21):2328-37. doi: 10.1097/00007632-200211010-00005.</citation>
    <PMID>12438980</PMID>
  </reference>
  <reference>
    <citation>Gottipati P, Fatone S, Koski T, Sugrue PA, Ganju A. Crouch gait in persons with positive sagittal spine alignment resolves with surgery. Gait Posture. 2014;39(1):372-7. doi: 10.1016/j.gaitpost.2013.08.012. Epub 2013 Aug 18.</citation>
    <PMID>24011797</PMID>
  </reference>
  <reference>
    <citation>Romei M, Galli M, Motta F, Schwartz M, Crivellini M. Use of the normalcy index for the evaluation of gait pathology. Gait Posture. 2004 Feb;19(1):85-90. doi: 10.1016/s0966-6362(03)00017-1.</citation>
    <PMID>14741307</PMID>
  </reference>
  <reference>
    <citation>Syczewska M, Dembowska-Baginska B, Perek-Polnik M, Kalinowska M, Perek D. Gait pathology assessed with Gillette Gait Index in patients after CNS tumour treatment. Gait Posture. 2010 Jul;32(3):358-62. doi: 10.1016/j.gaitpost.2010.06.006. Epub 2010 Jul 13.</citation>
    <PMID>20630761</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>May 5, 2020</last_update_submitted>
  <last_update_submitted_qc>May 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Kenny Kwan</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>ASD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03304405
org study id: UW 16-294
nct id: NCT03304405
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study intends to investigate the changes in gait pattern in adult spinal deformity (ASD)
      patients with sagittal imbalance. It will investigate the gait kinematics in patients who
      have a mismatch of their spinopelvic parameters, and a positive sagittal balance. The
      investigators hypothesise that patients with abnormal spinopelvic parameters may demonstrate
      a pathological gait pattern.
With an ageing population, ASD presents as a significant health issue with increasing
      incidence. Most of the earlier literature concentrated on radiographic measurements of the
      deformity in the coronal plane, and its surgical correction. However, recent publications
      have demonstrated that sagittal spinopelvic alignment plays a critical role in pain and
      disability in patients with ASD, and is a primary determinant of health related quality of
      life measures. There is substantial evidence that restoration of these parameters after
      spinal reconstructive surgery is correlated with good clinical outcome.

      Maintenance of the ideal sagittal alignment allows an individual to maintain an erect posture
      with minimal energy expenditure. When there is progressive loss of lumbar lordosis,
      compensatory mechanisms involving the pelvis, hips and knees occur to extend adjacent
      segments of the kyphotic spine to allow for compensation of anterior translation of the axis
      of gravity. However, this compensatory mechanism may potentially result in adverse effect.
      One of the main disabilities in ASD patients with sagittal imbalance is their decreased
      walking tolerance. The change in the spinal alignment along with these compensatory
      mechanisms may result in an inefficient gait worsening their walking tolerance.

      Few studies in the literature have investigated the changes in gait pattern in patients with
      sagittal imbalance. Of those, the patient group was heterogeneous, and the only criterion of
      sagittal imbalance was a positive sagittal vertical axis (SVA), which the investigators now
      know is not a complete assessment of the sagittal alignment. The investigators propose to
      study the change in gait pattern in individuals with abnormal spinopelvic parameters, and how
      this may affect their quality of lives.
observational model: Cohort
time perspective: Prospective
measure: Evaluate the effect of sagittal imbalance on the gait cycle using reflective surface markers
time frame: 1 year
description: To evaluate the effect of sagittal imbalance on the gait cycle using reflective surface markers
measure: Investigate the difference in gait kinematics between normal and abnormal sagittal balance using reflective surface markers
time frame: 1 year
description: To investigate the difference in gait kinematics between normal and abnormal sagittal balance using reflective surface markers
measure: Investigate the efficiency in gait differences between normal and abnormal sagittal balance using reflective surface markers
time frame: 1 year
description: To investigate the efficiency in gait differences between normal and abnormal sagittal balance using reflective surface markers
measure: Investigate different muscle recruitment in gait cycles between normal and abnormal sagittal balance using a submaximal graded exercise test
time frame: 1 year
description: To investigate different muscle recruitment in gait cycles between normal and abnormal sagittal balance using a submaximal graded exercise test
arm group label: Gait Analysis
description: All patients will undergo gait analysis using reflective surface markers placed at different locations on the head, trunk, upper and lower extremities, and pelvis. All patients will complete an analog pain scale, Oswestry, and SRS-22 questionnaires. These are health-related quality of life questionnaires that provide subjective assessment.
intervention type: Diagnostic Test
intervention name: Gait Analysis
description: All patients will undergo gait analysis using reflective surface markers placed at different locations on the head, trunk, upper and lower extremities, and pelvis. All patients will complete an analog pain scale, Oswestry, and SRS-22 questionnaires. These are health-related quality of life questionnaires that provide subjective assessment.
arm group label: Gait Analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dr Kenny Kwan, BMBCh(Oxon)
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
citation: Cho KJ, Suk SI, Park SR, Kim JH, Kang SB, Kim HS, Oh SJ. Risk factors of sagittal decompensation after long posterior instrumentation and fusion for degenerative lumbar scoliosis. Spine (Phila Pa 1976). 2010 Aug 1;35(17):1595-601. doi: 10.1097/BRS.0b013e3181bdad89.
PMID: 20386505
citation: Glassman SD, Berven S, Bridwell K, Horton W, Dimar JR. Correlation of radiographic parameters and clinical symptoms in adult scoliosis. Spine (Phila Pa 1976). 2005 Mar 15;30(6):682-8. doi: 10.1097/01.brs.0000155425.04536.f7.
PMID: 15770185
citation: Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S, Schwab F. The impact of positive sagittal balance in adult spinal deformity. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2024-9. doi: 10.1097/01.brs.0000179086.30449.96.
PMID: 16166889
citation: Smith JS, Bess S, Shaffrey CI, Burton DC, Hart RA, Hostin R, Klineberg E; International Spine Study Group. Dynamic changes of the pelvis and spine are key to predicting postoperative sagittal alignment after pedicle subtraction osteotomy: a critical analysis of preoperative planning techniques. Spine (Phila Pa 1976). 2012 May 1;37(10):845-53. doi: 10.1097/BRS.0b013e31823b0892.
PMID: 22024904
citation: Le Huec JC, Faundez A, Dominguez D, Hoffmeyer P, Aunoble S. Evidence showing the relationship between sagittal balance and clinical outcomes in surgical treatment of degenerative spinal diseases: a literature review. Int Orthop. 2015 Jan;39(1):87-95. doi: 10.1007/s00264-014-2516-6. Epub 2014 Sep 6.
PMID: 25192690
citation: Barrey C, Roussouly P, Le Huec JC, D'Acunzi G, Perrin G. Compensatory mechanisms contributing to keep the sagittal balance of the spine. Eur Spine J. 2013 Nov;22 Suppl 6(Suppl 6):S834-41. doi: 10.1007/s00586-013-3030-z. Epub 2013 Sep 20.
PMID: 24052406
citation: Engsberg JR, Bridwell KH, Reitenbach AK, Uhrich ML, Baldus C, Blanke K, Lenke LG. Preoperative gait comparisons between adults undergoing long spinal deformity fusion surgery (thoracic to L4, L5, or sacrum) and controls. Spine (Phila Pa 1976). 2001 Sep 15;26(18):2020-8. doi: 10.1097/00007632-200109150-00016.
PMID: 11547203
citation: Sarwahi V, Boachie-Adjei O, Backus SI, Taira G. Characterization of gait function in patients with postsurgical sagittal (flatback) deformity: a prospective study of 21 patients. Spine (Phila Pa 1976). 2002 Nov 1;27(21):2328-37. doi: 10.1097/00007632-200211010-00005.
PMID: 12438980
citation: Gottipati P, Fatone S, Koski T, Sugrue PA, Ganju A. Crouch gait in persons with positive sagittal spine alignment resolves with surgery. Gait Posture. 2014;39(1):372-7. doi: 10.1016/j.gaitpost.2013.08.012. Epub 2013 Aug 18.
PMID: 24011797
citation: Romei M, Galli M, Motta F, Schwartz M, Crivellini M. Use of the normalcy index for the evaluation of gait pathology. Gait Posture. 2004 Feb;19(1):85-90. doi: 10.1016/s0966-6362(03)00017-1.
PMID: 14741307
citation: Syczewska M, Dembowska-Baginska B, Perek-Polnik M, Kalinowska M, Perek D. Gait pathology assessed with Gillette Gait Index in patients after CNS tumour treatment. Gait Posture. 2010 Jul;32(3):358-62. doi: 10.1016/j.gaitpost.2010.06.006. Epub 2010 Jul 13.
PMID: 20630761
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Kenny Kwan
investigator title: Clinical Assistant Professor
mesh term: Congenital Abnormalities
sharing ipd: No