<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/NCT01689922</url>
  </required_header>
  <id_info>
    <org_study_id>JPNI-2</org_study_id>
    <nct_id>NCT01689922</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Anti-Gravity Treadmill Training</brief_title>
  <official_title>The Effectiveness of Anti-Gravity Treadmill Training in Patients After Lumbar Microdiscectomy and Fusion Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Justin Parker Neurological Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Justin Parker Neurological Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to compare the effectiveness of standard for our&#xD;
      practice postoperative physical therapy (PT) program to a PT program that incorporates lower&#xD;
      body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and&#xD;
      fusion surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, randomized, parallel group controlled clinical study is proposed. The patients&#xD;
      will be divided into the two study groups according to the surgical procedure:&#xD;
&#xD;
        1. patients undergoing one-level microdiscectomy for lumbar herniated disc&#xD;
&#xD;
        2. patients undergoing one-level lumbar fusion for degenerative disc disease without&#xD;
           notable spinal stenosis.&#xD;
&#xD;
      Each group will consist of 60 patients (see sample size calculations below) who will be&#xD;
      randomized into the two equal groups to undergo:&#xD;
&#xD;
        1. Standard postoperative rehabilitation program&#xD;
&#xD;
        2. Standard postoperative rehabilitation program with addition of lower body positive&#xD;
           pressure (LBPP) treadmill training&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    slow enrollment&#xD;
  </why_stopped>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry Disability Questionnaire</measure>
    <time_frame>24 months</time_frame>
    <description>10 points or 20% improvement on Oswestry Disability Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Global Outcome Ratings and Health Quality Improvement</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Lumbar Degenerative Disc Disease</condition>
  <arm_group>
    <arm_group_label>AlterG and Physical therapy</arm_group_label>
    <description>2) Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>1) Standard postoperative rehabilitation program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AlterG</intervention_name>
    <description>All patients will begin an early postoperative rehabilitation program and standard PT no later than 4 weeks following surgery and continue for at least 6 weeks. The duration of standard PT program could be extended depending on the patient needs. The patients randomized to undergo (LBPP) treadmill training will have an additional 7-week 3 times a week training on the antigravity</description>
    <arm_group_label>AlterG and Physical therapy</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing one-level microdiscectomy or fusion surgeries&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults between 18 and 65 years old&#xD;
&#xD;
          -  Willing and able to comply with protocol and PT requirements&#xD;
&#xD;
          -  Patients with primarily radicular and back pain due to degenerative disc disease&#xD;
             requiring one-level discectomy for herniated disc or lumbar fusion between L2 and S1&#xD;
&#xD;
          -  Willing and able to sign a study specific informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Require more than one-level surgery&#xD;
&#xD;
          -  No previous lumbar surgery&#xD;
&#xD;
          -  Any ongoing health condition that would make it difficult to adhere to postoperative&#xD;
             PT requirements&#xD;
&#xD;
          -  Peri-operative or post-operative complications (infection, pneumonia, nerve injury,&#xD;
             dural tear, etc.) that would constraint or delay the ability to participate in&#xD;
             postoperative PT&#xD;
&#xD;
          -  BMI greater than 40&#xD;
&#xD;
          -  Active local or systemic infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan T Villavicencio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boulder Neurosurgical Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boulder Neurosurgical Associates</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>June 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>February 28, 2017</last_update_submitted>
  <last_update_submitted_qc>February 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</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/NCT01689922
org study id: JPNI-2
nct id: NCT01689922
lead sponsor: 
has dmc: No
The primary objective of this study is to compare the effectiveness of standard for our
      practice postoperative physical therapy (PT) program to a PT program that incorporates lower
      body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and
      fusion surgeries.
A prospective, randomized, parallel group controlled clinical study is proposed. The patients
      will be divided into the two study groups according to the surgical procedure:

        1. patients undergoing one-level microdiscectomy for lumbar herniated disc

        2. patients undergoing one-level lumbar fusion for degenerative disc disease without
           notable spinal stenosis.

      Each group will consist of 60 patients (see sample size calculations below) who will be
      randomized into the two equal groups to undergo:

        1. Standard postoperative rehabilitation program

        2. Standard postoperative rehabilitation program with addition of lower body positive
           pressure (LBPP) treadmill training
observational model: Other
time perspective: Prospective
measure: Oswestry Disability Questionnaire
time frame: 24 months
description: 10 points or 20% improvement on Oswestry Disability Questionnaire
measure: Patient Global Outcome Ratings and Health Quality Improvement
time frame: 24 months
arm group label: AlterG and Physical therapy
description: 2) Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training
arm group label: Control group
description: 1) Standard postoperative rehabilitation program
intervention type: Other
intervention name: AlterG
description: All patients will begin an early postoperative rehabilitation program and standard PT no later than 4 weeks following surgery and continue for at least 6 weeks. The duration of standard PT program could be extended depending on the patient needs. The patients randomized to undergo (LBPP) treadmill training will have an additional 7-week 3 times a week training on the antigravity
arm group label: AlterG and Physical therapy
arm group label: Control group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Alan T Villavicencio, MD
role: Principal Investigator
affiliation: Boulder Neurosurgical Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Intervertebral Disc Degeneration