<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/NCT02201173</url>
  </required_header>
  <id_info>
    <org_study_id>376696</org_study_id>
    <nct_id>NCT02201173</nct_id>
  </id_info>
  <brief_title>Health Outcomes After Locomotor Training in Spinal Cord Injury</brief_title>
  <official_title>Health Outcomes After Locomotor Training in Spinal Cord Injury Across the NeuroRecovery Network</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kessler Institute for Rehabilitation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>TIRR Memorial Hermann</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Craig Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stony Brook University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with spinal cord injury (SCI) suffer from secondary health conditions that can result&#xD;
      in undue physical challenges and impact participation in activities in everyday life.&#xD;
      Locomotor Training (LT) has been shown to demonstrate improvements in balance and walking&#xD;
      function in both the animal and humans by reactivating spinal circuits through intensive&#xD;
      therapy of muscles below the level of the injury. However, it is not known if LT also has&#xD;
      beneficial health effects and it is the focus of this study proposed to be undertaken at&#xD;
      Stony Brook University (SBU) as the lead site. LT is thought to produce activation of spinal&#xD;
      networks to help recover balance and walking after SCI and may correspond with improvements&#xD;
      in health measures such as bladder function, breathing capacity, cholesterol and other&#xD;
      cardiac risk factors markers, and the ability to stand upright without drops in blood&#xD;
      pressure resulting in a sensation of dizziness. LT takes place on a treadmill with the body&#xD;
      weight supported in a harness, while walking overground and with the practice of key&#xD;
      exercises in the home and community. The emphasis is on loading the body through the legs&#xD;
      without braces and other devices except where necessary to function at home. The overall&#xD;
      objective of this study to capture and analyze health outcome data collected on 80 patients&#xD;
      enrolled in the 7 NeuroRecovery Network (NRN) clinics in the USA who receive LT. The NRN is&#xD;
      funded by the Christopher and Dana Reeve Foundation and the CDC to implement LT for people&#xD;
      with SCI. The purpose of this application is to leverage the NRN funding, that provides&#xD;
      support for LT and standardized outcome measures, to generate further knowledge on health&#xD;
      outcomes after LT for individuals with SCI. The proposed project will be accomplished through&#xD;
      the utilization of staff at each of the 6 NRN sites, lead by the study principal investigator&#xD;
      and the lead clinical research coordinator at SBU. They will ensure the data are captured&#xD;
      before and after LT in a standardized manner, at the correct time and entered into a&#xD;
      de-identified database. The study hypotheses are that after LT, compared to before, patients&#xD;
      with SCI will improve lipid profiles and insulin factors as measured by fasting blood tests;&#xD;
      respiratory function as measured by specialized but easy to use breathing equipment; and&#xD;
      blood pressure and heart rate during a maneuver to test for responses to abrupt changes in&#xD;
      posture. The relevance of this proposal is that it will help to determine if there is an&#xD;
      association between an intensive activity- based intervention (LT) and improvements in health&#xD;
      and will be used to form the basis for a larger randomized clinical trial and clinical&#xD;
      practice guidelines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Assays</measure>
    <time_frame>Baseline and after 80 sessions of Locomotor Training (LT). If continuous sessions are attended then 5d X 16 weeks or 4 months = 80 sessions.</time_frame>
    <description>Study supplements the Locomotor Training program sponsored by the NeuroRecovery Network except for this new study where blood is drawn before and after Locomotor Training (LT)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <condition>Spinal Cord Trauma</condition>
  <arm_group>
    <arm_group_label>Locomotor Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Locomotor Training</intervention_name>
    <description>Progressive retraining in functional skills including balance, transfers, activities of daily living and ambulation. Compliance to eliminate or minimize lower limb orthotics is also expected to optimize sensory input to the spinal cord and promote optimal recovery. Intensive therapy occurs in all three environments 5 times/ week for 90 minutes</description>
    <arm_group_label>Locomotor Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are classified as AIS C and D must have some lower limb movement or&#xD;
             visible voluntary contraction and the capacity to generate a lower limb reciprocal&#xD;
             alternating flexion/extension stepping pattern in the step training environment using&#xD;
             body weight support on a treadmill with manual facilitation.&#xD;
&#xD;
          -  Patients with AIS A and B need to be able to stand in the BWS harness system without&#xD;
             orthostatic hypotension for at least 1 minute.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anti-spasticity medication except night time dose.&#xD;
&#xD;
          -  The use of chemodenervation for spasticity will be avoided for the 3 months prior to&#xD;
             NRN admission.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Craig Hospital</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frazier Rehab</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rehabilitation Research and Movement Performance Lab</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-6018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stony Brook University</investigator_affiliation>
    <investigator_full_name>Sue Ann Sisto</investigator_full_name>
    <investigator_title>Professor of Health Sciences and Research Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT02201173
org study id: 376696
nct id: NCT02201173
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
People with spinal cord injury (SCI) suffer from secondary health conditions that can result
      in undue physical challenges and impact participation in activities in everyday life.
      Locomotor Training (LT) has been shown to demonstrate improvements in balance and walking
      function in both the animal and humans by reactivating spinal circuits through intensive
      therapy of muscles below the level of the injury. However, it is not known if LT also has
      beneficial health effects and it is the focus of this study proposed to be undertaken at
      Stony Brook University (SBU) as the lead site. LT is thought to produce activation of spinal
      networks to help recover balance and walking after SCI and may correspond with improvements
      in health measures such as bladder function, breathing capacity, cholesterol and other
      cardiac risk factors markers, and the ability to stand upright without drops in blood
      pressure resulting in a sensation of dizziness. LT takes place on a treadmill with the body
      weight supported in a harness, while walking overground and with the practice of key
      exercises in the home and community. The emphasis is on loading the body through the legs
      without braces and other devices except where necessary to function at home. The overall
      objective of this study to capture and analyze health outcome data collected on 80 patients
      enrolled in the 7 NeuroRecovery Network (NRN) clinics in the USA who receive LT. The NRN is
      funded by the Christopher and Dana Reeve Foundation and the CDC to implement LT for people
      with SCI. The purpose of this application is to leverage the NRN funding, that provides
      support for LT and standardized outcome measures, to generate further knowledge on health
      outcomes after LT for individuals with SCI. The proposed project will be accomplished through
      the utilization of staff at each of the 6 NRN sites, lead by the study principal investigator
      and the lead clinical research coordinator at SBU. They will ensure the data are captured
      before and after LT in a standardized manner, at the correct time and entered into a
      de-identified database. The study hypotheses are that after LT, compared to before, patients
      with SCI will improve lipid profiles and insulin factors as measured by fasting blood tests;
      respiratory function as measured by specialized but easy to use breathing equipment; and
      blood pressure and heart rate during a maneuver to test for responses to abrupt changes in
      posture. The relevance of this proposal is that it will help to determine if there is an
      association between an intensive activity- based intervention (LT) and improvements in health
      and will be used to form the basis for a larger randomized clinical trial and clinical
      practice guidelines.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Blood Assays
time frame: Baseline and after 80 sessions of Locomotor Training (LT). If continuous sessions are attended then 5d X 16 weeks or 4 months = 80 sessions.
description: Study supplements the Locomotor Training program sponsored by the NeuroRecovery Network except for this new study where blood is drawn before and after Locomotor Training (LT)
arm group label: Locomotor Training
arm group type: Experimental
intervention type: Behavioral
intervention name: Locomotor Training
description: Progressive retraining in functional skills including balance, transfers, activities of daily living and ambulation. Compliance to eliminate or minimize lower limb orthotics is also expected to optimize sensory input to the spinal cord and promote optimal recovery. Intensive therapy occurs in all three environments 5 times/ week for 90 minutes
arm group label: Locomotor Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stony Brook University
investigator full name: Sue Ann Sisto
investigator title: Professor of Health Sciences and Research Director
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries