<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/NCT02991248</url>
  </required_header>
  <id_info>
    <org_study_id>R01HD083314</org_study_id>
    <nct_id>NCT02991248</nct_id>
  </id_info>
  <brief_title>Improve Dynamic Lateral Balance of Humans With SCI</brief_title>
  <official_title>Improve Dynamic Lateral Balance of Humans With SCI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shirley Ryan AbilityLab</source>
  <oversight_info>
    <has_dmc>Yes</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 is to test whether pelvis perturbation training paired with transcutaneous spinal&#xD;
      direct current stimulation (tsDCS) will be effective in improving dynamic balance and&#xD;
      locomotor function in humans with SCI. One group will receive pelvis perturbation training&#xD;
      paired with tsDCS, one group will receive pelvis perturbation training paired with sham, and&#xD;
      one group will receive treadmill training only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A major goal of patients with spinal cord injury (SCI) is to regain walking ability, as&#xD;
      limitations in mobility can affect most activities of daily living. In addition, patients&#xD;
      with SCI may experience a higher incidence of falls due to impaired balance and gait. Dynamic&#xD;
      balance control plays a crucial role during locomotion in human SCI. Thus, improved dynamic&#xD;
      balance may facilitate locomotion in this population. Current balance training paradigms can&#xD;
      be effective in improving balance during standing, but are less effective in improving&#xD;
      dynamic balance during locomotion in humans with SCI. Thus, there is a need to develop new&#xD;
      paradigms for improving dynamic balance and locomotor function in patients with SCI. The goal&#xD;
      of this study is to test whether pelvis perturbation training paired with transcutaneous&#xD;
      spinal direct current stimulation (tsDCS) will be effective in improving dynamic balance and&#xD;
      locomotor function in humans with SCI. We postulate that providing a perturbation force to&#xD;
      the pelvis during treadmill training will increase the activation of muscles used for&#xD;
      maintaining lateral balance while walking. Further, repeated activation of particular&#xD;
      sensorimotor pathways may reinforce circuits and synapses used for lateral balance control&#xD;
      through a use-dependent neural plasticity mechanism. However, the excitability of spinal cord&#xD;
      neural circuitries may be depressed due to the reduced descending drive signals from the&#xD;
      upper level control center after SCI, which may reduce the efficacy of neuralplastic changes&#xD;
      achieved following rehabilitation. The excitability of neural pathways is crucial for neural&#xD;
      reorganization achieved following rehabilitation. Recently studies indicate that tsDCS may&#xD;
      modulate the excitability of neural circuitries of the spinal cord in patients with SCI.&#xD;
      Thus, we postulate that controlled pelvis perturbation training paired with tsDCS will be&#xD;
      more effective than that paired with a sham in improving dynamic balance and locomotor&#xD;
      function in humans with SCI. Results obtained from this study will lead to an innovative&#xD;
      clinical therapy aimed at improving balance and walking function in humans with SCI.&#xD;
      Improvements in balance and walking function may allow for increased participation in&#xD;
      community-based ambulation and activities, and significantly improve quality of life in&#xD;
      humans with SCI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in overground gait speed from baseline</measure>
    <time_frame>post 6 weeks of training and 8 weeks after the end of training</time_frame>
    <description>gait speed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in balance (BBS score) from baseline</measure>
    <time_frame>post 6 weeks of training and 8 weeks after the end of training</time_frame>
    <description>Berg Balance Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in dynamic gait index from baseline</measure>
    <time_frame>post 6 weeks of training and 8 weeks after the end of training</time_frame>
    <description>Dynamic Gait Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in 6 minutes walking distance from baseline</measure>
    <time_frame>post 6 weeks of training and 8 weeks after the end of training</time_frame>
    <description>Walking distance in 6 minutes</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>robotic training &amp; stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: robotic treadmill training paired with active spinal cord electrical stimulation, three times a week for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>robotic training &amp; sham</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: robotic training paired with sham spinal cord stimulation, three time a week for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treadmill only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Device: treadmill Conventional treadmill training only, three time a week for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>robotic training</intervention_name>
    <description>robotic training by applying pelvis force perturbation</description>
    <arm_group_label>robotic training &amp; sham</arm_group_label>
    <arm_group_label>robotic training &amp; stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>spinal cord electrical stimulation</intervention_name>
    <description>Applying direct current electrical stimulation on spinal cord</description>
    <arm_group_label>robotic training &amp; stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>treadmill</intervention_name>
    <description>conventional treadmill training only</description>
    <arm_group_label>robotic training &amp; sham</arm_group_label>
    <arm_group_label>robotic training &amp; stimulation</arm_group_label>
    <arm_group_label>treadmill only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age between 18 and 65 years;&#xD;
&#xD;
          2. medically stable with medical clearance to participate;&#xD;
&#xD;
          3. level of the SCI lesion between C4-T10;&#xD;
&#xD;
          4. passive range of motion of the legs within functional limits of ambulation;&#xD;
&#xD;
          5. ability to walk on a treadmill for more than 20 minutes with partial body weight&#xD;
             support as needed and short sitting/standing breaks;&#xD;
&#xD;
          6. ability to ambulate without orthotics or with orthotics that do not cross the knee for&#xD;
             more than 10 meters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. the presence of unhealed decubiti, existing infection, severe cardiovascular and&#xD;
             pulmonary disease, concomitant central or peripheral neurological injury (e.g.&#xD;
             traumatic head injury or peripheral nerve damage in lower limbs);&#xD;
&#xD;
          2. history of recurrent fractures and/or known orthopedic injury to the lower&#xD;
             extremities;&#xD;
&#xD;
          3. Botox injection within 6 months of starting the study, and current receiving physical&#xD;
             therapy treatment;&#xD;
&#xD;
          4. have metallic implantation in the spinal region underneath where electrodes may be&#xD;
             placed.&#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>Ming Wu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shirley Ryan AbilityLab</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weena Dee, PT</last_name>
    <phone>312-2384824</phone>
    <email>wdee@ric.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Abilitylab</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weena Dee, PT</last_name>
      <phone>312-238-7503</phone>
      <email>wdee@sralab.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Ming Wu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02991248
org study id: R01HD083314
nct id: NCT02991248
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is to test whether pelvis perturbation training paired with transcutaneous spinal
      direct current stimulation (tsDCS) will be effective in improving dynamic balance and
      locomotor function in humans with SCI. One group will receive pelvis perturbation training
      paired with tsDCS, one group will receive pelvis perturbation training paired with sham, and
      one group will receive treadmill training only.
A major goal of patients with spinal cord injury (SCI) is to regain walking ability, as
      limitations in mobility can affect most activities of daily living. In addition, patients
      with SCI may experience a higher incidence of falls due to impaired balance and gait. Dynamic
      balance control plays a crucial role during locomotion in human SCI. Thus, improved dynamic
      balance may facilitate locomotion in this population. Current balance training paradigms can
      be effective in improving balance during standing, but are less effective in improving
      dynamic balance during locomotion in humans with SCI. Thus, there is a need to develop new
      paradigms for improving dynamic balance and locomotor function in patients with SCI. The goal
      of this study is to test whether pelvis perturbation training paired with transcutaneous
      spinal direct current stimulation (tsDCS) will be effective in improving dynamic balance and
      locomotor function in humans with SCI. We postulate that providing a perturbation force to
      the pelvis during treadmill training will increase the activation of muscles used for
      maintaining lateral balance while walking. Further, repeated activation of particular
      sensorimotor pathways may reinforce circuits and synapses used for lateral balance control
      through a use-dependent neural plasticity mechanism. However, the excitability of spinal cord
      neural circuitries may be depressed due to the reduced descending drive signals from the
      upper level control center after SCI, which may reduce the efficacy of neuralplastic changes
      achieved following rehabilitation. The excitability of neural pathways is crucial for neural
      reorganization achieved following rehabilitation. Recently studies indicate that tsDCS may
      modulate the excitability of neural circuitries of the spinal cord in patients with SCI.
      Thus, we postulate that controlled pelvis perturbation training paired with tsDCS will be
      more effective than that paired with a sham in improving dynamic balance and locomotor
      function in humans with SCI. Results obtained from this study will lead to an innovative
      clinical therapy aimed at improving balance and walking function in humans with SCI.
      Improvements in balance and walking function may allow for increased participation in
      community-based ambulation and activities, and significantly improve quality of life in
      humans with SCI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in overground gait speed from baseline
time frame: post 6 weeks of training and 8 weeks after the end of training
description: gait speed
measure: Changes in balance (BBS score) from baseline
time frame: post 6 weeks of training and 8 weeks after the end of training
description: Berg Balance Score
measure: Changes in dynamic gait index from baseline
time frame: post 6 weeks of training and 8 weeks after the end of training
description: Dynamic Gait Index
measure: Changes in 6 minutes walking distance from baseline
time frame: post 6 weeks of training and 8 weeks after the end of training
description: Walking distance in 6 minutes
arm group label: robotic training & stimulation
arm group type: Experimental
description: Device: robotic treadmill training paired with active spinal cord electrical stimulation, three times a week for 6 weeks.
arm group label: robotic training & sham
arm group type: Active Comparator
description: Device: robotic training paired with sham spinal cord stimulation, three time a week for 6 weeks.
arm group label: treadmill only
arm group type: Placebo Comparator
description: Device: treadmill Conventional treadmill training only, three time a week for 6 weeks.
intervention type: Device
intervention name: robotic training
description: robotic training by applying pelvis force perturbation
arm group label: robotic training & sham
arm group label: robotic training & stimulation
intervention type: Device
intervention name: spinal cord electrical stimulation
description: Applying direct current electrical stimulation on spinal cord
arm group label: robotic training & stimulation
intervention type: Device
intervention name: treadmill
description: conventional treadmill training only
arm group label: robotic training & sham
arm group label: robotic training & stimulation
arm group label: treadmill only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ming Wu, PhD
role: Principal Investigator
affiliation: Shirley Ryan AbilityLab
last name: Weena Dee, PT
phone: 312-2384824
email: wdee@ric.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Ming Wu
investigator title: Principal Investigator
mesh term: Spinal Cord Injuries
sharing ipd: Yes