<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/NCT01668602</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00058363</org_study_id>
    <secondary_id>5K01HD079584-02</secondary_id>
    <secondary_id>13SDG13320000</secondary_id>
    <nct_id>NCT01668602</nct_id>
  </id_info>
  <brief_title>Stroke Gait Rehabilitation Using Functional Electrical Stimulation</brief_title>
  <official_title>Cortical and Spinal Correlates of Post-stroke Gait Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a prospective interventional study to assess the changes in corticospinal&#xD;
      excitability and spinal reflex excitability of in response to rehabilitative strategies and&#xD;
      protocols that are commonly used during physical therapy treatment of gait disorders among&#xD;
      post-stroke subjects. As part of this protocol, 55 individuals with chronic stroke will be&#xD;
      assigned to either Cohort 1 or Cohort 2, and will participate in 1-18 gait training sessions.&#xD;
      If interested, study participants can also complete both study cohorts sequentially (with at&#xD;
      least 3-weeks duration between switching from one cohort to the second). The study examines&#xD;
      the effects among two cohorts of post stroke patients. Cohort 1 will participate in 18&#xD;
      sessions of fast treadmill walking plus Functional Electrical Stimulation (FastFES) and&#xD;
      Cohort 2 will participate in 1-3 sessions of FastFES and fast walking without FES.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is the number one cause of disability. Difficulty with walking affects most stroke&#xD;
      survivors. Walking deficits (e.g. reduced ankle flexion during swing phase, decreased forward&#xD;
      propulsion during terminal stance) can cause risks of falls, slow walking speed, increased&#xD;
      effort of walking, and difficulties with activities of daily living. Restoration of walking&#xD;
      ability can improve quality of life, and is perceived as a major goal of rehabilitation by&#xD;
      stroke survivors. Examples of interventions that are used to rehabilitate walking post-stroke&#xD;
      are functional electrical stimulation, fast treadmill walking, and bio- feedback. While&#xD;
      recent research has focused on comparing the effectiveness of different gait rehabilitation&#xD;
      interventions, the neural and biomechanical mechanisms underlying different gait&#xD;
      rehabilitation strategies are unknown. FastFES is a novel gait training intervention that&#xD;
      combines the beneficial effects of two independent interventions: Fast treadmill walking and&#xD;
      FES. The FastFES intervention incorporates principles of physiology, biomechanics, motor&#xD;
      control and learning, and predictions of forward-dynamic gait simulations to improve&#xD;
      post-stroke gait.&#xD;
&#xD;
      The overall purpose of this protocol is to assess the biomechanical and neurophysiologic&#xD;
      effects of rehabilitative strategies and protocols that are commonly used during physical&#xD;
      therapy treatment of gait disorders post-stroke among two cohorts of people. Aim 1 of the&#xD;
      study will assess the changes in gait biomechanics, corticospinal excitability, and walking&#xD;
      function during 18 sessions of gait retraining, with participants in Cohort 1. Aim 2 of the&#xD;
      study assesses the effect of parameters such as walking speed (slow, fast, variable,&#xD;
      split-belt walking), functional electrical stimulation parameters (short-term changes induced&#xD;
      by fast versus FastFES, stimulation intensity, number of muscles stimulated), and&#xD;
      bio-feedback on within-session changes in gait biomechanics, walking function, and&#xD;
      corticospinal excitability, among participants in Cohort 2.&#xD;
&#xD;
      Within Cohort 1, participants will receive identical treatment throughout the 18 training&#xD;
      sessions (i.e. FastFES training). Within Cohort 2, participants will participate in 3&#xD;
      training sessions of both FastFES and fast walking training, with a 3-week break between the&#xD;
      two types of training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2013</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Assignment to either Cohort 1 or Cohort 2 will occur simultaneously and will be based on the lab/personnel and subject schedules. Participants in Cohort 1 receive only FastFES. Participants in Cohort 2 will receive 3 sessions of FastFES and 3 sessions of fast walking without FES.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2</measure>
    <time_frame>Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)</time_frame>
    <description>Change from baseline in MEP amplitude (transverse abdominal (TA) muscle) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2</measure>
    <time_frame>Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)</time_frame>
    <description>Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES After 18 Training Sessions in Cohort 1</measure>
    <time_frame>Baseline and up to 6 weeks</time_frame>
    <description>Change from baseline in MEP amplitude (TA muscle in a resting state) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1</measure>
    <time_frame>Baseline and up to 6 weeks</time_frame>
    <description>Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2</measure>
    <time_frame>Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)</time_frame>
    <description>Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1</measure>
    <time_frame>Baseline and up to 6 weeks</time_frame>
    <description>Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Cerebrovascular Accident</condition>
  <arm_group>
    <arm_group_label>Cohort 1 - FastFES Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with chronic stroke in Cohort 1 will receive 18 training sessions of FastFES (fast treadmill walking with electrical stimulation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 - FastFES and Fast Walking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with chronic stroke in Cohort 2 who complete 3 sessions of FastFES and 3 sessions of fast walking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fast Walking with Fast Functional Electrical Stimulation (FES) Training</intervention_name>
    <description>Functional electrical stimulation (FES) is a technique that causes a muscle to contract through the use of an electrical current. The therapist applies an electrical current to either the skin over the nerve, or over the bulk of the muscle, and this will cause a muscle contraction. The FES is delivered to 2 muscle groups (dorsiflexor and plantarflexor) timed appropriately with the gait cycle. FastFES gait training sessions may comprise up to six 6-minute bouts of walking with rest breaks between bouts (total 30-minutes of walking). The last training bout (bout 6) may comprise 6-minutes of over ground walking, during which subjects will be asked to walk as fast as they can. For safety, a physical therapist will walk with and guard the subject during over ground walking.</description>
    <arm_group_label>Cohort 1 - FastFES Training</arm_group_label>
    <arm_group_label>Cohort 2 - FastFES and Fast Walking</arm_group_label>
    <other_name>FastFES</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fast Walking</intervention_name>
    <description>Fast walking training sessions will be similar to FastFES in duration, dosage, structure but no FES will be provided.</description>
    <arm_group_label>Cohort 2 - FastFES and Fast Walking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic stroke (&gt;6 months post stroke)&#xD;
&#xD;
          -  First (single) lesion&#xD;
&#xD;
          -  Able to walk with or without the use of a cane or walker&#xD;
&#xD;
          -  Sufficient cardiovascular health and ankle stability to walk for 6 minutes at a&#xD;
             self-selected speed without an orthoses&#xD;
&#xD;
          -  Resting heart rate 40-100 beats per minute&#xD;
&#xD;
          -  Resting blood pressure between 90/60-70/90&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of moderate/ severe chronic white matter disease or cerebellar stroke on MRI&#xD;
&#xD;
          -  Cerebellar signs (ataxic (&quot;drunken&quot;) gait or decreased coordination during rapid&#xD;
             alternating hand or foot movements&#xD;
&#xD;
          -  Insulin dependent diabetes&#xD;
&#xD;
          -  History of lower extremity joint replacement&#xD;
&#xD;
          -  Score of &gt;1 on question 1b and &gt;0 on question 1c on NIH Stroke Scale&#xD;
&#xD;
          -  Inability to communicate with investigators&#xD;
&#xD;
          -  Neglect/hemianopia, or unexplained dizziness in last 6 months&#xD;
&#xD;
          -  Neurologic conditions other than stroke&#xD;
&#xD;
          -  Orthopedic problems in the lower limbs or spine (or other medical conditions) that&#xD;
             limit walking&#xD;
&#xD;
          -  Contraindications to transcranial magnetic stimulation (TMS) are: history of seizures,&#xD;
             metal implants in the head or face, history of recurring or severe headaches/migraine,&#xD;
             headache within the past 24 hours, presence of skull abnormalities or fractures,&#xD;
             hemorrhagic stroke, history of dizziness, syncope, nausea, or loss of consciousness in&#xD;
             the past 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Trisha Kesar, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <results_first_submitted>January 30, 2021</results_first_submitted>
  <results_first_submitted_qc>February 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2021</results_first_posted>
  <disposition_first_submitted>April 8, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>April 8, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 13, 2020</disposition_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Trisha Kesar, PT, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Gait disorders</keyword>
  <keyword>Chronic stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT01668602/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT01668602/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment began in August 2013 and all study follow up was completed on May 1, 2019.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1 - FastFES Training</title>
          <description>Participants with chronic stroke in Cohort 1 will receive 18 training sessions of fast walking on a treadmill plus Functional Electrical Stimulation (FastFES).</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2 - FastFES and Fast Walking</title>
          <description>Participants with chronic stroke in Cohort 2 who complete 3 sessions of FastFES and 3 sessions of fast walking on a treadmill.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Cohort 2 - Began FastFES Sessions</title>
              <participants_list>
                <participants group_id="P1" count="0">This milestone does not apply to Cohort 1.</participants>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Cohort 2 - Completed 3 Sessions of FastFES</title>
              <participants_list>
                <participants group_id="P1" count="0">This milestone does not apply to Cohort 1.</participants>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Cohort 2 - Began Fast Walking Sessions</title>
              <participants_list>
                <participants group_id="P1" count="0">This milestone does not apply to Cohort 1.</participants>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Cohort 2 - Completed 3 Sessions of Fast Walking</title>
              <participants_list>
                <participants group_id="P1" count="0">This milestone does not apply to Cohort 1.</participants>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1 - FastFES Training</title>
          <description>Participants in Cohort 1 will receive 18 training sessions of FastFES (fast treadmill walking with electrical stimulation).</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2 - FastFES and Fast Walking</title>
          <description>Participants in Cohort 2 who complete 3 sessions of FastFES and 3 sessions of fast walking.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2</title>
        <description>Change from baseline in MEP amplitude (transverse abdominal (TA) muscle) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.</description>
        <time_frame>Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)</time_frame>
        <population>This analysis includes participants in Cohort 2 who had complete data for this assessment. There were issues with data collection during the training sessions and stimulus artifact causing noise in data, resulting in incomplete data for some participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Three Sessions of FastFES</title>
            <description>Cohort 2 participants after having three sessions of FastFES</description>
          </group>
          <group group_id="O2">
            <title>Three Sessions of Fast Walking</title>
            <description>Cohort 2 participants after having three sessions of Fast Walking</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2</title>
          <description>Change from baseline in MEP amplitude (transverse abdominal (TA) muscle) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.</description>
          <population>This analysis includes participants in Cohort 2 who had complete data for this assessment. There were issues with data collection during the training sessions and stimulus artifact causing noise in data, resulting in incomplete data for some participants.</population>
          <units>mV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.058" spread="0.110"/>
                    <measurement group_id="O2" value="0.013" spread="0.200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2</title>
        <description>Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.</description>
        <time_frame>Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)</time_frame>
        <population>This analysis includes participants in Cohort 2 who have complete data for this assessment. There were issues with data collection during the training sessions and stimulus artifact causing noise in data, resulting in incomplete data for some participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Three Sessions of FastFES</title>
            <description>Cohort 2 participants after having three sessions of FastFES</description>
          </group>
          <group group_id="O2">
            <title>Three Sessions of Fast Walking</title>
            <description>Cohort 2 participants after having three sessions of Fast Walking</description>
          </group>
        </group_list>
        <measure>
          <title>Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2</title>
          <description>Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.</description>
          <population>This analysis includes participants in Cohort 2 who have complete data for this assessment. There were issues with data collection during the training sessions and stimulus artifact causing noise in data, resulting in incomplete data for some participants.</population>
          <units>percentage of Hmax/Mmax</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.14" spread="0.05"/>
                    <measurement group_id="O2" value="0.44" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES After 18 Training Sessions in Cohort 1</title>
        <description>Change from baseline in MEP amplitude (TA muscle in a resting state) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.</description>
        <time_frame>Baseline and up to 6 weeks</time_frame>
        <population>This analysis includes participants in Cohort 1.</population>
        <group_list>
          <group group_id="O1">
            <title>FastFES Training</title>
            <description>Participants in Cohort 1 receiving 18 sessions of FastFES Training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES After 18 Training Sessions in Cohort 1</title>
          <description>Change from baseline in MEP amplitude (TA muscle in a resting state) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.</description>
          <population>This analysis includes participants in Cohort 1.</population>
          <units>mV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1</title>
        <description>Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.</description>
        <time_frame>Baseline and up to 6 weeks</time_frame>
        <population>This analysis includes participants from Cohort 1.</population>
        <group_list>
          <group group_id="O1">
            <title>FastFES Training</title>
            <description>Participants in Cohort 1 receiving 18 sessions of FastFES Training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1</title>
          <description>Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.</description>
          <population>This analysis includes participants from Cohort 1.</population>
          <units>percentage of Hmax/Mmax</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.49" spread="45.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2</title>
        <description>Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.</description>
        <time_frame>Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)</time_frame>
        <population>This analysis includes participants from Cohort 2 who had complete data for this assessment. There were issues with data collection during the training sessions and stimulus artifact causing noise in data, resulting in incomplete data for some participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Three Sessions of FastFES</title>
            <description>Cohort 2 participants after having three sessions of FastFES</description>
          </group>
          <group group_id="O2">
            <title>Three Sessions of Fast Walking</title>
            <description>Cohort 2 participants after having three sessions of Fast Walking</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2</title>
          <description>Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.</description>
          <population>This analysis includes participants from Cohort 2 who had complete data for this assessment. There were issues with data collection during the training sessions and stimulus artifact causing noise in data, resulting in incomplete data for some participants.</population>
          <units>Newtons.milliseconds (N.ms)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.68" spread="11.76"/>
                    <measurement group_id="O2" value="-2.00" spread="12.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1</title>
        <description>Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.</description>
        <time_frame>Baseline and up to 6 weeks</time_frame>
        <population>This analysis includes participants in Cohort 1.</population>
        <group_list>
          <group group_id="O1">
            <title>FastFES Training</title>
            <description>Participants in Cohort 1 receiving 18 sessions of FastFES Training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1</title>
          <description>Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.</description>
          <population>This analysis includes participants in Cohort 1.</population>
          <units>Newtons.milliseconds (N.ms)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.40" spread="10.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during the training sessions, from the start of the study intervention session through the last session (up to 6 weeks).</time_frame>
      <desc>In Cohort 2 there were 20 participants who received at least one session of FastFES and 19 who received at least one session of Fast Walking.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1 - 18 Sessions of FastFES Training</title>
          <description>Participants in Cohort 1 will receive 18 training sessions of FastFES (fast treadmill walking with electrical stimulation).</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2 - Three Sessions of FastFES</title>
          <description>Participants in Cohort 2 during training sessions of FastFES.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 2 - Three Sessions of Fast Walking</title>
          <description>Participants in Cohort 2 during training sessions of Fast Walking.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Lightheadedness during H-reflex evaluation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trisha Kesar, PT, PhD</name_or_title>
      <organization>Emory University</organization>
      <phone>404-712-5803</phone>
      <email>trisha.m.kesar@emory.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01668602
org study id: IRB00058363
secondary id: 5K01HD079584-02
secondary id: 13SDG13320000
nct id: NCT01668602
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The study is a prospective interventional study to assess the changes in corticospinal
      excitability and spinal reflex excitability of in response to rehabilitative strategies and
      protocols that are commonly used during physical therapy treatment of gait disorders among
      post-stroke subjects. As part of this protocol, 55 individuals with chronic stroke will be
      assigned to either Cohort 1 or Cohort 2, and will participate in 1-18 gait training sessions.
      If interested, study participants can also complete both study cohorts sequentially (with at
      least 3-weeks duration between switching from one cohort to the second). The study examines
      the effects among two cohorts of post stroke patients. Cohort 1 will participate in 18
      sessions of fast treadmill walking plus Functional Electrical Stimulation (FastFES) and
      Cohort 2 will participate in 1-3 sessions of FastFES and fast walking without FES.
Stroke is the number one cause of disability. Difficulty with walking affects most stroke
      survivors. Walking deficits (e.g. reduced ankle flexion during swing phase, decreased forward
      propulsion during terminal stance) can cause risks of falls, slow walking speed, increased
      effort of walking, and difficulties with activities of daily living. Restoration of walking
      ability can improve quality of life, and is perceived as a major goal of rehabilitation by
      stroke survivors. Examples of interventions that are used to rehabilitate walking post-stroke
      are functional electrical stimulation, fast treadmill walking, and bio- feedback. While
      recent research has focused on comparing the effectiveness of different gait rehabilitation
      interventions, the neural and biomechanical mechanisms underlying different gait
      rehabilitation strategies are unknown. FastFES is a novel gait training intervention that
      combines the beneficial effects of two independent interventions: Fast treadmill walking and
      FES. The FastFES intervention incorporates principles of physiology, biomechanics, motor
      control and learning, and predictions of forward-dynamic gait simulations to improve
      post-stroke gait.

      The overall purpose of this protocol is to assess the biomechanical and neurophysiologic
      effects of rehabilitative strategies and protocols that are commonly used during physical
      therapy treatment of gait disorders post-stroke among two cohorts of people. Aim 1 of the
      study will assess the changes in gait biomechanics, corticospinal excitability, and walking
      function during 18 sessions of gait retraining, with participants in Cohort 1. Aim 2 of the
      study assesses the effect of parameters such as walking speed (slow, fast, variable,
      split-belt walking), functional electrical stimulation parameters (short-term changes induced
      by fast versus FastFES, stimulation intensity, number of muscles stimulated), and
      bio-feedback on within-session changes in gait biomechanics, walking function, and
      corticospinal excitability, among participants in Cohort 2.

      Within Cohort 1, participants will receive identical treatment throughout the 18 training
      sessions (i.e. FastFES training). Within Cohort 2, participants will participate in 3
      training sessions of both FastFES and fast walking training, with a 3-week break between the
      two types of training.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Assignment to either Cohort 1 or Cohort 2 will occur simultaneously and will be based on the lab/personnel and subject schedules. Participants in Cohort 1 receive only FastFES. Participants in Cohort 2 will receive 3 sessions of FastFES and 3 sessions of fast walking without FES.
primary purpose: Other
masking: None (Open Label)
measure: Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2
time frame: Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)
description: Change from baseline in MEP amplitude (transverse abdominal (TA) muscle) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.
measure: Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2
time frame: Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)
description: Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.
measure: Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES After 18 Training Sessions in Cohort 1
time frame: Baseline and up to 6 weeks
description: Change from baseline in MEP amplitude (TA muscle in a resting state) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.
measure: Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1
time frame: Baseline and up to 6 weeks
description: Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.
measure: Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2
time frame: Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)
description: Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.
measure: Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1
time frame: Baseline and up to 6 weeks
description: Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.
arm group label: Cohort 1 - FastFES Training
arm group type: Experimental
description: Participants with chronic stroke in Cohort 1 will receive 18 training sessions of FastFES (fast treadmill walking with electrical stimulation).
arm group label: Cohort 2 - FastFES and Fast Walking
arm group type: Experimental
description: Participants with chronic stroke in Cohort 2 who complete 3 sessions of FastFES and 3 sessions of fast walking.
intervention type: Device
intervention name: Fast Walking with Fast Functional Electrical Stimulation (FES) Training
description: Functional electrical stimulation (FES) is a technique that causes a muscle to contract through the use of an electrical current. The therapist applies an electrical current to either the skin over the nerve, or over the bulk of the muscle, and this will cause a muscle contraction. The FES is delivered to 2 muscle groups (dorsiflexor and plantarflexor) timed appropriately with the gait cycle. FastFES gait training sessions may comprise up to six 6-minute bouts of walking with rest breaks between bouts (total 30-minutes of walking). The last training bout (bout 6) may comprise 6-minutes of over ground walking, during which subjects will be asked to walk as fast as they can. For safety, a physical therapist will walk with and guard the subject during over ground walking.
arm group label: Cohort 1 - FastFES Training
arm group label: Cohort 2 - FastFES and Fast Walking
other name: FastFES
intervention type: Other
intervention name: Fast Walking
description: Fast walking training sessions will be similar to FastFES in duration, dosage, structure but no FES will be provided.
arm group label: Cohort 2 - FastFES and Fast Walking
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Trisha Kesar, PT, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Trisha Kesar, PT, PhD
investigator title: Associate Professor
mesh term: Stroke
sharing ipd: No
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