<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/NCT02199795</url>
  </required_header>
  <id_info>
    <org_study_id>K23HD060689</org_study_id>
    <secondary_id>K23HD060689</secondary_id>
    <nct_id>NCT02199795</nct_id>
  </id_info>
  <brief_title>Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke</brief_title>
  <official_title>Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MetroHealth Medical Center</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>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MetroHealth Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a small pilot randomized controlled trial which will enroll both subacute (&lt;6 mos)&#xD;
      and chronic (&gt;6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be&#xD;
      randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus&#xD;
      control. The primary objective of this study is to compare the effect of 6-weeks of lower&#xD;
      extremity CCNMES, applied in an anti-phase application, on motor impairment and functional&#xD;
      mobility to a control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Change in Lower Extremity Fugl-Meyer Score at End of Treatment</measure>
    <time_frame>Baseline and End of Treatment (6 weeks)</time_frame>
    <description>The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0 (i.e., full scale range 0-34).&#xD;
Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 10-Meter Walk Test</measure>
    <time_frame>Baseline and End of Treatment (6 weeks)</time_frame>
    <description>Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Ankle Movement Tracking Error at End of Treatment</measure>
    <time_frame>Baseline and End of Treatment (6 weeks)</time_frame>
    <description>Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point.&#xD;
Lower errors are considered to be better outcomes.&#xD;
For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment</measure>
    <time_frame>Baseline and End of Treatment (6 weeks)</time_frame>
    <description>The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.&#xD;
Lower times are considered to be a better outcome.&#xD;
For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Stroke</condition>
  <condition>Hemiparesis</condition>
  <condition>Footdrop</condition>
  <arm_group>
    <arm_group_label>CCNMES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cyclic NMES</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contralaterally Controlled Neuromuscular Electrical Stimulation</intervention_name>
    <arm_group_label>CCNMES</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cyclic Neuromuscular Electrical Stimulation</intervention_name>
    <arm_group_label>Cyclic NMES</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 to 75 years&#xD;
&#xD;
          -  Minimum of 2 wks from a first clinical non-hemorrhagic or hemorrhagic stroke&#xD;
&#xD;
          -  Medically stable&#xD;
&#xD;
          -  Unilateral lower extremity hemiparesis&#xD;
&#xD;
          -  Ankle dorsiflexor strength of ≤4/5 on the Medical Research Council scale, while seated&#xD;
&#xD;
          -  NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without&#xD;
             pain.&#xD;
&#xD;
          -  Full voluntary ROM of the contralateral ankle&#xD;
&#xD;
          -  Skin intact on bilateral lower extremities&#xD;
&#xD;
          -  Able to don the NMES system or caregiver available to assist with device if needed.&#xD;
&#xD;
          -  Able to hear and respond to stimulator auditory cues&#xD;
&#xD;
          -  Able to follow 3-stage commands&#xD;
&#xD;
          -  Able to recall 2 of 3 items after 30 minutes&#xD;
&#xD;
          -  Cognition and communication adequate for safe use of the device based on neurological&#xD;
             assessment by physician principal investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severely impaired cognition and communication&#xD;
&#xD;
          -  History of peroneal nerve injury&#xD;
&#xD;
          -  History of Parkinson's, spinal cord injury, traumatic brain injury, or multiple&#xD;
             sclerosis&#xD;
&#xD;
          -  Uncontrolled seizure disorder&#xD;
&#xD;
          -  Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)&#xD;
&#xD;
          -  Edema of the paretic lower extremity&#xD;
&#xD;
          -  Absent sensation of paretic lower extremity&#xD;
&#xD;
          -  Evidence of deep venous thrombosis or thromboembolism&#xD;
&#xD;
          -  History of cardiac arrhythmias with hemodynamic instability&#xD;
&#xD;
          -  Cardiac pacemaker or other implanted electronic system&#xD;
&#xD;
          -  Botulinum toxin injections to any lower extremity muscle in the last 3 months&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Symptomatic peripheral neuropathy&#xD;
&#xD;
          -  Current use of psychoactive medications (except selective serotonin reuptake inhibitor&#xD;
             and serotonin-norepinephrine reuptake inhibitor antidepressants)&#xD;
&#xD;
          -  Acetylcholinesterase inhibitor usage&#xD;
&#xD;
          -  Unstable asthmatic condition&#xD;
&#xD;
          -  Metallic implants (including clips and/or wires)&#xD;
&#xD;
          -  Prosthetic heart valves&#xD;
&#xD;
          -  Cardiac, renal or other stent&#xD;
&#xD;
          -  History of claustrophobia&#xD;
&#xD;
          -  Low visual acuity&#xD;
&#xD;
          -  Body weight or body habitus not compatible to MRI machine&#xD;
&#xD;
          -  Medical, psychological, or social concern identified by the principal investigator or&#xD;
             co-investigator which suggests inappropriateness of subject participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynne R. Sheffler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MetroHealth Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://fescenter.org/index.php</url>
    <description>Cleveland Functional Electrical Stimulation Center</description>
  </link>
  <reference>
    <citation>Knutson JS, Hansen K, Nagy J, Bailey SN, Gunzler DD, Sheffler LR, Chae J. Contralaterally controlled neuromuscular electrical stimulation for recovery of ankle dorsiflexion: a pilot randomized controlled trial in patients with chronic post-stroke hemiplegia. Am J Phys Med Rehabil. 2013 Aug;92(8):656-65. doi: 10.1097/PHM.0b013e31829b4c16.</citation>
    <PMID>23867888</PMID>
  </reference>
  <reference>
    <citation>Knutson JS, Chae J. A novel neuromuscular electrical stimulation treatment for recovery of ankle dorsiflexion in chronic hemiplegia: a case series pilot study. Am J Phys Med Rehabil. 2010 Aug;89(8):672-82. doi: 10.1097/PHM.0b013e3181e29bd7.</citation>
    <PMID>20531158</PMID>
  </reference>
  <reference>
    <citation>Swinnen SP. Intermanual coordination: from behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002 May;3(5):348-59. doi: 10.1038/nrn807.</citation>
    <PMID>11988774</PMID>
  </reference>
  <reference>
    <citation>Kawashima N, Nozaki D, Abe MO, Akai M, Nakazawa K. Alternate leg movement amplifies locomotor-like muscle activity in spinal cord injured persons. J Neurophysiol. 2005 Feb;93(2):777-85. doi: 10.1152/jn.00817.2004. Epub 2004 Sep 22.</citation>
    <PMID>15385590</PMID>
  </reference>
  <reference>
    <citation>Vasudevan EV, Zehr EP. Multi-frequency arm cycling reveals bilateral locomotor coupling to increase movement symmetry. Exp Brain Res. 2011 Jun;211(2):299-312. doi: 10.1007/s00221-011-2687-y. Epub 2011 Apr 23.</citation>
    <PMID>21516330</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <results_first_submitted>September 11, 2017</results_first_submitted>
  <results_first_submitted_qc>October 9, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 8, 2017</results_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MetroHealth Medical Center</investigator_affiliation>
    <investigator_full_name>Jayme Knutson</investigator_full_name>
    <investigator_title>Assistant Professor, Physical Medicine and Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>hemiplegia</keyword>
  <keyword>footdrop</keyword>
  <keyword>electrical stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Paresis</mesh_term>
    <mesh_term>Peroneal Neuropathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CCNMES</title>
          <description>Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.&#xD;
Contralaterally Controlled Neuromuscular Electrical Stimulation</description>
        </group>
        <group group_id="P2">
          <title>Cyclic NMES</title>
          <description>Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.&#xD;
Cyclic Neuromuscular Electrical Stimulation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>no longer met inclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>withdrew due to shoulder pain</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CCNMES</title>
          <description>Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.&#xD;
Contralaterally Controlled Neuromuscular Electrical Stimulation</description>
        </group>
        <group group_id="B2">
          <title>Cyclic NMES</title>
          <description>Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.&#xD;
Cyclic Neuromuscular Electrical Stimulation</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="3"/>
            <count group_id="B3" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25" spread="7.1"/>
                    <measurement group_id="B2" value="57" spread="31.8"/>
                    <measurement group_id="B3" value="44.2" spread="28.7"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Lower Extremity Fugl-Meyer Score at End of Treatment</title>
        <description>The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0 (i.e., full scale range 0-34).&#xD;
Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged.</description>
        <time_frame>Baseline and End of Treatment (6 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CCNMES</title>
            <description>Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.&#xD;
Contralaterally Controlled Neuromuscular Electrical Stimulation</description>
          </group>
          <group group_id="O2">
            <title>Cyclic NMES</title>
            <description>Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.&#xD;
Cyclic Neuromuscular Electrical Stimulation</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lower Extremity Fugl-Meyer Score at End of Treatment</title>
          <description>The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0 (i.e., full scale range 0-34).&#xD;
Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged.</description>
          <units>units on a scale</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 group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="1.4"/>
                    <measurement group_id="O2" value="1.7" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 10-Meter Walk Test</title>
        <description>Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged.</description>
        <time_frame>Baseline and End of Treatment (6 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CCNMES</title>
            <description>Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.&#xD;
Contralaterally Controlled Neuromuscular Electrical Stimulation</description>
          </group>
          <group group_id="O2">
            <title>Cyclic NMES</title>
            <description>Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.&#xD;
Cyclic Neuromuscular Electrical Stimulation</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 10-Meter Walk Test</title>
          <description>Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged.</description>
          <units>seconds</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 group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="7.6"/>
                    <measurement group_id="O2" value="0.5" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Ankle Movement Tracking Error at End of Treatment</title>
        <description>Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point.&#xD;
Lower errors are considered to be better outcomes.&#xD;
For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement.</description>
        <time_frame>Baseline and End of Treatment (6 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CCNMES</title>
            <description>Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.&#xD;
Contralaterally Controlled Neuromuscular Electrical Stimulation</description>
          </group>
          <group group_id="O2">
            <title>Cyclic NMES</title>
            <description>Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.&#xD;
Cyclic Neuromuscular Electrical Stimulation</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Ankle Movement Tracking Error at End of Treatment</title>
          <description>Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point.&#xD;
Lower errors are considered to be better outcomes.&#xD;
For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement.</description>
          <units>units on a scale</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 group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="4.6"/>
                    <measurement group_id="O2" value="4.0" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment</title>
        <description>The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.&#xD;
Lower times are considered to be a better outcome.&#xD;
For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged.</description>
        <time_frame>Baseline and End of Treatment (6 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CCNMES</title>
            <description>Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.&#xD;
Contralaterally Controlled Neuromuscular Electrical Stimulation</description>
          </group>
          <group group_id="O2">
            <title>Cyclic NMES</title>
            <description>Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.&#xD;
Cyclic Neuromuscular Electrical Stimulation</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment</title>
          <description>The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.&#xD;
Lower times are considered to be a better outcome.&#xD;
For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged.</description>
          <units>seconds</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 group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="9.6"/>
                    <measurement group_id="O2" value="-16.1" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>CCNMES</title>
          <description>Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.&#xD;
Contralaterally Controlled Neuromuscular Electrical Stimulation</description>
        </group>
        <group group_id="E2">
          <title>Cyclic NMES</title>
          <description>Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.&#xD;
Cyclic Neuromuscular Electrical Stimulation</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <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="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="3"/>
              </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>Dr. Jayme Knutson</name_or_title>
      <organization>MetroHealth Medical Center</organization>
      <phone>2169573557</phone>
      <email>jsk12@case.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/NCT02199795
org study id: K23HD060689
secondary id: K23HD060689
nct id: NCT02199795
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos)
      and chronic (>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be
      randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus
      control. The primary objective of this study is to compare the effect of 6-weeks of lower
      extremity CCNMES, applied in an anti-phase application, on motor impairment and functional
      mobility to a control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Lower Extremity Fugl-Meyer Score at End of Treatment
time frame: Baseline and End of Treatment (6 weeks)
description: The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0 (i.e., full scale range 0-34).
Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged.
measure: Change in 10-Meter Walk Test
time frame: Baseline and End of Treatment (6 weeks)
description: Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged.
measure: Change in Ankle Movement Tracking Error at End of Treatment
time frame: Baseline and End of Treatment (6 weeks)
description: Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point.
Lower errors are considered to be better outcomes.
For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement.
measure: Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment
time frame: Baseline and End of Treatment (6 weeks)
description: The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.
Lower times are considered to be a better outcome.
For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged.
arm group label: CCNMES
arm group type: Experimental
description: Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.
arm group label: Cyclic NMES
arm group type: Active Comparator
description: Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.
intervention type: Device
intervention name: Contralaterally Controlled Neuromuscular Electrical Stimulation
arm group label: CCNMES
intervention type: Device
intervention name: Cyclic Neuromuscular Electrical Stimulation
arm group label: Cyclic NMES
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Lynne R. Sheffler, MD
role: Principal Investigator
affiliation: MetroHealth Medical Center
facility: 
country: United States
url: http://fescenter.org/index.php
description: Cleveland Functional Electrical Stimulation Center
citation: Knutson JS, Hansen K, Nagy J, Bailey SN, Gunzler DD, Sheffler LR, Chae J. Contralaterally controlled neuromuscular electrical stimulation for recovery of ankle dorsiflexion: a pilot randomized controlled trial in patients with chronic post-stroke hemiplegia. Am J Phys Med Rehabil. 2013 Aug;92(8):656-65. doi: 10.1097/PHM.0b013e31829b4c16.
PMID: 23867888
citation: Knutson JS, Chae J. A novel neuromuscular electrical stimulation treatment for recovery of ankle dorsiflexion in chronic hemiplegia: a case series pilot study. Am J Phys Med Rehabil. 2010 Aug;89(8):672-82. doi: 10.1097/PHM.0b013e3181e29bd7.
PMID: 20531158
citation: Swinnen SP. Intermanual coordination: from behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002 May;3(5):348-59. doi: 10.1038/nrn807.
PMID: 11988774
citation: Kawashima N, Nozaki D, Abe MO, Akai M, Nakazawa K. Alternate leg movement amplifies locomotor-like muscle activity in spinal cord injured persons. J Neurophysiol. 2005 Feb;93(2):777-85. doi: 10.1152/jn.00817.2004. Epub 2004 Sep 22.
PMID: 15385590
citation: Vasudevan EV, Zehr EP. Multi-frequency arm cycling reveals bilateral locomotor coupling to increase movement symmetry. Exp Brain Res. 2011 Jun;211(2):299-312. doi: 10.1007/s00221-011-2687-y. Epub 2011 Apr 23.
PMID: 21516330
responsible party type: Principal Investigator
investigator affiliation: MetroHealth Medical Center
investigator full name: Jayme Knutson
investigator title: Assistant Professor, Physical Medicine and Rehabilitation
mesh term: Stroke
mesh term: Paresis
mesh term: Peroneal Neuropathies
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 