<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/NCT03019744</url>
  </required_header>
  <id_info>
    <org_study_id>RISES</org_study_id>
    <nct_id>NCT03019744</nct_id>
  </id_info>
  <brief_title>Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients</brief_title>
  <acronym>RiSES</acronym>
  <official_title>Studio Clinico di Efficacia Della Stimolazione Elettrica Funzionale Controllata da Segnale Elettromiografico Nel Trattamento Dell'Arto Superiore in Pazienti Con Esiti di Ictus Cerebrovascolare (Progetto Rises)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Don Carlo Gnocchi Onlus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Istituto Di Ricerche Farmacologiche Mario Negri</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione Don Carlo Gnocchi Onlus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled&#xD;
      Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in&#xD;
      post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care&#xD;
      rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation&#xD;
      to assist normal arm movements during rehabilitation of the upper limb in persons with stroke&#xD;
      will improve the movement quality and success and thus induce recovery at the body functions&#xD;
      level (impairment) and the activity level (disability) of the International Classification of&#xD;
      Function (ICF) superior to that induced by usual care rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 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 Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment</measure>
    <time_frame>5 weeks (post-treatment vs pre-treatment)</time_frame>
    <description>ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002).&#xD;
ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment</measure>
    <time_frame>5 weeks (post-treatment vs pre-treatment)</time_frame>
    <description>FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975).&#xD;
FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment</measure>
    <time_frame>5 weeks (post-treatment vs pre-treatment)</time_frame>
    <description>IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000).&#xD;
IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment</measure>
    <time_frame>5 weeks (post-treatment vs pre-treatment)</time_frame>
    <description>DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment</measure>
    <time_frame>5 weeks (post-treatment vs pre-treatment)</time_frame>
    <description>VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>MeCFES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MeCFES-assisted task-oriented upper limb rehabilitation</intervention_name>
    <arm_group_label>MeCFES</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care task-oriented upper limb rehabilitation</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke&#xD;
&#xD;
          -  at least 1 month post-stroke&#xD;
&#xD;
          -  willingness to participate the project&#xD;
&#xD;
          -  minimum voluntary muscle activation of shoulder flexors (&gt;1 Manual Muscle Test)&#xD;
&#xD;
          -  passive Range of Motion (ROM) of the shoulder and elbow of more than 90°&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  severe spasticity at upper limb (&gt;= 3 Ashworth scale)&#xD;
&#xD;
          -  implanted electronic device&#xD;
&#xD;
          -  respiratory insufficiency&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  peripheral neuropathies&#xD;
&#xD;
          -  cutaneous ulcers at the stimulation zone&#xD;
&#xD;
          -  other use of FES on the upper limb&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maurizio Ferrarin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione Don Carlo Gnocchi Onlus</affiliation>
  </overall_official>
  <reference>
    <citation>van der Lee JH, Roorda LD, Beckerman H, Lankhorst GJ, Bouter LM. Improving the Action Research Arm test: a unidimensional hierarchical scale. Clin Rehabil. 2002 Sep;16(6):646-53. doi: 10.1191/0269215502cr534oa.</citation>
    <PMID>12392340</PMID>
  </reference>
  <reference>
    <citation>Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.</citation>
    <PMID>1135616</PMID>
  </reference>
  <reference>
    <citation>Wessels R, de Witte L, Andrich R, Ferrario M, Persson J, Oberg B, Oortwijn W, VanBeekum T, Lorentsen Ã. IPPA, a user-centered approach to assess effectiveness of assistive technology provision. Technol Disabil. 2000;13:105-15</citation>
  </reference>
  <reference>
    <citation>Kennedy CA, Beaton DE, Solway S, McConnell S, Bombardier C. Disabilities of the Arm, Shoulder and Hand (DASH). The DASH and QuickDASH Outcome Measure User's Manual, Third Edition. Toronto, Ontario: Institute for Work &amp; Health, 2011.</citation>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>August 3, 2018</results_first_submitted>
  <results_first_submitted_qc>August 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 27, 2018</results_first_posted>
  <last_update_submitted>September 27, 2018</last_update_submitted>
  <last_update_submitted_qc>September 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione Don Carlo Gnocchi Onlus</investigator_affiliation>
    <investigator_full_name>Maurizio Ferrarin</investigator_full_name>
    <investigator_title>Dr.Eng., Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Functional Electrical Stimulation</keyword>
  <keyword>Cerebrovascular accident</keyword>
  <keyword>Stroke</keyword>
  <keyword>Electromyography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MeCFES</title>
          <description>25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation&#xD;
MeCFES-assisted task-oriented upper limb rehabilitation</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation&#xD;
Usual Care task-oriented upper limb rehabilitation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MeCFES</title>
          <description>25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation&#xD;
MeCFES-assisted task-oriented upper limb rehabilitation</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation&#xD;
Usual Care task-oriented upper limb rehabilitation</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="38"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="82"/>
          </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="66.2" spread="12.9"/>
                    <measurement group_id="B2" value="67.1" spread="13.8"/>
                    <measurement group_id="B3" value="66.6" spread="13.3"/>
                  </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="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment</title>
        <description>ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002).&#xD;
ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome.</description>
        <time_frame>5 weeks (post-treatment vs pre-treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MeCFES</title>
            <description>25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation&#xD;
MeCFES-assisted task-oriented upper limb rehabilitation</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation&#xD;
Usual Care task-oriented upper limb rehabilitation</description>
          </group>
        </group_list>
        <measure>
          <title>Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment</title>
          <description>ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002).&#xD;
ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome.</description>
          <units>score 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="32"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="8.1"/>
                    <measurement group_id="O2" value="5.0" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment</title>
        <description>FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975).&#xD;
FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome</description>
        <time_frame>5 weeks (post-treatment vs pre-treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MeCFES</title>
            <description>25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation&#xD;
MeCFES-assisted task-oriented upper limb rehabilitation</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation&#xD;
Usual Care task-oriented upper limb rehabilitation</description>
          </group>
        </group_list>
        <measure>
          <title>Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment</title>
          <description>FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975).&#xD;
FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome</description>
          <units>score 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="32"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="9.0"/>
                    <measurement group_id="O2" value="4.5" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment</title>
        <description>IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000).&#xD;
IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome.</description>
        <time_frame>5 weeks (post-treatment vs pre-treatment)</time_frame>
        <population>3 patients (1 belonging to MeCFES group and 2 to Control group) did not attend the post-treatment IPPA evaluation, thus they were excluded from this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>MeCFES</title>
            <description>25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation&#xD;
MeCFES-assisted task-oriented upper limb rehabilitation</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation&#xD;
Usual Care task-oriented upper limb rehabilitation</description>
          </group>
        </group_list>
        <measure>
          <title>Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment</title>
          <description>IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000).&#xD;
IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome.</description>
          <population>3 patients (1 belonging to MeCFES group and 2 to Control group) did not attend the post-treatment IPPA evaluation, thus they were excluded from this analysis.</population>
          <units>score 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="31"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="5.6"/>
                    <measurement group_id="O2" value="-3.2" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment</title>
        <description>DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome.</description>
        <time_frame>5 weeks (post-treatment vs pre-treatment)</time_frame>
        <population>2 patients (both belonging to Control group) did not attend the post-treatment DASH evaluation, thus they were excluded from this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>MeCFES</title>
            <description>25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation&#xD;
MeCFES-assisted task-oriented upper limb rehabilitation</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation&#xD;
Usual Care task-oriented upper limb rehabilitation</description>
          </group>
        </group_list>
        <measure>
          <title>Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment</title>
          <description>DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome.</description>
          <population>2 patients (both belonging to Control group) did not attend the post-treatment DASH evaluation, thus they were excluded from this analysis.</population>
          <units>score 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="32"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="9.4"/>
                    <measurement group_id="O2" value="-7.4" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment</title>
        <description>VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain).</description>
        <time_frame>5 weeks (post-treatment vs pre-treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MeCFES</title>
            <description>25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation&#xD;
MeCFES-assisted task-oriented upper limb rehabilitation</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation&#xD;
Usual Care task-oriented upper limb rehabilitation</description>
          </group>
        </group_list>
        <measure>
          <title>Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment</title>
          <description>VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain).</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-1" upper_limit="1"/>
                    <measurement group_id="O2" value="0" lower_limit="-1" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MeCFES</title>
          <description>25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation&#xD;
MeCFES-assisted task-oriented upper limb rehabilitation</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation&#xD;
Usual Care task-oriented upper limb rehabilitation</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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </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 Maurizio Ferrarin</name_or_title>
      <organization>Fondazione Don Carlo Gnocchi</organization>
      <phone>+390240308305</phone>
      <email>mferrarin@dongnocchi.it</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/NCT03019744
org study id: RISES
nct id: NCT03019744
lead sponsor: 
collaborator: 
has dmc: No
Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled
      Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in
      post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care
      rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation
      to assist normal arm movements during rehabilitation of the upper limb in persons with stroke
      will improve the movement quality and success and thus induce recovery at the body functions
      level (impairment) and the activity level (disability) of the International Classification of
      Function (ICF) superior to that induced by usual care rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment
time frame: 5 weeks (post-treatment vs pre-treatment)
description: ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002).
ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome.
measure: Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment
time frame: 5 weeks (post-treatment vs pre-treatment)
description: FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975).
FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome
measure: Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment
time frame: 5 weeks (post-treatment vs pre-treatment)
description: IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000).
IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome.
measure: Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment
time frame: 5 weeks (post-treatment vs pre-treatment)
description: DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome.
measure: Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment
time frame: 5 weeks (post-treatment vs pre-treatment)
description: VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain).
arm group label: MeCFES
arm group type: Experimental
description: 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation
arm group label: Control
arm group type: Active Comparator
description: 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation
intervention type: Device
intervention name: MeCFES-assisted task-oriented upper limb rehabilitation
arm group label: MeCFES
intervention type: Other
intervention name: Usual Care task-oriented upper limb rehabilitation
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maurizio Ferrarin, PhD
role: Principal Investigator
affiliation: Fondazione Don Carlo Gnocchi Onlus
citation: van der Lee JH, Roorda LD, Beckerman H, Lankhorst GJ, Bouter LM. Improving the Action Research Arm test: a unidimensional hierarchical scale. Clin Rehabil. 2002 Sep;16(6):646-53. doi: 10.1191/0269215502cr534oa.
PMID: 12392340
citation: Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PMID: 1135616
citation: Wessels R, de Witte L, Andrich R, Ferrario M, Persson J, Oberg B, Oortwijn W, VanBeekum T, Lorentsen Ã. IPPA, a user-centered approach to assess effectiveness of assistive technology provision. Technol Disabil. 2000;13:105-15
citation: Kennedy CA, Beaton DE, Solway S, McConnell S, Bombardier C. Disabilities of the Arm, Shoulder and Hand (DASH). The DASH and QuickDASH Outcome Measure User's Manual, Third Edition. Toronto, Ontario: Institute for Work & Health, 2011.
responsible party type: Principal Investigator
investigator affiliation: Fondazione Don Carlo Gnocchi Onlus
investigator full name: Maurizio Ferrarin
investigator title: Dr.Eng., Ph.D.
mesh term: Stroke
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 