<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/NCT04473391</url>
  </required_header>
  <id_info>
    <org_study_id>CorporacionRCLCS0004</org_study_id>
    <nct_id>NCT04473391</nct_id>
  </id_info>
  <brief_title>Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System</brief_title>
  <official_title>Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporación de Rehabilitación Club de Leones Cruz del Sur</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporación de Rehabilitación Club de Leones Cruz del Sur</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Functional electrical stimulation is a modality of motor rehabilitation that consists of the&#xD;
      programmed application of bursts of electrical current to the affected neuromuscular region&#xD;
      that aims to improve muscle strength, increase the range of motion, facilitate movement&#xD;
      control and decrease spasticity. The present study aimed to measure the changes in the&#xD;
      biomechanics of the gait of people with Stroke after training with functional electrical&#xD;
      stimulation for the lower extremities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is one of the leading causes of mortality, morbidity and disability in adults in&#xD;
      developed countries. Survivors may suffer several neurological deficits or deficiencies, such&#xD;
      as hemiparesis, communication disorders, cognitive deficits and visuospatial perception&#xD;
      disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain&#xD;
      injury, usually resulting in alterations of the locomotor system with persistent disorders of&#xD;
      movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an&#xD;
      important objective in the rehabilitation program for stroke patients.The currently available&#xD;
      treatment techniques include classical techniques of gait rehabilitation, functional&#xD;
      electrical stimulation, electromechanic devices, robotic devices and brain-computer&#xD;
      interfaces, among others.The evidence suggest that the combination of different&#xD;
      rehabilitation strategies is more effective than conventional rehabilitation techniques&#xD;
      alone. Technology-based rehabilitation methods such as robotic devices need more research to&#xD;
      demonstrate their effects on gait recovery.&#xD;
&#xD;
      The present study aimed to identify the changes in the gait characteristics of subjects with&#xD;
      stroke after a treatment program with FES for the lower extremities through instrumental gait&#xD;
      analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gait Deviation Index Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait Deviation Index Post-Intervention</measure>
    <time_frame>12 weeks</time_frame>
    <description>Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gait Speed Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait Speed Post-intervention</measure>
    <time_frame>12 weeks</time_frame>
    <description>Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Robot-assisted Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Functional Electrical Stimulation (FES) training with a lower extremity cycle-ergometer (MOTOmed Viva 2, Reck GmbH., Germany) and a 6-channel FES Device (TrainFES, Biomedical Devices SpA, Chile). Patients will perform lower limb exercises assisted by the device. Training involve 24 sessions, 3 sessions per week for 8 weeks, each lasting about 45 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cycle-ergometer training assisted by FES for lower extremities</intervention_name>
    <description>The intervention consists of FES treatment sessions on a cycle ergometer for the lower extremities. Each subject received 24 sessions lasting 45 minutes each and a frequency of 3 sessions per week. The sessions will be applied by a physiotherapist with experience in electrotherapy. A 6-channel FES device (TrainFES, Biomedical Devices SpA, Chile) will be used, which consists of a stimulator unit of 95x50x30mm and 100g of weight coupled to the motorized cycle ergometer (MOTOmed Viva 2, Reck GmbH., Germany), a remote user interface consisting of an android application for the configuration of the stimulation via Bluetooth 3.1, and an inertial measurement unit positioned on the rotation axis of the cycle ergometer to detect the rotations and trigger the synchronized electrical stimulation according to the stimulation pattern pre-configured for the pedaling exercise</description>
    <arm_group_label>Robot-assisted Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral lower extremity paresis&#xD;
&#xD;
          -  haemorrhagic or ischemic stroke&#xD;
&#xD;
          -  a minimum of six months after the acute infarction/onset of the disease&#xD;
&#xD;
          -  full passive range of motion in lower extremity or at least at neutral position&#xD;
&#xD;
          -  be able to stand freely&#xD;
&#xD;
          -  be able to walk with or without aid for at least 20 meters in less than 2 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  peripheral nervous system pathology&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  weight over 100 kg&#xD;
&#xD;
          -  no cognitive ability to follow the study instructions&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  use of implanted devices&#xD;
&#xD;
          -  instable lower extremity joints or fixed contracture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asterio H Andrade Gallardo, MSc.</last_name>
    <role>Study Chair</role>
    <affiliation>Corporación de Rehabilitacion Club de Leones Cruz del Sur</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corporación de Rehabilitación Club de Leones Cruz del Sur</name>
      <address>
        <city>Punta Arenas</city>
        <state>XII Región</state>
        <zip>6211525</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <reference>
    <citation>Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.</citation>
    <PMID>15788341</PMID>
  </reference>
  <reference>
    <citation>Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.</citation>
    <PMID>22165907</PMID>
  </reference>
  <reference>
    <citation>Gage JR. Gait analysis. An essential tool in the treatment of cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):126-34.</citation>
    <PMID>8458125</PMID>
  </reference>
  <reference>
    <citation>Schwartz MH, Rozumalski A. The Gait Deviation Index: a new comprehensive index of gait pathology. Gait Posture. 2008 Oct;28(3):351-7. doi: 10.1016/j.gaitpost.2008.05.001. Epub 2008 Jun 18.</citation>
    <PMID>18565753</PMID>
  </reference>
  <reference>
    <citation>Popovic DB, Sinkaer T, Popovic MB. Electrical stimulation as a means for achieving recovery of function in stroke patients. NeuroRehabilitation. 2009;25(1):45-58. doi: 10.3233/NRE-2009-0498.</citation>
    <PMID>19713618</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Hemiparesis</keyword>
  <keyword>Gait</keyword>
  <keyword>Functional Electrical Stimulation</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Gait Deviation Index</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04473391
org study id: CorporacionRCLCS0004
nct id: NCT04473391
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Functional electrical stimulation is a modality of motor rehabilitation that consists of the
      programmed application of bursts of electrical current to the affected neuromuscular region
      that aims to improve muscle strength, increase the range of motion, facilitate movement
      control and decrease spasticity. The present study aimed to measure the changes in the
      biomechanics of the gait of people with Stroke after training with functional electrical
      stimulation for the lower extremities.
Stroke is one of the leading causes of mortality, morbidity and disability in adults in
      developed countries. Survivors may suffer several neurological deficits or deficiencies, such
      as hemiparesis, communication disorders, cognitive deficits and visuospatial perception
      disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain
      injury, usually resulting in alterations of the locomotor system with persistent disorders of
      movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an
      important objective in the rehabilitation program for stroke patients.The currently available
      treatment techniques include classical techniques of gait rehabilitation, functional
      electrical stimulation, electromechanic devices, robotic devices and brain-computer
      interfaces, among others.The evidence suggest that the combination of different
      rehabilitation strategies is more effective than conventional rehabilitation techniques
      alone. Technology-based rehabilitation methods such as robotic devices need more research to
      demonstrate their effects on gait recovery.

      The present study aimed to identify the changes in the gait characteristics of subjects with
      stroke after a treatment program with FES for the lower extremities through instrumental gait
      analysis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Gait Deviation Index Baseline
time frame: Baseline
description: Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
measure: Gait Deviation Index Post-Intervention
time frame: 12 weeks
description: Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
measure: Gait Speed Baseline
time frame: Baseline
description: Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
measure: Gait Speed Post-intervention
time frame: 12 weeks
description: Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
arm group label: Robot-assisted Rehabilitation
arm group type: Experimental
description: Participants will receive Functional Electrical Stimulation (FES) training with a lower extremity cycle-ergometer (MOTOmed Viva 2, Reck GmbH., Germany) and a 6-channel FES Device (TrainFES, Biomedical Devices SpA, Chile). Patients will perform lower limb exercises assisted by the device. Training involve 24 sessions, 3 sessions per week for 8 weeks, each lasting about 45 minutes.
intervention type: Device
intervention name: Cycle-ergometer training assisted by FES for lower extremities
description: The intervention consists of FES treatment sessions on a cycle ergometer for the lower extremities. Each subject received 24 sessions lasting 45 minutes each and a frequency of 3 sessions per week. The sessions will be applied by a physiotherapist with experience in electrotherapy. A 6-channel FES device (TrainFES, Biomedical Devices SpA, Chile) will be used, which consists of a stimulator unit of 95x50x30mm and 100g of weight coupled to the motorized cycle ergometer (MOTOmed Viva 2, Reck GmbH., Germany), a remote user interface consisting of an android application for the configuration of the stimulation via Bluetooth 3.1, and an inertial measurement unit positioned on the rotation axis of the cycle ergometer to detect the rotations and trigger the synchronized electrical stimulation according to the stimulation pattern pre-configured for the pedaling exercise
arm group label: Robot-assisted Rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Asterio H Andrade Gallardo, MSc.
role: Study Chair
affiliation: Corporación de Rehabilitacion Club de Leones Cruz del Sur
facility: 
country: Chile
citation: Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.
PMID: 15788341
citation: Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.
PMID: 22165907
citation: Gage JR. Gait analysis. An essential tool in the treatment of cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):126-34.
PMID: 8458125
citation: Schwartz MH, Rozumalski A. The Gait Deviation Index: a new comprehensive index of gait pathology. Gait Posture. 2008 Oct;28(3):351-7. doi: 10.1016/j.gaitpost.2008.05.001. Epub 2008 Jun 18.
PMID: 18565753
citation: Popovic DB, Sinkaer T, Popovic MB. Electrical stimulation as a means for achieving recovery of function in stroke patients. NeuroRehabilitation. 2009;25(1):45-58. doi: 10.3233/NRE-2009-0498.
PMID: 19713618
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No