<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/NCT04494685</url>
  </required_header>
  <id_info>
    <org_study_id>Stroke_ERIGO</org_study_id>
    <nct_id>NCT04494685</nct_id>
  </id_info>
  <brief_title>Effects of Robotic Rehabilitation in Post-Stroke Patients</brief_title>
  <official_title>Effects of Robotic Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Health Science of Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Health Science of Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the effect of robotic rehabilitation through training on a&#xD;
      robot-assisted orthostatic board and neuromuscular electrical stimulation (NMES) on&#xD;
      functionality in post-stroke patients. In this randomized controlled trial the patients will&#xD;
      be allocated to a control group (which will receive conventional physiotherapy) or or to&#xD;
      intervention group (which will receive conventional physiotherapy and robotic&#xD;
      rehabilitation). Interventions will occur every day in the hospital phase and three&#xD;
      times/week after discharge, totaling 18 sessions.The groups will be evaluated prior to any&#xD;
      physiotherapy intervention, in the 10h session and at the end of six weeks of treatment (or&#xD;
      18 sessions).The following outcomes will be measured: functionality, peripheral muscle&#xD;
      strength, muscle architecture and echogenicity, spasticity, cardiorespiratory repercussions,&#xD;
      mobility, disability and dependence, quality of life and time of hospital stay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</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>Functionality</measure>
    <time_frame>Baseline, after 3 weeks and after 6 weeks</time_frame>
    <description>The change in functionality will be assessed using the Fugl-Meyer Scale. This scale consists of six domains: range of motion, pain, sensitivity, motor function of the upper and lower extremities, balance, coordination and speed. The score for each item ranges from 0 to 2, where 0 = cannot be performed; 1 = partially accomplished; 2 = completely accomplished. The total score ranges from 0 to 266 points and the higher the score the better the functionality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>Baseline, after 3 weeks and after 6 weeks.</time_frame>
    <description>The change in muscle strength will be assessed by the Medical Research Council (MRC) scale and by test of maximum repetition (1RM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quadriceps muscle thickness</measure>
    <time_frame>Baseline and after 6 weeks</time_frame>
    <description>The change in quadriceps muscle thickness will be evaluated for the acquisition of ultrasound images using a high resolution ultrasound device (Vivid-i, GE, USA). In order to verify the thickness of the muscle, the distance between the superficial and deep aponeurosis is measured.The thickness is given in centimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echogenicity of the rectus femoris muscle</measure>
    <time_frame>Baseline and after 6 weeks</time_frame>
    <description>The change in echogenicity will be evaluated for the acquisition of ultrasound images of the rectus femoris muscle using a high resolution ultrasound device (Vivid-i, GE, USA). To check the echogenicity of the rectus femoris an image of the cross-sectional area of the muscle will be taken. The echogenicity measurement is given in an arbitrary unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spasticity</measure>
    <time_frame>Baseline, after after 3 weeks and after 6 weeks</time_frame>
    <description>The change in spasticity will be assessed by the Modified Ashworth Scale. This scale consists of an ordinal classification of 5 points for grading the resistance found during passive stretching, with 0 indicating normal muscle tone and 4 severe increase in tone. The higher the score, the greater the spasticity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility</measure>
    <time_frame>After 3 weeks and after 6 weeks</time_frame>
    <description>The change in mobility will be assessed using the Timed Up and Go test (TUG), which will be associated with an inertial sensor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability and dependence</measure>
    <time_frame>Baseline and after 6 weeks</time_frame>
    <description>The change in disability and dependency will be assessed using the Modified Rankin Scale. This instrument has 6 scores, where: 0 = asymptomatic; 1 = symptoms without disabilities; 2 = mild disability; 3 = moderate disability; 4 = moderate to severe disability; 5 = severe disability and 6 = death. The higher the score, the greater the degree of disability and dependence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life indicator</measure>
    <time_frame>Baseline and after 6 weeks</time_frame>
    <description>The change in quality of life will be assessed using the EuroQol-5D questionnaire. This is a generic instrument that assesses mobility, personal care, usual activities, pain and anxiety/depression. It allows to generate a global index of the value of an individual's health status. The number 1 indicates the best state of health (perfect health) and 0 the worst state of health (death).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>From the 1st to the 18th day/session</time_frame>
    <description>Heart rate will be assessed by pulse oximetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral arterial oxygen saturation</measure>
    <time_frame>From the 1st to the 18th day/session</time_frame>
    <description>Peripheral arterial oxygen saturation will be assessed by pulse oximetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>From the 1st to the 18th day/session</time_frame>
    <description>Systolic blood pressure will be assessed through sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>From the 1st to the 18th day/session</time_frame>
    <description>Diastolic blood pressure will be assessed through sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle pain</measure>
    <time_frame>From the 1st to the 18th day/session</time_frame>
    <description>Pain perception will be assessed using the Visual Analog Scale. This scale ranges from 0 to 10, where 0 indicates no pain and 10 maximum pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower limb fatigue</measure>
    <time_frame>From the 1st to the 18th day/session</time_frame>
    <description>Lower limb fatigue will be assessed by Borg effort subjective perception scale. This scale ranges from 0 to 10, where 0 indicates no effort or fatigue and 10 indicates maximum effort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of hospital stay</measure>
    <time_frame>From the 1st to the last day of hospitalization</time_frame>
    <description>The days between admission and hospital discharge will be counted</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Robotic rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The protocol will be based on lower limb exercises, aiming at maintaining and gaining muscle strength through passive, assisted or active mobilization, when possible, on the affected side.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intervention group (Robotic rehabilitation)</intervention_name>
    <description>Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland). The training protocol has a progression of the board inclination up to 90º associated with flexion/extension movements of the knees and hips, with time evolution of up to 40 minutes. Such equipment is associated with electrostimulation of the quadriceps, hamstrings, sural triceps and anterior tibialis.</description>
    <arm_group_label>Robotic rehabilitation</arm_group_label>
    <other_name>Erigo®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group (Conventional physiotherapy)</intervention_name>
    <description>Knee and hip flexion and extension movements, hip adduction, and abduction, respecting the articular physiology of each joint. Weight transfer will also be performed in the sitting and standing position, mini squat, and gait training. All exercises will have a total of 10 repetitions in three sets. In the end, stretching of the upper and lower limbs will be performed.</description>
    <arm_group_label>Conventional physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical diagnosis of ischemic stroke, in the subacute phase (after 48 hours);&#xD;
&#xD;
          -  To present hemiparesis or muscle weakness defined by the Medical Research Council&#xD;
             (MRC) score;&#xD;
&#xD;
          -  To understand simple commands and being able to report signs of discomfort.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychomotor agitation;&#xD;
&#xD;
          -  Recent acute myocardial infarction (24 hours) and/or uncontrolled arrhythmias;&#xD;
&#xD;
          -  Intracranial hypertension (PIC&gt; 20mmHg);&#xD;
&#xD;
          -  Uncontrolled hypertension (PAS&gt; 230 mmHg and PAD&gt; 120 mmHg) or PAM &lt;60 mmHg;&#xD;
&#xD;
          -  Decompensated heart failure;&#xD;
&#xD;
          -  To present important hemodynamic changes during training;&#xD;
&#xD;
          -  Peripheral vascular disease in the lower limb such as untreated deep vein thrombosis;&#xD;
&#xD;
          -  Unconsolidated fractures or severe joint pain;&#xD;
&#xD;
          -  Feverish state;&#xD;
&#xD;
          -  Smokers;&#xD;
&#xD;
          -  Epidermal lesions on the thighs that make it impossible to place self-adhesive&#xD;
             electrodes for electrical stimulation;&#xD;
&#xD;
          -  Pre-existing neuromuscular disease;&#xD;
&#xD;
          -  Signs of rhabdomyolysis;&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo DM Plentz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Health Sciences of Porto Alegre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rodrigo DM Plentz, PhD</last_name>
    <phone>+555191131651</phone>
    <email>roplentz@yahoo.com.br</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Health Science of Porto Alegre</investigator_affiliation>
    <investigator_full_name>Rodrigo Della Méa Plentz</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Robotics</keyword>
  <keyword>Electric stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT04494685
org study id: Stroke_ERIGO
nct id: NCT04494685
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effect of robotic rehabilitation through training on a
      robot-assisted orthostatic board and neuromuscular electrical stimulation (NMES) on
      functionality in post-stroke patients. In this randomized controlled trial the patients will
      be allocated to a control group (which will receive conventional physiotherapy) or or to
      intervention group (which will receive conventional physiotherapy and robotic
      rehabilitation). Interventions will occur every day in the hospital phase and three
      times/week after discharge, totaling 18 sessions.The groups will be evaluated prior to any
      physiotherapy intervention, in the 10h session and at the end of six weeks of treatment (or
      18 sessions).The following outcomes will be measured: functionality, peripheral muscle
      strength, muscle architecture and echogenicity, spasticity, cardiorespiratory repercussions,
      mobility, disability and dependence, quality of life and time of hospital stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Functionality
time frame: Baseline, after 3 weeks and after 6 weeks
description: The change in functionality will be assessed using the Fugl-Meyer Scale. This scale consists of six domains: range of motion, pain, sensitivity, motor function of the upper and lower extremities, balance, coordination and speed. The score for each item ranges from 0 to 2, where 0 = cannot be performed; 1 = partially accomplished; 2 = completely accomplished. The total score ranges from 0 to 266 points and the higher the score the better the functionality.
measure: Muscle strength
time frame: Baseline, after 3 weeks and after 6 weeks.
description: The change in muscle strength will be assessed by the Medical Research Council (MRC) scale and by test of maximum repetition (1RM)
measure: Quadriceps muscle thickness
time frame: Baseline and after 6 weeks
description: The change in quadriceps muscle thickness will be evaluated for the acquisition of ultrasound images using a high resolution ultrasound device (Vivid-i, GE, USA). In order to verify the thickness of the muscle, the distance between the superficial and deep aponeurosis is measured.The thickness is given in centimeters.
measure: Echogenicity of the rectus femoris muscle
time frame: Baseline and after 6 weeks
description: The change in echogenicity will be evaluated for the acquisition of ultrasound images of the rectus femoris muscle using a high resolution ultrasound device (Vivid-i, GE, USA). To check the echogenicity of the rectus femoris an image of the cross-sectional area of the muscle will be taken. The echogenicity measurement is given in an arbitrary unit.
measure: Spasticity
time frame: Baseline, after after 3 weeks and after 6 weeks
description: The change in spasticity will be assessed by the Modified Ashworth Scale. This scale consists of an ordinal classification of 5 points for grading the resistance found during passive stretching, with 0 indicating normal muscle tone and 4 severe increase in tone. The higher the score, the greater the spasticity.
measure: Mobility
time frame: After 3 weeks and after 6 weeks
description: The change in mobility will be assessed using the Timed Up and Go test (TUG), which will be associated with an inertial sensor
measure: Disability and dependence
time frame: Baseline and after 6 weeks
description: The change in disability and dependency will be assessed using the Modified Rankin Scale. This instrument has 6 scores, where: 0 = asymptomatic; 1 = symptoms without disabilities; 2 = mild disability; 3 = moderate disability; 4 = moderate to severe disability; 5 = severe disability and 6 = death. The higher the score, the greater the degree of disability and dependence.
measure: Quality of life indicator
time frame: Baseline and after 6 weeks
description: The change in quality of life will be assessed using the EuroQol-5D questionnaire. This is a generic instrument that assesses mobility, personal care, usual activities, pain and anxiety/depression. It allows to generate a global index of the value of an individual's health status. The number 1 indicates the best state of health (perfect health) and 0 the worst state of health (death).
measure: Heart rate
time frame: From the 1st to the 18th day/session
description: Heart rate will be assessed by pulse oximetry
measure: Peripheral arterial oxygen saturation
time frame: From the 1st to the 18th day/session
description: Peripheral arterial oxygen saturation will be assessed by pulse oximetry
measure: Systolic blood pressure
time frame: From the 1st to the 18th day/session
description: Systolic blood pressure will be assessed through sphygmomanometer
measure: Diastolic blood pressure
time frame: From the 1st to the 18th day/session
description: Diastolic blood pressure will be assessed through sphygmomanometer
measure: Muscle pain
time frame: From the 1st to the 18th day/session
description: Pain perception will be assessed using the Visual Analog Scale. This scale ranges from 0 to 10, where 0 indicates no pain and 10 maximum pain.
measure: Lower limb fatigue
time frame: From the 1st to the 18th day/session
description: Lower limb fatigue will be assessed by Borg effort subjective perception scale. This scale ranges from 0 to 10, where 0 indicates no effort or fatigue and 10 indicates maximum effort.
measure: Time of hospital stay
time frame: From the 1st to the last day of hospitalization
description: The days between admission and hospital discharge will be counted
arm group label: Robotic rehabilitation
arm group type: Experimental
description: Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland).
arm group label: Conventional physiotherapy
arm group type: Active Comparator
description: The protocol will be based on lower limb exercises, aiming at maintaining and gaining muscle strength through passive, assisted or active mobilization, when possible, on the affected side.
intervention type: Device
intervention name: Intervention group (Robotic rehabilitation)
description: Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland). The training protocol has a progression of the board inclination up to 90º associated with flexion/extension movements of the knees and hips, with time evolution of up to 40 minutes. Such equipment is associated with electrostimulation of the quadriceps, hamstrings, sural triceps and anterior tibialis.
arm group label: Robotic rehabilitation
other name: Erigo®
intervention type: Other
intervention name: Control group (Conventional physiotherapy)
description: Knee and hip flexion and extension movements, hip adduction, and abduction, respecting the articular physiology of each joint. Weight transfer will also be performed in the sitting and standing position, mini squat, and gait training. All exercises will have a total of 10 repetitions in three sets. In the end, stretching of the upper and lower limbs will be performed.
arm group label: Conventional physiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Rodrigo DM Plentz, PhD
role: Principal Investigator
affiliation: Federal University of Health Sciences of Porto Alegre
last name: Rodrigo DM Plentz, PhD
phone: +555191131651
email: roplentz@yahoo.com.br
responsible party type: Principal Investigator
investigator affiliation: Federal University of Health Science of Porto Alegre
investigator full name: Rodrigo Della Méa Plentz
investigator title: PhD
mesh term: Stroke