<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/NCT03805009</url>
  </required_header>
  <id_info>
    <org_study_id>RP 15/13</org_study_id>
    <nct_id>NCT03805009</nct_id>
  </id_info>
  <brief_title>Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients</brief_title>
  <official_title>Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients: Clinical and Gait Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS San Raffaele Roma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondazione Don Carlo Gnocchi Onlus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IRCCS San Raffaele Roma</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>
      To date, no studies seems to compare conventional gait rehabilitation program with&#xD;
      end-effector RAGT in subacute stroke patients by analysing the variations of gait kinematics&#xD;
      beyond clinical multi prospective outcomes.&#xD;
&#xD;
      The aim of this pilot study is to evaluate the efficacy of end-effector RAGT in subacute&#xD;
      stroke patients in terms of clinical outcomes and gait kinematics, comparing them with&#xD;
      conventional gait rehabilitation program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of&#xD;
      clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation&#xD;
      program, patients following first ever stroke in sub-acute phase will be recruited and&#xD;
      assessed both clinically and instrumentally (Gait Analysis) at baseline (T0) and at the end&#xD;
      of training program (T1). The patients will be divided into 2 groups and will conduct two&#xD;
      different types of gait training: one group will be recruited by IRCCS San Raffaele Pisana of&#xD;
      Rome and will perform, in addition to conventional therapy, gait training using an&#xD;
      end-effector robotic device for RAGT(Robotic Group, RG); and another group will be recruited&#xD;
      by the Don Carlo Gnocchi Foundation Onlus of Rome, and will perform conventional gait&#xD;
      rehabilitation program(Conventional Group, CG).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 19, 2013</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single blinded, non randomized, pilot study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>All the clinical assessments are routinely administered by both participating centers, and the outcome assessors are blinded to the study protocols.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Six-Minute Walking Test (6MWT)</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters. The 6MWT is a patient self-paced walk test and assesses the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded. This test will be administered while wearing a pulse oximeter to monitor heart rate and oxygen saturation, also integrated with Borg scale to assess dyspnea.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fugl-Meyer Assessment (FMA) scale</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total:&#xD;
Motor functioning (the score ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.&#xD;
Sensory functioning (from 0 to 24 points)&#xD;
Balance (from 0 to 14)&#xD;
Joint range of motion (from 0 to 44)&#xD;
Joint pain (from 0 to 44 ) Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Motricity Index (MI)</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>The MI aims to evaluate lower limb motor impairment after stroke, administrated on both sides.&#xD;
Items to assess the lower limbs are 3, scoring from 0 to 33 each: (1) ankle dorsiflexion with foot in a plantar flexed position (2) knee extension with the foot unsupported and the knee at 90° (3) hip flexion with the hip at 90° moving the knee as close as possible to the chin. (no movement: 0, palpable flicker but no movement: 9, movement but not against gravity :14, movement against gravity movement against gravity: 19, movement against resistance: 25, normal:33)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Modified Ashworth Scale (MAS)</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>The MAS is a 6 point ordinal scale used for grading hypertonia in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tinetti Scale Balance (TIN-B)</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>Scales to measure activity ICF domain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tinetti Walking (TIN-W)</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>Scales to measure activity ICF domain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Ambulation Classification (FAC)</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Trunk Control Test (TCT)</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>The TCT assesses the motor impairment in stroke patients and it's correlated with eventual walking ability. Testing is done with the patient lying on a bed: (1) roll to weak side. (2) roll to strong side. (3) balance in sitting position on the edge of the bed with the feet off the ground for at least 30. (4) sit up from lying down. Total score: 0-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 10 Meter Walk Test (10MWT)</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>This test will assess the patient's speed during gait. Patients will be asked to walk at their preferred maximum and safe speed. Patients will be positioned 1 meter before the start line and instructed to walk 10 meters, and pass the end line approximately 1 meter after. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be measured using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 s). The test will be recorded 3 times, with adequate rests between them. The average of the 3 times should be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Time Up And Go (TUG)</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>The Time Up And Go is a test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leant against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible. Time will be measured using a chronometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Walking Handicap Scale (WHS)</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>The Walking Handicap Scale is a classification of 6 functional walking categories, considered as a participation category of the ICF because of its 3 items referred to community ambulation. The score ranges from 1 to 6, and do higher values represent a better outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Gait Analysis</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>Kinematic and kinetic gait parameters will be calculated from data acquired with a motion capture system (SMART-DX; BTSBioengneering, Italy).</description>
  </other_outcome>
  <other_outcome>
    <measure>Postural Analysis</measure>
    <time_frame>Session 1 (baseline), and Session 20 (week 7)</time_frame>
    <description>Posturographic parameters will be obtained from the analysis of the center of pressure (COP) trajectories measured by force platforms during standing in both open and closed eyes conditions.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Severe Stroke</condition>
  <condition>Acute Stroke</condition>
  <condition>Mild Stroke</condition>
  <condition>Central Nervous System Diseases</condition>
  <condition>Cerebrovascular Disease</condition>
  <condition>Brain Diseases</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Gait, Hemiplegic</condition>
  <arm_group>
    <arm_group_label>Robotic Group (RG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robotic Group (RG) will perform, in addition to conventional therapy, gait training using an end-effector robotic device for Robot-Assisted Gait Training (RAGT), 3 times/week for 20 sessions. During the training, patients will be asked to walk, at a varying speed, for 45 minutes and a partial Body Weight Support (BWS). Participants will start with 30-40% of BWS and an initial speed of 1.5 km/h; increasing to a maximum of between 2.2 and 2.5 km/h and reducing the initial BWS to 15%. The therapist will provide any help during sessions if required. Over 45 minutes, the patient simulates a minimum of 300 steps; patients could rest during the session, though they will be asked to walk continuously for a minimum of 5 minutes during each session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Group (CG)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conventional Group (CG) will perform conventional gait rehabilitation program. The treatment will include: muscle strengthening exercises and stretching of the lower limb, and static and dynamic exercises for the recovery of balance in the supine and standing positions using assistive devices; training gait exercises with parallel bars or in open spaces performed both with and without assistive devices; training to climb up and down stairs; exercises to improve proprioception in the supine, sitting and standing positions, using a proprioceptive footboard; exercises to improve trunk control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robot-Assisted Gait Training (RAGT)</intervention_name>
    <description>The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).</description>
    <arm_group_label>Robotic Group (RG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first cerebral stroke&#xD;
&#xD;
          -  2 weeks up to 6 months post the acute event (subacute patients)&#xD;
&#xD;
          -  age between 18-80 years&#xD;
&#xD;
          -  ability to fit into the end-effector footplates&#xD;
&#xD;
          -  no significant limitation of joint range of motion&#xD;
&#xD;
          -  ability to tolerate upright standing for 60 seconds&#xD;
&#xD;
          -  ability to walk unassisted or with little assistance&#xD;
&#xD;
          -  ability to give written consent&#xD;
&#xD;
          -  compliance with the study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contractures of the hip, knee, or ankle joints that might limit the range of motion&#xD;
             during gait&#xD;
&#xD;
          -  medical issue that precludes full weight bearing and ambulation (e.g. orthopaedic&#xD;
             injuries, pain, severe osteoporosis, or severe spasticity)&#xD;
&#xD;
          -  cognitive and/or communicative disability (e.g. due to brain injury): inability to&#xD;
             understand the instructions required for the study&#xD;
&#xD;
          -  cardiac pathologies, anxiety or psychosis that might interfere with the use of the&#xD;
             equipment or testing&#xD;
&#xD;
        Written informed consent was obtained from each subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Franceschini, MD</last_name>
    <role>Study Chair</role>
    <affiliation>IRCCS San Raffaele Pisana</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sanaz Pournajaf, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS San Raffaele Pisana</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michela Goffredo, Ing</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS San Raffaele Pisana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IRCCS San Raffaele Pisana</name>
      <address>
        <city>Rome</city>
        <state>RM</state>
        <zip>00163</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Don Carlo Gnocchi Onlus</name>
      <address>
        <city>Rome</city>
        <state>RM</state>
        <zip>00166</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
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    <citation>Bonnyaud C, Pradon D, Boudarham J, Robertson J, Vuillerme N, Roche N. Effects of gait training using a robotic constraint (Lokomat(R)) on gait kinematics and kinetics in chronic stroke patients. J Rehabil Med. 2014 Feb;46(2):132-8. doi: 10.2340/16501977-1248.</citation>
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    <citation>Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.</citation>
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  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS San Raffaele Roma</investigator_affiliation>
    <investigator_full_name>Marco Franceschini, MD</investigator_full_name>
    <investigator_title>Head of Neuro-Rehabilitation Research Area</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Robot</keyword>
  <keyword>Hemiparesis</keyword>
  <keyword>Gait Training</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Functional Recovery</keyword>
  <keyword>Robot-Assisted Gait Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03805009
org study id: RP 15/13
nct id: NCT03805009
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To date, no studies seems to compare conventional gait rehabilitation program with
      end-effector RAGT in subacute stroke patients by analysing the variations of gait kinematics
      beyond clinical multi prospective outcomes.

      The aim of this pilot study is to evaluate the efficacy of end-effector RAGT in subacute
      stroke patients in terms of clinical outcomes and gait kinematics, comparing them with
      conventional gait rehabilitation program.
To evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of
      clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation
      program, patients following first ever stroke in sub-acute phase will be recruited and
      assessed both clinically and instrumentally (Gait Analysis) at baseline (T0) and at the end
      of training program (T1). The patients will be divided into 2 groups and will conduct two
      different types of gait training: one group will be recruited by IRCCS San Raffaele Pisana of
      Rome and will perform, in addition to conventional therapy, gait training using an
      end-effector robotic device for RAGT(Robotic Group, RG); and another group will be recruited
      by the Don Carlo Gnocchi Foundation Onlus of Rome, and will perform conventional gait
      rehabilitation program(Conventional Group, CG).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Single blinded, non randomized, pilot study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: All the clinical assessments are routinely administered by both participating centers, and the outcome assessors are blinded to the study protocols.
measure: Change in Six-Minute Walking Test (6MWT)
time frame: Session 1 (baseline), and Session 20 (week 7)
description: The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters. The 6MWT is a patient self-paced walk test and assesses the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded. This test will be administered while wearing a pulse oximeter to monitor heart rate and oxygen saturation, also integrated with Borg scale to assess dyspnea.
measure: Change in Fugl-Meyer Assessment (FMA) scale
time frame: Session 1 (baseline), and Session 20 (week 7)
description: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total:
Motor functioning (the score ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.
Sensory functioning (from 0 to 24 points)
Balance (from 0 to 14)
Joint range of motion (from 0 to 44)
Joint pain (from 0 to 44 ) Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
measure: Change in Motricity Index (MI)
time frame: Session 1 (baseline), and Session 20 (week 7)
description: The MI aims to evaluate lower limb motor impairment after stroke, administrated on both sides.
Items to assess the lower limbs are 3, scoring from 0 to 33 each: (1) ankle dorsiflexion with foot in a plantar flexed position (2) knee extension with the foot unsupported and the knee at 90° (3) hip flexion with the hip at 90° moving the knee as close as possible to the chin. (no movement: 0, palpable flicker but no movement: 9, movement but not against gravity :14, movement against gravity movement against gravity: 19, movement against resistance: 25, normal:33)
measure: Change in Modified Ashworth Scale (MAS)
time frame: Session 1 (baseline), and Session 20 (week 7)
description: The MAS is a 6 point ordinal scale used for grading hypertonia in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.
measure: Change in Tinetti Scale Balance (TIN-B)
time frame: Session 1 (baseline), and Session 20 (week 7)
description: Scales to measure activity ICF domain.
measure: Change in Tinetti Walking (TIN-W)
time frame: Session 1 (baseline), and Session 20 (week 7)
description: Scales to measure activity ICF domain.
measure: Change in Functional Ambulation Classification (FAC)
time frame: Session 1 (baseline), and Session 20 (week 7)
description: Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.
measure: Change in Trunk Control Test (TCT)
time frame: Session 1 (baseline), and Session 20 (week 7)
description: The TCT assesses the motor impairment in stroke patients and it's correlated with eventual walking ability. Testing is done with the patient lying on a bed: (1) roll to weak side. (2) roll to strong side. (3) balance in sitting position on the edge of the bed with the feet off the ground for at least 30. (4) sit up from lying down. Total score: 0-100
measure: Change in 10 Meter Walk Test (10MWT)
time frame: Session 1 (baseline), and Session 20 (week 7)
description: This test will assess the patient's speed during gait. Patients will be asked to walk at their preferred maximum and safe speed. Patients will be positioned 1 meter before the start line and instructed to walk 10 meters, and pass the end line approximately 1 meter after. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be measured using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 s). The test will be recorded 3 times, with adequate rests between them. The average of the 3 times should be recorded.
measure: Change in Time Up And Go (TUG)
time frame: Session 1 (baseline), and Session 20 (week 7)
description: The Time Up And Go is a test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leant against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible. Time will be measured using a chronometer.
measure: Change in Walking Handicap Scale (WHS)
time frame: Session 1 (baseline), and Session 20 (week 7)
description: The Walking Handicap Scale is a classification of 6 functional walking categories, considered as a participation category of the ICF because of its 3 items referred to community ambulation. The score ranges from 1 to 6, and do higher values represent a better outcome.
measure: Gait Analysis
time frame: Session 1 (baseline), and Session 20 (week 7)
description: Kinematic and kinetic gait parameters will be calculated from data acquired with a motion capture system (SMART-DX; BTSBioengneering, Italy).
measure: Postural Analysis
time frame: Session 1 (baseline), and Session 20 (week 7)
description: Posturographic parameters will be obtained from the analysis of the center of pressure (COP) trajectories measured by force platforms during standing in both open and closed eyes conditions.
arm group label: Robotic Group (RG)
arm group type: Experimental
description: Robotic Group (RG) will perform, in addition to conventional therapy, gait training using an end-effector robotic device for Robot-Assisted Gait Training (RAGT), 3 times/week for 20 sessions. During the training, patients will be asked to walk, at a varying speed, for 45 minutes and a partial Body Weight Support (BWS). Participants will start with 30-40% of BWS and an initial speed of 1.5 km/h; increasing to a maximum of between 2.2 and 2.5 km/h and reducing the initial BWS to 15%. The therapist will provide any help during sessions if required. Over 45 minutes, the patient simulates a minimum of 300 steps; patients could rest during the session, though they will be asked to walk continuously for a minimum of 5 minutes during each session.
arm group label: Conventional Group (CG)
arm group type: No Intervention
description: Conventional Group (CG) will perform conventional gait rehabilitation program. The treatment will include: muscle strengthening exercises and stretching of the lower limb, and static and dynamic exercises for the recovery of balance in the supine and standing positions using assistive devices; training gait exercises with parallel bars or in open spaces performed both with and without assistive devices; training to climb up and down stairs; exercises to improve proprioception in the supine, sitting and standing positions, using a proprioceptive footboard; exercises to improve trunk control.
intervention type: Device
intervention name: Robot-Assisted Gait Training (RAGT)
description: The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).
arm group label: Robotic Group (RG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Marco Franceschini, MD
role: Study Chair
affiliation: IRCCS San Raffaele Pisana
last name: Sanaz Pournajaf, Dr
role: Principal Investigator
affiliation: IRCCS San Raffaele Pisana
last name: Michela Goffredo, Ing
role: Principal Investigator
affiliation: IRCCS San Raffaele Pisana
facility: 
facility: 
country: Italy
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responsible party type: Principal Investigator
investigator affiliation: IRCCS San Raffaele Roma
investigator full name: Marco Franceschini, MD
investigator title: Head of Neuro-Rehabilitation Research Area
mesh term: Stroke
mesh term: Nervous System Diseases
mesh term: Brain Diseases
mesh term: Central Nervous System Diseases
mesh term: Cerebrovascular Disorders
mesh term: Gait Disorders, Neurologic
mesh term: Cardiovascular Diseases
sharing ipd: Undecided