<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/NCT01678547</url>
  </required_header>
  <id_info>
    <org_study_id>RP 19/12</org_study_id>
    <nct_id>NCT01678547</nct_id>
  </id_info>
  <brief_title>Robot Walking Rehabilitation in Stroke Patients</brief_title>
  <acronym>RoboSTROKE</acronym>
  <official_title>Effect of Robot Assisted Treatment on Gait Performace in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS San Raffaele Roma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS San Raffaele Roma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke are the main causes of motor disability among adults and are expected to impose an&#xD;
      increasing social and economic burden for our Country. The impact of stroke on patients is&#xD;
      enormous, with negative ramifications on the persons participation in social, vocational, and&#xD;
      recreational activities. It is the primary cause of long-term disability in these countries.&#xD;
      At the present stage, it is well known that control of balance during upright standing&#xD;
      depends upon the central integration of afferent information from vestibular, somatosensory&#xD;
      (proprioceptive, tactile), and visual systems, which constitute a multilink neural network&#xD;
      for the control of neck, hip, and ankle joints. More recently, it has been studied at the&#xD;
      level of cerebral cortex; vestibular inputs would reach face/neck representation of primary&#xD;
      somatosensory cortex and would be then integrated with visual and somatosensory inputs in&#xD;
      intraparietal, posterior end of the insula and medial superior temporal cortices. Remarkably,&#xD;
      balance impairment and the associated risk of falling represent one of the most prominent and&#xD;
      potentially disabling features in stroke subjects. The specific aims of this project are: to&#xD;
      verify whether the robotics lower limb treatment with body weight support is more effective&#xD;
      than the treadmill treatment in the reduction of motor impairment in Stroke patients, and to&#xD;
      improve the quality of the gait and the endurance and to analyze possible improvements in&#xD;
      terms of physiological biomechanical gait through analysis of spatio-temporal parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: to assess the lower limb recovery after the gait rehabilitation training exercises&#xD;
      in acute and chronic stroke patients.&#xD;
&#xD;
      The proposed project, through a Randomized controlled observer-blind trial aimed at&#xD;
      evaluating the effectiveness of end-effector robot assisted therapy vs the treadmill and&#xD;
      ground treatment in sub-acute and chronic stroke subjects. 90 inpatients and out-patients&#xD;
      with a stroke will be recruited. We will randomize the patients on 3 groups [15 sub-acute&#xD;
      (ischemic and hemorrhagic) stroke patients (after 30±7 days from injury) and 15 chronic&#xD;
      (ischemic and hemorrhagic) patients (after 3/6 months days from injury) for all groups]:&#xD;
&#xD;
        1. sub-acute and chronic stroke patients robot treatment.&#xD;
&#xD;
        2. sub-acute and chronic patients treadmill treatment.&#xD;
&#xD;
        3. sub-acute and chronic patients ground treatment.&#xD;
&#xD;
      The specific aims of this project are:&#xD;
&#xD;
        1. to verify whether the robotics end-effector GEO lower limb treatment with body weight&#xD;
           support is more effective than the treadmill treatment or ground treatment in the&#xD;
           reduction of motor impairment in sub-acute and Chronic stroke patients, and to improve&#xD;
           the quality of the gait and the endurance;&#xD;
&#xD;
        2. to analyse possible improvements in terms of physiological biomechanical gait through&#xD;
           analysis of kinematics , kinetics and EMG evaluation;&#xD;
&#xD;
        3. to analyse possible improvements in terms of reduction of instable posture and&#xD;
           movements, which can represent a reduction of the risk of fall typical of these&#xD;
           subjects;&#xD;
&#xD;
        4. to evaluate the kinematic, kinetic and EMG quantitative data during selected movements&#xD;
           (gait, posture, ) compared with age matched reference data;&#xD;
&#xD;
        5. to investigate the stability of the effects of robot-assisted treatment at 4/6 months&#xD;
           follow-up in terms of Quality of Life (QoL).&#xD;
&#xD;
      A first goal of this project is to investigate the differences in improvement of the quality&#xD;
      and safety of the gait (motor performance and functional recovery) through kinematic/kinetic&#xD;
      and EMG parameters (Change in Step Length, Change in Gait Velocity and Change in Stride Time&#xD;
      Variability, 3D joints kinematics, ground reaction forces, joint kinetics, muscle&#xD;
      activation,) and traditional clinical scales in sub-acute and chronic stroke patients.&#xD;
&#xD;
      The second goals is aimed at identifying possible advantages in the QoL of patients&#xD;
      undergoing such a kind of in-patients and out-patients rehabilitation treatment and at&#xD;
      investigating novel methods enabling lower limb functional recovery, leading to wide&#xD;
      potential for regaining personal independence.&#xD;
&#xD;
      The third goal is to analyse direct cost savings associated with the use of such&#xD;
      technologies, measured as direct, indirect and intangible costs, through specific HTA&#xD;
      procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 minuts walking test.</measure>
    <time_frame>Change from Baseline in gait speed at 6 months follow up.</time_frame>
    <description>The 6 minuts walking test as primary outcome assessments will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day &gt; last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl Meyer (lower limb section)</measure>
    <time_frame>Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.</time_frame>
    <description>The Fugl Meyer (lower limb section) scale will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day &gt; last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borg scale</measure>
    <time_frame>Change from Baseline in Borg scale at 6 months follow up.</time_frame>
    <description>Cost of Waking walking effort using Borg scale will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day &gt; last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait Parameters with EMG</measure>
    <time_frame>baseline, weekly during intervention, 6 months follow up</time_frame>
    <description>Gait analysis with EMG will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day &gt; last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Ambulation Classification</measure>
    <time_frame>Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.</time_frame>
    <description>The Functional Ambulation Classification will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day &gt; last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walk Handicap Scale (WHS)</measure>
    <time_frame>Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.</time_frame>
    <description>The Walk Handicap Scale (WHS) will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day &gt; last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Stroke</condition>
  <condition>Gait Disorders, Neurologic</condition>
  <arm_group>
    <arm_group_label>Robot G-EO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treadmill Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) consisting of a treatment cycle using the treadmill system device, according to individually tailored exercise scheduling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ground treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ground Control Group (cCG): Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) of traditional lower limb physiotherapy treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robot-assisted walking</intervention_name>
    <description>The practice will included an add-on robot-assisted walking therapy at variable speeds for 40 min with a partial body weight support (BWS). All participants will start with 30-40% BWS and an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h and the BWS % will be decreased.</description>
    <arm_group_label>Robot G-EO</arm_group_label>
    <other_name>G-EO System (Reha Technology AG Switzerland)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Treadmill Training</intervention_name>
    <description>The practice will included an add-on treadmill walking therapy at variable speeds for 40 min with a partial body weight support (BWS). All participants will start with 30-40% BWS and an initial comfortable treadmill speed and the speed will be increased to a range of 1,0 to 2.5 km/h and the BWS % will be decreased.</description>
    <arm_group_label>Treadmill Training</arm_group_label>
    <other_name>Gait Trainer 3 (Biodex Medical Systems New York)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ground treatment</intervention_name>
    <description>The practice will included ground walking therapy s for 40 min with therapist support.</description>
    <arm_group_label>Ground treatment</arm_group_label>
    <other_name>Physiotherapy treatment.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between the ages of 18-95 years;&#xD;
&#xD;
          -  able to walk 25 feet unassisted or with assistance&#xD;
&#xD;
          -  truck control&#xD;
&#xD;
          -  first acute event of cerebrovascular stroke&#xD;
&#xD;
          -  unilateral paresis,&#xD;
&#xD;
          -  ability to understand and follow simple instructions&#xD;
&#xD;
          -  ability to walk without assistance prior to stroke&#xD;
&#xD;
          -  endurance sufficient to stand at least 20 minutes unassisted per patient report.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to understand instructions required by the study (Informed Consent Test of&#xD;
             Comprehension).&#xD;
&#xD;
          -  medical or neurological comorbidities that might contribute to significant gait&#xD;
             dysfunction.&#xD;
&#xD;
          -  uncontrolled hypertension &gt; 190/110 mmHg.&#xD;
&#xD;
          -  significant symptoms of orthostasis when standing up.&#xD;
&#xD;
          -  circulatory problems, history of vascular claudication or significant (+3) pitting&#xD;
             edema.&#xD;
&#xD;
          -  lower extremity injuries or joint problems (hip or leg) that limit range of motion or&#xD;
             function, or cause pain with movement&#xD;
&#xD;
          -  bilateral impairment,&#xD;
&#xD;
          -  severe sensory deficits in the paretic upper limb,&#xD;
&#xD;
          -  cognitive impairment or behavioral dysfunction that would influence the ability to&#xD;
             comprehend or participate in the study.&#xD;
&#xD;
          -  Women who are pregnant and/or lactating.&#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>Michela Goffredo, BME</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS San Raffaele Rome Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Raffaele Cassino</name>
      <address>
        <city>Cassino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS San Raffaele Roma</name>
      <address>
        <city>Rome</city>
        <zip>00166</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 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>Michela Goffredo</investigator_full_name>
    <investigator_title>Biomedical Engineer, PhD</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Robot</keyword>
  <keyword>Treatment</keyword>
  <keyword>Rehabilitation</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>Gait Disorders, Neurologic</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/NCT01678547
org study id: RP 19/12
nct id: NCT01678547
lead sponsor: 
has dmc: No
Stroke are the main causes of motor disability among adults and are expected to impose an
      increasing social and economic burden for our Country. The impact of stroke on patients is
      enormous, with negative ramifications on the persons participation in social, vocational, and
      recreational activities. It is the primary cause of long-term disability in these countries.
      At the present stage, it is well known that control of balance during upright standing
      depends upon the central integration of afferent information from vestibular, somatosensory
      (proprioceptive, tactile), and visual systems, which constitute a multilink neural network
      for the control of neck, hip, and ankle joints. More recently, it has been studied at the
      level of cerebral cortex; vestibular inputs would reach face/neck representation of primary
      somatosensory cortex and would be then integrated with visual and somatosensory inputs in
      intraparietal, posterior end of the insula and medial superior temporal cortices. Remarkably,
      balance impairment and the associated risk of falling represent one of the most prominent and
      potentially disabling features in stroke subjects. The specific aims of this project are: to
      verify whether the robotics lower limb treatment with body weight support is more effective
      than the treadmill treatment in the reduction of motor impairment in Stroke patients, and to
      improve the quality of the gait and the endurance and to analyze possible improvements in
      terms of physiological biomechanical gait through analysis of spatio-temporal parameters.
Objective: to assess the lower limb recovery after the gait rehabilitation training exercises
      in acute and chronic stroke patients.

      The proposed project, through a Randomized controlled observer-blind trial aimed at
      evaluating the effectiveness of end-effector robot assisted therapy vs the treadmill and
      ground treatment in sub-acute and chronic stroke subjects. 90 inpatients and out-patients
      with a stroke will be recruited. We will randomize the patients on 3 groups [15 sub-acute
      (ischemic and hemorrhagic) stroke patients (after 30±7 days from injury) and 15 chronic
      (ischemic and hemorrhagic) patients (after 3/6 months days from injury) for all groups]:

        1. sub-acute and chronic stroke patients robot treatment.

        2. sub-acute and chronic patients treadmill treatment.

        3. sub-acute and chronic patients ground treatment.

      The specific aims of this project are:

        1. to verify whether the robotics end-effector GEO lower limb treatment with body weight
           support is more effective than the treadmill treatment or ground treatment in the
           reduction of motor impairment in sub-acute and Chronic stroke patients, and to improve
           the quality of the gait and the endurance;

        2. to analyse possible improvements in terms of physiological biomechanical gait through
           analysis of kinematics , kinetics and EMG evaluation;

        3. to analyse possible improvements in terms of reduction of instable posture and
           movements, which can represent a reduction of the risk of fall typical of these
           subjects;

        4. to evaluate the kinematic, kinetic and EMG quantitative data during selected movements
           (gait, posture, ) compared with age matched reference data;

        5. to investigate the stability of the effects of robot-assisted treatment at 4/6 months
           follow-up in terms of Quality of Life (QoL).

      A first goal of this project is to investigate the differences in improvement of the quality
      and safety of the gait (motor performance and functional recovery) through kinematic/kinetic
      and EMG parameters (Change in Step Length, Change in Gait Velocity and Change in Stride Time
      Variability, 3D joints kinematics, ground reaction forces, joint kinetics, muscle
      activation,) and traditional clinical scales in sub-acute and chronic stroke patients.

      The second goals is aimed at identifying possible advantages in the QoL of patients
      undergoing such a kind of in-patients and out-patients rehabilitation treatment and at
      investigating novel methods enabling lower limb functional recovery, leading to wide
      potential for regaining personal independence.

      The third goal is to analyse direct cost savings associated with the use of such
      technologies, measured as direct, indirect and intangible costs, through specific HTA
      procedures.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 6 minuts walking test.
time frame: Change from Baseline in gait speed at 6 months follow up.
description: The 6 minuts walking test as primary outcome assessments will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
measure: Fugl Meyer (lower limb section)
time frame: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
description: The Fugl Meyer (lower limb section) scale will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
measure: Borg scale
time frame: Change from Baseline in Borg scale at 6 months follow up.
description: Cost of Waking walking effort using Borg scale will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
measure: Gait Parameters with EMG
time frame: baseline, weekly during intervention, 6 months follow up
description: Gait analysis with EMG will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
measure: Functional Ambulation Classification
time frame: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
description: The Functional Ambulation Classification will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
measure: Walk Handicap Scale (WHS)
time frame: Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.
description: The Walk Handicap Scale (WHS) will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
arm group label: Robot G-EO
arm group type: Experimental
description: Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling.
arm group label: Treadmill Training
arm group type: Active Comparator
description: Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) consisting of a treatment cycle using the treadmill system device, according to individually tailored exercise scheduling.
arm group label: Ground treatment
arm group type: Active Comparator
description: Ground Control Group (cCG): Each subject will be asked to perform 15 sessions (3 to 5 days a week for 4 up to 5 weeks) of traditional lower limb physiotherapy treatment.
intervention type: Device
intervention name: Robot-assisted walking
description: The practice will included an add-on robot-assisted walking therapy at variable speeds for 40 min with a partial body weight support (BWS). All participants will start with 30-40% BWS and an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h and the BWS % will be decreased.
arm group label: Robot G-EO
other name: G-EO System (Reha Technology AG Switzerland)
intervention type: Device
intervention name: Treadmill Training
description: The practice will included an add-on treadmill walking therapy at variable speeds for 40 min with a partial body weight support (BWS). All participants will start with 30-40% BWS and an initial comfortable treadmill speed and the speed will be increased to a range of 1,0 to 2.5 km/h and the BWS % will be decreased.
arm group label: Treadmill Training
other name: Gait Trainer 3 (Biodex Medical Systems New York)
intervention type: Other
intervention name: Ground treatment
description: The practice will included ground walking therapy s for 40 min with therapist support.
arm group label: Ground treatment
other name: Physiotherapy treatment.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michela Goffredo, BME
role: Principal Investigator
affiliation: IRCCS San Raffaele Rome Italy
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS San Raffaele Roma
investigator full name: Michela Goffredo
investigator title: Biomedical Engineer, PhD
mesh term: Stroke
mesh term: Nervous System Diseases
mesh term: Gait Disorders, Neurologic