<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/NCT01668407</url>
  </required_header>
  <id_info>
    <org_study_id>RP 04/12</org_study_id>
    <nct_id>NCT01668407</nct_id>
  </id_info>
  <brief_title>Robot Walking Rehabilitation in Parkinson's Disease</brief_title>
  <acronym>ROBOPARK</acronym>
  <official_title>Use of a Robot for the Rehabilitation of Walking in Patients With Parkinson's Disease.</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>
      The effectiveness of non-pharmacological treatment on gait impairment on Parkinson Disease&#xD;
      (PD) such as exercises has been demonstrated; in particular an example for patient tailored&#xD;
      exercises is physiotherapy. The goal of physiotherapy treatment is to enable PD patients to&#xD;
      maintain their maximum level of mobility, activity, and independence. Several systematic&#xD;
      reviews and clinical studies have shown that physical therapy can contribute to minimize the&#xD;
      disabling effects of motor and sensory impairments in order to enhance participation in&#xD;
      societal roles and quality of life. The use of electromechanical devices such as treadmill&#xD;
      training (a supplement to conventional therapies) in the last years has also been used with&#xD;
      PD patients and a systematic Cochrane has been conducted by Mehrholz in 2010 to assess the&#xD;
      effectiveness and acceptability of treadmill training in the treatment of gait disorders for&#xD;
      patients with PD. In the last years new robotic assisted device can be used in gait training&#xD;
      in neurological disorder. Till now only few studies, have focused on the effects of&#xD;
      exoskeleton or end effector robot-assisted training in PD patients, with a interesting&#xD;
      preliminary results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aims of this project are:&#xD;
&#xD;
        1. to verify whether the robotics lower limb treatment with body weight support is more&#xD;
           effective than the treadmill treatment in the reduction of motor impairment in PD or PSP&#xD;
           patients, and to improve the quality of the gait and the endurance;&#xD;
&#xD;
        2. to analyze possible improvements in terms of physiological biomechanical gait through&#xD;
           analysis of kinematics , kinetics and EMG evaluation;&#xD;
&#xD;
        3. to analyze possible improvements in terms of reduction of instable posture and movements&#xD;
           , which can represent a reduction of the risk of fall typical of these 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 Parkinson's patients.&#xD;
&#xD;
      The second goals is aimed at identifying possible advantages in the QoL of patients&#xD;
      undergoing such a kind of rehabilitation treatment and at investigating novel methods&#xD;
      enabling lower limb functional recovery, leading to wide potential for regaining personal&#xD;
      independence.&#xD;
&#xD;
      The third goal is to analyze 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>Completed</overall_status>
  <start_date type="Actual">March 30, 2012</start_date>
  <completion_date type="Actual">March 31, 2016</completion_date>
  <primary_completion_date type="Actual">August 30, 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 minutes 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 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot session) (T1) (no later than 1 day &gt; last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time Up and Go test.</measure>
    <time_frame>baseline, weekly during intervention, 6 months follow up.</time_frame>
    <description>Time Up and Go test will be collected 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot session) (T1) (no later than 1 day &gt; last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait Parameters</measure>
    <time_frame>baseline, weekly during intervention, 6 months follow up.</time_frame>
    <description>Gait Analysis will be collected 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot session) (T1) (no later than 1 day &gt; last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Idiopathic Parkinson's Disease</condition>
  <condition>Progressive Supranuclear Palsy</condition>
  <arm_group>
    <arm_group_label>Robot-Assisted Gait Training (RAGT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robot-Assisted Gait Training (RAGT): Subjects (at least 40) will undergo inpatient rehabilitation consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling. The practice will include robot-assisted walking at variable speeds for 45 min with a partial body weight support (BWS). All participants started 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 before BWS will be decreased.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treadmill Gait Training (TT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treadmill Gait Training (TT): Subjects (at least 40) will undergo inpatient rehabilitation consisting of a treatment cycle using the treadmill device, according to individually tailored exercise scheduling. The practice included treadmill walking at variable speed for 45 minutes. All participants will start at an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robot-Assisted Gait Training (RAGT)</intervention_name>
    <description>Subjects (at least 40 subjects) will undergo inpatient rehabilitation consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling. The practice will include robot-assisted walking at variable speeds for 45 min with a partial body weight support (BWS). All participants started 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 before BWS will be decreased.</description>
    <arm_group_label>Robot-Assisted Gait Training (RAGT)</arm_group_label>
    <other_name>End effector G-EO System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Treadmill Gait Training (TT)</intervention_name>
    <description>Subjects (at least 40 subjects) will undergo inpatient rehabilitation consisting of a treatment cycle using the treadmill device, according to individually tailored exercise scheduling. The practice included treadmill walking at variable speed for 45 minutes. All participants will start at an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h.&#xD;
All the treatment consists of 20 sessions for the lower limbs, each lasting 45 minutes, 5 days a week for 4 weeks.</description>
    <arm_group_label>Treadmill Gait Training (TT)</arm_group_label>
    <other_name>TREADMILL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria,&#xD;
&#xD;
          -  Age between 18-80;&#xD;
&#xD;
          -  Able to walk 25 feet unassisted or with minimal assistance;&#xD;
&#xD;
          -  On stable doses of Parkinson's medications for at least 2 weeks prior to study onset;&#xD;
&#xD;
          -  Endurance sufficient to stand at least 20 minutes unassisted per patient report.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other significant neurological or orthopedic problems.&#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>Patrizio Sale, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS San Raffale Pisana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Polytecnic University of Marche</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Raffaele Cassino</name>
      <address>
        <city>Cassino</city>
        <zip>03043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS San Raffaele Pisana</name>
      <address>
        <city>Rome</city>
        <zip>00163</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 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>BME, PhD</investigator_title>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>PSP</keyword>
  <keyword>Robot</keyword>
  <keyword>Gait rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Supranuclear Palsy, Progressive</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/NCT01668407
org study id: RP 04/12
nct id: NCT01668407
lead sponsor: 
has dmc: No
The effectiveness of non-pharmacological treatment on gait impairment on Parkinson Disease
      (PD) such as exercises has been demonstrated; in particular an example for patient tailored
      exercises is physiotherapy. The goal of physiotherapy treatment is to enable PD patients to
      maintain their maximum level of mobility, activity, and independence. Several systematic
      reviews and clinical studies have shown that physical therapy can contribute to minimize the
      disabling effects of motor and sensory impairments in order to enhance participation in
      societal roles and quality of life. The use of electromechanical devices such as treadmill
      training (a supplement to conventional therapies) in the last years has also been used with
      PD patients and a systematic Cochrane has been conducted by Mehrholz in 2010 to assess the
      effectiveness and acceptability of treadmill training in the treatment of gait disorders for
      patients with PD. In the last years new robotic assisted device can be used in gait training
      in neurological disorder. Till now only few studies, have focused on the effects of
      exoskeleton or end effector robot-assisted training in PD patients, with a interesting
      preliminary results.
The specific aims of this project are:

        1. 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 PD or PSP
           patients, and to improve the quality of the gait and the endurance;

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

        3. to analyze 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 Parkinson's patients.

      The second goals is aimed at identifying possible advantages in the QoL of patients
      undergoing such a kind of 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 analyze direct cost savings associated with the use of such
      technologies, measured as direct, indirect and intangible costs, through specific HTA
      procedures.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 6 minutes 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 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot session) (T1) (no later than 1 day > last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).
measure: Time Up and Go test.
time frame: baseline, weekly during intervention, 6 months follow up.
description: Time Up and Go test will be collected 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot session) (T1) (no later than 1 day > last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).
measure: Gait Parameters
time frame: baseline, weekly during intervention, 6 months follow up.
description: Gait Analysis will be collected 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot session) (T1) (no later than 1 day > last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).
arm group label: Robot-Assisted Gait Training (RAGT)
arm group type: Experimental
description: Robot-Assisted Gait Training (RAGT): Subjects (at least 40) will undergo inpatient rehabilitation consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling. The practice will include robot-assisted walking at variable speeds for 45 min with a partial body weight support (BWS). All participants started 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 before BWS will be decreased.
arm group label: Treadmill Gait Training (TT)
arm group type: Active Comparator
description: Treadmill Gait Training (TT): Subjects (at least 40) will undergo inpatient rehabilitation consisting of a treatment cycle using the treadmill device, according to individually tailored exercise scheduling. The practice included treadmill walking at variable speed for 45 minutes. All participants will start at an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h.
intervention type: Device
intervention name: Robot-Assisted Gait Training (RAGT)
description: Subjects (at least 40 subjects) will undergo inpatient rehabilitation consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling. The practice will include robot-assisted walking at variable speeds for 45 min with a partial body weight support (BWS). All participants started 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 before BWS will be decreased.
arm group label: Robot-Assisted Gait Training (RAGT)
other name: End effector G-EO System
intervention type: Procedure
intervention name: Treadmill Gait Training (TT)
description: Subjects (at least 40 subjects) will undergo inpatient rehabilitation consisting of a treatment cycle using the treadmill device, according to individually tailored exercise scheduling. The practice included treadmill walking at variable speed for 45 minutes. All participants will start at an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h.
All the treatment consists of 20 sessions for the lower limbs, each lasting 45 minutes, 5 days a week for 4 weeks.
arm group label: Treadmill Gait Training (TT)
other name: TREADMILL
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Patrizio Sale, MD
role: Principal Investigator
affiliation: IRCCS San Raffale Pisana
facility: 
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS San Raffaele Roma
investigator full name: Michela Goffredo
investigator title: BME, PhD
mesh term: Parkinson Disease
mesh term: Supranuclear Palsy, Progressive