<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/NCT03021408</url>
  </required_header>
  <id_info>
    <org_study_id>OGZonaMP-PD Gait Rehab</org_study_id>
    <nct_id>NCT03021408</nct_id>
  </id_info>
  <brief_title>Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease</brief_title>
  <acronym>Tr-T-VR</acronym>
  <official_title>Evaluation of the Effectiveness of Three Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease: Treadmill Versus Treadmill-plus Versus Virtual Reality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale Generale Di Zona Moriggia-Pelascini</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale Generale Di Zona Moriggia-Pelascini</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the effectiveness of three different approaches for the rehabilitation of gait&#xD;
      in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gait disorders represent one of principal hallmark of Parkinson's disease (PD). Typically, PD&#xD;
      patients demonstrate reduced stride length and walking speed during free ambulation, while&#xD;
      double support duration and cadence rate are increased. Gait disorders are generally poorly&#xD;
      responsive to dopaminergic treatments and are related to reduced quality of life and&#xD;
      augmented risk of falls. Different rehabilitation techniques based on compensatory and&#xD;
      learning strategies, which principally exploit the use of cues to bypass the defective basal&#xD;
      ganglia and to ameliorate performance through practice, have been demonstrated to be&#xD;
      effective in improving gait in patients with PD. Cueing techniques represent the central core&#xD;
      for the rehabilitation of parkinsonian gait. In this context, it has been demonstrated that&#xD;
      treadmill training can improve gait performance in PD patients. It probably acts as an&#xD;
      external cue exerting a normalizing effect on the spatiotemporal gait parameters and leading&#xD;
      to an enhanced gait rhythmicity and a reduced gait variability. The use of a treadmill with&#xD;
      visual and auditory cues (treadmill-plus) seems to lead to a better improvement in gait&#xD;
      parameters when compared to treadmill alone. Recently, the application of virtual reality&#xD;
      (VR) has been introduced in the rehabilitation of PD. The use of VR is based on the&#xD;
      interaction of the person with a virtual environment with the aim to promote motor learning&#xD;
      through enhanced perceptions (visual, auditory, and haptic inputs).&#xD;
&#xD;
      It has been widely demonstrated that a multidisciplinary, intensive, goal-based,&#xD;
      motor-cognitive and aerobic treatment (MIRT), specifically designed for PD patients, provide&#xD;
      parkinsonians with motor and functional benefits. Nevertheless, the contribution provided by&#xD;
      treadmill, treadmill-plus and VR on gait parameters has not been previously addressed within&#xD;
      MIRT.&#xD;
&#xD;
      This study aims at investigating the superiority or the non-inferiority of these different&#xD;
      devices in improving gait in PD patients in the context of MIRT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</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>6-minute walking test (6MWT)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Patient is first familiarized with the test by letting him/her go once forward and backward along a straight 15-m line on the ground in a gymnasium. Then, after 15 minutes rest, he/she is instructed to walk from end to end of the line for 6 minutes and to cover as much distance as possible. No encouragement is offered during the test and no cues are used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average length of right and left steps</measure>
    <time_frame>4 weeks</time_frame>
    <description>The average length of right and left steps (expressed in centimetres and calculated by averaging the length of all the right steps and left steps, respectively).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coefficient of variance</measure>
    <time_frame>4 weeks</time_frame>
    <description>coefficient of variance (CoV) of both right and left steps (which expresses the amount of variation occurring between footfalls).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step cycle</measure>
    <time_frame>4 weeks</time_frame>
    <description>Step cycle (cycle/s), calculated by averaging the step cycles during the exercise.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>PD</condition>
  <condition>Gait Dysfunction, Neurologic</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>MIRT + Treadmill</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MIRT + Treadmill Plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the context of MIRT, the gait training in this group will be performed by using a treadmill with visual and auditory cues.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MIRT + Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the context of MIRT, the gait training in this group will be performed by using Virtual Reality with enhanced perceptions (visual, auditory, and haptic inputs).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MIRT + Treadmill</intervention_name>
    <description>PD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill training twice per day, 5 times a week, for 4 weeks.</description>
    <arm_group_label>MIRT + Treadmill</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MIRT + Treadmill Plus</intervention_name>
    <description>PD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill-plus training (with visual and auditory cues) twice per day, 5 times a week, for 4 weeks.</description>
    <arm_group_label>MIRT + Treadmill Plus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MIRT + Virtual Reality</intervention_name>
    <description>PD patients will undergo a 4-week MIRT. All patients in the MIRT+Virtual Reality (VR) group will undergo 10-minutes VR training with enhanced perceptions (visual, auditory, and haptic inputs), twice per day, 5 times a week, for 4 weeks.</description>
    <arm_group_label>MIRT + Virtual Reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of &quot;probable&quot; idiopathic Parkinson's disease according to Gelb et al (Gelb,&#xD;
             1999);&#xD;
&#xD;
          -  Mild to moderate stage of disease (stage 2-3) according to Hoehn &amp; Yahr scale;&#xD;
&#xD;
          -  Ability to walk on treadmill;&#xD;
&#xD;
          -  Visual and hearing capacity sufficient to perceive the cues;&#xD;
&#xD;
          -  No cognitive impairment (Mini-Mental State Examination score ≥ 26);&#xD;
&#xD;
          -  Stable pharmacological treatment since 2 weeks before admission and during&#xD;
             rehabilitation;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of atypical or vascular Parkinsonism;&#xD;
&#xD;
          -  Occurrence of cardiovascular, orthopaedic, peripheral nerves, musculoskeletal and&#xD;
             vestibular disorders which could affect patient's locomotion or balance;&#xD;
&#xD;
          -  Neuropsychiatric disturbances;&#xD;
&#xD;
          -  Severe dyskinesia;&#xD;
&#xD;
          -  Severe freezing of gait;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frazzitta Giuseppe, MD</last_name>
    <role>Study Director</role>
    <affiliation>&quot;Moriggia-Pelascini&quot; Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Davide Ferrazzoli, MD</last_name>
    <phone>+393318643163</phone>
    <email>davideferrazzoli@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ilaria Zivi, MD</last_name>
    <phone>+39034492111</phone>
    <email>ilaria.zivi@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>&quot;Moriggia-Pelascini&quot; Hospital</name>
      <address>
        <city>Gravedona ed Uniti</city>
        <state>Como</state>
        <zip>22015</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Davide Ferrazzoli, MD</last_name>
      <phone>+393318643163</phone>
      <email>davideferrazzoli@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ilaria Zivi, MD</last_name>
      <phone>+393805468322</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 7, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Neurologic Manifestations</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03021408
org study id: OGZonaMP-PD Gait Rehab
nct id: NCT03021408
lead sponsor: 
has dmc: No
Evaluation of the effectiveness of three different approaches for the rehabilitation of gait
      in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT).
Gait disorders represent one of principal hallmark of Parkinson's disease (PD). Typically, PD
      patients demonstrate reduced stride length and walking speed during free ambulation, while
      double support duration and cadence rate are increased. Gait disorders are generally poorly
      responsive to dopaminergic treatments and are related to reduced quality of life and
      augmented risk of falls. Different rehabilitation techniques based on compensatory and
      learning strategies, which principally exploit the use of cues to bypass the defective basal
      ganglia and to ameliorate performance through practice, have been demonstrated to be
      effective in improving gait in patients with PD. Cueing techniques represent the central core
      for the rehabilitation of parkinsonian gait. In this context, it has been demonstrated that
      treadmill training can improve gait performance in PD patients. It probably acts as an
      external cue exerting a normalizing effect on the spatiotemporal gait parameters and leading
      to an enhanced gait rhythmicity and a reduced gait variability. The use of a treadmill with
      visual and auditory cues (treadmill-plus) seems to lead to a better improvement in gait
      parameters when compared to treadmill alone. Recently, the application of virtual reality
      (VR) has been introduced in the rehabilitation of PD. The use of VR is based on the
      interaction of the person with a virtual environment with the aim to promote motor learning
      through enhanced perceptions (visual, auditory, and haptic inputs).

      It has been widely demonstrated that a multidisciplinary, intensive, goal-based,
      motor-cognitive and aerobic treatment (MIRT), specifically designed for PD patients, provide
      parkinsonians with motor and functional benefits. Nevertheless, the contribution provided by
      treadmill, treadmill-plus and VR on gait parameters has not been previously addressed within
      MIRT.

      This study aims at investigating the superiority or the non-inferiority of these different
      devices in improving gait in PD patients in the context of MIRT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 6-minute walking test (6MWT)
time frame: 4 weeks
description: Patient is first familiarized with the test by letting him/her go once forward and backward along a straight 15-m line on the ground in a gymnasium. Then, after 15 minutes rest, he/she is instructed to walk from end to end of the line for 6 minutes and to cover as much distance as possible. No encouragement is offered during the test and no cues are used.
measure: Average length of right and left steps
time frame: 4 weeks
description: The average length of right and left steps (expressed in centimetres and calculated by averaging the length of all the right steps and left steps, respectively).
measure: Coefficient of variance
time frame: 4 weeks
description: coefficient of variance (CoV) of both right and left steps (which expresses the amount of variation occurring between footfalls).
measure: Step cycle
time frame: 4 weeks
description: Step cycle (cycle/s), calculated by averaging the step cycles during the exercise.
arm group label: MIRT + Treadmill
arm group type: Experimental
description: In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues.
arm group label: MIRT + Treadmill Plus
arm group type: Experimental
description: In the context of MIRT, the gait training in this group will be performed by using a treadmill with visual and auditory cues.
arm group label: MIRT + Virtual Reality
arm group type: Experimental
description: In the context of MIRT, the gait training in this group will be performed by using Virtual Reality with enhanced perceptions (visual, auditory, and haptic inputs).
intervention type: Other
intervention name: MIRT + Treadmill
description: PD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill training twice per day, 5 times a week, for 4 weeks.
arm group label: MIRT + Treadmill
intervention type: Other
intervention name: MIRT + Treadmill Plus
description: PD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill-plus training (with visual and auditory cues) twice per day, 5 times a week, for 4 weeks.
arm group label: MIRT + Treadmill Plus
intervention type: Other
intervention name: MIRT + Virtual Reality
description: PD patients will undergo a 4-week MIRT. All patients in the MIRT+Virtual Reality (VR) group will undergo 10-minutes VR training with enhanced perceptions (visual, auditory, and haptic inputs), twice per day, 5 times a week, for 4 weeks.
arm group label: MIRT + Virtual Reality
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Frazzitta Giuseppe, MD
role: Study Director
affiliation: "Moriggia-Pelascini" Hospital
last name: Davide Ferrazzoli, MD
phone: +393318643163
email: davideferrazzoli@gmail.com
last name: Ilaria Zivi, MD
phone: +39034492111
email: ilaria.zivi@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Neurologic Manifestations
mesh term: Gait Disorders, Neurologic
sharing ipd: No