<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/NCT04415580</url>
  </required_header>
  <id_info>
    <org_study_id>FSLCE/PROG.700</org_study_id>
    <nct_id>NCT04415580</nct_id>
  </id_info>
  <brief_title>Vestibular Rehabilitation and Severe Traumatic Brain Injury</brief_title>
  <official_title>Effects of Vestibular Rehabilitation in Patients With Severe Traumatic Brain Injury: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I.R.C.C.S. Fondazione Santa Lucia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I.R.C.C.S. Fondazione Santa Lucia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Severe brain injury (sTBI) is one of the most common causes of long-term disability and is&#xD;
      considered the most frequent cause of mortality and serious disability in young adults in&#xD;
      industrialized countries. It is defined as an alteration of brain function with loss of&#xD;
      consciousness in the acute phase for at least 24 hours (Glasgow Coma Scale (GCS) &lt;8) and it&#xD;
      can induce a wide range of deficit, including cognitive-behavioural, motors, psychics,&#xD;
      language, vision, coordination and balance impairments. Chronic vestibular symptoms such as&#xD;
      dizziness and balance deficits (both static and dynamic postural instability) are present in&#xD;
      patients with brain injury. These aspects can cause functions limitation and psychological&#xD;
      distress, negatively impacting negatively on subjects' quality of life and social&#xD;
      reintegration and are considered unfavourable prognostic factors of the recovery process. The&#xD;
      literature supports the use of vestibular rehabilitation techniques in patients with mild and&#xD;
      moderate brain injury, however, to date, no studies investigated the effect of vestibular&#xD;
      rehabilitation in sTBI patients. The main aim of this randomized controlled trail is to&#xD;
      verify the effect of a personalized vestibular training on balance and gait disorders in sTBI&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">June 21, 2021</completion_date>
  <primary_completion_date type="Actual">February 26, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dynamic Gait Index Scoring Form (DGI)</measure>
    <time_frame>Baseline to 8 weeks after the end training</time_frame>
    <description>Change of Dynamic Gait Index Scoring Form (DGI) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. DGI values ranging from 0 to 24, where 0 means the worse outcome and 24 the best one.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>Baseline to 8 weeks after the end training</time_frame>
    <description>Change of Berg Balance Scale (BBS) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. BBS values ranging from 0 to 56, where 0 means the worse outcome and 56 the best one</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community Balance &amp; Mobility Scale (CB&amp;M)</measure>
    <time_frame>Baseline to 8 weeks after the end training</time_frame>
    <description>Change of Community Balance and Mobility Scale (CB&amp;M) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. CB&amp;M values ranging from 0 to 96, where 0 means the worse outcome and 96 the best one.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities-specific Balance Confidence scale (ABC)</measure>
    <time_frame>Baseline to 8 weeks after the end training</time_frame>
    <description>Change of Activities-specific Balance Confidence scale (ABC) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. ABC values ranging from 0% to 100%, where 0% means the worse outcome and 100% the best one.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community Integration Questionnaire (CIQ)</measure>
    <time_frame>Baseline to 8 weeks after the end training</time_frame>
    <description>Change of Community Integration Questionnaire (CIQ) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. CIQ values ranging from 0 to 29, where 0means the worse outcome and 29 the best one.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness Handicap Inventory (DHI)</measure>
    <time_frame>Baseline to 8 weeks after the end training</time_frame>
    <description>Dizziness Handicap Inventory (DHI) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. DHI values ranging from 0 to 100, where 100 means the worse outcome and 0 the best one.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instrumental Assessment</measure>
    <time_frame>Baseline to 8 weeks after the end training</time_frame>
    <description>Postural and gait functional assessment performed using inertial motion capture systems (Opal, APDM Inc., Portland, Oregon, USA, portable devices controlling 6 inertial/magnetic measurement units providing 3D orientation and kinematic). The assessments were performed at the baseline, 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Severe Traumatic Brain Injury</condition>
  <condition>Gait Disorders, Neurologic</condition>
  <arm_group>
    <arm_group_label>Vestibular Rehabilitation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional rehabilitation Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vestibular Rehabilitation (VR)</intervention_name>
    <description>VR consisted of two types of exercises, i.e., those for gaze stability and those for postural stability&#xD;
Gaze stability exercises The patients will perform the exercises while holding their gaze on a firm target (VORx1) during active horizontal and vertical head movements (one minute for each axis).&#xD;
Postural stability exercises March in Place Each patient will ask to get on a foam cushion of 10 cm in height and then will blindfold. Treadmill Training As preparation for training, all subjects underwent a 1-minute walk on treadmill with open eyes using preferred walking speed. Immediately after preparation, patients will blindfold and will ask to walk on treadmill without support of hands for 4 minutes.&#xD;
When patients made the mistake of changing direction, the physiotherapist help them to keep the right position using verbal cues (e.g., you are turning left or right).</description>
    <arm_group_label>Vestibular Rehabilitation Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Neurorehabilitation</intervention_name>
    <description>muscles stretching, active and assisted limbs mobilization, four limbs coordination exercises, balance training on instable platform and gait training</description>
    <arm_group_label>Conventional rehabilitation Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 15 and 65 years;&#xD;
&#xD;
          -  Glasgow coma scale (GCS) score ≤ 8 (used to objectively describe the severity of&#xD;
             impaired consciousness at the time of injury)&#xD;
&#xD;
          -  Level of cognitive functioning (LCF) ≥7;&#xD;
&#xD;
          -  Ability to understand verbal commands and the informed consent.&#xD;
&#xD;
          -  Presence of static and dynamic balance impairments.&#xD;
&#xD;
          -  Functional Ambulation Classification (FAC) ≥ 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Glasgow coma scale (GCS) score &gt;8&#xD;
&#xD;
          -  Level of cognitive functioning (LCF) &lt;7&#xD;
&#xD;
          -  Inability to understand verbal commands&#xD;
&#xD;
          -  Absence of static and dynamic balance impairments.&#xD;
&#xD;
          -  Functional Ambulation Classification (FAC) &lt; 3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marco Tramontano</name>
      <address>
        <city>Roma</city>
        <state>Rm</state>
        <zip>00179</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Lucia Foundation I.R.C.C.S.</name>
      <address>
        <city>Roma</city>
        <state>Rm</state>
        <zip>00179</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 21, 2021</last_update_submitted>
  <last_update_submitted_qc>June 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>I.R.C.C.S. Fondazione Santa Lucia</investigator_affiliation>
    <investigator_full_name>Marco Tramontano</investigator_full_name>
    <investigator_title>head of rehabilitation Services</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT04415580
org study id: FSLCE/PROG.700
nct id: NCT04415580
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Severe brain injury (sTBI) is one of the most common causes of long-term disability and is
      considered the most frequent cause of mortality and serious disability in young adults in
      industrialized countries. It is defined as an alteration of brain function with loss of
      consciousness in the acute phase for at least 24 hours (Glasgow Coma Scale (GCS) <8) and it
      can induce a wide range of deficit, including cognitive-behavioural, motors, psychics,
      language, vision, coordination and balance impairments. Chronic vestibular symptoms such as
      dizziness and balance deficits (both static and dynamic postural instability) are present in
      patients with brain injury. These aspects can cause functions limitation and psychological
      distress, negatively impacting negatively on subjects' quality of life and social
      reintegration and are considered unfavourable prognostic factors of the recovery process. The
      literature supports the use of vestibular rehabilitation techniques in patients with mild and
      moderate brain injury, however, to date, no studies investigated the effect of vestibular
      rehabilitation in sTBI patients. The main aim of this randomized controlled trail is to
      verify the effect of a personalized vestibular training on balance and gait disorders in sTBI
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Dynamic Gait Index Scoring Form (DGI)
time frame: Baseline to 8 weeks after the end training
description: Change of Dynamic Gait Index Scoring Form (DGI) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. DGI values ranging from 0 to 24, where 0 means the worse outcome and 24 the best one.
measure: Berg Balance Scale (BBS)
time frame: Baseline to 8 weeks after the end training
description: Change of Berg Balance Scale (BBS) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. BBS values ranging from 0 to 56, where 0 means the worse outcome and 56 the best one
measure: Community Balance & Mobility Scale (CB&M)
time frame: Baseline to 8 weeks after the end training
description: Change of Community Balance and Mobility Scale (CB&M) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. CB&M values ranging from 0 to 96, where 0 means the worse outcome and 96 the best one.
measure: Activities-specific Balance Confidence scale (ABC)
time frame: Baseline to 8 weeks after the end training
description: Change of Activities-specific Balance Confidence scale (ABC) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. ABC values ranging from 0% to 100%, where 0% means the worse outcome and 100% the best one.
measure: Community Integration Questionnaire (CIQ)
time frame: Baseline to 8 weeks after the end training
description: Change of Community Integration Questionnaire (CIQ) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. CIQ values ranging from 0 to 29, where 0means the worse outcome and 29 the best one.
measure: Dizziness Handicap Inventory (DHI)
time frame: Baseline to 8 weeks after the end training
description: Dizziness Handicap Inventory (DHI) from baseline at 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training. DHI values ranging from 0 to 100, where 100 means the worse outcome and 0 the best one.
measure: Instrumental Assessment
time frame: Baseline to 8 weeks after the end training
description: Postural and gait functional assessment performed using inertial motion capture systems (Opal, APDM Inc., Portland, Oregon, USA, portable devices controlling 6 inertial/magnetic measurement units providing 3D orientation and kinematic). The assessments were performed at the baseline, 4 weeks of training, at 4 weeks after the end of the training and after 8 weeks after the end of the training
arm group label: Vestibular Rehabilitation Group
arm group type: Experimental
arm group label: Conventional rehabilitation Group
arm group type: Active Comparator
intervention type: Other
intervention name: Vestibular Rehabilitation (VR)
description: VR consisted of two types of exercises, i.e., those for gaze stability and those for postural stability
Gaze stability exercises The patients will perform the exercises while holding their gaze on a firm target (VORx1) during active horizontal and vertical head movements (one minute for each axis).
Postural stability exercises March in Place Each patient will ask to get on a foam cushion of 10 cm in height and then will blindfold. Treadmill Training As preparation for training, all subjects underwent a 1-minute walk on treadmill with open eyes using preferred walking speed. Immediately after preparation, patients will blindfold and will ask to walk on treadmill without support of hands for 4 minutes.
When patients made the mistake of changing direction, the physiotherapist help them to keep the right position using verbal cues (e.g., you are turning left or right).
arm group label: Vestibular Rehabilitation Group
intervention type: Other
intervention name: Conventional Neurorehabilitation
description: muscles stretching, active and assisted limbs mobilization, four limbs coordination exercises, balance training on instable platform and gait training
arm group label: Conventional rehabilitation Group
criteria: 
gender: All
minimum age: 15 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: I.R.C.C.S. Fondazione Santa Lucia
investigator full name: Marco Tramontano
investigator title: head of rehabilitation Services
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Nervous System Diseases
mesh term: Gait Disorders, Neurologic
mesh term: Wounds and Injuries