<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/NCT03034655</url>
  </required_header>
  <id_info>
    <org_study_id>PI1500329</org_study_id>
    <nct_id>NCT03034655</nct_id>
  </id_info>
  <brief_title>Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation (ReFOVeRe Study)</brief_title>
  <acronym>ReFOVeRe</acronym>
  <official_title>Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation (ReFOVeRe Study): Optimizing Costs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinico Universitario de Santiago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Regional Development Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Clinico Universitario de Santiago</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of this study is to evaluate and compare the effectiveness of vestibular&#xD;
      rehabilitation developed using computerized dynamic posturography or a mobile posturographic&#xD;
      system with vibrotactile stimulation, to improve the balance in older people and reduce the&#xD;
      number of falls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Accidental falls, particularly in the elderly, are one of the most important socio-healthcare&#xD;
      problems of ageing western societies. Many factors condition and favour falls; one of them is&#xD;
      old age, usually related to a decline in sensorial functions and worsening of balance&#xD;
      Vestibular rehabilitation has been shown to be effective to improve balance and reduce the&#xD;
      number of falls in older people. Previous studies have demonstrated that exercises in&#xD;
      computerized dynamic posturography (CDP) are more effective than other vestibular&#xD;
      rehabilitation strategies in this group of age. But CDP is very expensive and not widespread.&#xD;
      It would be important to minimize cost of posturographic vestibular rehabilitation.&#xD;
&#xD;
      This study compare vestibular rehabilitation with two different posturographic devices (CDP&#xD;
      and mobile posturographic system with vibrotactile stimulation), in people over 65 years.&#xD;
      Additionally, we try to assess whether the reduction in the number of vestibular&#xD;
      rehabilitation sessions (five) leads to an improvement in balance and in reducing the number&#xD;
      of falls similar to those obtained with ten sessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</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>
    <intervention_model_description>Experimental study, single-center, open, randomized (balanced blocks of patients) in four branches in parallel, in 220 elderly patients (over 65 years) with high risk of falls; follow-up period: twelve months.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>After the first screening visit, the patients who grant their consent will be included in the study and randomised to one of the following study arms. Randomisation will be performed by C.H.U de Santiago Clinical Epidemiology and Biostatistics Unit. Once the informed consent form is signed, the care provider will contact the unit, which will give him the code of the arm to which the patient is assigned. A n= 20 block balanced randomisation sequence will be used. The investigator will analyse results and evolution, being blind type and duration of vestibular rehabilitation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CDP Average</measure>
    <time_frame>12 months</time_frame>
    <description>Average score in the Sensory Organization Test of the Computerized Dynamic Posturography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mobile posturografphy gSBDT</measure>
    <time_frame>12 months</time_frame>
    <description>Geriatric Standard Balance Deficit Test (gSBDT) score in mobile posturography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls</measure>
    <time_frame>12 months</time_frame>
    <description>Number of falls after vestibular rehabilitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DHI</measure>
    <time_frame>12 months</time_frame>
    <description>Dizziness Handicap Inventory score; it assesses disability perceived by the patient in relation to instability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short FES-I</measure>
    <time_frame>12 months</time_frame>
    <description>Score of a shortened version of the falls efficacy scale-international to assess fear of falling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TUG</measure>
    <time_frame>12 months</time_frame>
    <description>Timed up and go test: time (in seconds), number of steps and need for support</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Dizziness Chronic</condition>
  <condition>Fall</condition>
  <arm_group>
    <arm_group_label>CDP exercises (10 sessions)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A. The Smart Equitest program was used with a protocol of 10 exercises per session, which were customized depending on each patient´s deficit. The exercises involve visual biofeedback together with sensitive, real-time monitoring of movement. In some exercises, patients must maintain their center of gravity (COG) over the base of support, while in others the COG must be moved to a series of targets. In addition, the support surface and/or visual surround may also move in response to the patient´s own movement. The exercise difficulty was progressively increased throughout the rehabilitation sessions. The duration of each session was approximately 15 minutes. The distribution of sessions was one per day and five per week (2 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CDP exercises (5 sessions)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile posturography exercises (10 sess)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group C. Up to six tasks with the most prominent deviations from normative control values were included in the training program. Training was performed by using the training function of Vertiguard1-RT device. This neurofeedback system contains one vibration stimulator on the front, back, left and right side, respectively. Training was performed daily under supervision of a physician over 2 weeks (10 sessions, weekend was excluded). A training session consisted of 5 repetitions of six selected training tasks. The patient received a vibrotactile feedback signal during training in those directions which showed a higher body sway than preset thresholds. Vibration was reinforced with increasing sway No vibrotactile feedback was applied if the patient's sway was below preset thresholds. The exercise difficulty was progressively increase throughout the rehabilitation sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile posturography exercises (5 sess)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group D. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CDP</intervention_name>
    <description>Vestibular rehabilitation using CDP</description>
    <arm_group_label>CDP exercises (10 sessions)</arm_group_label>
    <arm_group_label>CDP exercises (5 sessions)</arm_group_label>
    <other_name>Computerized Dynamic Posturography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mobile posturography</intervention_name>
    <description>Vestibular rehabilitation using mobile posturography</description>
    <arm_group_label>Mobile posturography exercises (10 sess)</arm_group_label>
    <arm_group_label>Mobile posturography exercises (5 sess)</arm_group_label>
    <other_name>Vertiguard's Mobile Posturography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>10 sessions</intervention_name>
    <description>Vestibular rehabilitation, ten sessions</description>
    <arm_group_label>CDP exercises (10 sessions)</arm_group_label>
    <arm_group_label>Mobile posturography exercises (10 sess)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>5 sessions</intervention_name>
    <description>Vestibular rehabilitation, five sessions</description>
    <arm_group_label>CDP exercises (5 sessions)</arm_group_label>
    <arm_group_label>Mobile posturography exercises (5 sess)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Persons with a high risk of falling shall meet at least two of the following requirements:&#xD;
&#xD;
          -  Having fallen at least once in the last 12 months.&#xD;
&#xD;
          -  Using more than 15 seconds or needing support in the TUG test.&#xD;
&#xD;
          -  Obtaining a mean CDP SOT balance score of &lt; 68%.&#xD;
&#xD;
          -  Having fallen at least once in the CDP SOT.&#xD;
&#xD;
          -  A score in Mobile posturography gSBDT &gt; 60 %.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive decline or reduce cultural level that prevents the patient from&#xD;
             understanding the assessment, vestibular rehabilitation exercises and granting&#xD;
             informed consent.&#xD;
&#xD;
          -  Organic conditions that prevent standing on two feet, necessary for assessment of&#xD;
             balance and performance of VR exercises.&#xD;
&#xD;
          -  Balance disorders caused by conditions other than age (neurologic, vestibular,....).&#xD;
&#xD;
          -  Current treatment with drugs that potentially disturb balance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrés Soto-Varela, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinico Universitario de Santiago</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrés Soto-Varela, PhD</last_name>
    <phone>0034981951155</phone>
    <email>andres.soto.varela@sergas.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Complexo Hospitalario Universitario</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruña</state>
        <zip>15701</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrés Soto-Varela, PhD</last_name>
      <phone>0034981951155</phone>
      <email>andres.soto.varela@sergas.es</email>
    </contact>
    <contact_backup>
      <last_name>Sofía Santos-Pérez, PhD</last_name>
      <phone>0034981951155</phone>
      <email>sofia.santos@usc.es</email>
    </contact_backup>
    <investigator>
      <last_name>Sofía Santos-Pérez, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marcos Rossi-Izquierdo, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ana Faraldo-García, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>María del-Río-Valeiras, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Isabel Vaamonde-Sánchez-Andrade, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Antonio Lirola-Delgado, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pilar Gayoso-Diz, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>February 20, 2018</last_update_submitted>
  <last_update_submitted_qc>February 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinico Universitario de Santiago</investigator_affiliation>
    <investigator_full_name>Andrés Soto-Varela</investigator_full_name>
    <investigator_title>Professor and Attending Physician</investigator_title>
  </responsible_party>
  <keyword>Vestibular rehabilitation</keyword>
  <keyword>Falls in elderly</keyword>
  <keyword>Computerized dynamic posturography</keyword>
  <keyword>Mobile posturography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dizziness</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/NCT03034655
org study id: PI1500329
nct id: NCT03034655
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate and compare the effectiveness of vestibular
      rehabilitation developed using computerized dynamic posturography or a mobile posturographic
      system with vibrotactile stimulation, to improve the balance in older people and reduce the
      number of falls.
Accidental falls, particularly in the elderly, are one of the most important socio-healthcare
      problems of ageing western societies. Many factors condition and favour falls; one of them is
      old age, usually related to a decline in sensorial functions and worsening of balance
      Vestibular rehabilitation has been shown to be effective to improve balance and reduce the
      number of falls in older people. Previous studies have demonstrated that exercises in
      computerized dynamic posturography (CDP) are more effective than other vestibular
      rehabilitation strategies in this group of age. But CDP is very expensive and not widespread.
      It would be important to minimize cost of posturographic vestibular rehabilitation.

      This study compare vestibular rehabilitation with two different posturographic devices (CDP
      and mobile posturographic system with vibrotactile stimulation), in people over 65 years.
      Additionally, we try to assess whether the reduction in the number of vestibular
      rehabilitation sessions (five) leads to an improvement in balance and in reducing the number
      of falls similar to those obtained with ten sessions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental study, single-center, open, randomized (balanced blocks of patients) in four branches in parallel, in 220 elderly patients (over 65 years) with high risk of falls; follow-up period: twelve months.
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: After the first screening visit, the patients who grant their consent will be included in the study and randomised to one of the following study arms. Randomisation will be performed by C.H.U de Santiago Clinical Epidemiology and Biostatistics Unit. Once the informed consent form is signed, the care provider will contact the unit, which will give him the code of the arm to which the patient is assigned. A n= 20 block balanced randomisation sequence will be used. The investigator will analyse results and evolution, being blind type and duration of vestibular rehabilitation.
measure: CDP Average
time frame: 12 months
description: Average score in the Sensory Organization Test of the Computerized Dynamic Posturography
measure: Mobile posturografphy gSBDT
time frame: 12 months
description: Geriatric Standard Balance Deficit Test (gSBDT) score in mobile posturography
measure: Falls
time frame: 12 months
description: Number of falls after vestibular rehabilitation
measure: DHI
time frame: 12 months
description: Dizziness Handicap Inventory score; it assesses disability perceived by the patient in relation to instability
measure: Short FES-I
time frame: 12 months
description: Score of a shortened version of the falls efficacy scale-international to assess fear of falling
measure: TUG
time frame: 12 months
description: Timed up and go test: time (in seconds), number of steps and need for support
arm group label: CDP exercises (10 sessions)
arm group type: Experimental
description: Group A. The Smart Equitest program was used with a protocol of 10 exercises per session, which were customized depending on each patient´s deficit. The exercises involve visual biofeedback together with sensitive, real-time monitoring of movement. In some exercises, patients must maintain their center of gravity (COG) over the base of support, while in others the COG must be moved to a series of targets. In addition, the support surface and/or visual surround may also move in response to the patient´s own movement. The exercise difficulty was progressively increased throughout the rehabilitation sessions. The duration of each session was approximately 15 minutes. The distribution of sessions was one per day and five per week (2 weeks).
arm group label: CDP exercises (5 sessions)
arm group type: Experimental
description: Group B. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks).
arm group label: Mobile posturography exercises (10 sess)
arm group type: Experimental
description: Group C. Up to six tasks with the most prominent deviations from normative control values were included in the training program. Training was performed by using the training function of Vertiguard1-RT device. This neurofeedback system contains one vibration stimulator on the front, back, left and right side, respectively. Training was performed daily under supervision of a physician over 2 weeks (10 sessions, weekend was excluded). A training session consisted of 5 repetitions of six selected training tasks. The patient received a vibrotactile feedback signal during training in those directions which showed a higher body sway than preset thresholds. Vibration was reinforced with increasing sway No vibrotactile feedback was applied if the patient's sway was below preset thresholds. The exercise difficulty was progressively increase throughout the rehabilitation sessions.
arm group label: Mobile posturography exercises (5 sess)
arm group type: Experimental
description: Group D. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks).
intervention type: Device
intervention name: CDP
description: Vestibular rehabilitation using CDP
arm group label: CDP exercises (10 sessions)
arm group label: CDP exercises (5 sessions)
other name: Computerized Dynamic Posturography
intervention type: Device
intervention name: Mobile posturography
description: Vestibular rehabilitation using mobile posturography
arm group label: Mobile posturography exercises (10 sess)
arm group label: Mobile posturography exercises (5 sess)
other name: Vertiguard's Mobile Posturography
intervention type: Other
intervention name: 10 sessions
description: Vestibular rehabilitation, ten sessions
arm group label: CDP exercises (10 sessions)
arm group label: Mobile posturography exercises (10 sess)
intervention type: Other
intervention name: 5 sessions
description: Vestibular rehabilitation, five sessions
arm group label: CDP exercises (5 sessions)
arm group label: Mobile posturography exercises (5 sess)
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Andrés Soto-Varela, PhD
role: Principal Investigator
affiliation: Hospital Clinico Universitario de Santiago
last name: Andrés Soto-Varela, PhD
phone: 0034981951155
email: andres.soto.varela@sergas.es
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinico Universitario de Santiago
investigator full name: Andrés Soto-Varela
investigator title: Professor and Attending Physician
mesh term: Dizziness
sharing ipd: No