<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/NCT01695577</url>
  </required_header>
  <id_info>
    <org_study_id>OUSHIOA2012</org_study_id>
    <secondary_id>2012/195b</secondary_id>
    <secondary_id>2012/1623</secondary_id>
    <nct_id>NCT01695577</nct_id>
  </id_info>
  <brief_title>Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury</brief_title>
  <acronym>VRTBI2012</acronym>
  <official_title>Vestibular Rehabilitation and Balance Training for Patients With Dizziness and Balance Problems After Traumatic Brain Injury.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oslo University College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of this study is to evaluate the effect of vestibular rehabilitation and balance&#xD;
      training on patients with dizziness and balance problems after traumatic brain injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      8 000 to 10 000 persons are admitted to hospitals in Norway with traumatic brain injury&#xD;
      (TBI)annually. Dizziness and balance problems have an incidence of 30-80% in this population.&#xD;
&#xD;
      Studies show that dizziness and imbalance has the potential to restrict several aspects of&#xD;
      personal and social life.&#xD;
&#xD;
      Vestibular rehabilitation (VR) is an accepted and effective treatment for dizziness and&#xD;
      imbalance. However there is lack of evidence/knowledge about its effect on TBI patients.&#xD;
&#xD;
      The study is designed as a randomized controlled trial study (RCT). Patients aged 16-60&#xD;
      admitted to Oslo University Hospital with TBI and symptoms of dizziness and imbalance are&#xD;
      included 8 weeks after the injury.&#xD;
&#xD;
      The intervention and control group will receive multidisciplinary assessment and evaluation.&#xD;
      The intervention group will in addition receive group training and a home exercise program by&#xD;
      physiotherapists. The intervention will consist of a individually adapted Vestibular&#xD;
      Rehabilitation and balance program.&#xD;
&#xD;
      The main outcome measurement is the Dizziness Handicap Inventory (DHI). The study has several&#xD;
      other self-report and performance based outcome measures. The outcome measures will be&#xD;
      performed before and after the intervention and 6 months after the injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2013</start_date>
  <completion_date type="Actual">August 30, 2016</completion_date>
  <primary_completion_date type="Actual">August 30, 2016</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>Dizziness Handicap Inventory (DHI)</measure>
    <time_frame>Up to 12 months post injury</time_frame>
    <description>The Dizziness Handicap Inventory (DHI) was developed to measure the self-perceived level of handicap associated with the symptom of dizziness (Jacobson, 1990). The DHI is a 25 item self-report questionnaire with 3 response levels: yes = 4, sometimes = 2, no = 0. The total score is obtained by summing the ordinal scale responses obtained from the 3 response levels (0-100, higher score indicates worse handicap) (Jacobson, 1990).&#xD;
The DHI has been translated into Norwegian and has demonstrated satisfactory measurement properties (Tamber, 2009).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>High level mobility assessment tool for traumatic brain injury (HiMAT)</measure>
    <time_frame>Up to 12 months post injury</time_frame>
    <description>The HiMAT is a uni-dimensional performance-based measure of balance and mobility. It consists of 13 walking, running, skipping, hopping and stair items that are measured either by a stopwatch or tape-measure. Raw scores measured in times and distances are noted and converted to a score on a 5-point scale from 0-4, except the two dependent stair items that are rated on a 6- point scale from 0-5. A 0 corresponds to inability to perform the item, and 1 -4/5 represents increasing levels of ability. The sum score range is 0-54 (worst-best). A user/instruction manual for the testers describing the test in detail is developed. (Williams, 2006;Williams, 2006).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Balance Error Scoring System (BESS).</measure>
    <time_frame>Up to 12 months post injury</time_frame>
    <description>The Bess is a standardized balance testing system. It consists of three 20 second, standardized stances on a firm surface and on a foam surface with eyes closed. The stances are: double leg stance, single-leg stance and tandem stance. Errors are counted during each 20-second trial(Bell, 2011;Finnoff, 2009). The Bess has variable but satisfactory measurement properties and norms are developed (Bell, 2011).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Brain Concussion</condition>
  <condition>Head Injury</condition>
  <condition>Dizziness</condition>
  <arm_group>
    <arm_group_label>Multidisciplinary evaluation and VR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vestibular rehabilitation and balance training. Twice a week for eight weeks.Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multidisciplinary evaluation and no VR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multidisciplinary evaluation and VR</intervention_name>
    <description>Multidisciplinary assessment and evaluation and VR - Vestibular rehabilitation and balance training. Individually adjusted exercises in groups twice a week for two months. Home exercise program.</description>
    <arm_group_label>Multidisciplinary evaluation and VR</arm_group_label>
    <other_name>Multidisciplinary evaluation and Vestibular rehabilitation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multidisciplinary evaluation</intervention_name>
    <description>Multidisciplinary assessment and evaluation.</description>
    <arm_group_label>Multidisciplinary evaluation and no VR</arm_group_label>
    <other_name>Multidisciplinary assessment and evaluation.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  TBI patients enrolled at Oslo University Hospital.&#xD;
&#xD;
          -  persistent dizziness and/or balance problems 2 months post-injury.&#xD;
&#xD;
          -  functionally and cognitively able to attend a group training program with vestibular&#xD;
             rehabilitation and balance training as the main focus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe psychiatric disorder,&#xD;
&#xD;
          -  language problems,&#xD;
&#xD;
          -  cognitive dysfunction that makes self-report difficult,&#xD;
&#xD;
          -  extremity injuries,&#xD;
&#xD;
          -  not being able to walk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingerid Kleffelgård, MSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Ingerid Kleffelgård</investigator_full_name>
    <investigator_title>Physical Therapist/ PhD student</investigator_title>
  </responsible_party>
  <keyword>Traumatic brain injury</keyword>
  <keyword>Dizziness</keyword>
  <keyword>Vestibular rehabilitation</keyword>
  <keyword>Balance rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Craniocerebral Trauma</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Dizziness</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01695577
org study id: OUSHIOA2012
secondary id: 2012/195b
secondary id: 2012/1623
nct id: NCT01695577
lead sponsor: 
collaborator: 
has dmc: Yes
The main aim of this study is to evaluate the effect of vestibular rehabilitation and balance
      training on patients with dizziness and balance problems after traumatic brain injury.
8 000 to 10 000 persons are admitted to hospitals in Norway with traumatic brain injury
      (TBI)annually. Dizziness and balance problems have an incidence of 30-80% in this population.

      Studies show that dizziness and imbalance has the potential to restrict several aspects of
      personal and social life.

      Vestibular rehabilitation (VR) is an accepted and effective treatment for dizziness and
      imbalance. However there is lack of evidence/knowledge about its effect on TBI patients.

      The study is designed as a randomized controlled trial study (RCT). Patients aged 16-60
      admitted to Oslo University Hospital with TBI and symptoms of dizziness and imbalance are
      included 8 weeks after the injury.

      The intervention and control group will receive multidisciplinary assessment and evaluation.
      The intervention group will in addition receive group training and a home exercise program by
      physiotherapists. The intervention will consist of a individually adapted Vestibular
      Rehabilitation and balance program.

      The main outcome measurement is the Dizziness Handicap Inventory (DHI). The study has several
      other self-report and performance based outcome measures. The outcome measures will be
      performed before and after the intervention and 6 months after the injury.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Dizziness Handicap Inventory (DHI)
time frame: Up to 12 months post injury
description: The Dizziness Handicap Inventory (DHI) was developed to measure the self-perceived level of handicap associated with the symptom of dizziness (Jacobson, 1990). The DHI is a 25 item self-report questionnaire with 3 response levels: yes = 4, sometimes = 2, no = 0. The total score is obtained by summing the ordinal scale responses obtained from the 3 response levels (0-100, higher score indicates worse handicap) (Jacobson, 1990).
The DHI has been translated into Norwegian and has demonstrated satisfactory measurement properties (Tamber, 2009).
measure: High level mobility assessment tool for traumatic brain injury (HiMAT)
time frame: Up to 12 months post injury
description: The HiMAT is a uni-dimensional performance-based measure of balance and mobility. It consists of 13 walking, running, skipping, hopping and stair items that are measured either by a stopwatch or tape-measure. Raw scores measured in times and distances are noted and converted to a score on a 5-point scale from 0-4, except the two dependent stair items that are rated on a 6- point scale from 0-5. A 0 corresponds to inability to perform the item, and 1 -4/5 represents increasing levels of ability. The sum score range is 0-54 (worst-best). A user/instruction manual for the testers describing the test in detail is developed. (Williams, 2006;Williams, 2006).
measure: Balance Error Scoring System (BESS).
time frame: Up to 12 months post injury
description: The Bess is a standardized balance testing system. It consists of three 20 second, standardized stances on a firm surface and on a foam surface with eyes closed. The stances are: double leg stance, single-leg stance and tandem stance. Errors are counted during each 20-second trial(Bell, 2011;Finnoff, 2009). The Bess has variable but satisfactory measurement properties and norms are developed (Bell, 2011).
arm group label: Multidisciplinary evaluation and VR
arm group type: Experimental
description: Vestibular rehabilitation and balance training. Twice a week for eight weeks.Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.
arm group label: Multidisciplinary evaluation and no VR
arm group type: Active Comparator
description: Multidisciplinary evaluation. Outcome measures and tests at baseline, after 8 weeks and 6 months after the injury.
intervention type: Other
intervention name: Multidisciplinary evaluation and VR
description: Multidisciplinary assessment and evaluation and VR - Vestibular rehabilitation and balance training. Individually adjusted exercises in groups twice a week for two months. Home exercise program.
arm group label: Multidisciplinary evaluation and VR
other name: Multidisciplinary evaluation and Vestibular rehabilitation
intervention type: Other
intervention name: Multidisciplinary evaluation
description: Multidisciplinary assessment and evaluation.
arm group label: Multidisciplinary evaluation and no VR
other name: Multidisciplinary assessment and evaluation.
criteria: 
gender: All
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ingerid Kleffelgård, MSc.
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Ingerid Kleffelgård
investigator title: Physical Therapist/ PhD student
mesh term: Vertigo
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Craniocerebral Trauma
mesh term: Brain Concussion
mesh term: Dizziness
mesh term: Wounds and Injuries
sharing ipd: Undecided