xml: <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/NCT05986279</url>
    </required_header>
    <id_info>
      <org_study_id>168-22</org_study_id>
      <nct_id>NCT05986279</nct_id>
    </id_info>
    <brief_title>Improving Psychological and Vestibular Health: MINDGAPS</brief_title>
    <acronym>MINDGAPS</acronym>
    <official_title>Improving Psychological and Vestibular Health Using a Novel Intervention: The Making Informed Decisions in Gaze and Postural Stability (MINDGAPS) System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Montana</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>United States Naval Medical Center, San Diego</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
      <collaborator>
        <agency>Congressionally Directed Medical Research Programs</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Montana</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 purpose of this study is twofold: 1) Develop norms for measures of inner ear function and&#xD;
        psychological health, and 2) Examine the feasibility of using the MINDGAPS system (a remote&#xD;
        monitoring system) to track progress during physical therapy or rehabilitation for inner ear&#xD;
        problems following a concussion or mild Traumatic Brain Injury.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The intersection between vestibular disturbance and psychological health provides a unique&#xD;
        clinical opportunity to address both the modifiable symptoms of vestibular disturbance as&#xD;
        well as psychological health. This project aims to advance our understanding of the causal&#xD;
        link between vestibular disturbance and poor psychological health and aligns directly with&#xD;
        the Traumatic Brain Injury and Psychological Health Research Program (Funding Opportunity:&#xD;
        W81XWH-21-TBIPHRP-TRA). Specifically, the proposed research is responsive to each of the&#xD;
        three focus areas: Understand- this project is designed to advance the understanding of an&#xD;
        established link between vestibular disturbance (e.g., dizziness and poor balance) and poor&#xD;
        psychological health (e.g., anxiety, depression, and social isolation) in survivors of mild&#xD;
        traumatic brain injury (mTBI). Prevent- the MINDGAPS system allows for precise assessment of&#xD;
        dynamic visual acuity (computerized dynamic visual acuity [cDVA]) and postural sway&#xD;
        (instrumented balance accelerometry measure [iBAM]), two objective and extensively validated&#xD;
        surrogates of vestibular health. Additionally, MINDGAPS uses these measures to inform care&#xD;
        decisions via a user-friendly web application. Treat- vestibular assessment is key to&#xD;
        effective vestibular care, as it allows for personalization of treatment programs and&#xD;
        monitoring progress over time.&#xD;
  &#xD;
        Objective/Hypothesis:&#xD;
  &#xD;
        The overall objective of this project is two-fold: 1) Test the preliminary efficacy of the&#xD;
        MINDGAPS system to improve psychological health and vestibular disturbance in active-duty and&#xD;
        Veteran Service Members (SM) with history of mTBI and 2) refine the MINDGAPS system by&#xD;
        developing military-specific normative data and using Community-Based Participatory Research&#xD;
        (CBPR) to incorporate the lived experiences of mTBI survivors, their caregivers, and&#xD;
        clinicians in the design of the MINDGAPS technology and intervention.&#xD;
  &#xD;
        Specific Aims:&#xD;
  &#xD;
        Specific Aim 1 (Preliminary Efficacy): Examine the preliminary efficacy of the MINDGAPS&#xD;
        system to improve psychological and vestibular health in active-duty and Veteran SM with&#xD;
        sub-acute and chronic mTBI.&#xD;
  &#xD;
        Specific Aim 2 (Military-specific Normative Data): Collect a cross-sectional sample of cDVA,&#xD;
        iBAM, and other relevant measures in active-duty and Veteran Service Members across three&#xD;
        different stages of mTBI-no diagnosed history of mTBI, sub-acute mTBI (2-6 months), and&#xD;
        chronic mTBI (&gt;6 months)-for the development of normative values in military-specific&#xD;
        populations.&#xD;
  &#xD;
        Specific Aim 3 (Refinement of MINDGAPS): Utilize CBPR to refine and improve the MINDGAPS&#xD;
        system for different stakeholders (SM, caregivers, and clinicians) and position MINDGAPS for&#xD;
        examination in a large-scale clinical trial as well as translation into clinical practice.&#xD;
  &#xD;
        Study Design:&#xD;
  &#xD;
        Aim 1: Using a single-cohort (N=36) double-baseline design, all participants will be tested&#xD;
        twice during a no-intervention baseline period, then once following a 6-week course of&#xD;
        vestibular training with the MINDGAPS system. Efficacy will be determined by comparing change&#xD;
        during the baseline period to change over the course of the intervention period. Aim 2: A&#xD;
        large sample of active-duty and Veteran SM (N=300) will be tested in a single,&#xD;
        cross-sectional assessment to build military-specific normative vestibular data. Aim 3: We&#xD;
        will use a convergent mixed-methods analysis of study participant feedback, in combination&#xD;
        with quantitative results and stakeholder engagement, to drive refinement of the MINDGAPS&#xD;
        system throughout the study period.&#xD;
  &#xD;
        Impact:&#xD;
  &#xD;
        Signs of vestibular disturbance are the most commonly reported symptoms following mTBI, and&#xD;
        vestibular disturbance is causally implicated in the development of poor psychological health&#xD;
        following mTBI. Interventions aimed at improving vestibular disturbance can improve&#xD;
        debilitating symptoms such as poor balance and dizziness. The completion of this study will&#xD;
        move MINDGAPS to a technology readiness level of 8, preparing it to be studied in a large&#xD;
        clinical trial in the next phase of work.&#xD;
  &#xD;
        Relevance to Military Health:&#xD;
  &#xD;
        Interventions aimed at improving vestibular disturbance would have profound impacts on both&#xD;
        active-duty SM (inability to visually focus during dynamic tasks- e.g., field of fire) and&#xD;
        Veterans (increased risk of falls). Furthermore, the MINDGAPS system enables rapid and&#xD;
        precise assessment of vestibular functioning at low cost and therefore has tremendous&#xD;
        potential to enhance the delivery of clinical services within a number of active-duty&#xD;
        environments including far-forward military settings or Veterans living in rural areas.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">September 29, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 29, 2027</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>
      <intervention_model_description>One group is enrolled into a longitudinal, single group intervention using vestibular rehab. The other group is enrolled as a cross-sectional observational assessment used for developing normative data.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Computerized Dynamic Visual Acuity (cDVA)</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>computerized measure of functional gaze stability</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Instrumented postural sway assessment</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>instrumented assessment of static postural stability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Video head impulse testing (vHIT)</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>computerized assessment of vestibulo-ocular reflex function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Gait Assessment (FGA)</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>The Functional Gait Assessment (FGA) is a 10-item measure that examines dynamic stability during various walking tasks on a marked 6-m (20-ft) length and 12-inch wide walkway. Each item is rated from 0-3 with higher scores indicating better dynamic stability. Tasks within the FGA require head and/or body motion during walking activities which will be assessed using body-worn 3D inertial measurement units</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dizziness Handicap Inventory (DHI)</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>The DHI is a self assessment inventory designed to evaluate the self-perceived handicap effects imposed by dizziness or unsteadiness and has documented test-retest and internal consistency reliability. The DHI consists of 25 questions subgroup into functional, emotional, and physical components. The total score ranges from 0-100, with higher scores indicating greater handicap.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Life Space Mobility Assessment (LSA)</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>patient reported questionnaire examining community mobility. The maximum possible score is 40 with higher scores indicating better life space mobility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Role Participation Questionnaire</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>patient reported questionnaire assessing participant role in society. The questionnaire asks 17 questions with lower scores indicating greater societal role.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Well Being Scale</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>patient reported questionnaire assessing psychological health. Consists of 18 questions with scores ranging from 0-110 and higher scores indicating better well-being.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare Utilization Questionnaire</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>patient reported questionnaire assessing participants use of healthcare.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Administered Comorbidity Questionnaire (SCQ)</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>patient reported questionnaire assessing health related problems, treatment and limitations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Military Service Information (MSI)</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>patient reported questionnaire inquiring about military service</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ohio State University Head Injury History</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>patient reported questionnaire assessing injuries to head and neck</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Primary Care 5-Item PTSD Screen</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>patient reported questionnaire to identify individuals with probable PTSD</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogy Scale of Dizziness and Unsteadiness</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
      <description>patient report of severity of dizziness and unsteadiness. Participants are asked to draw a single line on a 10 cm line with a higher number indicating greater dizziness or unsteadiness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High-Level Mobility Assessment (HiMT)</measure>
      <time_frame>through study completion, an average of 12 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Vestibular Hypofunction</condition>
    <arm_group>
      <arm_group_label>Rehab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 weeks of vestibular physical therapy guided by the use of the MINDGAPS decision support system</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Observational</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Normative data development of performance on vestibular measures following mTBI</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rehab</intervention_name>
      <description>6 weeks of vestibular rehabilitation guided by the MINDGAPS decision support system</description>
      <arm_group_label>Rehab</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Veteran or Active Duty Military Service Member&#xD;
  &#xD;
            -  Ability to stand independently&#xD;
  &#xD;
            -  Legally autonomous and able to self-consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acute head injury (within the previous 2 months)&#xD;
  &#xD;
            -  History of moderate or severe head injury (i.e., loss of consciousness greater than 30&#xD;
               minutes or post-traumatic amnesia greater than 1 day)&#xD;
  &#xD;
            -  Current diagnosis of spine disorders in the neck&#xD;
  &#xD;
            -  Diagnosis of problems with the arteries in your neck&#xD;
  &#xD;
            -  Blindness&#xD;
  &#xD;
            -  If you have been diagnosed with abnormal eye movements (also called &quot;ocular motor&#xD;
               palsy&quot;)&#xD;
  &#xD;
            -  If you have previously had a stroke or been diagnosed with a neurodegenerative&#xD;
               disorder ( e.g., Parkinson's Disease, Multiple Sclerosis)&#xD;
  &#xD;
            -  If you have been previously diagnosed primary vestibular dysfunction ( e.g.,&#xD;
               congenital peripheral vestibular syndrome)&#xD;
  &#xD;
            -  If you have previously been diagnosed with a brain tumor&#xD;
  &#xD;
            -  If you are currently receiving physical therapy care for balance or dizziness problems&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Brian Loyd, PhD</last_name>
      <phone>406-243-4015</phone>
      <email>Brian.loyd@umontana.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Andy Kittelson, PhD</last_name>
      <phone>406-243-4015</phone>
      <email>Andy.kittelson@umontana.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Naval Medical Center San Diego</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92134</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Trevor Kingsbury</last_name>
        <phone>619-532-7136</phone>
        <email>trevor.d.kingsbury.civ@health.mil</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Montana</name>
        <address>
          <city>Missoula</city>
          <state>Montana</state>
          <zip>59812</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Brian Loyd, PhD</last_name>
        <phone>406-243-4015</phone>
        <email>brian.loyd@umontana.edu</email>
      </contact>
      <contact_backup>
        <last_name>Andy Kittelson, PhD</last_name>
        <phone>406-243-4015</phone>
        <email>andy.kittelson@umontana.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Montana</investigator_affiliation>
      <investigator_full_name>Brian Loyd</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Rehabilitation</keyword>
    <keyword>mild traumatic brain injury</keyword>
    <keyword>dynamic visual acuity</keyword>
    <keyword>gaze stability</keyword>
    <keyword>postural stability</keyword>
    <keyword>dizziness</keyword>
    <keyword>psychological health</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986279
  org study id: 168-22
  nct id: NCT05986279
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is twofold: 1) Develop norms for measures of inner ear function and
        psychological health, and 2) Examine the feasibility of using the MINDGAPS system (a remote
        monitoring system) to track progress during physical therapy or rehabilitation for inner ear
        problems following a concussion or mild Traumatic Brain Injury.
  The intersection between vestibular disturbance and psychological health provides a unique
        clinical opportunity to address both the modifiable symptoms of vestibular disturbance as
        well as psychological health. This project aims to advance our understanding of the causal
        link between vestibular disturbance and poor psychological health and aligns directly with
        the Traumatic Brain Injury and Psychological Health Research Program (Funding Opportunity:
        W81XWH-21-TBIPHRP-TRA). Specifically, the proposed research is responsive to each of the
        three focus areas: Understand- this project is designed to advance the understanding of an
        established link between vestibular disturbance (e.g., dizziness and poor balance) and poor
        psychological health (e.g., anxiety, depression, and social isolation) in survivors of mild
        traumatic brain injury (mTBI). Prevent- the MINDGAPS system allows for precise assessment of
        dynamic visual acuity (computerized dynamic visual acuity [cDVA]) and postural sway
        (instrumented balance accelerometry measure [iBAM]), two objective and extensively validated
        surrogates of vestibular health. Additionally, MINDGAPS uses these measures to inform care
        decisions via a user-friendly web application. Treat- vestibular assessment is key to
        effective vestibular care, as it allows for personalization of treatment programs and
        monitoring progress over time.
  
        Objective/Hypothesis:
  
        The overall objective of this project is two-fold: 1) Test the preliminary efficacy of the
        MINDGAPS system to improve psychological health and vestibular disturbance in active-duty and
        Veteran Service Members (SM) with history of mTBI and 2) refine the MINDGAPS system by
        developing military-specific normative data and using Community-Based Participatory Research
        (CBPR) to incorporate the lived experiences of mTBI survivors, their caregivers, and
        clinicians in the design of the MINDGAPS technology and intervention.
  
        Specific Aims:
  
        Specific Aim 1 (Preliminary Efficacy): Examine the preliminary efficacy of the MINDGAPS
        system to improve psychological and vestibular health in active-duty and Veteran SM with
        sub-acute and chronic mTBI.
  
        Specific Aim 2 (Military-specific Normative Data): Collect a cross-sectional sample of cDVA,
        iBAM, and other relevant measures in active-duty and Veteran Service Members across three
        different stages of mTBI-no diagnosed history of mTBI, sub-acute mTBI (2-6 months), and
        chronic mTBI (>6 months)-for the development of normative values in military-specific
        populations.
  
        Specific Aim 3 (Refinement of MINDGAPS): Utilize CBPR to refine and improve the MINDGAPS
        system for different stakeholders (SM, caregivers, and clinicians) and position MINDGAPS for
        examination in a large-scale clinical trial as well as translation into clinical practice.
  
        Study Design:
  
        Aim 1: Using a single-cohort (N=36) double-baseline design, all participants will be tested
        twice during a no-intervention baseline period, then once following a 6-week course of
        vestibular training with the MINDGAPS system. Efficacy will be determined by comparing change
        during the baseline period to change over the course of the intervention period. Aim 2: A
        large sample of active-duty and Veteran SM (N=300) will be tested in a single,
        cross-sectional assessment to build military-specific normative vestibular data. Aim 3: We
        will use a convergent mixed-methods analysis of study participant feedback, in combination
        with quantitative results and stakeholder engagement, to drive refinement of the MINDGAPS
        system throughout the study period.
  
        Impact:
  
        Signs of vestibular disturbance are the most commonly reported symptoms following mTBI, and
        vestibular disturbance is causally implicated in the development of poor psychological health
        following mTBI. Interventions aimed at improving vestibular disturbance can improve
        debilitating symptoms such as poor balance and dizziness. The completion of this study will
        move MINDGAPS to a technology readiness level of 8, preparing it to be studied in a large
        clinical trial in the next phase of work.
  
        Relevance to Military Health:
  
        Interventions aimed at improving vestibular disturbance would have profound impacts on both
        active-duty SM (inability to visually focus during dynamic tasks- e.g., field of fire) and
        Veterans (increased risk of falls). Furthermore, the MINDGAPS system enables rapid and
        precise assessment of vestibular functioning at low cost and therefore has tremendous
        potential to enhance the delivery of clinical services within a number of active-duty
        environments including far-forward military settings or Veterans living in rural areas.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: One group is enrolled into a longitudinal, single group intervention using vestibular rehab. The other group is enrolled as a cross-sectional observational assessment used for developing normative data.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Computerized Dynamic Visual Acuity (cDVA)
  time frame: through study completion, an average of 12 weeks
  description: computerized measure of functional gaze stability
  measure: Instrumented postural sway assessment
  time frame: through study completion, an average of 12 weeks
  description: instrumented assessment of static postural stability
  measure: Video head impulse testing (vHIT)
  time frame: through study completion, an average of 12 weeks
  description: computerized assessment of vestibulo-ocular reflex function
  measure: Functional Gait Assessment (FGA)
  time frame: through study completion, an average of 12 weeks
  description: The Functional Gait Assessment (FGA) is a 10-item measure that examines dynamic stability during various walking tasks on a marked 6-m (20-ft) length and 12-inch wide walkway. Each item is rated from 0-3 with higher scores indicating better dynamic stability. Tasks within the FGA require head and/or body motion during walking activities which will be assessed using body-worn 3D inertial measurement units
  measure: Dizziness Handicap Inventory (DHI)
  time frame: through study completion, an average of 12 weeks
  description: The DHI is a self assessment inventory designed to evaluate the self-perceived handicap effects imposed by dizziness or unsteadiness and has documented test-retest and internal consistency reliability. The DHI consists of 25 questions subgroup into functional, emotional, and physical components. The total score ranges from 0-100, with higher scores indicating greater handicap.
  measure: Life Space Mobility Assessment (LSA)
  time frame: through study completion, an average of 12 weeks
  description: patient reported questionnaire examining community mobility. The maximum possible score is 40 with higher scores indicating better life space mobility.
  measure: Role Participation Questionnaire
  time frame: through study completion, an average of 12 weeks
  description: patient reported questionnaire assessing participant role in society. The questionnaire asks 17 questions with lower scores indicating greater societal role.
  measure: General Well Being Scale
  time frame: through study completion, an average of 12 weeks
  description: patient reported questionnaire assessing psychological health. Consists of 18 questions with scores ranging from 0-110 and higher scores indicating better well-being.
  measure: Healthcare Utilization Questionnaire
  time frame: through study completion, an average of 12 weeks
  description: patient reported questionnaire assessing participants use of healthcare.
  measure: Self-Administered Comorbidity Questionnaire (SCQ)
  time frame: through study completion, an average of 12 weeks
  description: patient reported questionnaire assessing health related problems, treatment and limitations.
  measure: Military Service Information (MSI)
  time frame: through study completion, an average of 12 weeks
  description: patient reported questionnaire inquiring about military service
  measure: Ohio State University Head Injury History
  time frame: through study completion, an average of 12 weeks
  description: patient reported questionnaire assessing injuries to head and neck
  measure: Primary Care 5-Item PTSD Screen
  time frame: through study completion, an average of 12 weeks
  description: patient reported questionnaire to identify individuals with probable PTSD
  measure: Visual Analogy Scale of Dizziness and Unsteadiness
  time frame: through study completion, an average of 12 weeks
  description: patient report of severity of dizziness and unsteadiness. Participants are asked to draw a single line on a 10 cm line with a higher number indicating greater dizziness or unsteadiness.
  measure: High-Level Mobility Assessment (HiMT)
  time frame: through study completion, an average of 12 weeks
  arm group label: Rehab
  arm group type: Experimental
  description: 6 weeks of vestibular physical therapy guided by the use of the MINDGAPS decision support system
  arm group label: Observational
  arm group type: No Intervention
  description: Normative data development of performance on vestibular measures following mTBI
  intervention type: Other
  intervention name: Rehab
  description: 6 weeks of vestibular rehabilitation guided by the MINDGAPS decision support system
  arm group label: Rehab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Brian Loyd, PhD
  phone: 406-243-4015
  email: Brian.loyd@umontana.edu
  last name: Andy Kittelson, PhD
  phone: 406-243-4015
  email: Andy.kittelson@umontana.edu
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Montana
  investigator full name: Brian Loyd
  investigator title: Professor