<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01672658</url>
  </required_header>
  <id_info>
    <org_study_id>NUSTU58913</org_study_id>
    <nct_id>NCT01672658</nct_id>
  </id_info>
  <brief_title>Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation</brief_title>
  <official_title>Standard Vestibular Rehabilitation Training (VRT) vs. Sensory Kinetics Balance System (SKBS) + VRT on Balance and Functional Outcomes in the Mild Traumatic Brain Injury (mTBI) Population.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Edward Hines Jr. VA Hospital</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Shirley Ryan AbilityLab</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study at RIC is to determine the value and benefit of the&#xD;
      SK multimodal balance training system through independent clinical evaluations. The&#xD;
      functional benefit of the SK Balance system will be measured by any improvements in balance&#xD;
      and functional assessments.&#xD;
&#xD;
      This study is primarily funded through Engineering Acoustics as a subcontract for a phase II&#xD;
      Small Business Innovation Research by the Department of Defense.&#xD;
&#xD;
      3) Hypotheses &amp; Research Objectives and Purpose:&#xD;
&#xD;
      The specific research questions to be addressed are:&#xD;
&#xD;
        1. How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT&#xD;
           intervention on balance and functional gait measures in mild traumatic brain injury&#xD;
           (mTBI) participants.&#xD;
&#xD;
        2. How do SKBS measurement tools compare to standard clinical assessments of gait and&#xD;
           balance in mTBI patients The purpose of this clinical research study is to compare the&#xD;
           value and benefit of the SK multimodal balance training system in combination with&#xD;
           traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone&#xD;
           through independent clinical evaluations. The functional benefit of the SK Balance&#xD;
           system will be measured by any improvements in clinical measures of balance, functional&#xD;
           mobility, and gait assessment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traumatic brain injury (TBI) occurs when physical trauma causes temporary or permanent&#xD;
      neurological damage. In some cases, symptoms can continue over time and contribute to&#xD;
      disability. Dizziness and vertigo are associated with nearly all reported studies of mild&#xD;
      Traumatic Brain Injury (mTBI) and are a significant and functionally limiting component of&#xD;
      the overall disability.&#xD;
&#xD;
      TBI is one of the many risks faced by military personnel in combat activities . In a RAND&#xD;
      Corporation survey of service members who had been deployed to Iraq or Afghanistan, 19%&#xD;
      reported probable TBI. Dizziness and vertigo are associated with nearly all reported studies&#xD;
      of mTBI and are a significant and debilitating component of the overall disability. mTBI are&#xD;
      currently caused by both blast and impact injuries resulting in variable disabilities . Overt&#xD;
      symptoms may include balance and spatial disorientation problems (vertigo) related to&#xD;
      vestibular dysfunction, vision disturbances, inner-ear edema, and/or other sensory&#xD;
      integration deficits.&#xD;
&#xD;
      Treatment of this particular population group has several challenges which include: 1)&#xD;
      difficulty with early and specific injury assessment 2) the determination of appropriate&#xD;
      return-to-duty measures 3) selection of effective individualized balance rehabilitation and&#xD;
      treatment tools 4) Prolonged length of rehabilitation and uncertain measureable endpoints.&#xD;
      The group is also highly variable in the nature and extent of balance deficits and cognitive&#xD;
      and / or related psychological impairments. It appears that almost all subjects with mTBI&#xD;
      show some susceptibility to vestibular or vestibular/ocular disorders.&#xD;
&#xD;
      After assessment of disequilibrium, rehabilitation is often a course of remedial physical&#xD;
      therapy (PT). To affect change in mobility by standard physical therapy, sensory and motor&#xD;
      systems are &quot;habituated&quot; through exercise, with hope of rehabilitating the system and&#xD;
      &quot;compensating&quot; by instructing the patient to alter skill sets associated with a task.&#xD;
      Compensation (without immediate sensory feedback) is problematic and prone to patient (and&#xD;
      caregiver) interpretation and error, because it may not address the underlying problems and&#xD;
      may not have long term therapeutic benefits. There is also a very limited pool of PTs who&#xD;
      specialize in the treatment of neurological problems resulting from brain injuries.&#xD;
      Individual vestibular rehabilitation treatment programs are designed by these specialist PTs&#xD;
      who also monitor and participate in each patient's recovery. This approach is labor&#xD;
      intensive, time consuming (up to 14 weeks of therapy is often needed) and some patients do&#xD;
      not recover fully .&#xD;
&#xD;
      The overall objective of this research effort is to use novel combinations of multi-modal&#xD;
      sensory guided feedback (especially tactile) and traditional vestibular rehabilitation to&#xD;
      retrain military personnel suffering balance disorders as a result of mTBI. The investigators&#xD;
      therapeutic goal is to test technology that will return the patient, in the shortest period&#xD;
      of time, to a level of balance performance consistent with return to the community and/or&#xD;
      military duty.&#xD;
&#xD;
      The sense of touch is intrinsically linked with the neuro-motor channel, both at the reflex&#xD;
      and higher cognitive regions, which makes it uniquely tied to orientation and localization.&#xD;
      Vibrotactile arrays are therefore intuitive and are an effective sensory feedback pathway.&#xD;
&#xD;
      Recent research has also demonstrated that tactile cueing yield significantly faster and more&#xD;
      accurate performance than comparable spatial auditory cues. Further research has demonstrated&#xD;
      this finding is relatively stable across a variety of body orientations, even when spatial&#xD;
      translation is required and under physiological stress.&#xD;
&#xD;
      Over a Phase I SBIR and current Phase II effort, Engineering Acoustics Inc. has developed the&#xD;
      Sensory Kinetics (SK) Balance System. In the SK system, patients move on a force platform&#xD;
      (see Figure 1) while movement and posture data is interpreted by advanced software a mapped&#xD;
      to a wearable vibrotactile belt array and visual display. Vibrotactile cueing provides&#xD;
      continuous and instantaneous feedback to the patient that compliments their postural and&#xD;
      mobility decisions. The investigators believe that vibrotactile feedback can greatly increase&#xD;
      spatial awareness and consequently mobility. Further, the ability of the brain to re-organize&#xD;
      and relearn functional movement activities provides an intriguing potential pathway for the&#xD;
      retention of learned functional mobility strategies.Vibrotactile cueing involves short&#xD;
      duration bursts of mechanical vibration from actuators, or tactors, that are mounted within a&#xD;
      torso worn belt. The person's position is measured and calculated using a force plate sensor&#xD;
      and camera sensors. The computerized system is then used as part of physical therapy balance&#xD;
      training to improve the patient's balance and potentially reduce their risk of falling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)</time_frame>
    <description>The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Gait Assessment (FGA)</measure>
    <time_frame>Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)</time_frame>
    <description>Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect.&#xD;
10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment&#xD;
= moderate impairment&#xD;
= mild impairment&#xD;
= normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>10 Meter Walk Test</measure>
    <time_frame>Pre-training, mid training (4 weeks), post training (8 weeks)</time_frame>
    <description>assesses walking speed of short duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six Minute Walk Test</measure>
    <time_frame>Pre-training, mid training (4 weeks), post training (8 weeks)</time_frame>
    <description>Assesses distance walked over 6 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed</measure>
    <time_frame>Pre-training, mid training, post training</time_frame>
    <description>Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges.&#xD;
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.&#xD;
The scores of the 3 trials are averages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open</measure>
    <time_frame>Pre-training, mid training (4 weeks), post training (8 weeks)</time_frame>
    <description>The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions.&#xD;
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.&#xD;
The scores of the 3 trials are averages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities Balance Confidence Scale (ABC)</measure>
    <time_frame>Pre-training, mid training, post training</time_frame>
    <description>Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.&#xD;
16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: &quot;How confident are you that you will not lose your balance or become unsteady when you...&quot; Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness Handicap Inventory</measure>
    <time_frame>Pre-training, mid training, post training</time_frame>
    <description>A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness.&#xD;
Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Vestibular Deficits</condition>
  <arm_group>
    <arm_group_label>Sensory Kinectics Balance System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Vestibular Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sensory Kinetics Balance System</intervention_name>
    <description>Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
    <arm_group_label>Sensory Kinectics Balance System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional Vestibular Rehabilitation</intervention_name>
    <description>Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
    <arm_group_label>Traditional Vestibular Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild to moderate Traumatic Brain Injury&#xD;
&#xD;
          -  Adults 18 years-75 years old&#xD;
&#xD;
          -  Vestibular &amp;/or balance deficit following mild/moderate TBI and confirmed by&#xD;
             healthcare professional&#xD;
&#xD;
          -  Subjects reporting head injury from exposure to a blast/concussion injury with one or&#xD;
             more of the following symptoms: dizziness, vertigo, headache, migraine, oscillopsia,&#xD;
             movement induced vertigo.&#xD;
&#xD;
          -  Able to sit unaided for two minutes&#xD;
&#xD;
          -  Able to stand independently with or without a cane, or with no more than moderate&#xD;
             assistance from the physical therapist/researcher.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple trauma&#xD;
&#xD;
          -  Severe brain injury as defined above&#xD;
&#xD;
          -  Pacemakers&#xD;
&#xD;
          -  Weight greater than 250 lbs&#xD;
&#xD;
          -  Mini Mental Status Exam score of less than 24 and/or Cognitive Log score of less than&#xD;
             25&#xD;
&#xD;
          -  A diagnosis of:&#xD;
&#xD;
          -  Peripheral neuropathy&#xD;
&#xD;
          -  Severe neuromuscular diseases&#xD;
&#xD;
          -  Severe Cardiovascular disease&#xD;
&#xD;
          -  Associated high-level stroke or spinal cord injury&#xD;
&#xD;
          -  Amputees&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arun Jayaraman, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shirley Ryan AbilityLab</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehabilitation Institute of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>May 22, 2015</results_first_submitted>
  <results_first_submitted_qc>March 3, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 4, 2016</results_first_posted>
  <last_update_submitted>March 3, 2016</last_update_submitted>
  <last_update_submitted_qc>March 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Arun Jayaraman</investigator_full_name>
    <investigator_title>Research Scientist</investigator_title>
  </responsible_party>
  <keyword>TBI,</keyword>
  <keyword>vestibular</keyword>
  <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>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sensory Kinectics Balance System</title>
          <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Traditional Vestibular Rehabilitation</title>
          <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sensory Kinectics Balance System</title>
          <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Traditional Vestibular Rehabilitation</title>
          <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.5" spread="16.4"/>
                    <measurement group_id="B2" value="41.9" spread="9.6"/>
                    <measurement group_id="B3" value="42.2" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Berg Balance Scale</title>
        <description>The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.</description>
        <time_frame>Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sensory Kinectics Balance System</title>
            <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Vestibular Rehabilitation</title>
            <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
          </group>
        </group_list>
        <measure>
          <title>Berg Balance Scale</title>
          <description>The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.</description>
          <units>Units on a continuous scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" spread="10.94969558"/>
                    <measurement group_id="O2" value="44" spread="10.65338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" spread="10.83743512"/>
                    <measurement group_id="O2" value="47" spread="10.27212167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" spread="8.932851355"/>
                    <measurement group_id="O2" value="47" spread="11.25649995"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Functional Gait Assessment (FGA)</title>
        <description>Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect.&#xD;
10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment&#xD;
= moderate impairment&#xD;
= mild impairment&#xD;
= normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device</description>
        <time_frame>Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sensory Kinectics Balance System</title>
            <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Vestibular Rehabilitation</title>
            <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Gait Assessment (FGA)</title>
          <description>Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect.&#xD;
10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment&#xD;
= moderate impairment&#xD;
= mild impairment&#xD;
= normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.714" spread="6.51"/>
                    <measurement group_id="O2" value="17.125" spread="5.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid-training assessment (4 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.929" spread="6.52"/>
                    <measurement group_id="O2" value="21.21" spread="6.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-training (8 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.642" spread="6.52"/>
                    <measurement group_id="O2" value="23.36" spread="6.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>10 Meter Walk Test</title>
        <description>assesses walking speed of short duration</description>
        <time_frame>Pre-training, mid training (4 weeks), post training (8 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sensory Kinectics Balance System</title>
            <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Vestibular Rehabilitation</title>
            <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
          </group>
        </group_list>
        <measure>
          <title>10 Meter Walk Test</title>
          <description>assesses walking speed of short duration</description>
          <units>m/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.873" spread="0.496"/>
                    <measurement group_id="O2" value="1.067" spread="0.532"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid-training assessment (4 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.944" spread="0.617"/>
                    <measurement group_id="O2" value="1.236" spread="0.632"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-training (8 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.021" spread="0.652"/>
                    <measurement group_id="O2" value="1.253" spread="0.749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Six Minute Walk Test</title>
        <description>Assesses distance walked over 6 minutes</description>
        <time_frame>Pre-training, mid training (4 weeks), post training (8 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sensory Kinectics Balance System</title>
            <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Vestibular Rehabilitation</title>
            <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
          </group>
        </group_list>
        <measure>
          <title>Six Minute Walk Test</title>
          <description>Assesses distance walked over 6 minutes</description>
          <units>Feet</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1021.6" spread="544.1"/>
                    <measurement group_id="O2" value="1158.2" spread="490.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid-training assessment (4 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1075.4" spread="624.1"/>
                    <measurement group_id="O2" value="1271.1" spread="566.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-training (8 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1165.6" spread="662.1"/>
                    <measurement group_id="O2" value="1312.7" spread="627.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed</title>
        <description>Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges.&#xD;
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.&#xD;
The scores of the 3 trials are averages</description>
        <time_frame>Pre-training, mid training, post training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sensory Kinectics Balance System</title>
            <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Vestibular Rehabilitation</title>
            <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed</title>
          <description>Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges.&#xD;
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.&#xD;
The scores of the 3 trials are averages</description>
          <units>sec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.18375" spread="10.15539992"/>
                    <measurement group_id="O2" value="9.119280952" spread="7.06647348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.98062479" spread="12.19808074"/>
                    <measurement group_id="O2" value="16.99357119" spread="11.85259485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.986458" spread="11.13131861"/>
                    <measurement group_id="O2" value="20.423095" spread="9.057258643"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open</title>
        <description>The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions.&#xD;
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.&#xD;
The scores of the 3 trials are averages</description>
        <time_frame>Pre-training, mid training (4 weeks), post training (8 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sensory Kinectics Balance System</title>
            <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Vestibular Rehabilitation</title>
            <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open</title>
          <description>The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions.&#xD;
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.&#xD;
The scores of the 3 trials are averages</description>
          <units>sec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.13041667" spread="10.59997686"/>
                    <measurement group_id="O2" value="21.13333333" spread="10.93591753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.039375" spread="10.71693518"/>
                    <measurement group_id="O2" value="25.715" spread="9.43461609"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.467271" spread="9.635670393"/>
                    <measurement group_id="O2" value="26.277143" spread="9.195793711"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activities Balance Confidence Scale (ABC)</title>
        <description>Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.&#xD;
16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: &quot;How confident are you that you will not lose your balance or become unsteady when you...&quot; Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items</description>
        <time_frame>Pre-training, mid training, post training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sensory Kinectics Balance System</title>
            <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Vestibular Rehabilitation</title>
            <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
          </group>
        </group_list>
        <measure>
          <title>Activities Balance Confidence Scale (ABC)</title>
          <description>Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.&#xD;
16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: &quot;How confident are you that you will not lose your balance or become unsteady when you...&quot; Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.1396875" spread="23.04021958"/>
                    <measurement group_id="O2" value="55.53035714" spread="23.85675041"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.1828125" spread="21.01544763"/>
                    <measurement group_id="O2" value="60.11178571" spread="20.51856435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.445313" spread="22.50808738"/>
                    <measurement group_id="O2" value="66.151786" spread="19.0398228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dizziness Handicap Inventory</title>
        <description>A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness.&#xD;
Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)</description>
        <time_frame>Pre-training, mid training, post training</time_frame>
        <population>This data includes the participants in this study that self reported yes to dizziness. If they answered no to dizziness they did not have the scale administered to them.</population>
        <group_list>
          <group group_id="O1">
            <title>Sensory Kinectics Balance System</title>
            <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Vestibular Rehabilitation</title>
            <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
          </group>
        </group_list>
        <measure>
          <title>Dizziness Handicap Inventory</title>
          <description>A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness.&#xD;
Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)</description>
          <population>This data includes the participants in this study that self reported yes to dizziness. If they answered no to dizziness they did not have the scale administered to them.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.6" spread="26.87"/>
                    <measurement group_id="O2" value="40.5" spread="10.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.0" spread="28.41"/>
                    <measurement group_id="O2" value="38.5" spread="11.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6" spread="25.58"/>
                    <measurement group_id="O2" value="26.0" spread="9.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>0% Indicates that no adverse events were encountered during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Sensory Kinectics Balance System</title>
          <description>Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.&#xD;
Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Traditional Vestibular Rehabilitation</title>
          <description>Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.&#xD;
Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Arun Jayaraman, PT, PhD</name_or_title>
      <organization>Rehabilitation Instititute of Chicago</organization>
      <phone>312-238-2091</phone>
      <email>a-jayaraman@northwestern.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01672658
org study id: NUSTU58913
nct id: NCT01672658
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The goal of this clinical research study at RIC is to determine the value and benefit of the
      SK multimodal balance training system through independent clinical evaluations. The
      functional benefit of the SK Balance system will be measured by any improvements in balance
      and functional assessments.

      This study is primarily funded through Engineering Acoustics as a subcontract for a phase II
      Small Business Innovation Research by the Department of Defense.

      3) Hypotheses & Research Objectives and Purpose:

      The specific research questions to be addressed are:

        1. How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT
           intervention on balance and functional gait measures in mild traumatic brain injury
           (mTBI) participants.

        2. How do SKBS measurement tools compare to standard clinical assessments of gait and
           balance in mTBI patients The purpose of this clinical research study is to compare the
           value and benefit of the SK multimodal balance training system in combination with
           traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone
           through independent clinical evaluations. The functional benefit of the SK Balance
           system will be measured by any improvements in clinical measures of balance, functional
           mobility, and gait assessment.
Traumatic brain injury (TBI) occurs when physical trauma causes temporary or permanent
      neurological damage. In some cases, symptoms can continue over time and contribute to
      disability. Dizziness and vertigo are associated with nearly all reported studies of mild
      Traumatic Brain Injury (mTBI) and are a significant and functionally limiting component of
      the overall disability.

      TBI is one of the many risks faced by military personnel in combat activities . In a RAND
      Corporation survey of service members who had been deployed to Iraq or Afghanistan, 19%
      reported probable TBI. Dizziness and vertigo are associated with nearly all reported studies
      of mTBI and are a significant and debilitating component of the overall disability. mTBI are
      currently caused by both blast and impact injuries resulting in variable disabilities . Overt
      symptoms may include balance and spatial disorientation problems (vertigo) related to
      vestibular dysfunction, vision disturbances, inner-ear edema, and/or other sensory
      integration deficits.

      Treatment of this particular population group has several challenges which include: 1)
      difficulty with early and specific injury assessment 2) the determination of appropriate
      return-to-duty measures 3) selection of effective individualized balance rehabilitation and
      treatment tools 4) Prolonged length of rehabilitation and uncertain measureable endpoints.
      The group is also highly variable in the nature and extent of balance deficits and cognitive
      and / or related psychological impairments. It appears that almost all subjects with mTBI
      show some susceptibility to vestibular or vestibular/ocular disorders.

      After assessment of disequilibrium, rehabilitation is often a course of remedial physical
      therapy (PT). To affect change in mobility by standard physical therapy, sensory and motor
      systems are "habituated" through exercise, with hope of rehabilitating the system and
      "compensating" by instructing the patient to alter skill sets associated with a task.
      Compensation (without immediate sensory feedback) is problematic and prone to patient (and
      caregiver) interpretation and error, because it may not address the underlying problems and
      may not have long term therapeutic benefits. There is also a very limited pool of PTs who
      specialize in the treatment of neurological problems resulting from brain injuries.
      Individual vestibular rehabilitation treatment programs are designed by these specialist PTs
      who also monitor and participate in each patient's recovery. This approach is labor
      intensive, time consuming (up to 14 weeks of therapy is often needed) and some patients do
      not recover fully .

      The overall objective of this research effort is to use novel combinations of multi-modal
      sensory guided feedback (especially tactile) and traditional vestibular rehabilitation to
      retrain military personnel suffering balance disorders as a result of mTBI. The investigators
      therapeutic goal is to test technology that will return the patient, in the shortest period
      of time, to a level of balance performance consistent with return to the community and/or
      military duty.

      The sense of touch is intrinsically linked with the neuro-motor channel, both at the reflex
      and higher cognitive regions, which makes it uniquely tied to orientation and localization.
      Vibrotactile arrays are therefore intuitive and are an effective sensory feedback pathway.

      Recent research has also demonstrated that tactile cueing yield significantly faster and more
      accurate performance than comparable spatial auditory cues. Further research has demonstrated
      this finding is relatively stable across a variety of body orientations, even when spatial
      translation is required and under physiological stress.

      Over a Phase I SBIR and current Phase II effort, Engineering Acoustics Inc. has developed the
      Sensory Kinetics (SK) Balance System. In the SK system, patients move on a force platform
      (see Figure 1) while movement and posture data is interpreted by advanced software a mapped
      to a wearable vibrotactile belt array and visual display. Vibrotactile cueing provides
      continuous and instantaneous feedback to the patient that compliments their postural and
      mobility decisions. The investigators believe that vibrotactile feedback can greatly increase
      spatial awareness and consequently mobility. Further, the ability of the brain to re-organize
      and relearn functional movement activities provides an intriguing potential pathway for the
      retention of learned functional mobility strategies.Vibrotactile cueing involves short
      duration bursts of mechanical vibration from actuators, or tactors, that are mounted within a
      torso worn belt. The person's position is measured and calculated using a force plate sensor
      and camera sensors. The computerized system is then used as part of physical therapy balance
      training to improve the patient's balance and potentially reduce their risk of falling.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Berg Balance Scale
time frame: Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)
description: The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.
measure: Functional Gait Assessment (FGA)
time frame: Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)
description: Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect.
10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment
= moderate impairment
= mild impairment
= normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device
measure: 10 Meter Walk Test
time frame: Pre-training, mid training (4 weeks), post training (8 weeks)
description: assesses walking speed of short duration
measure: Six Minute Walk Test
time frame: Pre-training, mid training (4 weeks), post training (8 weeks)
description: Assesses distance walked over 6 minutes
measure: Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed
time frame: Pre-training, mid training, post training
description: Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges.
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.
The scores of the 3 trials are averages
measure: Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open
time frame: Pre-training, mid training (4 weeks), post training (8 weeks)
description: The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions.
The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.
The scores of the 3 trials are averages
measure: Activities Balance Confidence Scale (ABC)
time frame: Pre-training, mid training, post training
description: Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.
16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items
measure: Dizziness Handicap Inventory
time frame: Pre-training, mid training, post training
description: A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness.
Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)
arm group label: Sensory Kinectics Balance System
arm group type: Experimental
description: Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.
arm group label: Traditional Vestibular Rehabilitation
arm group type: Active Comparator
description: Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.
intervention type: Device
intervention name: Sensory Kinetics Balance System
description: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.
arm group label: Sensory Kinectics Balance System
intervention type: Other
intervention name: Traditional Vestibular Rehabilitation
description: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
arm group label: Traditional Vestibular Rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Arun Jayaraman, PT, PhD
role: Principal Investigator
affiliation: Shirley Ryan AbilityLab
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Arun Jayaraman
investigator title: Research Scientist
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 