<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/NCT01729039</url>
  </required_header>
  <id_info>
    <org_study_id>E7613-R</org_study_id>
    <nct_id>NCT01729039</nct_id>
  </id_info>
  <brief_title>Vestibular Rehabilitation and Dizziness</brief_title>
  <acronym>DZO</acronym>
  <official_title>Vestibular Rehabilitation and Dizziness in Geriatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether vestibular exercises provide added benefit&#xD;
      to balance rehabilitation in older adults with dizziness and normal vestibular function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dizziness is among the most prevalent complaints for which people seek medical help and the&#xD;
      incidence increases with advancing age. Dizziness represents a diagnostic and treatment&#xD;
      challenge because it is a subjective sensation, refers to a variety of symptoms&#xD;
      (unsteadiness, spinning, sense of motion or lightheadedness), and has many potential&#xD;
      contributory factors. Dizziness is often related to vestibular disease which is treated&#xD;
      effectively with vestibular exercises. Successful management of dizziness is critical because&#xD;
      dizziness is a major risk factor for falls in older adults.&#xD;
&#xD;
      There are parallels between the effects of age-related versus disease-related loss of&#xD;
      vestibular function - in complaints of dizziness and increased risk for falls. The&#xD;
      investigators' question, then, is whether the same exercises that are beneficial for patients&#xD;
      with vestibular pathology are beneficial for older patients with dizziness but normal&#xD;
      vestibular function.&#xD;
&#xD;
      Older adults with dizziness who have been referred to Audiology for vestibular evaluation&#xD;
      will be randomized to receive either standard balance rehabilitation plus placebo eye&#xD;
      exercises (CON) or standard balance rehabilitation plus vestibular-specific exercises (GS).&#xD;
      Primary outcomes include symptoms, balance-related confidence, dynamic visual acuity,&#xD;
      postural stability as measured by sensory organization test, fall risk as measured by dynamic&#xD;
      gait index, and gait speed. Assessment will occur at baseline, discharge from physical&#xD;
      therapy (PT), 1 and 6 months post-PT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2012</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale - Head Movement</measure>
    <time_frame>6 weeks</time_frame>
    <description>This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale - Disequilibrium</measure>
    <time_frame>6 weeks</time_frame>
    <description>This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dynamic Gait Index</measure>
    <time_frame>6 weeks</time_frame>
    <description>The dynamic gait index (DGI) assesses an individual's ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of &lt; 20 indicate high risk for falling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities-specific Balance Confidence Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure the subject's confidence with their balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10 Meter Walk Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Dizziness</condition>
  <arm_group>
    <arm_group_label>gaze stability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>standard balance rehabilitation plus vestibular-specific exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>standard balance rehabilitation plus placebo eye exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>standard balance rehabilitation</intervention_name>
    <description>All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility with progressively challenging tasks. Balance exercises include maintaining stability with vision and somatosensory cues altered, dynamic weight shifts and performing ankle, hip and step strategies. Gait activities include negotiating uneven terrains and obstacles, gait with head turns, varied speed, and unpredictable starts and stops. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>gaze stability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>gaze stability</intervention_name>
    <description>Vestibular adaptation and substitution exercises will be performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target, which may be stationary or moving. Typical progression of adaptation exercises involve increased velocity of head movement, movement of both target and head, target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target, potentially facilitating use of preprogrammed eye movements.</description>
    <arm_group_label>gaze stability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The placebo exercises will consist of saccadic eye movements while the head is stationary and will be performed by the control group. These eye movements will be performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 50 years of age&#xD;
&#xD;
          -  documented balance or mobility problems&#xD;
&#xD;
          -  normal vestibular function, including otolith function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment&#xD;
&#xD;
          -  progressive medical issues that would impact mobility (e.g., Parkinson's disease,&#xD;
             cerebellar atrophy)&#xD;
&#xD;
          -  dizziness due to orthostatic hypotension or Benign Paroxysmal Positional Vertigo&#xD;
             (BPPV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Courtney D Hall, PhD PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atlanta VA Medical and Rehab Center, Decatur, GA</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN</name>
      <address>
        <city>Mountain Home</city>
        <state>Tennessee</state>
        <zip>37684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>October 17, 2017</results_first_submitted>
  <results_first_submitted_qc>August 20, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 22, 2018</results_first_posted>
  <last_update_submitted>August 20, 2018</last_update_submitted>
  <last_update_submitted_qc>August 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>aged</keyword>
  <keyword>aged, 80 and over</keyword>
  <keyword>vestibular diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Dizziness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Gaze Stability</title>
          <description>Standard balance rehabilitation plus Vestibular-specific exercises&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Vestibular-specific exercises: Gaze stability exercises are performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target. Progression involves increased velocity of head movement and target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Standard balance rehabilitation plus Placebo eye exercises&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Control: Placebo exercises consist of saccadic eye movements while the head is stationary and are performed by the control group (CON). These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>disqualified</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Gaze Stability (GS)</title>
          <description>Gaze Stability group intervention includes standard balance rehabilitation plus vestibular-specific exercises.&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Vestibular-specific exercises: Gaze stability exercises involve head movement while maintaining focus on a target. Progression involves increased velocity of head movement and target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.</description>
        </group>
        <group group_id="B2">
          <title>Control (CON)</title>
          <description>Control group intervention includes standard balance rehabilitation plus placebo eye exercises.&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Control exercises: Placebo eye exercises consist of saccadic eye movements while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.</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="13"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="69.85" spread="8.80"/>
                    <measurement group_id="B2" value="72.36" spread="6.07"/>
                    <measurement group_id="B3" value="71.15" spread="7.47"/>
                  </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="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Visual Analog Scale - Head Movement</title>
          <description>This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 Hz. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.06" spread="2.69"/>
                    <measurement group_id="B2" value="2.58" spread="2.74"/>
                    <measurement group_id="B3" value="2.33" spread="2.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Visual Analog Scale - Disequilibrium</title>
          <description>This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.77" spread="1.69"/>
                    <measurement group_id="B2" value="2.74" spread="2.10"/>
                    <measurement group_id="B3" value="2.29" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dynamic Gait Index</title>
          <description>The dynamic gait index (DGI) assesses an individual's ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of &lt; 20 indicate high risk for falling.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.46" spread="3.15"/>
                    <measurement group_id="B2" value="18.36" spread="2.62"/>
                    <measurement group_id="B3" value="18.41" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Activities-specific balance confidence scale</title>
          <description>As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure confidence with balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.</description>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.64" spread="21.12"/>
                    <measurement group_id="B2" value="78.03" spread="9.68"/>
                    <measurement group_id="B3" value="74.00" spread="16.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>10 Meter Walk Test</title>
          <description>This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.</description>
          <units>ft/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.05" spread="0.58"/>
                    <measurement group_id="B2" value="2.96" spread="0.58"/>
                    <measurement group_id="B3" value="3.00" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale - Head Movement</title>
        <description>This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gaze Stability</title>
            <description>Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group (CON) intervention includes standard balance rehabilitation plus placebo eye exercises.&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale - Head Movement</title>
          <description>This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.</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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.56" spread="2.55"/>
                    <measurement group_id="O2" value="1.81" spread="2.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.356</p_value>
            <p_value_desc>Main effect of time (baseline to post-PT) alpha = .05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.840</p_value>
            <p_value_desc>Interaction of Time by Group (GS vs. CON) alpha = .05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale - Disequilibrium</title>
        <description>This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.</description>
        <time_frame>6 weeks</time_frame>
        <population>Repeated Measure (RM) ANOVA</population>
        <group_list>
          <group group_id="O1">
            <title>Gaze Stability</title>
            <description>Standard balance rehabilitation plus Vestibular-specific exercises&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Vestibular-specific exercises: Gaze stability exercises are performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target. Progression involves increased velocity of head movement and target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard balance rehabilitation plus Placebo eye exercises&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Control: Placebo exercises consist of saccadic eye movements while the head is stationary and are performed by the control group (CON). These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale - Disequilibrium</title>
          <description>This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.</description>
          <population>Repeated Measure (RM) ANOVA</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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.66" spread="2.29"/>
                    <measurement group_id="O2" value="1.96" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.170</p_value>
            <p_value_desc>Main effect of Time (baseline to post-PT) Alpha=.05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.297</p_value>
            <p_value_desc>Interaction of Time by Group (GS vs. CON) alpha = .05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dynamic Gait Index</title>
        <description>The dynamic gait index (DGI) assesses an individual's ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of &lt; 20 indicate high risk for falling.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gaze Stability</title>
            <description>Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control (CON) group intervention includes standard balance rehabilitation plus placebo eye exercises.&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.</description>
          </group>
        </group_list>
        <measure>
          <title>Dynamic Gait Index</title>
          <description>The dynamic gait index (DGI) assesses an individual's ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of &lt; 20 indicate high risk for falling.</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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.54" spread="2.02"/>
                    <measurement group_id="O2" value="21.21" spread="2.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>ANOVA</method>
            <method_desc>Main effect of Time (baseline to post-PT) alpha = .05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.817</p_value>
            <p_value_desc>Interaction of Time by Group (GS vs. CON) alpha = .05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activities-specific Balance Confidence Scale</title>
        <description>As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure the subject's confidence with their balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gaze Stability</title>
            <description>Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control (CON) group intervention includes standard balance rehabilitation plus placebo eye exercises.&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.</description>
          </group>
        </group_list>
        <measure>
          <title>Activities-specific Balance Confidence Scale</title>
          <description>As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure the subject's confidence with their balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.</description>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.98" spread="14.40"/>
                    <measurement group_id="O2" value="83.37" spread="6.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.005</p_value>
            <p_value_desc>Main effect of Time (baseline to post-PT) alpha = .05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.172</p_value>
            <p_value_desc>Interaction of Time by Group (GS vs. CON) alpha = .05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>10 Meter Walk Test</title>
        <description>This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gaze Stability</title>
            <description>Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control (CON) group intervention includes standard balance rehabilitation plus placebo eye exercises.&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.</description>
          </group>
        </group_list>
        <measure>
          <title>10 Meter Walk Test</title>
          <description>This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.</description>
          <units>ft/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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.15" spread="0.54"/>
                    <measurement group_id="O2" value="3.28" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.009</p_value>
            <p_value_desc>Main effect of time (baseline to post-PT) alpha = .05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.146</p_value>
            <p_value_desc>Interaction of Time by Grou (GS vs. CON) alpha = .05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Gaze Stability</title>
          <description>Gaze stability (GS) group intervention includes standard balance rehabilitation plus vestibular-specific exercises&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Vestibular-specific exercises: Gaze stability exercises include adaptation exercises which involve head movement while maintaining focus on a target. Typical progression involves increased velocity of head movement and target placed in a distracting visual pattern. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Control group (CON intervention includes standard balance rehabilitation plus placebo eye exercises.&#xD;
Standard balance rehabilitation: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.&#xD;
Placebo eye exercises: Saccadic eye movements are performed while the head is stationary. These eye movements are performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Fall resulting in fracture</sub_title>
                <description>Fall while performing home exercise program</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Fall without injury</sub_title>
                <description>Loss of balance without injury while performing home exercise program</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>High dropout rate; small sample size</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Courtney Hall</name_or_title>
      <organization>James H Quillen VAMC</organization>
      <phone>423-926-1171 ext 7518</phone>
      <email>courtney.hall@va.gov</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/NCT01729039
org study id: E7613-R
nct id: NCT01729039
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether vestibular exercises provide added benefit
      to balance rehabilitation in older adults with dizziness and normal vestibular function.
Dizziness is among the most prevalent complaints for which people seek medical help and the
      incidence increases with advancing age. Dizziness represents a diagnostic and treatment
      challenge because it is a subjective sensation, refers to a variety of symptoms
      (unsteadiness, spinning, sense of motion or lightheadedness), and has many potential
      contributory factors. Dizziness is often related to vestibular disease which is treated
      effectively with vestibular exercises. Successful management of dizziness is critical because
      dizziness is a major risk factor for falls in older adults.

      There are parallels between the effects of age-related versus disease-related loss of
      vestibular function - in complaints of dizziness and increased risk for falls. The
      investigators' question, then, is whether the same exercises that are beneficial for patients
      with vestibular pathology are beneficial for older patients with dizziness but normal
      vestibular function.

      Older adults with dizziness who have been referred to Audiology for vestibular evaluation
      will be randomized to receive either standard balance rehabilitation plus placebo eye
      exercises (CON) or standard balance rehabilitation plus vestibular-specific exercises (GS).
      Primary outcomes include symptoms, balance-related confidence, dynamic visual acuity,
      postural stability as measured by sensory organization test, fall risk as measured by dynamic
      gait index, and gait speed. Assessment will occur at baseline, discharge from physical
      therapy (PT), 1 and 6 months post-PT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Visual Analog Scale - Head Movement
time frame: 6 weeks
description: This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.
measure: Visual Analog Scale - Disequilibrium
time frame: 6 weeks
description: This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.
measure: Dynamic Gait Index
time frame: 6 weeks
description: The dynamic gait index (DGI) assesses an individual's ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of < 20 indicate high risk for falling.
measure: Activities-specific Balance Confidence Scale
time frame: 6 weeks
description: As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure the subject's confidence with their balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.
measure: 10 Meter Walk Test
time frame: 6 weeks
description: This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.
arm group label: gaze stability
arm group type: Experimental
description: standard balance rehabilitation plus vestibular-specific exercises
arm group label: control
arm group type: Placebo Comparator
description: standard balance rehabilitation plus placebo eye exercises
intervention type: Behavioral
intervention name: standard balance rehabilitation
description: All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility with progressively challenging tasks. Balance exercises include maintaining stability with vision and somatosensory cues altered, dynamic weight shifts and performing ankle, hip and step strategies. Gait activities include negotiating uneven terrains and obstacles, gait with head turns, varied speed, and unpredictable starts and stops. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.
arm group label: control
arm group label: gaze stability
intervention type: Behavioral
intervention name: gaze stability
description: Vestibular adaptation and substitution exercises will be performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target, which may be stationary or moving. Typical progression of adaptation exercises involve increased velocity of head movement, movement of both target and head, target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target, potentially facilitating use of preprogrammed eye movements.
arm group label: gaze stability
intervention type: Behavioral
intervention name: Control
description: The placebo exercises will consist of saccadic eye movements while the head is stationary and will be performed by the control group. These eye movements will be performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
arm group label: control
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Courtney D Hall, PhD PT
role: Principal Investigator
affiliation: Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Dizziness
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: High dropout rate; small sample size
point of contact: 