<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/NCT01691027</url>
  </required_header>
  <id_info>
    <org_study_id>C1000-R</org_study_id>
    <nct_id>NCT01691027</nct_id>
  </id_info>
  <brief_title>Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas</brief_title>
  <acronym>VRT</acronym>
  <official_title>Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas</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 research is aimed at developing and testing a new method of visual-motor rehabilitation&#xD;
      of Veterans with macular degeneration by using inexpensive &quot;tablet&quot; computers at home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research objective is to test the hypothesis that practicing eye-hand coordination using&#xD;
      tablet-computers can improve manual skills of those with Age-related Macular Degeneration&#xD;
      (AMD). AMD causes the loss of sharp central vision used for reading and many other everyday&#xD;
      activities. Those with AMD experience a &quot;macular scotoma&quot;, a blanked-out area of whatever&#xD;
      they're attempting to look at, and they must use an area of peripheral vision, the &quot;Preferred&#xD;
      Retinal Locus (PRL)&quot; to look at objects of interest. The PRL does not provide sharp vision,&#xD;
      causing deficits in eye-hand coordination needed for manual tasks. There have been few&#xD;
      studies of visuo-motor rehabilitation training for deficits caused by macular scotomas.&#xD;
      However, a recent study demonstrated that visuo-motor eye movement training dramatically&#xD;
      improved reading ability of subjects with AMD. In addition, it has been shown that playing&#xD;
      action video games can improve certain visual skills. Thus, a small but growing body of&#xD;
      research suggests that it may be possible to ameliorate manual task deficits caused by AMD&#xD;
      through computer-based visuo-motor rehabilitation training.&#xD;
&#xD;
      To test this idea, two visuo-motor training modules will be developed for low-cost tablet&#xD;
      computers that subjects will use at home. Modules will be for, line and circle tracing, and&#xD;
      video games. Both modules will involve PRL-hand coordination by moving a stylus on the tablet&#xD;
      screen in response to stimuli. Line and circle tracing will develop eye-hand coordination&#xD;
      skills needed for printing. The video game module will provide practice in PRL-hand&#xD;
      coordination. Progress in PRL-hand coordination will be automatically recorded on the&#xD;
      tablet-computer.&#xD;
&#xD;
      Changes in manual task performance from the training modules will be assessed after each&#xD;
      training module using previously developed Scanning Laser Ophthalmoscope (SLO) tests of&#xD;
      maze-tracing, and printing. The SLO will also be used to determine the position and fixation&#xD;
      stability of the subject's PRL and the retinal position of the scotoma. SLO testing will be&#xD;
      repeated three months after all training. Digitized SLO video images showing the hand,&#xD;
      stylus, and object on the retina will be measured and analyzed. Several performance measures&#xD;
      will be derived from the SLO image analysis including maze-tracing accuracy, printing&#xD;
      legibility, retinal area of the stylus, percentage of time the stylus is in the scotoma, and&#xD;
      PRL retinal area. This data will be statistically analyzed to determine whether visuo-motor&#xD;
      training with the computer tablets improves manual task performance and whether one module is&#xD;
      more effective than other.&#xD;
&#xD;
      There will be six groups of five subjects. Subjects will be assigned as they are recruited to&#xD;
      a group until the group is full. Two groups will have training delayed by 6 months and will&#xD;
      be tested on the SLO 4 times to assess changes in the dependent measure without training.&#xD;
      Following training on each module, subject will be tested on maze tracing and printing in the&#xD;
      SLO. Two groups undergo four SLO tests without training and begin training six months later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All eligible subjects trained on three computer-based training modules. SLO assessment of changes in fine manual task performance and in retinal functional geography was done before and after each training module.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Eye-hand Coordination</measure>
    <time_frame>base line, pre-test, post tracing and videogames training</time_frame>
    <description>Maze tracing represents the fine eye-hand coordination needed for a wide variety of manual tasks and an improvement in maze tracing indicates an improvement in eye-hand coordination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stylus to Eclipse Area</measure>
    <time_frame>Base line, Pre and Post training (approximately 3 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Scotoma, Central</condition>
  <condition>Central Visual Impairment</condition>
  <arm_group>
    <arm_group_label>Visuo-motor training for low vision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Visuo-motor training</intervention_name>
    <description>Participants will undergo training on three developed software modules on Samsung Galaxy Note Pro tablets to see their effect on low vision rehabilitation</description>
    <arm_group_label>Visuo-motor training for low vision</arm_group_label>
    <other_name>Scotoma Awareness</other_name>
    <other_name>Line and Circle Tracing</other_name>
    <other_name>Video games (Pong and PacMan)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bilateral macular scotomas&#xD;
&#xD;
          -  Preferred Retinal Locus (PRL) in at least one eye&#xD;
&#xD;
          -  Visual acuity 20/400 or better in at least one eye&#xD;
&#xD;
          -  No peripheral visual field loss&#xD;
&#xD;
          -  No medications that could affect motor control&#xD;
&#xD;
          -  Normal arm/hand range of motion&#xD;
&#xD;
          -  Pass cognitive ability exam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No macular scotomas&#xD;
&#xD;
          -  Visual acuity of 20/30 or better&#xD;
&#xD;
          -  Medications that affect motor control&#xD;
&#xD;
          -  Limited arm/hand range of motion&#xD;
&#xD;
          -  Fail cognitive ability exam&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George T Timberlake, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas City VA Medical Center, Kansas City, MO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kansas City VA Medical Center, Kansas City, MO</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>January 24, 2017</results_first_submitted>
  <results_first_submitted_qc>August 2, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2018</results_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>scotoma, central</keyword>
  <keyword>visual motor coordination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vision Disorders</mesh_term>
    <mesh_term>Vision, Low</mesh_term>
    <mesh_term>Scotoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects with bilateral AMD, no foveal vision, and acuities poorer than 20/60 in each eye were screened in the eye clinic and those who met inclusion criteria were enrolled in the study. On each laboratory visit, subjects' eyes were checked for angle closure and, if angles wee open, dilated the eye to be tested</recruitment_details>
      <pre_assignment_details>Enrolled subjects when found to have residual foveal vision in baseline SLO retinal functional map and/or are unable to follow the instructions for SLO testing were excluded from the study before training assignment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Visuo-motor Training for Low Vision</title>
          <description>All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Scotoma Awareness</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4">Four subjects started scotoma awareness training module</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4">Four subjects were able to complete scotoma awareness training module</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Line and Circle Tracing Training</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4">Four subjects started line and circle tracing training module</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4">Four subjects were able to complete line and circle tracing training module.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Video Games Training</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4">Four subjects started video game training module</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4">Four subjects were able to complete video games training module</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>For each subject, SLO retinal functional maps are shown for Baseline, Pre-training, Post line and Circle Tracing training, and Post Video Game training for both maze tracing and printing. Tables show data derived from the retinal maps and associated performance measurement.</population>
      <group_list>
        <group group_id="B1">
          <title>Crossover Design. All Subjects Undergo All Treatments.</title>
          <description>Each participating subject will have three training modules on a tablet computer: scotoma awareness, line and curve tracing, and video games. The order of modules will be different for different groups of subjects. Training on a module will cease when the subject reaches a performance criterion. Retinal assessments will occur after each training module completion.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Only 4 subjects with ages in range of 65 to 92 participated and were able to complete all training.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84.5" lower_limit="65" upper_limit="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Four subjects 1 female and 3 males participated and completed all testing</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SLO retinal functional map</title>
          <units>percent traced</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Improvement in Eye-hand Coordination</title>
        <description>Maze tracing represents the fine eye-hand coordination needed for a wide variety of manual tasks and an improvement in maze tracing indicates an improvement in eye-hand coordination</description>
        <time_frame>base line, pre-test, post tracing and videogames training</time_frame>
        <population>Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing.</population>
        <group_list>
          <group group_id="O1">
            <title>Visuo-motor Training</title>
            <description>Participants undergo training on three modules, (1)scotoma awareness, (2) line and curve tracing, and (3) video games. SLO assessments of changes in fine manual task performance was measured by an improvement in mean maze tracing and printing score. Improvement in visuo-motor control was measured by stylus ellipse area and stylus-PRL distance before and after training.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Eye-hand Coordination</title>
          <description>Maze tracing represents the fine eye-hand coordination needed for a wide variety of manual tasks and an improvement in maze tracing indicates an improvement in eye-hand coordination</description>
          <population>Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing.</population>
          <units>Percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participant 1 baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 1 pretest</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 1 post tracing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 1 post gaming</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 2 baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 2 pretest</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>participant 2 post tracing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 2 post games</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 3 baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 3 pre test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 3 post tracing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participating 3 post games</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 4 baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 4 pre test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 4 post tracing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 4 post games</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stylus to Eclipse Area</title>
        <time_frame>Base line, Pre and Post training (approximately 3 months)</time_frame>
        <population>Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing.</population>
        <group_list>
          <group group_id="O1">
            <title>SLO Measurements Pre and Post-training</title>
            <description>All subjects trained on two computer-based training modules. SLO assessment of changes in fine manual task performance and in retinal functional geography was done before training and after each training module&#xD;
SLO measurements pre and post-training</description>
          </group>
        </group_list>
        <measure>
          <title>Stylus to Eclipse Area</title>
          <population>Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing.</population>
          <units>Degree</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participant 1 baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 1 pre test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 1 post tracing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 1 post games</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 2 base line</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 2 pre test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 2 post tracing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 2 post games</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 3 base line</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 3 pre test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 3 post tracing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participating 3 post games</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participnat 4 base line</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 4 pre test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 4 post tracing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant 4 post games</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Subjects With Bilateral AMD, no Foveal Vision and 20/60 Vision</title>
          <description>Crossover design. All subjects undergo all treatments.&#xD;
Practice tracing objects and printing with a stylus on a tablet computer: Subjects will have three training modules on a tablet computer: scotoma awareness, line and curve tracing, and video games. The order of modules will be different for different groups of subjects. Training on a module will cease when the subject reaches a performance criterion. Retinal assessments will occur after each training module completion.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
              </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="4"/>
              </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>
    <point_of_contact>
      <name_or_title>Health Scientist</name_or_title>
      <organization>Kansas City VA Medical center</organization>
      <phone>816-861-4700 ext 52755</phone>
      <email>George.Timberlake@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/NCT01691027
org study id: C1000-R
nct id: NCT01691027
lead sponsor: 
has dmc: No
The research is aimed at developing and testing a new method of visual-motor rehabilitation
      of Veterans with macular degeneration by using inexpensive "tablet" computers at home.
The research objective is to test the hypothesis that practicing eye-hand coordination using
      tablet-computers can improve manual skills of those with Age-related Macular Degeneration
      (AMD). AMD causes the loss of sharp central vision used for reading and many other everyday
      activities. Those with AMD experience a "macular scotoma", a blanked-out area of whatever
      they're attempting to look at, and they must use an area of peripheral vision, the "Preferred
      Retinal Locus (PRL)" to look at objects of interest. The PRL does not provide sharp vision,
      causing deficits in eye-hand coordination needed for manual tasks. There have been few
      studies of visuo-motor rehabilitation training for deficits caused by macular scotomas.
      However, a recent study demonstrated that visuo-motor eye movement training dramatically
      improved reading ability of subjects with AMD. In addition, it has been shown that playing
      action video games can improve certain visual skills. Thus, a small but growing body of
      research suggests that it may be possible to ameliorate manual task deficits caused by AMD
      through computer-based visuo-motor rehabilitation training.

      To test this idea, two visuo-motor training modules will be developed for low-cost tablet
      computers that subjects will use at home. Modules will be for, line and circle tracing, and
      video games. Both modules will involve PRL-hand coordination by moving a stylus on the tablet
      screen in response to stimuli. Line and circle tracing will develop eye-hand coordination
      skills needed for printing. The video game module will provide practice in PRL-hand
      coordination. Progress in PRL-hand coordination will be automatically recorded on the
      tablet-computer.

      Changes in manual task performance from the training modules will be assessed after each
      training module using previously developed Scanning Laser Ophthalmoscope (SLO) tests of
      maze-tracing, and printing. The SLO will also be used to determine the position and fixation
      stability of the subject's PRL and the retinal position of the scotoma. SLO testing will be
      repeated three months after all training. Digitized SLO video images showing the hand,
      stylus, and object on the retina will be measured and analyzed. Several performance measures
      will be derived from the SLO image analysis including maze-tracing accuracy, printing
      legibility, retinal area of the stylus, percentage of time the stylus is in the scotoma, and
      PRL retinal area. This data will be statistically analyzed to determine whether visuo-motor
      training with the computer tablets improves manual task performance and whether one module is
      more effective than other.

      There will be six groups of five subjects. Subjects will be assigned as they are recruited to
      a group until the group is full. Two groups will have training delayed by 6 months and will
      be tested on the SLO 4 times to assess changes in the dependent measure without training.
      Following training on each module, subject will be tested on maze tracing and printing in the
      SLO. Two groups undergo four SLO tests without training and begin training six months later.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All eligible subjects trained on three computer-based training modules. SLO assessment of changes in fine manual task performance and in retinal functional geography was done before and after each training module.
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in Eye-hand Coordination
time frame: base line, pre-test, post tracing and videogames training
description: Maze tracing represents the fine eye-hand coordination needed for a wide variety of manual tasks and an improvement in maze tracing indicates an improvement in eye-hand coordination
measure: Stylus to Eclipse Area
time frame: Base line, Pre and Post training (approximately 3 months)
arm group label: Visuo-motor training for low vision
arm group type: Experimental
description: All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games
intervention type: Behavioral
intervention name: Visuo-motor training
description: Participants will undergo training on three developed software modules on Samsung Galaxy Note Pro tablets to see their effect on low vision rehabilitation
arm group label: Visuo-motor training for low vision
other name: Scotoma Awareness
other name: Line and Circle Tracing
other name: Video games (Pong and PacMan)
criteria: 
gender: All
minimum age: 55 Years
maximum age: 95 Years
healthy volunteers: No
last name: George T Timberlake, PhD
role: Principal Investigator
affiliation: Kansas City VA Medical Center, Kansas City, MO
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vision Disorders
mesh term: Vision, Low
mesh term: Scotoma
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 