xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06000865</url>
    </required_header>
    <id_info>
      <org_study_id>15602821</org_study_id>
      <nct_id>NCT06000865</nct_id>
    </id_info>
    <brief_title>Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE</brief_title>
    <official_title>The GRADE Randomized Trial: Glaucoma Rehabilitation With Action viDeo Games and Exercise</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Hong Kong Polytechnic University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Waterloo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Leicester</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Hong Kong Polytechnic University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Falls are one of the most serious public health concerns for seniors, with significant&#xD;
        medical and economic consequences. This concern is even higher in patients with peripheral&#xD;
        field loss due to glaucoma because of the patients' compromised visual input. The&#xD;
        investigators' project proposes an innovative, entertaining, easily accessible and enjoyable&#xD;
        intervention for improving mobility and postural control function in glaucoma patients with&#xD;
        peripheral vision loss, who are more prone to falls and suffer from fear of falling. The new&#xD;
        intervention examined in this project can be implemented in current vision and balance&#xD;
        rehabilitation programs, and may benefit patients with different types of visual impairment&#xD;
        to minimize their risk of falls and improve their quality of life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective, 2-arm, randomized, single-blind, active-control trial will enroll 56&#xD;
        moderately- to severely-affected glaucoma patients with stable peripheral field loss, intact&#xD;
        cognitive function, and no history of balance training. Participants will be randomly&#xD;
        assigned 1:1 to one of two groups: 1) standing, physically interactive action video-game&#xD;
        training (AVG_PI); and 2) conventional physical training (PT). AVG using a Nintendo Switch&#xD;
        gaming station will be administered in 20 sessions over 10 weeks (45 minutes per session, 2&#xD;
        sessions per week). Participants in the AVG_PI will be in standing position with game&#xD;
        controllers or sensors attached to the body while playing games involving muscle stretching&#xD;
        and strengthening exercises. Participants in the PT will receive 45-minutes conventional&#xD;
        physical training. Outcome measures will be assessed before training, and after 10 and 20&#xD;
        training sessions. The primary outcome measure is a test of mobility, and the secondary&#xD;
        outcome measures include tests for dynamic balance plus visual cognition, static balance,&#xD;
        visual cognition, and patient reported outcomes for fear of falling and quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 10, 2024</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>Factorial Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gait Measure - Time Up and Go test combining Narrow path walking test</measure>
      <time_frame>Change from baseline at week 5 and change from baseline at week 10.</time_frame>
      <description>Time Up and Go test combining Narrow path walking test: All participants need to stand up from a 46 cm height chair, walk on the path at their usual pace until the strip of a non-reflective tape, cross over the tape, turn 180°, walk to the starting position and finally sit down. Then repeat the same procedure within a narrower width. Participants need to use the dominant leg to step onto the standing position on one force plate while the non-dominant leg stands on the other force plate.&#xD;
  The test will repeat for 10 times. Participants' gait parameters including hip flexion/extension (degree), knee Min/Max (degree), ankle flexion/extension (degree), walking speed (mm/s), step width (mm), and step length(mm) will be measured and analyzed for each condition.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Static Balance Measure</measure>
      <time_frame>Change from baseline at week 5 and change from baseline at week 10.</time_frame>
      <description>Static Balance: Participants will be asked to stand on a force place with a foam while performing visual searching. Parameters including maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.&#xD;
  Each test would be repeated for 3 times.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perturbed Balance Measure</measure>
      <time_frame>Change from baseline at week 5 and change from baseline at week 10.</time_frame>
      <description>Perturbed Balance: Participants will be asked to stand on a force place which will translate forward or backward while performing visual searching. Parameters including latency (ms) reacting to the perturbation, maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.&#xD;
  Each test would be repeated for 3 times.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Useful field of view (UFOV)</measure>
      <time_frame>Change from baseline at week 5 and change from baseline at week 10.</time_frame>
      <description>Visual attention will be examined by Useful Field of View (UFOV). Participants will be asked to complete the following 3 tasks.&#xD;
  Processing speed: Participants will be asked to discriminate the central presented stimulus as a target or distractor.&#xD;
  Divided attention: In addition to discriminating the central target, participants are required to identify the location of the peripheral target.&#xD;
  Selective attention: Procedure is similar as &quot;Divided attention&quot;. Participants are required to identify the location of peripheral target among the distractors.&#xD;
  Parameter includes time to reach threshold(ms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reaction time (RT)</measure>
      <time_frame>Change from baseline at week 5 and change from baseline at week 10.</time_frame>
      <description>Each participant is asked to complete the following task using a customized computer programme.&#xD;
  Reaction Time Test: Participants will be asked to respond as fast as possible when the same stimulus (an 'x' emerging in a square in the middle of the screen) was presented.&#xD;
  This test will be repeated for 3 blocks with 46 trials per block. Parameter includes reaction time to correct answer(ms).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Reflection Test</measure>
      <time_frame>Change from baseline at week 5 and change from baseline at week 10.</time_frame>
      <description>Each participant is asked to complete the following task using a customized computer programme.&#xD;
  Cognitive Reflection Test: Participants will be presented with four squares horizontally on the screen. They will be asked to react to an 'x' emerging in one of the squares (40 trials in total) by pressing a corresponding key on a keyboard-'1', '2', '3', or '4' which present the position of 'x' . Parameter includes reaction time to correct answer(ms).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life Questionnaire measure</measure>
      <time_frame>Change from baseline at week 5 and change from baseline at week 10.</time_frame>
      <description>The effect of intervention on quality of life will be evaluated using the Learning Vector Quantization (LvQ) Scale.&#xD;
  In the LvQ, participants will be asked to rate how much their eyesight has interfered with each of 24 activities in the past month. The completion results in a summed score between 0 (a low quality of life) and 125 (a high quality of life).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fear of Falling Questionnaire measure</measure>
      <time_frame>Change from baseline at week 5 and change from baseline at week 10.</time_frame>
      <description>The effect of intervention on fear of falling will be evaluated using the Chinese versions of Falls Efficacy Scale International (FES-I).&#xD;
  In the FES-I, participants will be asked &quot;how concerned they are about the possibility of falling&quot; for each of the 16 social and physical activities. The completion results in a summed score between minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Glaucoma</condition>
    <condition>Visual Impairment</condition>
    <arm_group>
      <arm_group_label>Interactive action video-game training (AVG)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>AVG using a Nintendo Switch gaming station will be administered in 20 sessions over 10 weeks (45 minutes per session, 2 sessions per week). Participants will be in standing position with game controllers or sensors attached to the body while playing games involving muscle stretching and strengthening exercises.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional physical training (PT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the PT will receive 45-minutes conventional physical training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Action video game training</intervention_name>
      <description>20 sessions of AVG over 10 weeks (45 minutes per session, 2 sessions per week)</description>
      <arm_group_label>Interactive action video-game training (AVG)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Conventional physical training</intervention_name>
      <description>20 sessions of physical training over 10 weeks (45 minutes per session, 2 sessions per week)</description>
      <arm_group_label>Conventional physical training (PT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Presence of moderate to severe bilateral glaucomatous optic neuropathy (GON) from&#xD;
               primary open-angle (including normal tension) or angle-closure glaucoma, as determined&#xD;
               by an ophthalmologist, with abnormal Glaucoma Hemifield Test on standard Humphrey&#xD;
               Field Analyzer 24-2 testing and matching nerve-fiber layer thinning on optical&#xD;
               coherence tomography;&#xD;
  &#xD;
            2. Stable vision and visual field loss for at least 3 months;&#xD;
  &#xD;
            3. With a best-corrected distance acuity of 6/12 or better (equivalent to 0.3 logMAR&#xD;
               acuity or better to confirm that participant's central vision is preserved);&#xD;
  &#xD;
            4. With a cognitive functional score of 22 or above in the Montreal Cognitive Assessment&#xD;
               - Hong Kong version (to confirm participants' intact cognitive function).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Advanced glaucoma with GON of median deviation worse than -25 decibel;&#xD;
  &#xD;
            2. Ocular diseases other than glaucoma (e.g., age-related macular degeneration, diabetic&#xD;
               retinopathy, and moderate to severe cataract);&#xD;
  &#xD;
            3. Severe medical problems (e.g., stroke, Parkinson's disease) or self-reported&#xD;
               neurological (e.g. brain surgery, brain tumor and peripheral neuropathy), or cognitive&#xD;
               disorders (e.g., diagnosed dementia or cognitive impairment);&#xD;
  &#xD;
            4. Physical impairments (e.g. need the use of orthopedic and mobility aids) or physical&#xD;
               limitations restricting them from independent walking;&#xD;
  &#xD;
            5. Self-reported or medically diagnosed vestibular/ cerebellar dysfunction, history of&#xD;
               vertigo, or severe hearing loss;&#xD;
  &#xD;
            6. Using any medications for any neurological conditions or psychiatric drugs (e.g.&#xD;
               sedative, hypnotic) that might interfere motor control; and&#xD;
  &#xD;
            7. Currently attending any intensive physical/balance training.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Allen Cheong, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Hong Kong Polytechnic University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Allen Cheong, PhD</last_name>
      <phone>852-27666108</phone>
      <email>allen.my.cheong@polyu.edu.hk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mable Tong, BSc</last_name>
      <phone>852-92523992</phone>
      <email>mable.mp.tong@polyu.edu.hk</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 25, 2022</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
      <investigator_full_name>Allen MY Cheong</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Glaucoma</keyword>
    <keyword>Peripheral field loss</keyword>
    <keyword>Action video games</keyword>
    <keyword>Balance functions</keyword>
    <keyword>Fear of falling</keyword>
    <keyword>Quality of life</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>Glaucoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>IPD that underlie results in a publication will be available upon reasonable request to the research team.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>IPD will be available no later than 6 months following publication and for 1 year.</ipd_time_frame>
      <ipd_access_criteria>IPD will be shared with investigators who provide a methodologically sound proposal.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06000865
  org study id: 15602821
  nct id: NCT06000865
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Falls are one of the most serious public health concerns for seniors, with significant
        medical and economic consequences. This concern is even higher in patients with peripheral
        field loss due to glaucoma because of the patients' compromised visual input. The
        investigators' project proposes an innovative, entertaining, easily accessible and enjoyable
        intervention for improving mobility and postural control function in glaucoma patients with
        peripheral vision loss, who are more prone to falls and suffer from fear of falling. The new
        intervention examined in this project can be implemented in current vision and balance
        rehabilitation programs, and may benefit patients with different types of visual impairment
        to minimize their risk of falls and improve their quality of life.
  A prospective, 2-arm, randomized, single-blind, active-control trial will enroll 56
        moderately- to severely-affected glaucoma patients with stable peripheral field loss, intact
        cognitive function, and no history of balance training. Participants will be randomly
        assigned 1:1 to one of two groups: 1) standing, physically interactive action video-game
        training (AVG_PI); and 2) conventional physical training (PT). AVG using a Nintendo Switch
        gaming station will be administered in 20 sessions over 10 weeks (45 minutes per session, 2
        sessions per week). Participants in the AVG_PI will be in standing position with game
        controllers or sensors attached to the body while playing games involving muscle stretching
        and strengthening exercises. Participants in the PT will receive 45-minutes conventional
        physical training. Outcome measures will be assessed before training, and after 10 and 20
        training sessions. The primary outcome measure is a test of mobility, and the secondary
        outcome measures include tests for dynamic balance plus visual cognition, static balance,
        visual cognition, and patient reported outcomes for fear of falling and quality of life.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Gait Measure - Time Up and Go test combining Narrow path walking test
  time frame: Change from baseline at week 5 and change from baseline at week 10.
  description: Time Up and Go test combining Narrow path walking test: All participants need to stand up from a 46 cm height chair, walk on the path at their usual pace until the strip of a non-reflective tape, cross over the tape, turn 180°, walk to the starting position and finally sit down. Then repeat the same procedure within a narrower width. Participants need to use the dominant leg to step onto the standing position on one force plate while the non-dominant leg stands on the other force plate.
  The test will repeat for 10 times. Participants' gait parameters including hip flexion/extension (degree), knee Min/Max (degree), ankle flexion/extension (degree), walking speed (mm/s), step width (mm), and step length(mm) will be measured and analyzed for each condition.
  measure: Static Balance Measure
  time frame: Change from baseline at week 5 and change from baseline at week 10.
  description: Static Balance: Participants will be asked to stand on a force place with a foam while performing visual searching. Parameters including maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.
  Each test would be repeated for 3 times.
  measure: Perturbed Balance Measure
  time frame: Change from baseline at week 5 and change from baseline at week 10.
  description: Perturbed Balance: Participants will be asked to stand on a force place which will translate forward or backward while performing visual searching. Parameters including latency (ms) reacting to the perturbation, maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.
  Each test would be repeated for 3 times.
  measure: Useful field of view (UFOV)
  time frame: Change from baseline at week 5 and change from baseline at week 10.
  description: Visual attention will be examined by Useful Field of View (UFOV). Participants will be asked to complete the following 3 tasks.
  Processing speed: Participants will be asked to discriminate the central presented stimulus as a target or distractor.
  Divided attention: In addition to discriminating the central target, participants are required to identify the location of the peripheral target.
  Selective attention: Procedure is similar as "Divided attention". Participants are required to identify the location of peripheral target among the distractors.
  Parameter includes time to reach threshold(ms)
  measure: Reaction time (RT)
  time frame: Change from baseline at week 5 and change from baseline at week 10.
  description: Each participant is asked to complete the following task using a customized computer programme.
  Reaction Time Test: Participants will be asked to respond as fast as possible when the same stimulus (an 'x' emerging in a square in the middle of the screen) was presented.
  This test will be repeated for 3 blocks with 46 trials per block. Parameter includes reaction time to correct answer(ms).
  measure: Cognitive Reflection Test
  time frame: Change from baseline at week 5 and change from baseline at week 10.
  description: Each participant is asked to complete the following task using a customized computer programme.
  Cognitive Reflection Test: Participants will be presented with four squares horizontally on the screen. They will be asked to react to an 'x' emerging in one of the squares (40 trials in total) by pressing a corresponding key on a keyboard-'1', '2', '3', or '4' which present the position of 'x' . Parameter includes reaction time to correct answer(ms).
  measure: Quality of Life Questionnaire measure
  time frame: Change from baseline at week 5 and change from baseline at week 10.
  description: The effect of intervention on quality of life will be evaluated using the Learning Vector Quantization (LvQ) Scale.
  In the LvQ, participants will be asked to rate how much their eyesight has interfered with each of 24 activities in the past month. The completion results in a summed score between 0 (a low quality of life) and 125 (a high quality of life).
  measure: Fear of Falling Questionnaire measure
  time frame: Change from baseline at week 5 and change from baseline at week 10.
  description: The effect of intervention on fear of falling will be evaluated using the Chinese versions of Falls Efficacy Scale International (FES-I).
  In the FES-I, participants will be asked "how concerned they are about the possibility of falling" for each of the 16 social and physical activities. The completion results in a summed score between minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).
  arm group label: Interactive action video-game training (AVG)
  arm group type: Active Comparator
  description: AVG using a Nintendo Switch gaming station will be administered in 20 sessions over 10 weeks (45 minutes per session, 2 sessions per week). Participants will be in standing position with game controllers or sensors attached to the body while playing games involving muscle stretching and strengthening exercises.
  arm group label: Conventional physical training (PT)
  arm group type: Experimental
  description: Participants in the PT will receive 45-minutes conventional physical training.
  intervention type: Behavioral
  intervention name: Action video game training
  description: 20 sessions of AVG over 10 weeks (45 minutes per session, 2 sessions per week)
  arm group label: Interactive action video-game training (AVG)
  intervention type: Behavioral
  intervention name: Conventional physical training
  description: 20 sessions of physical training over 10 weeks (45 minutes per session, 2 sessions per week)
  arm group label: Conventional physical training (PT)
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Allen Cheong, PhD
  role: Principal Investigator
  affiliation: The Hong Kong Polytechnic University
  last name: Allen Cheong, PhD
  phone: 852-27666108
  email: allen.my.cheong@polyu.edu.hk
  last name: Mable Tong, BSc
  phone: 852-92523992
  email: mable.mp.tong@polyu.edu.hk
  responsible party type: Principal Investigator
  investigator affiliation: The Hong Kong Polytechnic University
  investigator full name: Allen MY Cheong
  investigator title: Professor
  mesh term: Vision Disorders
  mesh term: Vision, Low
  mesh term: Glaucoma
  sharing ipd: Yes
  ipd description: IPD that underlie results in a publication will be available upon reasonable request to the research team.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: IPD will be available no later than 6 months following publication and for 1 year.
  ipd access criteria: IPD will be shared with investigators who provide a methodologically sound proposal.