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/NCT06037603</url>
    </required_header>
    <id_info>
      <org_study_id>UNLV-2023-245</org_study_id>
      <nct_id>NCT06037603</nct_id>
    </id_info>
    <brief_title>Dual-Task Exercise for Mild Traumatic Brain Injury (mTBI)</brief_title>
    <official_title>Home-based and Mobile App-guided Dual-Task Exercise for Cognition and Functional Capacity After Mild Traumatic Brain Injury (mTBI)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Nevada, Las Vegas</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Nevada, Las Vegas</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators previously developed a virtual 14-day dual-task walking exercise program&#xD;
        and tested its feasibility with individuals with mild traumatic brain injury (mTBI) history.&#xD;
        The investigators will test the feasibility and efficacy of a mobile app-version (Uplode) of&#xD;
        the same 14-day exercise program (Brain &amp; Walk Exercise Every Day [BraW-Day]), on cognition,&#xD;
        sensorimotor, and other functions in a group of voluntary young adults with an mTBI between&#xD;
        last three months to two years, including student athletes, Veterans, and ethnic minorities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There is a critical need to develop an effective intervention for a chronic concussion or&#xD;
        mild traumatic brain injury (mTBI) that presents persistent post-injury functional declines.&#xD;
        Up to 40% of mTBIs cause multifaceted and long-term functional declines, including cognitive&#xD;
        declines, psychosocial or sensorimotor problems, which results in $17B medical costs each&#xD;
        year. Long-term functional impairments have been reported even 5 to 19 years post-injury,&#xD;
        which exacerbate neurodegeneration, such as chronic traumatic encephalopathy or Parkinson's&#xD;
        disease. Yet, only a very limited or few studies have investigated a followup screening or&#xD;
        intervention for long-term and persistent functional declines, suggesting important&#xD;
        deficiencies in long-term care for mTBI. The investigators previously developed a virtual&#xD;
        14-day dual-task walking exercise program and tested its feasibility with Asian and Pacific&#xD;
        Islanders (API), including those with mTBI history. The investigators will test the&#xD;
        feasibility and efficacy of a mobile app-version (Uplode) of the same 14-day exercise program&#xD;
        (Brain &amp; Walk Exercise Every Day [BraW-Day]), on cognition, sensorimotor, and other functions&#xD;
        in a group of voluntary young adults with an mTBI between last three months to two years,&#xD;
        including student athletes, Veterans, and ethnic minorities. The specific aims of the current&#xD;
        study are:&#xD;
  &#xD;
        Aim 1: Examine if the mobile app, home-based BraW-Day program is acceptable to young adults&#xD;
        with an mTBI. H1. BraW-Day program will (a) be acceptable to the participants, (b) fit with&#xD;
        their daily life, and (c) demonstrate feasible and suitable data collection of the daily&#xD;
        participation.&#xD;
  &#xD;
        Aim 2: Test the efficacy of the BraW-Day program on functions after mTBI. H2. BraW-Day&#xD;
        program will improve (a) cognitive (measured by a computerized CNS-VS), (b) psychosocial (by&#xD;
        Neuro QoL, a standardized self-report tool for neuro-psychosocial conditions), or (c)&#xD;
        sensorimotor functions (by walking movement measuring app, 3D kinematic and kinetic gait&#xD;
        analysis, and EyeLink rapid eye movement tracker) in mTBI at post-intervention (T2), compared&#xD;
        to wait-list controls.&#xD;
  &#xD;
        Aim 3: Examine the sustained effect of the BraW-Day program on function after mTBI. H3.&#xD;
        Functional levels one month after intervention (T3) will be equivalent to or higher than&#xD;
        baseline (T1) and postintervention (T2) levels.&#xD;
  &#xD;
        Our interdisciplinary team (nursing, athletic training, physical therapy, and computer&#xD;
        science) aims to use advances in objective functional assessments to address how these relate&#xD;
        to home-based and mobile app-based mTBI recovery, which can contribute to developing&#xD;
        effective rehabilitation and mTBI care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 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>Parallel Assignment</intervention_model>
      <intervention_model_description>Non-blinded randomized trial with a wait-list control design</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Non-blinded randomized trial with a wait-list control design</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in cognitive function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)</measure>
      <time_frame>45 days</time_frame>
      <description>The CNS-Vital Signs Test (CNS-VS) is a computerized test of cognitive functioning with good-to-excellent reliabilities (most r's &gt; 0.8) in its different sub-tests. It will measure comprehensive neurocognitive function, including memory, attention psychomotor speed, reaction time, and cognitive flexibility. Higher scores mean better cognitive functioning outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in psychosocial function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)</measure>
      <time_frame>45 days</time_frame>
      <description>The Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank will be used to assess depressive, anxious symptoms, fatigue, sleep disturbances, and other functions that may be affected by chronic mTBI. Each domain measure has undergone rigorous qualitative and psychometric evaluation and refinement through numerous clinical studies, so the measures could provide efficient, precise, valid, and responsive indicators of a person's health status. Higher scores mean better psychosocial functioning outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in sensorimotor function - vision from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)</measure>
      <time_frame>45 days</time_frame>
      <description>Rapid eye movement by EyeLink 1000 Plus System (SR Research)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in sensorimotor function - walking from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)</measure>
      <time_frame>45 days</time_frame>
      <description>Walking features and balance by mobile health application for walking balance (mHealth-WB)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in sensorimotor function - gait from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)</measure>
      <time_frame>45 days</time_frame>
      <description>3-dimensional kinematic and kinetic gait analysis (lab-based approach)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability, feasibility of the BraW-Day program on Uplode app</measure>
      <time_frame>15 days</time_frame>
      <description>semi-structured interview (max. 20 mins) based on components of the System Usability Scale (SUS) focusing on acceptability, feasibility, and barriers and facilitators for the BraW-Day exercise program on the Uplode app</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in salivary exosomal microRNA from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)</measure>
      <time_frame>45 days</time_frame>
      <description>Saliva samples will be collected for future characterization of exosomal microRNAs as potential neurodegenerative biomarkers associated with functional level alterations.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>TBI (Traumatic Brain Injury)</condition>
    <condition>Brain Concussion</condition>
    <condition>Clinical Trial</condition>
    <condition>Rehabilitation</condition>
    <condition>Cognition</condition>
    <condition>Psychosocial Functioning</condition>
    <condition>Walking</condition>
    <condition>Vision, Ocular</condition>
    <condition>Mobile Application</condition>
    <condition>Saliva</condition>
    <condition>microRNA</condition>
    <condition>Exercise</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group will be asked to visit the UNLV study site three times to evaluate baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wait-list Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The wait-list control group will be will be asked to visit the UNLV study site four times to evaluate pre-baseline (T0), baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Brain &amp; Walk Exercise Every Day (BraW-Day)</intervention_name>
      <description>The Brain &amp; Walk Exercise Every Day (BraW-Day) program comprises 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).</description>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_label>Wait-list Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female adults aged 18-40 years&#xD;
  &#xD;
            -  reporting a recent history of mTBI (3 months - 2 years) based on the Ohio State&#xD;
               University TBI Identification Method (OSU TBI-ID)&#xD;
  &#xD;
            -  understanding the protocol, and&#xD;
  &#xD;
            -  capable of participating in the full BraW-Day program and completing assessments&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those with other active medical disease or such history&#xD;
  &#xD;
            -  psychiatric disturbance, substance abuse, learning disorder, or attention deficit&#xD;
               hyperactivity disorder (ADHD)&#xD;
  &#xD;
            -  any impairments that may prevent the participant from completing the tests safely, or&#xD;
  &#xD;
            -  currently on prescribed medications&#xD;
  &#xD;
            -  involved in any type of legal action related to the mTBI&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hyunhwa Lee, Ph.D.</last_name>
      <phone>7028953492</phone>
      <email>hyunhwa.lee@unlv.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Nevada, Las Vegas</name>
        <address>
          <city>Las Vegas</city>
          <state>Nevada</state>
          <zip>89154-3018</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Hyunhwa Lee, Ph.D.</last_name>
        <phone>702-895-3492</phone>
        <email>hyunhwa.lee@unlv.edu</email>
      </contact>
      <investigator>
        <last_name>Hyunhwa Lee, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dual-task exercise</keyword>
    <keyword>mobile app-guided</keyword>
    <keyword>home-based</keyword>
    <keyword>mild traumatic brain injury (mTBI)</keyword>
    <keyword>cognitive function</keyword>
    <keyword>physical function</keyword>
    <keyword>psychosocial function</keyword>
    <keyword>salivary exosomal microRNA</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Brain Injuries, Traumatic</mesh_term>
      <mesh_term>Brain Concussion</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06037603
  org study id: UNLV-2023-245
  nct id: NCT06037603
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators previously developed a virtual 14-day dual-task walking exercise program
        and tested its feasibility with individuals with mild traumatic brain injury (mTBI) history.
        The investigators will test the feasibility and efficacy of a mobile app-version (Uplode) of
        the same 14-day exercise program (Brain & Walk Exercise Every Day [BraW-Day]), on cognition,
        sensorimotor, and other functions in a group of voluntary young adults with an mTBI between
        last three months to two years, including student athletes, Veterans, and ethnic minorities.
  There is a critical need to develop an effective intervention for a chronic concussion or
        mild traumatic brain injury (mTBI) that presents persistent post-injury functional declines.
        Up to 40% of mTBIs cause multifaceted and long-term functional declines, including cognitive
        declines, psychosocial or sensorimotor problems, which results in $17B medical costs each
        year. Long-term functional impairments have been reported even 5 to 19 years post-injury,
        which exacerbate neurodegeneration, such as chronic traumatic encephalopathy or Parkinson's
        disease. Yet, only a very limited or few studies have investigated a followup screening or
        intervention for long-term and persistent functional declines, suggesting important
        deficiencies in long-term care for mTBI. The investigators previously developed a virtual
        14-day dual-task walking exercise program and tested its feasibility with Asian and Pacific
        Islanders (API), including those with mTBI history. The investigators will test the
        feasibility and efficacy of a mobile app-version (Uplode) of the same 14-day exercise program
        (Brain & Walk Exercise Every Day [BraW-Day]), on cognition, sensorimotor, and other functions
        in a group of voluntary young adults with an mTBI between last three months to two years,
        including student athletes, Veterans, and ethnic minorities. The specific aims of the current
        study are:
  
        Aim 1: Examine if the mobile app, home-based BraW-Day program is acceptable to young adults
        with an mTBI. H1. BraW-Day program will (a) be acceptable to the participants, (b) fit with
        their daily life, and (c) demonstrate feasible and suitable data collection of the daily
        participation.
  
        Aim 2: Test the efficacy of the BraW-Day program on functions after mTBI. H2. BraW-Day
        program will improve (a) cognitive (measured by a computerized CNS-VS), (b) psychosocial (by
        Neuro QoL, a standardized self-report tool for neuro-psychosocial conditions), or (c)
        sensorimotor functions (by walking movement measuring app, 3D kinematic and kinetic gait
        analysis, and EyeLink rapid eye movement tracker) in mTBI at post-intervention (T2), compared
        to wait-list controls.
  
        Aim 3: Examine the sustained effect of the BraW-Day program on function after mTBI. H3.
        Functional levels one month after intervention (T3) will be equivalent to or higher than
        baseline (T1) and postintervention (T2) levels.
  
        Our interdisciplinary team (nursing, athletic training, physical therapy, and computer
        science) aims to use advances in objective functional assessments to address how these relate
        to home-based and mobile app-based mTBI recovery, which can contribute to developing
        effective rehabilitation and mTBI care.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Non-blinded randomized trial with a wait-list control design
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: Non-blinded randomized trial with a wait-list control design
  measure: Change in cognitive function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
  time frame: 45 days
  description: The CNS-Vital Signs Test (CNS-VS) is a computerized test of cognitive functioning with good-to-excellent reliabilities (most r's > 0.8) in its different sub-tests. It will measure comprehensive neurocognitive function, including memory, attention psychomotor speed, reaction time, and cognitive flexibility. Higher scores mean better cognitive functioning outcomes.
  measure: Change in psychosocial function from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
  time frame: 45 days
  description: The Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank will be used to assess depressive, anxious symptoms, fatigue, sleep disturbances, and other functions that may be affected by chronic mTBI. Each domain measure has undergone rigorous qualitative and psychometric evaluation and refinement through numerous clinical studies, so the measures could provide efficient, precise, valid, and responsive indicators of a person's health status. Higher scores mean better psychosocial functioning outcomes.
  measure: Change in sensorimotor function - vision from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
  time frame: 45 days
  description: Rapid eye movement by EyeLink 1000 Plus System (SR Research)
  measure: Change in sensorimotor function - walking from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
  time frame: 45 days
  description: Walking features and balance by mobile health application for walking balance (mHealth-WB)
  measure: Change in sensorimotor function - gait from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
  time frame: 45 days
  description: 3-dimensional kinematic and kinetic gait analysis (lab-based approach)
  measure: Acceptability, feasibility of the BraW-Day program on Uplode app
  time frame: 15 days
  description: semi-structured interview (max. 20 mins) based on components of the System Usability Scale (SUS) focusing on acceptability, feasibility, and barriers and facilitators for the BraW-Day exercise program on the Uplode app
  measure: Change in salivary exosomal microRNA from baseline at 15 days (Post-intervention) and 45 days (1-month post-intervention)
  time frame: 45 days
  description: Saliva samples will be collected for future characterization of exosomal microRNAs as potential neurodegenerative biomarkers associated with functional level alterations.
  arm group label: Intervention
  arm group type: Experimental
  description: The intervention group will be asked to visit the UNLV study site three times to evaluate baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).
  arm group label: Wait-list Control
  arm group type: Active Comparator
  description: The wait-list control group will be will be asked to visit the UNLV study site four times to evaluate pre-baseline (T0), baseline (T1), post-intervention (T2), and at 1-month post-intervention (T3) for functional assessments and saliva collection. Each participant will complete the BraW-Day program between baseline (T1) and post-intervention (T2). The program consists of 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).
  intervention type: Behavioral
  intervention name: Brain & Walk Exercise Every Day (BraW-Day)
  description: The Brain & Walk Exercise Every Day (BraW-Day) program comprises 15-minute-long daily cognitive-walking tasks for 14 consecutive days. The program will be delivered on the Uplode mobile app. Each participant will be asked to perform three different 5-minute-long cognitive tasks (e.g., subtracting numbers or remembering long phrases) and one physical task (tandem walking or 8-shape walking) either indoors or outdoors at the same time for 15 minutes every day, which they will repeat daily for the next 13 days (2 weeks in total).
  arm group label: Intervention
  arm group label: Wait-list Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hyunhwa Lee, Ph.D.
  phone: 7028953492
  email: hyunhwa.lee@unlv.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  mesh term: Brain Concussion
  mesh term: Wounds and Injuries
  sharing ipd: Undecided