<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/NCT03773419</url>
  </required_header>
  <id_info>
    <org_study_id>IFRE17000031</org_study_id>
    <nct_id>NCT03773419</nct_id>
  </id_info>
  <brief_title>Improving Electronic Written Communication in Aphasia</brief_title>
  <acronym>T-WRITE</acronym>
  <official_title>Improving Electronic Written Communication in Persons With Aphasia: A Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>James Madison University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shirley Ryan AbilityLab</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>
      People with aphasia have difficulty with writing and often struggle to use electronic&#xD;
      communication that connects people to one another. The goal of this project is to evaluate&#xD;
      the extent to which a novel treatment (T-WRITE) improves written language function and the&#xD;
      use of text messaging; we also evaluate whether there are subsequent positive effects on the&#xD;
      participant's social connectedness and ultimately health-related quality of life (HRQOL).&#xD;
&#xD;
      T-WRITE involves choral reading and repeated writing of sentences via texting. Participants&#xD;
      work intensively and independently at home on a laptop computer. A virtual therapist directs&#xD;
      the participant to practice copying and independently writing phrases and short sentences&#xD;
      using the typing feature on a cellular phone. The specific objective of this randomized&#xD;
      clinical trial is to compare T-WRITE to ORLA+WTG, a similar treatment that targets written&#xD;
      expression using handwriting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An acquired impairment in writing, also known as agraphia, is a characteristic symptom of&#xD;
      aphasia, i.e., a language disorder resulting from damage to the language centers of the&#xD;
      brain. Written communication via text and instant messaging, electronic mail, and various&#xD;
      types of social media has become an increasingly important part of everyday life in our&#xD;
      technology driven society. Consequently, difficulty with written expression can significantly&#xD;
      restrict people with aphasia from participation in community life, including social,&#xD;
      professional, and educational realms. Improving writing in persons with aphasia could improve&#xD;
      communication, increase access to information, reduce isolation and facilitate social&#xD;
      connectedness. Furthermore, delivering writing treatment via an electronic modality, such as&#xD;
      texting, could be particularly advantageous given the increasing reliance on electronic&#xD;
      communication. This study investigates the efficacy of T-WRITE, a computer-based writing&#xD;
      treatment for aphasia that targets phrase/sentence level writing using texting. Its aims are&#xD;
      to: 1) evaluate the efficacy of computer-based texting treatment for improving written&#xD;
      communication in persons with aphasia and 2) assess the extent to which improvements in&#xD;
      electronic written communication impact social connectedness and health-related quality of&#xD;
      life (HRQOL). This will be accomplished via a randomized controlled trial across two sites&#xD;
      that compares computer-based texting treatment (T-WRITE) to a control group that receives a&#xD;
      hand-writing treatment (ORLA+WTG).&#xD;
&#xD;
      The intervention is delivered via computer using state-of-the-art virtual therapist&#xD;
      technology. A perceptive, life-like animated computer agent (virtual therapist), using&#xD;
      visible speech, guides the participant so he or she can independently work through the set of&#xD;
      choral reading and writing activities (see figure above showing a screen shot of the virtual&#xD;
      therapist). The objective is to assure an optimal learning experience in the comfort of the&#xD;
      participant's home by using a virtual therapist with accurate visible speech feedback. The&#xD;
      virtual therapist reads aloud, speaks with accurate visible speech, highlights and repeats&#xD;
      words and sentences, directs the participant to copy/write phrases or sentences, and provides&#xD;
      guidance much like a real therapist. The sequence of steps in the ORLA+WTG and the T-WRITE&#xD;
      treatments are identical. The output modality for participants randomized to T-WRITE is&#xD;
      texting using a cellular phone whereas participants in the ORLA+WTG will hand-write their&#xD;
      responses using pen and paper. Participants will practice their writing for 90 minutes a day,&#xD;
      6 days a week for 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2018</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">August 13, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Western Aphasia Battery-Revised (WAB-R) Writing subtest</measure>
    <time_frame>Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)</time_frame>
    <description>Performance-based measure of written language; score ranges from 0 - 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stroke and Aphasia Quality of Life Scale (SAQOL-39)</measure>
    <time_frame>Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)</time_frame>
    <description>Self-report measure of health-related quality of life, validated with persons with aphasia; provides a total mean score that ranges from 1 - 39.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Friendship Scale</measure>
    <time_frame>Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)</time_frame>
    <description>Six-item self-report scale that measures dimensions that contribute to social isolation and social connection. Each item is scored on a 5-point scale (0-4); overall score ranges from 1-24.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Aphasia</condition>
  <arm_group>
    <arm_group_label>Texting Intervention (T-WRITE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computer-based treatment targeting written language via texting (90 minutes a day, 5 days a week for 4 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HandWriting Intervention (ORLA+WTG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Computer-based treatment targeting written language via handwriting (90 minutes a day, 5 days a week for 4 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Texting Intervention (T-WRITE)</intervention_name>
    <description>Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using a cellular phone</description>
    <arm_group_label>Texting Intervention (T-WRITE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HandWriting Intervention (ORLA+WTG)</intervention_name>
    <description>Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using pen and paper</description>
    <arm_group_label>HandWriting Intervention (ORLA+WTG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed&#xD;
             by CT scan or MRI&#xD;
&#xD;
          2. Aphasia Quotient score on the Western Aphasia Battery-Revised of 40-85.&#xD;
&#xD;
          3. &gt; 6 months post injury&#xD;
&#xD;
          4. premorbidly right handed, determined by Edinburgh Handedness Inventory&#xD;
&#xD;
          5. completed at least an eighth grade education&#xD;
&#xD;
          6. premorbid proficiency in English by self-report&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. any other neurological condition (other than cerebral vascular disease) that could&#xD;
             potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's&#xD;
             Dementia, traumatic brain injury.&#xD;
&#xD;
          2. active substance abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leora Cherney, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shirley Ryan AbilityLab</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shirley Ryan AbilityLab</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Madison University</name>
      <address>
        <city>Harrisonburg</city>
        <state>Virginia</state>
        <zip>22807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Leora Cherney</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stroke-related aphasia</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Writing</keyword>
  <keyword>Texting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03773419
org study id: IFRE17000031
nct id: NCT03773419
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People with aphasia have difficulty with writing and often struggle to use electronic
      communication that connects people to one another. The goal of this project is to evaluate
      the extent to which a novel treatment (T-WRITE) improves written language function and the
      use of text messaging; we also evaluate whether there are subsequent positive effects on the
      participant's social connectedness and ultimately health-related quality of life (HRQOL).

      T-WRITE involves choral reading and repeated writing of sentences via texting. Participants
      work intensively and independently at home on a laptop computer. A virtual therapist directs
      the participant to practice copying and independently writing phrases and short sentences
      using the typing feature on a cellular phone. The specific objective of this randomized
      clinical trial is to compare T-WRITE to ORLA+WTG, a similar treatment that targets written
      expression using handwriting.
An acquired impairment in writing, also known as agraphia, is a characteristic symptom of
      aphasia, i.e., a language disorder resulting from damage to the language centers of the
      brain. Written communication via text and instant messaging, electronic mail, and various
      types of social media has become an increasingly important part of everyday life in our
      technology driven society. Consequently, difficulty with written expression can significantly
      restrict people with aphasia from participation in community life, including social,
      professional, and educational realms. Improving writing in persons with aphasia could improve
      communication, increase access to information, reduce isolation and facilitate social
      connectedness. Furthermore, delivering writing treatment via an electronic modality, such as
      texting, could be particularly advantageous given the increasing reliance on electronic
      communication. This study investigates the efficacy of T-WRITE, a computer-based writing
      treatment for aphasia that targets phrase/sentence level writing using texting. Its aims are
      to: 1) evaluate the efficacy of computer-based texting treatment for improving written
      communication in persons with aphasia and 2) assess the extent to which improvements in
      electronic written communication impact social connectedness and health-related quality of
      life (HRQOL). This will be accomplished via a randomized controlled trial across two sites
      that compares computer-based texting treatment (T-WRITE) to a control group that receives a
      hand-writing treatment (ORLA+WTG).

      The intervention is delivered via computer using state-of-the-art virtual therapist
      technology. A perceptive, life-like animated computer agent (virtual therapist), using
      visible speech, guides the participant so he or she can independently work through the set of
      choral reading and writing activities (see figure above showing a screen shot of the virtual
      therapist). The objective is to assure an optimal learning experience in the comfort of the
      participant's home by using a virtual therapist with accurate visible speech feedback. The
      virtual therapist reads aloud, speaks with accurate visible speech, highlights and repeats
      words and sentences, directs the participant to copy/write phrases or sentences, and provides
      guidance much like a real therapist. The sequence of steps in the ORLA+WTG and the T-WRITE
      treatments are identical. The output modality for participants randomized to T-WRITE is
      texting using a cellular phone whereas participants in the ORLA+WTG will hand-write their
      responses using pen and paper. Participants will practice their writing for 90 minutes a day,
      6 days a week for 4 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Western Aphasia Battery-Revised (WAB-R) Writing subtest
time frame: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
description: Performance-based measure of written language; score ranges from 0 - 100
measure: Stroke and Aphasia Quality of Life Scale (SAQOL-39)
time frame: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
description: Self-report measure of health-related quality of life, validated with persons with aphasia; provides a total mean score that ranges from 1 - 39.
measure: The Friendship Scale
time frame: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
description: Six-item self-report scale that measures dimensions that contribute to social isolation and social connection. Each item is scored on a 5-point scale (0-4); overall score ranges from 1-24.
arm group label: Texting Intervention (T-WRITE)
arm group type: Experimental
description: Computer-based treatment targeting written language via texting (90 minutes a day, 5 days a week for 4 weeks)
arm group label: HandWriting Intervention (ORLA+WTG)
arm group type: Active Comparator
description: Computer-based treatment targeting written language via handwriting (90 minutes a day, 5 days a week for 4 weeks)
intervention type: Behavioral
intervention name: Texting Intervention (T-WRITE)
description: Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using a cellular phone
arm group label: Texting Intervention (T-WRITE)
intervention type: Behavioral
intervention name: HandWriting Intervention (ORLA+WTG)
description: Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using pen and paper
arm group label: HandWriting Intervention (ORLA+WTG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leora Cherney, PhD
role: Principal Investigator
affiliation: Shirley Ryan AbilityLab
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Leora Cherney
investigator title: Principal Investigator
mesh term: Aphasia
sharing ipd: No