<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/NCT04413136</url>
  </required_header>
  <id_info>
    <org_study_id>STU00000150</org_study_id>
    <nct_id>NCT04413136</nct_id>
  </id_info>
  <brief_title>Web-Based Treatment for Aphasia</brief_title>
  <acronym>Web-ORLA</acronym>
  <official_title>Web-Based Treatment for Aphasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Boulder</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>
      This prospective randomized clinical trial implements an innovative broadband web-based&#xD;
      treatment program for individuals with chronic aphasia, and evaluates its efficacy. The&#xD;
      treatment, Oral Reading for Language in Aphasia (ORLA), has been shown to be efficacious when&#xD;
      provided by a speech-language pathologist. The treatment has been computerized and the&#xD;
      current version of ORLA uses state-of-the-art virtual therapist technology that allows the&#xD;
      individual with aphasia to read aloud, and ultimately speak, sentences at the same time as&#xD;
      the words are produced by a perceptive, life-like, animated computer agent, using visible&#xD;
      speech. In this clinical trial, ORLA treatment is delivered via the internet and outcomes are&#xD;
      compared to a placebo computer treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aphasia is an acquired multi-modality disturbance of language, resulting from focal damage to&#xD;
      portions of the brain, typically within the left hemisphere, that are responsible for&#xD;
      language. The disorder impairs, in varying degrees, the understanding and expression of oral&#xD;
      language, as well as reading and writing. The research literature is replete with information&#xD;
      about the treatment of aphasia. Individual studies, together with expert opinion and&#xD;
      meta-analyses indicate that those with aphasia benefit from treatments that focus on&#xD;
      improving linguistic skills. Furthermore, recent studies have indicated that patients with&#xD;
      aphasia, even those beyond the period of spontaneous recovery, benefit from treatment that is&#xD;
      provided more frequently. Yet people with aphasia represent an underserved population.&#xD;
      Legislation and reimbursement have seriously curtailed the amount of treatment a patient with&#xD;
      aphasia may receive. Often patients may be eligible for only a limited number of treatment&#xD;
      sessions over a limited period of time. In some cases, patients may not receive any treatment&#xD;
      for their communication disorder following their acute hospitalization. Communication&#xD;
      treatment costs delivered to patients with chronic aphasia (beyond six months after onset)&#xD;
      are seldom reimbursable. Therefore, the establishment and maintenance of programs for&#xD;
      effective aphasia remediation are posing new challenges.&#xD;
&#xD;
      There is clearly a need for the development of innovative and effective ways for individuals&#xD;
      with aphasia to continue to receive much needed intensive and long-term services that are&#xD;
      typically unavailable beyond the acute stage of this disability. Web-based treatment may be a&#xD;
      cost-effective way of extending therapy beyond the hospital and clinic, thereby meeting the&#xD;
      needs of the growing numbers of individuals with chronic aphasia. This project evaluates the&#xD;
      effectiveness of a theoretically-motivated and efficacious treatment that has been integrated&#xD;
      with novel computer-based virtual therapy systems and is provided via the internet to&#xD;
      individuals with chronic aphasia.&#xD;
&#xD;
      The treatment, Oral Reading for Language in Aphasia (ORLA), is based on a theoretical&#xD;
      framework that incorporates two lines of work: the neuropsychological models of reading and&#xD;
      observation-execution-matching. Preliminary studies have indicated that this treatment is&#xD;
      efficacious when provided by a speech-language pathologist. The treatment has been&#xD;
      computerized and the current version of ORLA uses state-of-the-art virtual therapist&#xD;
      technology that allows the individual with aphasia to read aloud, and ultimately speak,&#xD;
      sentences at the same time as the words are produced by a perceptive, life-like, animated&#xD;
      computer agent, using visible speech. In the web-based version, individuals with aphasia work&#xD;
      independently on their home computer. The clinician is able to monitor patient use and&#xD;
      progress remotely either in real time during the treatment session or after the session at a&#xD;
      convenient time.&#xD;
&#xD;
      In this clinical trial, ORLA treatment is delivered via the internet and outcomes are&#xD;
      compared to a placebo computer treatment. Thirty-five individuals with chronic aphasia (at&#xD;
      least 6 months post onset) are randomized to one of two groups: oral reading (ORLA) treatment&#xD;
      group and a control group in which subjects participate in non-language computer activities.&#xD;
      Both groups practice for 9 hours per week and treatment continues for a six week period of&#xD;
      time. Laptops and high-speed internet connections are provided to the subjects for home&#xD;
      practice. Language and communication skills are evaluated pre-treatment, immediately&#xD;
      post-treatment, and at 6 weeks after the end of treatment to assess maintenance effects. The&#xD;
      primary outcome measure is the Language Quotient of the Western Aphasia Battery.&#xD;
&#xD;
      We hypothesize that implementation of a web-based ORLA treatment for patients with chronic&#xD;
      aphasia will result in significant improvements in language, that these improvements are&#xD;
      significantly greater than those resulting from placebo computer treatment, and that these&#xD;
      improvements will be maintained over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2008</start_date>
  <completion_date type="Actual">September 29, 2011</completion_date>
  <primary_completion_date type="Actual">October 27, 2010</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 Language Quotient (LQ)</measure>
    <time_frame>Change from baseline to immediately following 6 weeks of treatment</time_frame>
    <description>Performance on measures of auditory comprehension, oral expression, reading comprehension and written expression on the WAB-R LQ scale which goes from 0-100. A higher score indicates better performance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Western Aphasia Battery Revised Language Quotient (LQ)</measure>
    <time_frame>Change from baseline to 6 weeks after the end of treatment.</time_frame>
    <description>Performance on measures of auditory comprehension, oral expression, reading comprehension and written expression on the WAB-R LQ scale which goes from 0-100. A higher score indicates better performance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Aphasia</condition>
  <arm_group>
    <arm_group_label>Web-ORLA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered 90 minutes a day, six days a week ( i.e. nine hours of computer treatment per week) for a total of six weeks.&#xD;
The participant is presented with 3-5 word (level 1) or 8-10 word (level 2) sentences, depending upon the severity of the aphasia. Each sentence is chosen by the software program at random from a group of 150 sentences. The participant is instructed to look, listen, and point to words spoken by the virtual therapist, read highlighted words aloud, and then read the sentence aloud, both chorally with the virtual therapist and independently.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administered 90 minutes a day, six days a week ( i.e. nine hours of computer treatment per week) for a total of six weeks.&#xD;
A commercially available game, Bejeweled 2, by PopCap. Participants use loaned 13-in laptop computers to access the Bejeweled interface, which displays an 8 X 8 grid of gems of varying shapes and colors. The objective is to match three gems of the same color and shape to score points and advance to more difficult levels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Web-ORLA</intervention_name>
    <arm_group_label>Web-ORLA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men or women with diagnosis of an aphasia subsequent to a left-hemisphere infarct(s)&#xD;
             that is confirmed by CT scan or MRI&#xD;
&#xD;
          -  an Aphasia Quotient score on the Western Aphasia Battery of 20-80.&#xD;
&#xD;
          -  &gt; 6 months post injury&#xD;
&#xD;
          -  completed at least an eighth grade education&#xD;
&#xD;
          -  premorbidly literate in English&#xD;
&#xD;
          -  sufficient auditory and visual acuity to interact with a laptop&#xD;
&#xD;
          -  not receiving other speech/language treatment for at least one month prior to or&#xD;
             during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  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;
          -  any significant psychiatric history prior to the stroke, such as severe major&#xD;
             depression or psychotic disorder requiring hospitalization; subjects with mood&#xD;
             disorders who are currently stable on treatment will be considered.&#xD;
&#xD;
          -  active substance abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leora R Cherney, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shirley Ryan AbilityLab</affiliation>
  </overall_official>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>April 11, 2021</last_update_submitted>
  <last_update_submitted_qc>April 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</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>Aphasia</keyword>
  <keyword>Stroke</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Computer</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/NCT04413136
org study id: STU00000150
nct id: NCT04413136
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective randomized clinical trial implements an innovative broadband web-based
      treatment program for individuals with chronic aphasia, and evaluates its efficacy. The
      treatment, Oral Reading for Language in Aphasia (ORLA), has been shown to be efficacious when
      provided by a speech-language pathologist. The treatment has been computerized and the
      current version of ORLA uses state-of-the-art virtual therapist technology that allows the
      individual with aphasia to read aloud, and ultimately speak, sentences at the same time as
      the words are produced by a perceptive, life-like, animated computer agent, using visible
      speech. In this clinical trial, ORLA treatment is delivered via the internet and outcomes are
      compared to a placebo computer treatment.
Aphasia is an acquired multi-modality disturbance of language, resulting from focal damage to
      portions of the brain, typically within the left hemisphere, that are responsible for
      language. The disorder impairs, in varying degrees, the understanding and expression of oral
      language, as well as reading and writing. The research literature is replete with information
      about the treatment of aphasia. Individual studies, together with expert opinion and
      meta-analyses indicate that those with aphasia benefit from treatments that focus on
      improving linguistic skills. Furthermore, recent studies have indicated that patients with
      aphasia, even those beyond the period of spontaneous recovery, benefit from treatment that is
      provided more frequently. Yet people with aphasia represent an underserved population.
      Legislation and reimbursement have seriously curtailed the amount of treatment a patient with
      aphasia may receive. Often patients may be eligible for only a limited number of treatment
      sessions over a limited period of time. In some cases, patients may not receive any treatment
      for their communication disorder following their acute hospitalization. Communication
      treatment costs delivered to patients with chronic aphasia (beyond six months after onset)
      are seldom reimbursable. Therefore, the establishment and maintenance of programs for
      effective aphasia remediation are posing new challenges.

      There is clearly a need for the development of innovative and effective ways for individuals
      with aphasia to continue to receive much needed intensive and long-term services that are
      typically unavailable beyond the acute stage of this disability. Web-based treatment may be a
      cost-effective way of extending therapy beyond the hospital and clinic, thereby meeting the
      needs of the growing numbers of individuals with chronic aphasia. This project evaluates the
      effectiveness of a theoretically-motivated and efficacious treatment that has been integrated
      with novel computer-based virtual therapy systems and is provided via the internet to
      individuals with chronic aphasia.

      The treatment, Oral Reading for Language in Aphasia (ORLA), is based on a theoretical
      framework that incorporates two lines of work: the neuropsychological models of reading and
      observation-execution-matching. Preliminary studies have indicated that this treatment is
      efficacious when provided by a speech-language pathologist. The treatment has been
      computerized and the current version of ORLA uses state-of-the-art virtual therapist
      technology that allows the individual with aphasia to read aloud, and ultimately speak,
      sentences at the same time as the words are produced by a perceptive, life-like, animated
      computer agent, using visible speech. In the web-based version, individuals with aphasia work
      independently on their home computer. The clinician is able to monitor patient use and
      progress remotely either in real time during the treatment session or after the session at a
      convenient time.

      In this clinical trial, ORLA treatment is delivered via the internet and outcomes are
      compared to a placebo computer treatment. Thirty-five individuals with chronic aphasia (at
      least 6 months post onset) are randomized to one of two groups: oral reading (ORLA) treatment
      group and a control group in which subjects participate in non-language computer activities.
      Both groups practice for 9 hours per week and treatment continues for a six week period of
      time. Laptops and high-speed internet connections are provided to the subjects for home
      practice. Language and communication skills are evaluated pre-treatment, immediately
      post-treatment, and at 6 weeks after the end of treatment to assess maintenance effects. The
      primary outcome measure is the Language Quotient of the Western Aphasia Battery.

      We hypothesize that implementation of a web-based ORLA treatment for patients with chronic
      aphasia will result in significant improvements in language, that these improvements are
      significantly greater than those resulting from placebo computer treatment, and that these
      improvements will be maintained over time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Western Aphasia Battery Revised Language Quotient (LQ)
time frame: Change from baseline to immediately following 6 weeks of treatment
description: Performance on measures of auditory comprehension, oral expression, reading comprehension and written expression on the WAB-R LQ scale which goes from 0-100. A higher score indicates better performance.
measure: Western Aphasia Battery Revised Language Quotient (LQ)
time frame: Change from baseline to 6 weeks after the end of treatment.
description: Performance on measures of auditory comprehension, oral expression, reading comprehension and written expression on the WAB-R LQ scale which goes from 0-100. A higher score indicates better performance.
arm group label: Web-ORLA
arm group type: Experimental
description: Administered 90 minutes a day, six days a week ( i.e. nine hours of computer treatment per week) for a total of six weeks.
The participant is presented with 3-5 word (level 1) or 8-10 word (level 2) sentences, depending upon the severity of the aphasia. Each sentence is chosen by the software program at random from a group of 150 sentences. The participant is instructed to look, listen, and point to words spoken by the virtual therapist, read highlighted words aloud, and then read the sentence aloud, both chorally with the virtual therapist and independently.
arm group label: Control
arm group type: Placebo Comparator
description: Administered 90 minutes a day, six days a week ( i.e. nine hours of computer treatment per week) for a total of six weeks.
A commercially available game, Bejeweled 2, by PopCap. Participants use loaned 13-in laptop computers to access the Bejeweled interface, which displays an 8 X 8 grid of gems of varying shapes and colors. The objective is to match three gems of the same color and shape to score points and advance to more difficult levels.
intervention type: Behavioral
intervention name: Web-ORLA
arm group label: Web-ORLA
intervention type: Behavioral
intervention name: Control
arm group label: Control
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Leora R Cherney, PhD
role: Principal Investigator
affiliation: Shirley Ryan AbilityLab
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