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Web-Based Treatment for Aphasia (Web-ORLA)

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-ORLA
Control
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Stroke, Rehabilitation, Computer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • men or women with diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by CT scan or MRI
  • an Aphasia Quotient score on the Western Aphasia Battery of 20-80.
  • > 6 months post injury
  • completed at least an eighth grade education
  • premorbidly literate in English
  • sufficient auditory and visual acuity to interact with a laptop
  • not receiving other speech/language treatment for at least one month prior to or during the study.

Exclusion Criteria:

  • any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's Dementia, traumatic brain injury.
  • any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization; subjects with mood disorders who are currently stable on treatment will be considered.
  • active substance abuse.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Web-ORLA

    Control

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Western Aphasia Battery Revised Language Quotient (LQ)
    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.

    Secondary Outcome Measures

    Western Aphasia Battery Revised Language Quotient (LQ)
    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.

    Full Information

    First Posted
    May 29, 2020
    Last Updated
    April 11, 2021
    Sponsor
    Shirley Ryan AbilityLab
    Collaborators
    Northwestern University, University of Colorado, Boulder
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04413136
    Brief Title
    Web-Based Treatment for Aphasia
    Acronym
    Web-ORLA
    Official Title
    Web-Based Treatment for Aphasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 7, 2008 (Actual)
    Primary Completion Date
    October 27, 2010 (Actual)
    Study Completion Date
    September 29, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shirley Ryan AbilityLab
    Collaborators
    Northwestern University, University of Colorado, Boulder

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aphasia
    Keywords
    Aphasia, Stroke, Rehabilitation, Computer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Web-ORLA
    Arm Type
    Experimental
    Arm 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 Title
    Control
    Arm Type
    Placebo Comparator
    Arm 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(s)
    Web-ORLA
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control
    Primary Outcome Measure Information:
    Title
    Western Aphasia Battery Revised Language Quotient (LQ)
    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.
    Time Frame
    Change from baseline to immediately following 6 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    Western Aphasia Battery Revised Language Quotient (LQ)
    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.
    Time Frame
    Change from baseline to 6 weeks after the end of treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: men or women with diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by CT scan or MRI an Aphasia Quotient score on the Western Aphasia Battery of 20-80. > 6 months post injury completed at least an eighth grade education premorbidly literate in English sufficient auditory and visual acuity to interact with a laptop not receiving other speech/language treatment for at least one month prior to or during the study. Exclusion Criteria: any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's Dementia, traumatic brain injury. any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization; subjects with mood disorders who are currently stable on treatment will be considered. active substance abuse.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leora R Cherney, PhD
    Organizational Affiliation
    Shirley Ryan AbilityLab
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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