search
Back to results

Enhancing Written Communication in Persons With Aphasia

Primary Purpose

Aphasia, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ORLA
ORLA + Writing
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, Speech Rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. men or women with diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by CT scan or MRI
  2. an Aphasia Quotient score on the Western Aphasia Battery of 50-85.
  3. 6 months post injury
  4. premorbidly right handed, determined by Edinburgh Handedness Inventory
  5. completed at least an eighth grade education
  6. premorbidly literate in English
  7. visual acuity may be corrected but must be sufficient for reading visual stimuli on computer screen
  8. auditory acuity may be aided but must be sufficient for hearing auditory stimuli in ORLA program

Exclusion Criteria:

  1. 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.
  2. 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.
  3. active substance abuse.

    -

Sites / Locations

  • Center for Aphasia Research and Treatment, Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ORLA

ORLA + Writing

Arm Description

Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system, for 90 minutes per day, 6 days per week for 6 weeks.

Practice on "ORLA + writing" computer program, 90 minutes per day, 6 days per week, for 6 weeks.

Outcomes

Primary Outcome Measures

Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment

Secondary Outcome Measures

Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
Written Language Sample Analysis
Written responses on the Picture Description task of the Western Aphasia Battery-Revised and on a written picture-sequenced story retelling task will be scored for Correct Information Units
Communicative Effectiveness Index (CETI)
ASHA Quality of Communication Life Scale (QCL)
Community Integration Questionnaire (CIQ)

Full Information

First Posted
February 11, 2013
Last Updated
March 17, 2020
Sponsor
Shirley Ryan AbilityLab
search

1. Study Identification

Unique Protocol Identification Number
NCT01790880
Brief Title
Enhancing Written Communication in Persons With Aphasia
Official Title
Enhancing Written Communication in Persons With Aphasia: A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether a computerized speech-language treatment delivered by a virtual therapist (Oral Reading for Language in Aphasia (ORLA) + Writing) results in improved written communication skills of study participants with aphasia (i.e., difficulty with the comprehension and expression of spoken and written language).
Detailed Description
Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year. A common neurological deficit among stroke survivors, and thus a substantial contributor to post-stroke disability, is aphasia. The loss of, or difficulty with language is extremely debilitating. Adequate written communication skills may be one of the barriers that has prevented individuals with aphasia from returning to work. Writing skills are also important for participation in social roles, such as household management, civic activities, or recreational activities with friends. Individuals with aphasia struggle to compose written documents such as personal letters, memos and reports. Furthermore, society's increased reliance on written forms of communication including email correspondence, instant messaging, texting, Twitter, and social networking sites such as Facebook, exacerbate the challenge that individuals with aphasia have in connecting with others, reestablishing and redefining their social roles and accomplishing their life-participation goals. Computer-directed treatment offers a practical alternative to one-on-one traditional treatment provided by a clinician and may be a cost-effective way of extending therapy beyond the hospital and clinic to meet the needs of the growing numbers of individuals with chronic aphasia and to help them reintegrate into the community and workforce. This project evaluates the efficacy of a theoretically-motivated writing program that has been integrated with novel computer-based virtual therapy systems and that can be provided intensively to individuals with chronic aphasia.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ORLA
Arm Type
Active Comparator
Arm Description
Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system, for 90 minutes per day, 6 days per week for 6 weeks.
Arm Title
ORLA + Writing
Arm Type
Experimental
Arm Description
Practice on "ORLA + writing" computer program, 90 minutes per day, 6 days per week, for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
ORLA
Intervention Description
Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system.
Intervention Type
Behavioral
Intervention Name(s)
ORLA + Writing
Intervention Description
Treatment includes writing of sentences in combination with ORLA
Primary Outcome Measure Information:
Title
Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment
Time Frame
Change from baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
Time Frame
Change from baseline to 6 weeks
Title
Written Language Sample Analysis
Description
Written responses on the Picture Description task of the Western Aphasia Battery-Revised and on a written picture-sequenced story retelling task will be scored for Correct Information Units
Time Frame
Change from baseline to 6 weeks
Title
Communicative Effectiveness Index (CETI)
Time Frame
Change from baseline to 6 weeks
Title
ASHA Quality of Communication Life Scale (QCL)
Time Frame
Change from baseline to 6 weeks
Title
Community Integration Questionnaire (CIQ)
Time Frame
Change from baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 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 50-85. 6 months post injury premorbidly right handed, determined by Edinburgh Handedness Inventory completed at least an eighth grade education premorbidly literate in English visual acuity may be corrected but must be sufficient for reading visual stimuli on computer screen auditory acuity may be aided but must be sufficient for hearing auditory stimuli in ORLA program 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. -
Facility Information:
Facility Name
Center for Aphasia Research and Treatment, Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Enhancing Written Communication in Persons With Aphasia

We'll reach out to this number within 24 hrs