Enhancing Written Communication in Persons With Aphasia

This study is currently recruiting participants.
Verified September 2013 by Rehabilitation Institute of Chicago
Sponsor:
Information provided by (Responsible Party):
Leora Cherney, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01790880
First received: February 11, 2013
Last updated: September 25, 2013
Last verified: September 2013

February 11, 2013
September 25, 2013
February 2013
September 2015   (final data collection date for primary outcome measure)
Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01790880 on ClinicalTrials.gov Archive Site
  • Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Written Language Sample Analysis [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
  • ASHA Quality of Communication Life Scale (QCL) [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Community Integration Questionnaire (CIQ) [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Enhancing Written Communication in Persons With Aphasia
Enhancing Written Communication in Persons With Aphasia: A Clinical Trial

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Aphasia
  • Stroke
  • Behavioral: ORLA
    Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system.
  • Behavioral: ORLA + Writing
    Treatment includes writing of sentences in combination with ORLA
  • Active Comparator: ORLA
    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.
    Intervention: Behavioral: ORLA
  • Experimental: ORLA + Writing
    Practice on "ORLA + writing" computer program, 90 minutes per day, 6 days per week, for 6 weeks.
    Intervention: Behavioral: ORLA + Writing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
September 2015
September 2015   (final data collection date for primary outcome measure)

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.

    -

Both
18 Years to 80 Years
No
Contact: Leora R Cherney, Ph.D. 312-238-1117 lcherney@ric.org
Contact: Jaime B. Lee, M.S. 312-238-6163 jlee@ric.org
United States
 
NCT01790880
74374
No
Leora Cherney, Rehabilitation Institute of Chicago
Rehabilitation Institute of Chicago
Not Provided
Not Provided
Rehabilitation Institute of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP