Enhancing Written Communication in Persons With Aphasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 24, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Aphasia
Stroke
Behavioral: ORLA
Behavioral: ORLA + Writing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Written Communication in Persons With Aphasia: A Clinical Trial

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: ORLA
Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system.
Experimental: ORLA + Writing
Practice on "ORLA + writing" computer program, 90 minutes per day, 6 days per week, for 6 weeks.
Behavioral: ORLA + Writing
Treatment includes writing of sentences in combination with ORLA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790880

Contacts
Contact: Leora R Cherney, Ph.D. 312-238-1117 lcherney@ric.org
Contact: Jaime B. Lee, M.S. 312-238-6163 jlee@ric.org

Locations
United States, Illinois
Center for Aphasia Research and Treatment, Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Leora R Cherney, Ph.D.    312-238-1117    lcherney@ric.org   
Contact: Jaime B Lee, M.S.    312-238-6163    jlee@ric.org   
Sponsors and Collaborators
Rehabilitation Institute of Chicago
  More Information

No publications provided

Responsible Party: Leora Cherney, Senior Research Scientist, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01790880     History of Changes
Other Study ID Numbers: 74374
Study First Received: February 11, 2013
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
Aphasia
Stroke
Speech Rehabilitation

Additional relevant MeSH terms:
Aphasia
Stroke
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014