Clinical trial NCT01790880: Enhancing Written Communication in Persons With Aphasia
Official title: Enhancing Written Communication in Persons With Aphasia: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Keywords: Aphasia
Stroke
Speech Rehabilitation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

   -

Primary outcomes:
measure: Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment
timeFrame: Change from baseline to 6 weeks
Secondary outcomes:
measure: Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
timeFrame: Change from baseline to 6 weeks
measure: Written Language Sample Analysis
timeFrame: Change from baseline to 6 weeks
measure: Communicative Effectiveness Index (CETI)
timeFrame: Change from baseline to 6 weeks
measure: ASHA Quality of Communication Life Scale (QCL)
timeFrame: Change from baseline to 6 weeks
measure: Community Integration Questionnaire (CIQ)
timeFrame: Change from baseline to 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Center for Aphasia Research and Treatment, Rehabilitation Institute of Chicago
state: Illinois
Study officials:
References: