Enhancing Written Communication in Persons With Aphasia

Stroke Clinical Trial

Official title:

Enhancing Written Communication in Persons With Aphasia: A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790880
• Other study ID #: 74374
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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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Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Behavioral:
• ORLA
Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system.
• ORLA + Writing
Treatment includes writing of sentences in combination with ORLA

Locations

Country	Name	City	State
United States	Center for Aphasia Research and Treatment, Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment		Change from baseline to 6 weeks
Secondary	Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)		Change from baseline to 6 weeks
Secondary	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	Change from baseline to 6 weeks
Secondary	Communicative Effectiveness Index (CETI)		Change from baseline to 6 weeks
Secondary	ASHA Quality of Communication Life Scale (QCL)		Change from baseline to 6 weeks
Secondary	Community Integration Questionnaire (CIQ)		Change from baseline to 6 weeks