Clinical trial NCT03773419: Improving Electronic Written Communication in Aphasia
Official title: Improving Electronic Written Communication in Persons With Aphasia: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: Stroke-related aphasia
Rehabilitation
Writing
Texting
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: James Madison University
First posted: 2018-12-12
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People with aphasia have difficulty with writing and often struggle to use electronic communication that connects people to one another. The goal of this project is to evaluate the extent to which a novel treatment (T-WRITE) improves written language function and the use of text messaging; we also evaluate whether there are subsequent positive effects on the participant's social connectedness and ultimately health-related quality of life (HRQOL).

T-WRITE involves choral reading and repeated writing of sentences via texting. Participants work intensively and independently at home on a laptop computer. A virtual therapist directs the participant to practice copying and independently writing phrases and short sentences using the typing feature on a cellular phone. The specific objective of this randomized clinical trial is to compare T-WRITE to ORLA+WTG, a similar treatment that targets written expression using handwriting.

Detailed description: An acquired impairment in writing, also known as agraphia, is a characteristic symptom of aphasia, i.e., a language disorder resulting from damage to the language centers of the brain. Written communication via text and instant messaging, electronic mail, and various types of social media has become an increasingly important part of everyday life in our technology driven society. Consequently, difficulty with written expression can significantly restrict people with aphasia from participation in community life, including social, professional, and educational realms. Improving writing in persons with aphasia could improve communication, increase access to information, reduce isolation and facilitate social connectedness. Furthermore, delivering writing treatment via an electronic modality, such as texting, could be particularly advantageous given the increasing reliance on electronic communication. This study investigates the efficacy of T-WRITE, a computer-based writing treatment for aphasia that targets phrase/sentence level writing using texting. Its aims are to: 1) evaluate the efficacy of computer-based texting treatment for improving written communication in persons with aphasia and 2) assess the extent to which improvements in electronic written communication impact social connectedness and health-related quality of life (HRQOL). This will be accomplished via a randomized controlled trial across two sites that compares computer-based texting treatment (T-WRITE) to a control group that receives a hand-writing treatment (ORLA+WTG).

The intervention is delivered via computer using state-of-the-art virtual therapist technology. A perceptive, life-like animated computer agent (virtual therapist), using visible speech, guides the participant so he or she can independently work through the set of choral reading and writing activities (see figure above showing a screen shot of the virtual therapist). The objective is to assure an optimal learning experience in the comfort of the participant's home by using a virtual therapist with accurate visible speech feedback. The virtual therapist reads aloud, speaks with accurate visible speech, highlights and repeats words and sentences, directs the participant to copy/write phrases or sentences, and provides guidance much like a real therapist. The sequence of steps in the ORLA+WTG and the T-WRITE treatments are identical. The output modality for participants randomized to T-WRITE is texting using a cellular phone whereas participants in the ORLA+WTG will hand-write their responses using pen and paper. Participants will practice their writing for 90 minutes a day, 6 days a week for 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by CT scan or MRI
2. Aphasia Quotient score on the Western Aphasia Battery-Revised of 40-85.
3. \> 6 months post injury
4. premorbidly right handed, determined by Edinburgh Handedness Inventory
5. completed at least an eighth grade education
6. premorbid proficiency in English by self-report

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. active substance abuse.

Primary outcomes:
measure: Western Aphasia Battery-Revised (WAB-R) Writing subtest
timeFrame: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
Secondary outcomes:
measure: Stroke and Aphasia Quality of Life Scale (SAQOL-39)
timeFrame: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
measure: The Friendship Scale
timeFrame: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
city: Harrisonburg
country: United States
facility: James Madison University
state: Virginia
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Leora Cherney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kinsey LE, Lee JB, Larkin EM, Cherney LR. Texting Behaviors of Individuals With Chronic Aphasia: A Descriptive Study. Am J Speech Lang Pathol. 2022 Jan 18;31(1):99-112. doi: 10.1044/2021_AJSLP-20-00287. Epub 2021 Jun 1.