Improving Electronic Written Communication in Aphasia

Aphasia Clinical Trial

— T-WRITE  

Official title:

Improving Electronic Written Communication in Persons With Aphasia: A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773419
• Other study ID #: IFRE17000031
• Status: Completed
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 30, 2022
• Est. primary completion date: August 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia

Intervention

Behavioral:
• Texting Intervention (T-WRITE)
Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using a cellular phone
• HandWriting Intervention (ORLA+WTG)
Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using pen and paper

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois
United States	James Madison University	Harrisonburg	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	James Madison University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Aphasia Battery-Revised (WAB-R) Writing subtest	Performance-based measure of written language; score ranges from 0 - 100	Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
Secondary	Stroke and Aphasia Quality of Life Scale (SAQOL-39)	Self-report measure of health-related quality of life, validated with persons with aphasia; provides a total mean score that ranges from 1 - 39.	Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
Secondary	The Friendship Scale	Six-item self-report scale that measures dimensions that contribute to social isolation and social connection. Each item is scored on a 5-point scale (0-4); overall score ranges from 1-24.	Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)