- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03773419
Improving Electronic Written Communication in Aphasia (T-WRITE)
Improving Electronic Written Communication in Persons With Aphasia: A Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Illinois
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Chicago, Illinois, United States, 60611
- Shirley Ryan AbilityLab
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Virginia
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Harrisonburg, Virginia, United States, 22807
- James Madison University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by CT scan or MRI
- Aphasia Quotient score on the Western Aphasia Battery-Revised of 40-85.
- > 6 months post injury
- premorbidly right handed, determined by Edinburgh Handedness Inventory
- completed at least an eighth grade education
- premorbid proficiency in English by self-report
Exclusion Criteria:
- 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.
- active substance abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Texting Intervention (T-WRITE)
Computer-based treatment targeting written language via texting (90 minutes a day, 5 days a week for 4 weeks)
|
Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using a cellular phone
|
Active Comparator: HandWriting Intervention (ORLA+WTG)
Computer-based treatment targeting written language via handwriting (90 minutes a day, 5 days a week for 4 weeks)
|
Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using pen and paper
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Western Aphasia Battery-Revised (WAB-R) Writing subtest
Time Frame: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke and Aphasia Quality of Life Scale (SAQOL-39)
Time Frame: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
|
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)
|
The Friendship Scale
Time Frame: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leora Cherney, PhD, Shirley Ryan AbilityLab
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFRE17000031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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