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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03773419
Other study ID # IFRE17000031
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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:

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Study Design


Related Conditions & MeSH terms


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)
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