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Improving Electronic Written Communication in Aphasia (T-WRITE)

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Texting Intervention (T-WRITE)
HandWriting Intervention (ORLA+WTG)
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Stroke-related aphasia, Rehabilitation, Writing, Texting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shirley Ryan AbilityLab
  • James Madison University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Texting Intervention (T-WRITE)

HandWriting Intervention (ORLA+WTG)

Arm Description

Computer-based treatment targeting written language via texting (90 minutes a day, 5 days a week for 4 weeks)

Computer-based treatment targeting written language via handwriting (90 minutes a day, 5 days a week for 4 weeks)

Outcomes

Primary Outcome Measures

Western Aphasia Battery-Revised (WAB-R) Writing subtest
Performance-based measure of written language; score ranges from 0 - 100

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 10, 2018
Last Updated
October 25, 2022
Sponsor
Shirley Ryan AbilityLab
Collaborators
James Madison University
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1. Study Identification

Unique Protocol Identification Number
NCT03773419
Brief Title
Improving Electronic Written Communication in Aphasia
Acronym
T-WRITE
Official Title
Improving Electronic Written Communication in Persons With Aphasia: A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
August 13, 2021 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
James Madison University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Stroke-related aphasia, Rehabilitation, Writing, Texting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Texting Intervention (T-WRITE)
Arm Type
Experimental
Arm Description
Computer-based treatment targeting written language via texting (90 minutes a day, 5 days a week for 4 weeks)
Arm Title
HandWriting Intervention (ORLA+WTG)
Arm Type
Active Comparator
Arm Description
Computer-based treatment targeting written language via handwriting (90 minutes a day, 5 days a week for 4 weeks)
Intervention Type
Behavioral
Intervention Name(s)
Texting Intervention (T-WRITE)
Intervention Description
Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using a cellular phone
Intervention Type
Behavioral
Intervention Name(s)
HandWriting Intervention (ORLA+WTG)
Intervention Description
Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using pen and paper
Primary Outcome Measure Information:
Title
Western Aphasia Battery-Revised (WAB-R) Writing subtest
Description
Performance-based measure of written language; score ranges from 0 - 100
Time Frame
Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
Secondary Outcome Measure Information:
Title
Stroke and Aphasia Quality of Life Scale (SAQOL-39)
Description
Self-report measure of health-related quality of life, validated with persons with aphasia; provides a total mean score that ranges from 1 - 39.
Time Frame
Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
Title
The Friendship Scale
Description
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.
Time Frame
Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leora Cherney, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
James Madison University
City
Harrisonburg
State/Province
Virginia
ZIP/Postal Code
22807
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34061572
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.
Results Reference
derived

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Improving Electronic Written Communication in Aphasia

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