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Improving Electronic Written Communication in Aphasia (T-WRITE)

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ClinicalTrials.gov Identifier: NCT03773419
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
James Madison University
Information provided by (Responsible Party):
Leora Cherney, Shirley Ryan AbilityLab

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.


Condition or disease Intervention/treatment Phase
Aphasia Behavioral: Texting Intervention (T-WRITE) Behavioral: HandWriting Intervention (ORLA+WTG) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Electronic Written Communication in Persons With Aphasia: A Clinical Trial
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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)
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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773419


Contacts
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Contact: Elissa Conlon, MA 312-238-6163 econlon@sralab.org
Contact: Leora Cherney, PhD 312-238-6163 lcherney@sralab.org

Locations
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United States, Illinois
Shirley Ryan AbilityLab Recruiting
Chicago, Illinois, United States, 60611
Contact: Leora Cherney, PhD    312-238-6163    lcherney@sralab.org   
United States, Virginia
James Madison University Recruiting
Harrisonburg, Virginia, United States, 22807
Contact: Jaime B Lee, PhD    540-568-2618    lee2jb@jmu.edu   
Sponsors and Collaborators
Shirley Ryan AbilityLab
James Madison University
Investigators
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Principal Investigator: Leora Cherney, PhD Shirley Ryan AbilityLab

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Responsible Party: Leora Cherney, Principal Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT03773419    
Other Study ID Numbers: IFRE17000031
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leora Cherney, Shirley Ryan AbilityLab:
Stroke-related aphasia
Rehabilitation
Writing
Texting
Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms