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AphasiaT-WRITENCT03773419

Improving Electronic Written Communication in Aphasia

A study testing Texting Intervention (T-WRITE) and HandWriting Intervention (ORLA+WTG) in people with Aphasia, run by Shirley Ryan AbilityLab at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aphasia
What is being tested?
Texting Intervention (T-WRITE) and HandWriting Intervention (ORLA+WTG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
2 sitesUnited States
Study dates
20 Sep 2018to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60611

  • James Madison University

    Harrisonburg, Virginia, 22807

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Aphasia
Being tested
Texting Intervention (T-WRITE), HandWriting Intervention (ORLA+WTG)
Keywords
Stroke-related aphasia, Rehabilitation, Writing, Texting
Medical subject headings
Aphasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Texting Intervention (T-WRITE)Behavioural

    Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using a cellular phone

  • HandWriting Intervention (ORLA+WTG)Behavioural

    Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using pen and paper

Study groups in NCT03773419
Study groupRoleWhat they receive
Texting Intervention (T-WRITE)ExperimentalComputer-based treatment targeting written language via texting (90 minutes a day, 5 days a week for 4 weeks)
Receives: Behavioral: Texting Intervention (T-WRITE)
HandWriting Intervention (ORLA+WTG)Active comparatorComputer-based treatment targeting written language via handwriting (90 minutes a day, 5 days a week for 4 weeks)
Receives: Behavioral: HandWriting Intervention (ORLA+WTG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Western Aphasia Battery-Revised (WAB-R) Writing subtest

    Performance-based measure of written language; score ranges from 0 - 100

    Measured: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)

Secondary outcomes (2)
  1. 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.

    Measured: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)

  2. 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.

    Measured: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2018
  2. Study start20 Sep 2018
  3. Primary completion13 Aug 2021
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03773419
Sponsor's protocol ID
IFRE17000031
Acronym
T-WRITE
Status last verified
Oct 2022
First submitted
10 Dec 2018
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34061572

Questions about this trial

What is this clinical trial studying?

A study testing Texting Intervention (T-WRITE) and HandWriting Intervention (ORLA+WTG) in people with Aphasia, run by Shirley Ryan AbilityLab at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03773419, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.

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