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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Texting Intervention (T-WRITE) | Experimental | Computer-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 comparator | Computer-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.
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)
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)
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.
- First posted12 Dec 2018
- Study start20 Sep 2018
- Primary completion13 Aug 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- James Madison University
- Responsible party
- Principal investigator, Leora Cherney, Shirley Ryan AbilityLab
- Investigators
- Leora Cherney, PhD, Principal investigator, Shirley Ryan AbilityLab
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Electronic Written Communication in Persons With Aphasia: A Clinical Trial
- ClinicalTrials.gov ID
- NCT03773419
- Acronym / sponsor ID
- T-WRITE / IFRE17000031
- Conditions
- Aphasia
- Keywords
- Stroke-related aphasia, Rehabilitation, Writing, Texting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- James Madison University
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Texting Intervention (T-WRITE) | Experimental | Behavioral: Texting Intervention (T-WRITE)Computer-based treatment targeting written language via texting (90 minutes a day, 5 days a week for 4 weeks) |
| HandWriting Intervention (ORLA+WTG) | Active comparator | Behavioral: HandWriting Intervention (ORLA+WTG)Computer-based treatment targeting written language via handwriting (90 minutes a day, 5 days a week for 4 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Texting Intervention (T-WRITE)Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using a cellular phone | Behavioural | Texting Intervention (T-WRITE) |
| HandWriting Intervention (ORLA+WTG)Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using pen and paper | Behavioural | HandWriting Intervention (ORLA+WTG) |
Primary outcome
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
2 secondary outcomes
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)
The Friendship Scale
Time frame: Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 34061572Kinsey 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.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leora Cherney, PhD principal investigator
Shirley Ryan AbilityLab
2 sites in 1 country: see every site and its status.
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.