AphasiaNCT01790880
Enhancing Written Communication in Persons With Aphasia
A study testing ORLA and ORLA + Writing in people with Aphasia and Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether a computerized speech-language treatment delivered by a virtual therapist (Oral Reading for Language in Aphasia (ORLA) + Writing) results in improved written communication skills of study participants with aphasia (i.e., difficulty with the comprehension and expression… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- ORLA and ORLA + Writing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or women with diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by CT scan or MRI
- an Aphasia Quotient score on the Western Aphasia Battery of 50-85.
- 6 months post injury
- premorbidly right handed, determined by Edinburgh Handedness Inventory
- completed at least an eighth grade education
- premorbidly literate in English
- visual acuity may be corrected but must be sufficient for reading visual stimuli on computer screen
- auditory acuity may be aided but must be sufficient for hearing auditory stimuli in ORLA program
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.
- any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization; subjects with mood disorders who are currently stable on treatment will be considered.
- active substance abuse.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Aphasia Research and Treatment, Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
Official title: Enhancing Written Communication in Persons With Aphasia: A Clinical Trial
The purpose of this study is to evaluate whether a computerized speech-language treatment delivered by a virtual therapist (Oral Reading for Language in Aphasia (ORLA) + Writing) results in improved written communication skills of study participants with aphasia (i.e., difficulty with the comprehension and expression of spoken and written language).
Read the detailed description
Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year. A common neurological deficit among stroke survivors, and thus a substantial contributor to post-stroke disability, is aphasia. The loss of, or difficulty with language is extremely debilitating.
Adequate written communication skills may be one of the barriers that has prevented individuals with aphasia from returning to work. Writing skills are also important for participation in social roles, such as household management, civic activities, or recreational activities with friends. Individuals with aphasia struggle to compose written documents such as personal letters, memos and reports. Furthermore, society's increased reliance on written forms of communication including email correspondence, instant messaging, texting, Twitter, and social networking sites such as Facebook, exacerbate the challenge that individuals with aphasia have in connecting with others, reestablishing and redefining their social roles and accomplishing their life-participation goals.
Computer-directed treatment offers a practical alternative to one-on-one traditional treatment provided by a clinician and may be a cost-effective way of extending therapy beyond the hospital and clinic to meet the needs of the growing numbers of individuals with chronic aphasia and to help them reintegrate into the community and workforce. This project evaluates the efficacy of a theoretically-motivated writing program that has been integrated with novel computer-based virtual therapy systems and that can be provided intensively to individuals with chronic aphasia.
- Being tested
- ORLA, ORLA + Writing
- Keywords
- Aphasia, Stroke, Speech Rehabilitation
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORLABehavioural
Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system.
ORLA + WritingBehavioural
Treatment includes writing of sentences in combination with ORLA
| Study group | Role | What they receive |
|---|---|---|
| ORLA | Active comparator | Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system, for 90 minutes per day, 6 days per week for 6 weeks. Receives: Behavioral: ORLA |
| ORLA + Writing | Experimental | Practice on "ORLA + writing" computer program, 90 minutes per day, 6 days per week, for 6 weeks. Receives: Behavioral: ORLA + Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment
Measured: Change from baseline to 6 weeks
Secondary outcomes (5)
Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
Measured: Change from baseline to 6 weeks
Written Language Sample Analysis
Written responses on the Picture Description task of the Western Aphasia Battery-Revised and on a written picture-sequenced story retelling task will be scored for Correct Information Units
Measured: Change from baseline to 6 weeks
Communicative Effectiveness Index (CETI)
Measured: Change from baseline to 6 weeks
ASHA Quality of Communication Life Scale (QCL)
Measured: Change from baseline to 6 weeks
Community Integration Questionnaire (CIQ)
Measured: Change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2017
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leora Cherney, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790880
- Sponsor's protocol ID
- 74374
- Status last verified
- Mar 2020
- First submitted
- 11 Feb 2013
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Written Communication in Persons With Aphasia: A Clinical Trial
- ClinicalTrials.gov ID
- NCT01790880
- Acronym / sponsor ID
- 74374
- Keywords
- Aphasia, Stroke, Speech Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 13 Feb 2013 (estimated)
- 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.
The purpose of this study is to evaluate whether a computerized speech-language treatment delivered by a virtual therapist (Oral Reading for Language in Aphasia (ORLA) + Writing) results in improved written communication skills of study participants with aphasia (i.e., difficulty with the comprehension and expression of spoken and written language).
Detailed description
Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year. A common neurological deficit among stroke survivors, and thus a substantial contributor to post-stroke disability, is aphasia. The loss of, or difficulty with language is extremely debilitating.
Adequate written communication skills may be one of the barriers that has prevented individuals with aphasia from returning to work. Writing skills are also important for participation in social roles, such as household management, civic activities, or recreational activities with friends. Individuals with aphasia struggle to compose written documents such as personal letters, memos and reports. Furthermore, society's increased reliance on written forms of communication including email correspondence, instant messaging, texting, Twitter, and social networking sites such as Facebook, exacerbate the challenge that individuals with aphasia have in connecting with others, reestablishing and redefining their social roles and accomplishing their life-participation goals.
Computer-directed treatment offers a practical alternative to one-on-one traditional treatment provided by a clinician and may be a cost-effective way of extending therapy beyond the hospital and clinic to meet the needs of the growing numbers of individuals with chronic aphasia and to help them reintegrate into the community and workforce. This project evaluates the efficacy of a theoretically-motivated writing program that has been integrated with novel computer-based virtual therapy systems and that can be provided intensively to individuals with chronic aphasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORLA | Active comparator | Behavioral: ORLAPractice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system, for 90 minutes per day, 6 days per week for 6 weeks. |
| ORLA + Writing | Experimental | Behavioral: ORLA + WritingPractice on "ORLA + writing" computer program, 90 minutes per day, 6 days per week, for 6 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- men or women with diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by CT scan or MRI
- an Aphasia Quotient score on the Western Aphasia Battery of 50-85.
- 6 months post injury
- premorbidly right handed, determined by Edinburgh Handedness Inventory
- completed at least an eighth grade education
Key exclusion criteria (4 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.
- any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization; subjects with mood disorders who are currently stable on treatment will be considered.
- 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 |
|---|---|---|
| ORLAPractice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system. | Behavioural | ORLA |
| ORLA + WritingTreatment includes writing of sentences in combination with ORLA | Behavioural | ORLA + Writing |
Primary outcome
Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment
Time frame: Change from baseline to 6 weeks
5 secondary outcomes
Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
Time frame: Change from baseline to 6 weeks
Written Language Sample Analysis
Time frame: Change from baseline to 6 weeks
Communicative Effectiveness Index (CETI)
Time frame: Change from baseline to 6 weeks
ASHA Quality of Communication Life Scale (QCL)
Time frame: Change from baseline to 6 weeks
Community Integration Questionnaire (CIQ)
Time frame: Change from baseline to 6 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 18 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORLA and ORLA + Writing in people with Aphasia and Stroke, run by Shirley Ryan AbilityLab at 1 site 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 8 inclusion and 4 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment (time frame: Change from baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2020.