AphasiaWeb-ORLANCT04413136
Web-Based Treatment for Aphasia
A study testing Web-ORLA in people with Aphasia, run by Shirley Ryan AbilityLab.
Trial summary
This prospective randomized clinical trial implements an innovative broadband web-based treatment program for individuals with chronic aphasia, and evaluates its efficacy. The treatment, Oral Reading for Language in Aphasia (ORLA), has been shown to be efficacious when provided by a speech-language pathologist. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aphasia
- What is being tested?
- Web-ORLA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2008to 29 Sep 2011
- 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 21 years and older
- 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 20-80.
- > 6 months post injury
- completed at least an eighth grade education
- premorbidly literate in English
- sufficient auditory and visual acuity to interact with a laptop
- not receiving other speech/language treatment for at least one month prior to or during the study.
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.
About this study
This prospective randomized clinical trial implements an innovative broadband web-based treatment program for individuals with chronic aphasia, and evaluates its efficacy. The treatment, Oral Reading for Language in Aphasia (ORLA), has been shown to be efficacious when provided by a speech-language pathologist. The treatment has been computerized and the current version of ORLA uses state-of-the-art virtual therapist technology that allows the individual with aphasia to read aloud, and ultimately speak, sentences at the same time as the words are produced by a perceptive, life-like, animated computer agent, using visible speech. In this clinical trial, ORLA treatment is delivered via the internet and outcomes are compared to a placebo computer treatment.
Read the detailed description
Aphasia is an acquired multi-modality disturbance of language, resulting from focal damage to portions of the brain, typically within the left hemisphere, that are responsible for language. The disorder impairs, in varying degrees, the understanding and expression of oral language, as well as reading and writing. The research literature is replete with information about the treatment of aphasia. Individual studies, together with expert opinion and meta-analyses indicate that those with aphasia benefit from treatments that focus on improving linguistic skills. Furthermore, recent studies have indicated that patients with aphasia, even those beyond the period of spontaneous recovery, benefit from treatment that is provided more frequently. Yet people with aphasia represent an underserved population. Legislation and reimbursement have seriously curtailed the amount of treatment a patient with aphasia may receive. Often patients may be eligible for only a limited number of treatment sessions over a limited period of time. In some cases, patients may not receive any treatment for their communication disorder following their acute hospitalization. Communication treatment costs delivered to patients with chronic aphasia (beyond six months after onset) are seldom reimbursable. Therefore, the establishment and maintenance of programs for effective aphasia remediation are posing new challenges.
There is clearly a need for the development of innovative and effective ways for individuals with aphasia to continue to receive much needed intensive and long-term services that are typically unavailable beyond the acute stage of this disability. Web-based treatment may be a cost-effective way of extending therapy beyond the hospital and clinic, thereby meeting the needs of the growing numbers of individuals with chronic aphasia. This project evaluates the effectiveness of a theoretically-motivated and efficacious treatment that has been integrated with novel computer-based virtual therapy systems and is provided via the internet to individuals with chronic aphasia.
The treatment, Oral Reading for Language in Aphasia (ORLA), is based on a theoretical framework that incorporates two lines of work: the neuropsychological models of reading and observation-execution-matching. Preliminary studies have indicated that this treatment is efficacious when provided by a speech-language pathologist. The treatment has been computerized and the current version of ORLA uses state-of-the-art virtual therapist technology that allows the individual with aphasia to read aloud, and ultimately speak, sentences at the same time as the words are produced by a perceptive, life-like, animated computer agent, using visible speech. In the web-based version, individuals with aphasia work independently on their home computer. The clinician is able to monitor patient use and progress remotely either in real time during the treatment session or after the session at a convenient time.
In this clinical trial, ORLA treatment is delivered via the internet and outcomes are compared to a placebo computer treatment. Thirty-five individuals with chronic aphasia (at least 6 months post onset) are randomized to one of two groups: oral reading (ORLA) treatment group and a control group in which subjects participate in non-language computer activities. Both groups practice for 9 hours per week and treatment continues for a six week period of time. Laptops and high-speed internet connections are provided to the subjects for home practice. Language and communication skills are evaluated pre-treatment, immediately post-treatment, and at 6 weeks after the end of treatment to assess maintenance effects. The primary outcome measure is the Language Quotient of the Western Aphasia Battery.
We hypothesize that implementation of a web-based ORLA treatment for patients with chronic aphasia will result in significant improvements in language, that these improvements are significantly greater than those resulting from placebo computer treatment, and that these improvements will be maintained over time.
- Conditions
- Aphasia
- Being tested
- Web-ORLA, Control
- Keywords
- Aphasia, Stroke, Rehabilitation, Computer
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-ORLABehavioural
ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Web-ORLA | Experimental | Administered 90 minutes a day, six days a week ( i.e. nine hours of computer treatment per week) for a total of six weeks.
The participant is presented with 3-5 word (level 1) or 8-10 word (level 2) sentences, depending upon the severity of the aphasia. Each sentence is chosen by the software program at random from a group of 150 sentences. The participant is instructed to look, listen, and point to words spoken by the virtual therapist, read highlighted words aloud, and then read the sentence aloud, both chorally with the virtual therapist and independently. Receives: Behavioral: Web-ORLA |
| Control | Placebo comparator | Administered 90 minutes a day, six days a week ( i.e. nine hours of computer treatment per week) for a total of six weeks.
A commercially available game, Bejeweled 2, by PopCap. Participants use loaned 13-in laptop computers to access the Bejeweled interface, which displays an 8 X 8 grid of gems of varying shapes and colors. The objective is to match three gems of the same color and shape to score points and advance to more difficult levels. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Aphasia Battery Revised Language Quotient (LQ)
Performance on measures of auditory comprehension, oral expression, reading comprehension and written expression on the WAB-R LQ scale which goes from 0-100. A higher score indicates better performance.
Measured: Change from baseline to immediately following 6 weeks of treatment
Secondary outcomes (1)
Western Aphasia Battery Revised Language Quotient (LQ)
Performance on measures of auditory comprehension, oral expression, reading comprehension and written expression on the WAB-R LQ scale which goes from 0-100. A higher score indicates better performance.
Measured: Change from baseline to 6 weeks after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start7 Jan 2008
- Primary completion27 Oct 2010
- Study completion29 Sep 2011
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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of Colorado, Boulder
- Responsible party
- Principal investigator, Leora Cherney, Shirley Ryan AbilityLab
- Investigators
- Leora R Cherney, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413136
- Sponsor's protocol ID
- STU00000150
- Acronym
- Web-ORLA
- Status last verified
- Apr 2021
- First submitted
- 29 May 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Treatment for Aphasia
- ClinicalTrials.gov ID
- NCT04413136
- Acronym / sponsor ID
- Web-ORLA / STU00000150
- Conditions
- Aphasia
- Keywords
- Aphasia, Stroke, Rehabilitation, Computer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Northwestern University, University of Colorado, Boulder
- Study start
- 7 Jan 2008 (actual)
- Primary completion
- 27 Oct 2010 (actual)
- Study completion
- 29 Sep 2011 (actual)
- First posted
- 2 Jun 2020 (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.
This prospective randomized clinical trial implements an innovative broadband web-based treatment program for individuals with chronic aphasia, and evaluates its efficacy. The treatment, Oral Reading for Language in Aphasia (ORLA), has been shown to be efficacious when provided by a speech-language pathologist. The treatment has been computerized and the current version of ORLA uses state-of-the-art virtual therapist technology that allows the individual with aphasia to read aloud, and ultimately speak, sentences at the same time as the words are produced by a perceptive, life-like, animated computer agent, using visible speech. In this clinical trial, ORLA treatment is delivered via the internet and outcomes are compared to a placebo computer treatment.
Detailed description
Aphasia is an acquired multi-modality disturbance of language, resulting from focal damage to portions of the brain, typically within the left hemisphere, that are responsible for language. The disorder impairs, in varying degrees, the understanding and expression of oral language, as well as reading and writing. The research literature is replete with information about the treatment of aphasia. Individual studies, together with expert opinion and meta-analyses indicate that those with aphasia benefit from treatments that focus on improving linguistic skills. Furthermore, recent studies have indicated that patients with aphasia, even those beyond the period of spontaneous recovery, benefit from treatment that is provided more frequently. Yet people with aphasia represent an underserved population. Legislation and reimbursement have seriously curtailed the amount of treatment a patient with aphasia may receive. Often patients may be eligible for only a limited number of treatment sessions over a limited period of time. In some cases, patients may not receive any treatment for their communication disorder following their acute hospitalization. Communication treatment costs delivered to patients with chronic aphasia (beyond six months after onset) are seldom reimbursable. Therefore, the establishment and maintenance of programs for effective aphasia remediation are posing new challenges.
There is clearly a need for the development of innovative and effective ways for individuals with aphasia to continue to receive much needed intensive and long-term services that are typically unavailable beyond the acute stage of this disability. Web-based treatment may be a cost-effective way of extending therapy beyond the hospital and clinic, thereby meeting the needs of the growing numbers of individuals with chronic aphasia. This project evaluates the effectiveness of a theoretically-motivated and efficacious treatment that has been integrated with novel computer-based virtual therapy systems and is provided via the internet to individuals with chronic aphasia.
The treatment, Oral Reading for Language in Aphasia (ORLA), is based on a theoretical framework that incorporates two lines of work: the neuropsychological models of reading and observation-execution-matching. Preliminary studies have indicated that this treatment is efficacious when provided by a speech-language pathologist. The treatment has been computerized and the current version of ORLA uses state-of-the-art virtual therapist technology that allows the individual with aphasia to read aloud, and ultimately speak, sentences at the same time as the words are produced by a perceptive, life-like, animated computer agent, using visible speech. In the web-based version, individuals with aphasia work independently on their home computer. The clinician is able to monitor patient use and progress remotely either in real time during the treatment session or after the session at a convenient time.
In this clinical trial, ORLA treatment is delivered via the internet and outcomes are compared to a placebo computer treatment. Thirty-five individuals with chronic aphasia (at least 6 months post onset) are randomized to one of two groups: oral reading (ORLA) treatment group and a control group in which subjects participate in non-language computer activities. Both groups practice for 9 hours per week and treatment continues for a six week period of time. Laptops and high-speed internet connections are provided to the subjects for home practice. Language and communication skills are evaluated pre-treatment, immediately post-treatment, and at 6 weeks after the end of treatment to assess maintenance effects. The primary outcome measure is the Language Quotient of the Western Aphasia Battery.
We hypothesize that implementation of a web-based ORLA treatment for patients with chronic aphasia will result in significant improvements in language, that these improvements are significantly greater than those resulting from placebo computer treatment, and that these improvements will be maintained over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-ORLA | Experimental | Behavioral: Web-ORLAAdministered 90 minutes a day, six days a week ( i.e. nine hours of computer treatment per week) for a total of six weeks. The participant is presented with 3-5 word (level 1) or 8-10 word (level 2) sentences, depending upon the severity of the aphasia. Each sentence is chosen by the software program at random from a group of 150 sentences. The participant is instructed to look, listen, and point to words spoken by the virtual therapist, read highlighted words aloud, and then read the sentence aloud, both chorally with the virtual therapist and independently. |
| Control | Placebo comparator | Behavioral: ControlAdministered 90 minutes a day, six days a week ( i.e. nine hours of computer treatment per week) for a total of six weeks. A commercially available game, Bejeweled 2, by PopCap. Participants use loaned 13-in laptop computers to access the Bejeweled interface, which displays an 8 X 8 grid of gems of varying shapes and colors. The objective is to match three gems of the same color and shape to score points and advance to more difficult levels. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 20-80.
- > 6 months post injury
- completed at least an eighth grade education
- premorbidly literate in English
Key exclusion criteria (3 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 |
|---|---|---|
| Web-ORLA | Behavioural | Web-ORLA |
| Control | Behavioural | Control |
Primary outcome
Western Aphasia Battery Revised Language Quotient (LQ)
Time frame: Change from baseline to immediately following 6 weeks of treatment
Performance on measures of auditory comprehension, oral expression, reading comprehension and written expression on the WAB-R LQ scale which goes from 0-100. A higher score indicates better performance.
1 secondary outcome
Western Aphasia Battery Revised Language Quotient (LQ)
Time frame: Change from baseline to 6 weeks after the end of treatment.
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 14 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Leora R Cherney, PhD principal investigator
Shirley Ryan AbilityLab
Questions about this trial
What is this clinical trial studying?
A study testing Web-ORLA in people with Aphasia, run by Shirley Ryan AbilityLab.
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 7 inclusion and 3 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Language Quotient (LQ) (time frame: Change from baseline to immediately following 6 weeks of treatment). 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 14 Apr 2021.