AphasiaNCT01597037
Aphasia Rehabilitation: Modulating Cues, Feedback & Practice
A study testing Script training 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 how changing different conditions of the speech-language treatment (such as cues, feedback, complexity and practice schedule) affects the language outcome of study subjects with aphasia (i.e., difficulty with the comprehension and expression of spoken and written language)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Script training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Apr 2018
- 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
- A single unilateral left-hemisphere stroke
- Aphasia Quotient between 40 and 80 on the Western Aphasia Battery
- Age 21 or older
- At least 6 months post-stroke
- Able to comply with the study protocol
- Premorbidly right-handed, as determined by the Edinburgh Handedness Inventory
- Fluent in English premorbidly
- Completed at least 8th grade education
Who cannot join
- More than one stroke
- Any other neurological condition that could potentially affect cognition, speech or language.
- Global aphasia or inability to participate in routine speech therapy
- Major active psychiatric illness that may interfere with required study procedures
- Untreated or inadequately treated depression
- Current abuse of alcohol or drugs
- Unable to understand, cooperate or comply with study procedures
- Significant visual or auditory impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
The purpose of this study is to evaluate how changing different conditions of the speech-language treatment (such as cues, feedback, complexity and practice schedule) affects the language outcome of study subjects with aphasia (i.e., difficulty with the comprehension and expression of spoken and written language) following a stroke.
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. Recently, there has been an emphasis on the need for intensive aphasia treatment in order to make the long-term neuroplastic changes associated with recovery. However, specific information regarding effective learning parameters is limited.
A number of variables and practice conditions, deriving from motor learning theory, potentially impact the rehabilitation process. Several of these variables have begun to be addressed in the literature, but with conflicting or scant evidence to date. Variables include the type and degree of external cueing, low versus high feedback conditions, task complexity, and practice distribution and schedule.
The purpose of this study is to:
- Modulate variables of cuing, feedback and script complexity that potentially affect treatment outcomes, and measure their effects on acquisition, maintenance and generalization of script learning. These investigations are conducted as separate studies, with the first study being a cross-over study investigating cuing and the second study being a 2x2 factorial design investigating feedback and complexity.
- Modify and optimize AphasiaScripts-an existing treatment program having experimental support for its efficacy-by incorporating these findings.
- Conduct a clinical trial, incorporating the optimized AphasiaScripts program, in order to measure the effect of massed vs distributed practice, and blocked vs random practice schedules, on the acquisition, maintenance and generalization of script learning.
Measures will include independent pre-and post assessments of acquisition, maintenance and generalization of script learning as well as dependent item/cue level measures of progress.
Results and computational models of acquisition, maintenance and generalization will contribute new evidence to support not just the efficacy and delivery of AphasiaScripts, but also the application of practice principles to aphasia treatment in general.
The first part of the study - a cross-over study that evaluates error-free versus error-reducing script training has been done. Below is a description of the second part of the study which evaluates feedback and script complexity.
- Being tested
- Script training
- Keywords
- Aphasia, 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.
Script trainingBehavioural
90 minutes/day, 6 days a week; includes 3 weeks of training
| Study group | Role | What they receive |
|---|---|---|
| High complexity, high feedback | Active comparator | Scripts are one grade level higher than the typical script that would be provided for the severity of aphasia; there is an opportunity for the participant to listen to his/her production and assess performance. Receives: Behavioral: Script training |
| High complexity, low feedback | Active comparator | Scripts are one grade level higher than the typical script that would be provided for the severity of aphasia; there is no opportunity for the participant to listen to his/her production and assess performance. Receives: Behavioral: Script training |
| Low complexity, high feedback | Active comparator | Scripts are one grade level lower than the typical script that would be provided for the severity of aphasia; there is an opportunity for the participant to listen to his/her production and assess performance. Receives: Behavioral: Script training |
| Low complexity, low feedback | Active comparator | Scripts are one grade level lower than the typical script that would be provided for the severity of aphasia; there is no opportunity for the participant to listen to his/her production and assess performance. Receives: Behavioral: Script training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent accurate script related words
For trained script, untrained script, generalization script
Measured: Change from baseline to post-treatment in three weeks
Secondary outcomes (1)
Rate of script-related words
For trained script, untrained script, generalization script
Measured: Change from baseline to post-treatment in three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startJun 2011
- Primary completionSep 2017
- Study completionApr 2018
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.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Principal investigator, Leora Cherney, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597037
- Sponsor's protocol ID
- 1R01DC011754
- Status last verified
- Nov 2018
- First submitted
- 9 May 2012
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cherney LR, Van Vuuren S. Complexity and Feedback During Script Training in Aphasia: A Feasibility Study. Arch Phys Med Rehabil. 2022 Jul;103(7S):S205-S214. doi: 10.1016/j.apmr.2022.03.002. Epub 2022 Mar 15.
PubMed 35304120
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aphasia Rehabilitation: Modulating Cues, Feedback & Practice
- ClinicalTrials.gov ID
- NCT01597037
- Acronym / sponsor ID
- 1R01DC011754
- Keywords
- Aphasia, Speech Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- University of Colorado, Boulder
- Study start
- Jun 2011
- Primary completion
- Sep 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 11 May 2012 (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 how changing different conditions of the speech-language treatment (such as cues, feedback, complexity and practice schedule) affects the language outcome of study subjects with aphasia (i.e., difficulty with the comprehension and expression of spoken and written language) following a stroke.
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. Recently, there has been an emphasis on the need for intensive aphasia treatment in order to make the long-term neuroplastic changes associated with recovery. However, specific information regarding effective learning parameters is limited.
A number of variables and practice conditions, deriving from motor learning theory, potentially impact the rehabilitation process. Several of these variables have begun to be addressed in the literature, but with conflicting or scant evidence to date. Variables include the type and degree of external cueing, low versus high feedback conditions, task complexity, and practice distribution and schedule.
The purpose of this study is to:
- Modulate variables of cuing, feedback and script complexity that potentially affect treatment outcomes, and measure their effects on acquisition, maintenance and generalization of script learning. These investigations are conducted as separate studies, with the first study being a cross-over study investigating cuing and the second study being a 2x2 factorial design investigating feedback and complexity.
- Modify and optimize AphasiaScripts-an existing treatment program having experimental support for its efficacy-by incorporating these findings.
- Conduct a clinical trial, incorporating the optimized AphasiaScripts program, in order to measure the effect of massed vs distributed practice, and blocked vs random practice schedules, on the acquisition, maintenance and generalization of script learning.
Measures will include independent pre-and post assessments of acquisition, maintenance and generalization of script learning as well as dependent item/cue level measures of progress.
Results and computational models of acquisition, maintenance and generalization will contribute new evidence to support not just the efficacy and delivery of AphasiaScripts, but also the application of practice principles to aphasia treatment in general.
The first part of the study - a cross-over study that evaluates error-free versus error-reducing script training has been done. Below is a description of the second part of the study which evaluates feedback and script complexity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High complexity, high feedback | Active comparator | Behavioral: Script trainingScripts are one grade level higher than the typical script that would be provided for the severity of aphasia; there is an opportunity for the participant to listen to his/her production and assess performance. |
| High complexity, low feedback | Active comparator | Behavioral: Script trainingScripts are one grade level higher than the typical script that would be provided for the severity of aphasia; there is no opportunity for the participant to listen to his/her production and assess performance. |
| Low complexity, high feedback | Active comparator | Behavioral: Script trainingScripts are one grade level lower than the typical script that would be provided for the severity of aphasia; there is an opportunity for the participant to listen to his/her production and assess performance. |
| Low complexity, low feedback | Active comparator | Behavioral: Script trainingScripts are one grade level lower than the typical script that would be provided for the severity of aphasia; there is no opportunity for the participant to listen to his/her production and assess performance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A single unilateral left-hemisphere stroke
- Aphasia Quotient between 40 and 80 on the Western Aphasia Battery
- Age 21 or older
- At least 6 months post-stroke
- Able to comply with the study protocol
Key exclusion criteria (8 listed)
- More than one stroke
- Any other neurological condition that could potentially affect cognition, speech or language.
- Global aphasia or inability to participate in routine speech therapy
- Major active psychiatric illness that may interfere with required study procedures
- Untreated or inadequately treated depression
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 |
|---|---|---|
| Script training90 minutes/day, 6 days a week; includes 3 weeks of training | Behavioural | High complexity, high feedback, High complexity, low feedback, Low complexity, high feedback, Low complexity, low feedback |
Primary outcome
Percent accurate script related words
Time frame: Change from baseline to post-treatment in three weeks
For trained script, untrained script, generalization script
1 secondary outcome
Rate of script-related words
Time frame: Change from baseline to post-treatment in three 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 30 Nov 2018.
- Derived from this study: PubMed 35304120Cherney LR, Van Vuuren S. Complexity and Feedback During Script Training in Aphasia: A Feasibility Study. Arch Phys Med Rehabil. 2022 Jul;103(7S):S205-S214. doi: 10.1016/j.apmr.2022.03.002. Epub 2022 Mar 15.
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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 Script training 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 8 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 30 Nov 2018. 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?
Percent accurate script related words (time frame: Change from baseline to post-treatment in three 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 NCT01597037, 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 30 Nov 2018.