Aphasia Rehabilitation: Modulating Cues, Feedback & Practice
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Illinois
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Chicago, Illinois, United States, 60611
- Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: High complexity, high feedback
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.
|
90 minutes/day, 6 days a week; includes 3 weeks of training
|
|
Active Comparator: High complexity, low feedback
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.
|
90 minutes/day, 6 days a week; includes 3 weeks of training
|
|
Active Comparator: Low complexity, high feedback
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.
|
90 minutes/day, 6 days a week; includes 3 weeks of training
|
|
Active Comparator: Low complexity, low feedback
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.
|
90 minutes/day, 6 days a week; includes 3 weeks of training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent accurate script related words
Time Frame: Change from baseline to post-treatment in three weeks
|
For trained script, untrained script, generalization script
|
Change from baseline to post-treatment in three weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of script-related words
Time Frame: Change from baseline to post-treatment in three weeks
|
For trained script, untrained script, generalization script
|
Change from baseline to post-treatment in three weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DC011754 (U.S. NIH Grant/Contract)
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