Aphasia Rehabilitation: Modulating Cues, Feedback & Practice
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Aphasia Rehabilitation: Modulating Cues, Feedback & Practice|
- Percent accurate script related words [ Time Frame: Change from baseline to post-treatment in three weeks ] [ Designated as safety issue: No ]For trained script, untrained script, generalization script
- Rate of script-related words [ Time Frame: Change from baseline to post-treatment in three weeks ] [ Designated as safety issue: No ]For trained script, untrained script, generalization script
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Behavioral: Script training
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.
Below is the description for the first part of the study only - a cross-over study that evaluates error-free versus error-reducing script training.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597037
|Contact: Leora R Cherney, Ph.D.||312 firstname.lastname@example.org|
|Contact: Rosalind C Kaye, Ph.D.||312 email@example.com|
|United States, Illinois|
|Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Roz Kaye, PhD 312-238-6163 firstname.lastname@example.org|