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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 14, 2003 | ||||||||
| Last Updated Date | September 11, 2008 | ||||||||
| Start Date ICMJE | August 2002 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Improved accuracy and/or speed of reading individual words aloud. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00064805 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Improved accuracy and/or speed of reading text aloud. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Therapy for Reading Problems in Adults After Brain Injury | ||||||||
| Official Title ICMJE | Cognitively-Based Treatments of Acquired Dyslexias | ||||||||
| Brief Summary | Adults who sustain brain damage due to stroke, head injury, or traumatic surgery may develop difficulty reading. This study examines the effectiveness of behavior-based programs to improve reading ability in these individuals. |
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| Detailed Description | Acquired disorders of reading (acquired dyslexia) are common in patients with aphasia subsequent to left hemisphere stroke. Even when language functions recover sufficiently to enable the patient to return to work, continuing dyslexia often interferes significantly with job performance. This study will evaluate cognitive therapies for the treatment of acquired dyslexia. Each therapy is based upon a cognitive neuropsychological model of reading; the therapies target specific types of reading deficit and stem from the question of re-learning versus re-organization of function. The therapies focus on dyslexic disorders stemming from the following underlying deficits: 1) impaired access to the orthographic word form from the visual modality (pure alexia); 2) impaired orthographic/phonologic connections (phonologic/deep dyslexia); and 3) decreased ability to hold phonologic codes in memory (phonologic text alexia). Participants in this study will undergo a comprehensive and detailed battery of reading and reading-related tests to determine the underlying impairment causing the reading deficit. Based upon the results of these tests, the patient's dyslexic disorder will be characterized and, if appropriate, the patient will be assigned to one of the treatment programs devised specifically for that type of deficit. Treatment programs are evaluated for efficacy by comparing the accuracy and speed of reading pre- and post-treatment. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Cognitive Therapy to Improve Reading | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 58 | ||||||||
| Estimated Completion Date | July 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00064805 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | R01HD36019 | ||||||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Verification Date | January 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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