Evaluation of the Effects of Response Elaboration Training for Aphasia
| Tracking Information | |||||
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| First Received Date ICMJE | July 27, 2005 | ||||
| Last Updated Date | April 15, 2013 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
verbal production of meaningful content words in connected speech [ Time Frame: 3 and 6 weeks following completion of treatment ] [ Designated as safety issue: No ] Participants were asked to describe pictured scenes and to provide a monologue on a topic of their choice. Their speech/language was audio recorded during these tasks and recordings were transcribed by project speech/language pathologists. Counts of content words were made. |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00125216 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of the Effects of Response Elaboration Training for Aphasia | ||||
| Official Title ICMJE | Evaluation of the Effects of Response Elaboration Training for Aphasia | ||||
| Brief Summary | The purpose of this study is to evaluate the effects of Response Elaboration Training (RET), which is a speech/language therapy for aphasia. The study is designed to determine whether verbal language production improves in terms of content and length of utterances as a result of treatment. |
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| Detailed Description | Detailed Description: Extended description of the protocol, including information not already contained in other fields, such as comparison(s) studied. Example: Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Existing methods of emergency resuscitation are inadequate due to time delays inherent in the transport of a trained responder with defibrillation capabilities to the side of the OOH-CA victim. Existing Emergency Medical Services (EMS) systems typically combine paramedic Emergency Medical Technician (EMT) services with some level of community involvement, such as bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. A comprehensive, integrated community approach to treatment with AEDs would have community units served by these volunteer non-medical responders who can quickly identify and treat a patient with OOH-CA. Such an approach is termed Public Access Defibrillation (PAD). Comparison(s): Community units trained and equipped to provide public access defibrillation in addition to optimal standard care, compared to community units trained to provide optimal standard care (recognition of out-of-hospital cardiac arrest, 911 access, and cardiopulmonary resuscitation). The purpose of the proposed research is to thoroughly evaluate the effects of Response Elaboration Training (RET) with persons with aphasia. Specifically, the proposed research investigation is designed to delineate the outcomes that may be expected with RET. The study is also designed to improve outcomes in the area of stimulus generalization effects of treatment by testing a modification of RET designed to facilitate generalization. The specific experimental questions to be addressed are as follows:
A series of single-subject experimental designs across subjects, behaviors, and contexts will be conducted to address these questions. Twenty-four adults with chronic, moderate to severe aphasia secondary to unilateral, left-hemisphere brain-injury will serve as participants for this investigation. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Response Elaboration Training
Therapist modeling, reinforcement and forward-chaining are used to stimulate verbal descriptions of pictures |
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| Study Arm (s) | Arm 1
Single subject design - participant receives three administrations of the same treatment
Intervention: Behavioral: Response Elaboration Training |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 47 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00125216 | ||||
| Other Study ID Numbers ICMJE | C3719-R | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | April 2013 | ||||
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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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