Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT00125216
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2005-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effects of Response Elaboration Training for Aphasia
Sponsor:
US Department of Veterans Affairs
Organization:
Study Overview
Official Title:
Evaluation of the Effects of Response Elaboration Training for Aphasia
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
* Will RET result in increased production of correct information units and increased length and changes in composition of utterances as measured in \*trained and untrained picture descriptions; \*story retells; \*conversations with significant others/family members/friends; and \*personal recounts?
* Will modification and extension of RET to additional training contexts result in further increases in production of CIUs and increased length and complexity of utterances?
* Will the effects\* of RET vary among participants with fluent aphasia, participants with nonfluent aphasia who present with mild to moderate verbal production deficits, and participants with nonfluent aphasia who present with severe verbal production deficits?
\* Effects = effects on production of CIUs and on measures of functional communication
* Will changes in measures of functional communication be observed following administration of RET?
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.
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:
* Will RET result in increased production of correct information units and increased length and changes in composition of utterances as measured in \*trained and untrained picture descriptions; \*story retells; \*conversations with significant others/family members/friends; and \*personal recounts?
* Will modification and extension of RET to additional training contexts result in further increases in production of CIUs and increased length and complexity of utterances?
* Will the effects\* of RET vary among participants with fluent aphasia, participants with nonfluent aphasia who present with mild to moderate verbal production deficits, and participants with nonfluent aphasia who present with severe verbal production deficits?
\* Effects = effects on production of CIUs and on measures of functional communication
* Will changes in measures of functional communication be observed following administration of RET?
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: