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 verbal language production improves in terms of content and length of utterances as a result of treatment.

Condition	Intervention
Aphasia Speech Disorders Language Disorders	Behavior: Response Elaboration Training

Further Study Details: 

Primary Outcomes: Production of content in discourse at 6 weeks following; completion of treatment.
Secondary Outcomes: Production of content and mean length of utterance; in 1) picture descriptions, 2) story retells, 3); conversations with familiar speaking partners, and; 4) 5 minute monologues. Measures will be taken repeatedly; through all phases of the study and at 3 and 6 weeks post-; treatment.
Expected Total Enrollment:  54

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).

(May insert all of study abstract)

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: 1. Will RET result in increased production of correct information units and increased length and changes in composition of utterances as measured in a) trained and untrained picture descriptions, b) story retells, c) conversations with significant others/family members/friends, and d) personal recounts? 2. 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? 3. 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 4. 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.

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria: • Diagnosis of moderate to severe nonfluent or fluent aphasia • Nonverbal intelligence within normal limits • Auditory and visual acuity adequate for experimental tasks • 6 months post-onset of single, focal brain injury (e.g., stroke) -

Exclusion Criteria: • Previous history of therapy with RET • Diagnosed psychological disorder other than depression • Neurological condition other than that which resulted in aphasia • History of alcohol or substance abuse • Non-native English speaker • Premorbid history of speech/language disorder -

Please refer to this study by ClinicalTrials.gov identifier  NCT00125216

Reuben T Walize, MPH      801-582-1565  Ext. 4857    reuben.walize@med.va.gov
Laurence J Meyer, MD, Ph.D.      801-582-1565    laurence.meyer@med.va.gov

Utah
      VA Salt Lake City Healthcare System, Salt Lake City,  Utah,  84148,  United States; Recruiting

Study chairs or principal investigators

Julie L Wambaugh, Ph.D.,  Principal Investigator,  VA Salt Lake City Healthcare System   

Study ID Numbers:  C3719R
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125216
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-02