- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125216
Evaluation of the Effects of Response Elaboration Training for Aphasia
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
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Salt Lake City, Utah, United States, 84148
- VA Salt Lake City Health Care System, Salt Lake City
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm 1
Single subject design - participant receives three administrations of the same treatment
|
Therapist modeling, reinforcement and forward-chaining are used to stimulate verbal descriptions of pictures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
verbal production of meaningful content words in connected speech
Time Frame: 3 and 6 weeks following completion of treatment
|
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.
|
3 and 6 weeks following completion of treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Julie L. Wambaugh, PhD, VA Salt Lake City Health Care System, Salt Lake City
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C3719-R
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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