Evaluation of the Effects of Response Elaboration Training for Aphasia

April 4, 2014 updated by: US Department of Veterans Affairs
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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health Care System, Salt Lake City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julie L. Wambaugh, PhD, VA Salt Lake City Health Care System, Salt Lake City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 27, 2005

First Submitted That Met QC Criteria

July 27, 2005

First Posted (Estimate)

July 29, 2005

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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