AphasiaNCT00125216
Evaluation of the Effects of Response Elaboration Training for Aphasia
A study testing Response Elaboration Training in people with Aphasia and Language Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphasia, Language Disorders, Speech Disorders
- What is being tested?
- Response Elaboration Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, 84148
About this study
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.
Read the 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.
- Conditions
- Aphasia, Language Disorders, Speech Disorders
- Being tested
- Response Elaboration Training
- Keywords
- Aphasia, Language Therapy, Rehabilitation of speech and language disorders, Speech-language pathology
- Medical subject headings
- Aphasia, Language Disorders, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response Elaboration TrainingBehavioural
Therapist modeling, reinforcement and forward-chaining are used to stimulate verbal descriptions of pictures
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Single subject design - participant receives three administrations of the same treatment Receives: Behavioral: Response Elaboration Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
verbal production of meaningful content words in connected speech
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.
Measured: 3 and 6 weeks following completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2007
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie L. Wambaugh, PhD, Principal investigator, VA Salt Lake City Health Care System, Salt Lake City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125216
- Sponsor's protocol ID
- C3719-R
- Status last verified
- Apr 2014
- First submitted
- 27 Jul 2005
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wambaugh JL, Nessler C, Wright S. Modified response elaboration training: application to procedural discourse and personal recounts. Am J Speech Lang Pathol. 2013 May;22(2):S409-25. doi: 10.1044/1058-0360(2013/12-0063).
PubMed 23695913
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Response Elaboration Training for Aphasia
- ClinicalTrials.gov ID
- NCT00125216
- Acronym / sponsor ID
- C3719-R
- Conditions
- Aphasia, Language Disorders, Speech Disorders
- Keywords
- Aphasia, Language Therapy, Rehabilitation of speech and language disorders, Speech-language pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Dec 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Response Elaboration TrainingSingle subject design - participant receives three administrations of the same treatment |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Response Elaboration TrainingTherapist modeling, reinforcement and forward-chaining are used to stimulate verbal descriptions of pictures | Behavioural | Arm 1 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
- Results publication: PubMed 23695913Wambaugh JL, Nessler C, Wright S. Modified response elaboration training: application to procedural discourse and personal recounts. Am J Speech Lang Pathol. 2013 May;22(2):S409-25. doi: 10.1044/1058-0360(2013/12-0063).
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie L. Wambaugh, PhD principal investigator
VA Salt Lake City Health Care System, Salt Lake City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Response Elaboration Training in people with Aphasia and Language Disorders, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
verbal production of meaningful content words in connected speech (time frame: 3 and 6 weeks following completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.