StrokeNCT00764400
Treatment for Word Retrieval Impairments in Aphasia
A study testing Word Retrieval Treatments for Aphasia in people with Stroke, run by Old Dominion University at 1 site in United States.
Trial summary
In this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia. One treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Word Retrieval Treatments for Aphasia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jul 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- left hemisphere stroke >4 months earlier
- aphasia with word retrieval impairments
- >21 years of age right handed
- speaker of English as the preferred language
- >6 grade education
Who cannot join
- history of developmental learning difficulties
- history of prior neurological illnesses
- chronic medical illnesses that restrict participation in speech therapy
- alcohol or drug dependence
- severe uncorrected impairments of vision or hearing
Trial locations and contacts
1 site in 1 country.
United States1 site
Old Dominion University Speech and Hearing Clinic
Norfolk, Virginia, 23529
About this study
Official title: Communication Outcomes for Naming Treatments in Aphasia
In this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia. One treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval. Participants will receive one of the two treatments over several months. Before and after treatment the investigators will administer several tests and conversational samples to examine changes associated with the treatments. The investigators hypothesize that, whereas both treatments will lead to improvements in words rehearsed in therapy, communication outcomes in conversation will be broader for the verbal plus gestural protocol.
Read the detailed description
In this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia. One treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval. Participants will receive one of the two treatments over several months. Before and after treatment the investigators will administer several tests and conversational samples to examine changes associated with the treatments. The investigators hypothesize that, whereas both treatments will lead to improvements in words rehearsed in therapy, communication outcomes in conversation will be broader for the verbal plus gestural protocol.
- Conditions
- Stroke
- Being tested
- Word Retrieval Treatments for Aphasia
- Keywords
- aphasia, anomia, speech therapy, rehabilitation
- Medical subject headings
- Stroke, Aphasia, Anomia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Word Retrieval Treatments for AphasiaBehavioural
Speech therapy sessions take place 4 times per week for up to 90 minutes per session. Following a phase of baseline pre-testing, two phases of speech therapy will take place lasting up to 20 sessions per phase. Post-testing will take place immediately upon completion of the treatment phases and again at 1 month post study completion.
| Study group | Role | What they receive |
|---|---|---|
| Errorless Naming Treatment | Experimental | Not described Receives: Behavioral: Word Retrieval Treatments for Aphasia |
| Verbal+Gestural Facilitation | Experimental | Not described Receives: Behavioral: Word Retrieval Treatments for Aphasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Probe Picture Naming
Measured: daily probes from three times per week for up to 3 months and one month posttreatment
Secondary outcomes (3)
Western Aphasia Battery
Measured: pre-treatment and at treatment completion
Boston Naming Test
Measured: pretreatment and at treatment completion
Discourse Sample
Measured: pre-treatment and at treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Dr. Anastasia Raymer, Old Dominion University
- Investigators
- Anastasia M Raymer, PhD, Principal investigator, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764400
- Sponsor's protocol ID
- R15DC009690
- Other IDs
- 3R15DC009690
- Status last verified
- Apr 2018
- First submitted
- 30 Sep 2008
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Outcomes for Naming Treatments in Aphasia
- ClinicalTrials.gov ID
- NCT00764400
- Acronym / sponsor ID
- R15DC009690
- Conditions
- Stroke
- Keywords
- aphasia, anomia, speech therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Aug 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Oct 2008 (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.
In this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia. One treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval. Participants will receive one of the two treatments over several months. Before and after treatment the investigators will administer several tests and conversational samples to examine changes associated with the treatments. The investigators hypothesize that, whereas both treatments will lead to improvements in words rehearsed in therapy, communication outcomes in conversation will be broader for the verbal plus gestural protocol.
Detailed description
In this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia. One treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval. Participants will receive one of the two treatments over several months. Before and after treatment the investigators will administer several tests and conversational samples to examine changes associated with the treatments. The investigators hypothesize that, whereas both treatments will lead to improvements in words rehearsed in therapy, communication outcomes in conversation will be broader for the verbal plus gestural protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Errorless Naming Treatment | Experimental | Behavioral: Word Retrieval Treatments for Aphasia |
| Verbal+Gestural Facilitation | Experimental | Behavioral: Word Retrieval Treatments for Aphasia |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- left hemisphere stroke >4 months earlier
- aphasia with word retrieval impairments
- >21 years of age right handed
- speaker of English as the preferred language
- >6 grade education
Key exclusion criteria (5 listed)
- history of developmental learning difficulties
- history of prior neurological illnesses
- chronic medical illnesses that restrict participation in speech therapy
- alcohol or drug dependence
- severe uncorrected impairments of vision or hearing
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 |
|---|---|---|
| Word Retrieval Treatments for AphasiaSpeech therapy sessions take place 4 times per week for up to 90 minutes per session. Following a phase of baseline pre-testing, two phases of speech therapy will take place lasting up to 20 sessions per phase. Post-testing will take place immediately upon completion of the treatment phases and again at 1 month post study completion. | Behavioural | Errorless Naming Treatment, Verbal+Gestural Facilitation |
Primary outcome
Daily Probe Picture Naming
Time frame: daily probes from three times per week for up to 3 months and one month posttreatment
3 secondary outcomes
Western Aphasia Battery
Time frame: pre-treatment and at treatment completion
Boston Naming Test
Time frame: pretreatment and at treatment completion
Discourse Sample
Time frame: pre-treatment and at treatment completion
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 6 Apr 2018.
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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.
Anastasia M Raymer, PhD principal investigator
Old Dominion University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Word Retrieval Treatments for Aphasia in people with Stroke, run by Old Dominion University 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 5 inclusion and 5 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 6 Apr 2018. 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?
Daily Probe Picture Naming (time frame: daily probes from three times per week for up to 3 months and one month posttreatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2018.