AphasiaNCT01163461
Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia
A study testing speech therapy in people with Aphasia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called 'aphasia'. Individuals who participate in this study will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aphasia
- What is being tested?
- speech therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2010to 30 Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- left hemisphere stroke
- monolingual English speaking
- right handed
- presence of aphasia
Who cannot join
- preexisting neurological condition
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Real Word Effects in Phonological Treatment for Word Retrieval
This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called 'aphasia'. Individuals who participate in this study will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).
Read the detailed description
The study design was a single group (n=26) with repeated testing (3 times) pre- and post-treatment. All participants received the same treatment protocol (described in detail in Appendix A and in Minkina et al. (under review)). In order to control for improvement in language function related to passage of time, and for the effect of repeated exposure to outcome measures, individuals were randomly assigned to one of two conditions: delayed treatment or immediate treatment (Figure 2). Participants who were randomized to the delayed group received repeated testing three times before and three times after a six-week delay. During the delay phase they were permitted to participate in usual speech-language care (e.g., conversation groups and individual therapy).
Standardized assessments and outcome measures (described in detail below) were administered prior to the start of treatment (for both immediate and delayed groups), at the end of the delay phase (delayed group only), immediately after treatment termination, and at three months post-treatment.
- Conditions
- Aphasia
- Being tested
- speech therapy
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech therapyBehavioural
individuals will receive 60 hours of behavioral speech therapy
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | individuals will receive 60 hours of speech therapy Receives: Behavioral: speech therapy |
| Delayed Treatment | Experimental | individuals will receive 60 hours of speech therapy after 6 week delay period Receives: Behavioral: speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Production
percent change in the number of untrained words spoken correctly
Measured: Baseline to one week post treatment termination and three months post treatment termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study start1 Sep 2010
- Primary completion30 Jun 2013
- Study completion30 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Diane L. Kendall, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163461
- Sponsor's protocol ID
- C6572-R
- Status last verified
- Aug 2017
- First submitted
- 14 Jul 2010
- Last updated
- 31 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kendall DL, Hunting Pompon R, Brookshire CE, Minkina I, Bislick L. An analysis of aphasic naming errors as an indicator of improved linguistic processing following phonomotor treatment. Am J Speech Lang Pathol. 2013 May;22(2):S240-9. doi: 10.1044/1058-0360(2012/12-0078).
PubMed 23695900
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Word Effects in Phonological Treatment for Word Retrieval
- ClinicalTrials.gov ID
- NCT01163461
- Acronym / sponsor ID
- C6572-R
- Conditions
- Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Posted 16 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called 'aphasia'. Individuals who participate in this study will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).
Detailed description
The study design was a single group (n=26) with repeated testing (3 times) pre- and post-treatment. All participants received the same treatment protocol (described in detail in Appendix A and in Minkina et al. (under review)). In order to control for improvement in language function related to passage of time, and for the effect of repeated exposure to outcome measures, individuals were randomly assigned to one of two conditions: delayed treatment or immediate treatment (Figure 2). Participants who were randomized to the delayed group received repeated testing three times before and three times after a six-week delay. During the delay phase they were permitted to participate in usual speech-language care (e.g., conversation groups and individual therapy).
Standardized assessments and outcome measures (described in detail below) were administered prior to the start of treatment (for both immediate and delayed groups), at the end of the delay phase (delayed group only), immediately after treatment termination, and at three months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: speech therapyindividuals will receive 60 hours of speech therapy |
| Delayed Treatment | Experimental | Behavioral: speech therapyindividuals will receive 60 hours of speech therapy after 6 week delay period |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- left hemisphere stroke
- monolingual English speaking
- right handed
- presence of aphasia
Key exclusion criteria (1 listed)
- preexisting neurological condition
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 |
|---|---|---|
| speech therapyindividuals will receive 60 hours of behavioral speech therapy | Behavioural | Delayed Treatment, Immediate Treatment |
Primary outcome
Speech Production
Time frame: Baseline to one week post treatment termination and three months post treatment termination
percent change in the number of untrained words spoken correctly
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23695900Kendall DL, Hunting Pompon R, Brookshire CE, Minkina I, Bislick L. An analysis of aphasic naming errors as an indicator of improved linguistic processing following phonomotor treatment. Am J Speech Lang Pathol. 2013 May;22(2):S240-9. doi: 10.1044/1058-0360(2012/12-0078).
- Individual participant dataSharing planned: No
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.
Diane L. Kendall, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speech therapy in people with Aphasia, run by VA Office of Research and Development 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 1 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 31 Aug 2017. 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?
Yes. Results are posted in the registry (first posted 16 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Speech Production (time frame: Baseline to one week post treatment termination and three months post treatment termination). 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 NCT01163461, 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 31 Aug 2017.