StrokePMvSFANCT02153710
Speech Therapy for Aphasia: Comparing Two Treatments
A study testing Semantic Feature Analysis therapy and Phonomotor Therapy in people with Stroke, 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 in this study will receive one of two treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Semantic Feature Analysis therapy and Phonomotor Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2014to 29 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single, left-hemisphere stroke
- English as primary language prior to stroke
Who cannot join
- Other neurological disorders
- Untreated depression
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: A Prospective, Controlled Study of Rehabilitation of Anomia in Aphasia
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 in this study will receive one of two treatments. The first is a phonological (sound level) treatment and the second is a semantic (word level) treatment. Individuals in both groups will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).
Read the detailed description
Purpose: The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session as well as generalization to untrained exemplars and contexts. Phonomotor treatment (PMT) has shown such effects but has not yet been compared to a commonly used lexical/semantic based treatment (semantic feature analysis; SFA).
Methods: In a between group randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56-60 hours of intensively delivered treatment over 6 weeks with testing pre-, post- and three-months post treatment termination.
- Conditions
- Stroke
- Being tested
- Semantic Feature Analysis therapy, Phonomotor Therapy
- Keywords
- Aphasia, Anomia
- Medical subject headings
- Stroke, Aphasia, Anomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semantic Feature Analysis therapyBehavioural
Control therapy; current standard of care therapy
Phonomotor TherapyBehavioural
Experimental therapy.
| Study group | Role | What they receive |
|---|---|---|
| Phonomotor therapy | Experimental | Experimental group Receives: Behavioral: Phonomotor Therapy |
| Semantic Feature Analysis therapy | Active comparator | Current standard of care therapy Receives: Behavioral: Semantic Feature Analysis therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spoken Word Production (Confrontation Naming)
Reporting a change in percent correct scores pre-treatment versus 3-months post treatment. (0-100% scale)
Measured: Pretreatment to 3 months following treatment termination change
Secondary outcomes (2)
Response Latency
Change in response latency of confrontation naming pre-treatment versus 3 months post treatment.
Measured: Pretreatment to 3 months following treatment termination change
Verbs Correctly Named
Change in confrontation naming of verbs were scored for accuracy and percent correct (0% to 100%) was analyzed before versus 3 months post treatment.
Measured: Pretreatment to 3 months following treatment termination change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start11 Mar 2014
- Primary completion21 Aug 2017
- Study completion29 Sep 2017
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.
- Other trials for StrokeStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Portland State University, University of Washington
- 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
- NCT02153710
- Sponsor's protocol ID
- O1183-R
- Acronym
- PMvSFA
- Status last verified
- Jul 2019
- First submitted
- 20 Mar 2014
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled Study of Rehabilitation of Anomia in Aphasia
- ClinicalTrials.gov ID
- NCT02153710
- Acronym / sponsor ID
- PMvSFA / O1183-R
- Conditions
- Stroke
- Keywords
- Aphasia, Anomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Portland State University, University of Washington
- Study start
- 11 Mar 2014 (actual)
- Primary completion
- 21 Aug 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 6 Sep 2019
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 in this study will receive one of two treatments. The first is a phonological (sound level) treatment and the second is a semantic (word level) treatment. Individuals in both groups will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).
Detailed description
Purpose: The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session as well as generalization to untrained exemplars and contexts. Phonomotor treatment (PMT) has shown such effects but has not yet been compared to a commonly used lexical/semantic based treatment (semantic feature analysis; SFA).
Methods: In a between group randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56-60 hours of intensively delivered treatment over 6 weeks with testing pre-, post- and three-months post treatment termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phonomotor therapy | Experimental | Behavioral: Phonomotor TherapyExperimental group |
| Semantic Feature Analysis therapy | Active comparator | Behavioral: Semantic Feature Analysis therapyCurrent standard of care therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single, left-hemisphere stroke
- English as primary language prior to stroke
Key exclusion criteria (2 listed)
- Other neurological disorders
- Untreated depression
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 |
|---|---|---|
| Semantic Feature Analysis therapyControl therapy; current standard of care therapy | Behavioural | Semantic Feature Analysis therapy |
| Phonomotor TherapyExperimental therapy. | Behavioural | Phonomotor therapy |
Primary outcome
Spoken Word Production (Confrontation Naming)
Time frame: Pretreatment to 3 months following treatment termination change
Reporting a change in percent correct scores pre-treatment versus 3-months post treatment. (0-100% scale)
2 secondary outcomes
Response Latency
Time frame: Pretreatment to 3 months following treatment termination change
Verbs Correctly Named
Time frame: Pretreatment to 3 months following treatment termination change
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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 Semantic Feature Analysis therapy and Phonomotor Therapy in people with Stroke, 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 2 inclusion and 2 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 Sep 2019. 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 6 Sep 2019). 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?
Spoken Word Production (Confrontation Naming) (time frame: Pretreatment to 3 months following treatment termination change). 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 Sep 2019.