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| Name | Class |
|---|---|
| Portland State University | OTHER |
| University of Washington | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phonomotor therapy | Experimental | Experimental group |
|
| Semantic Feature Analysis therapy | Active Comparator | Current standard of care therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semantic Feature Analysis therapy | Behavioral | Control therapy; current standard of care therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spoken Word Production (Confrontation Naming) | Reporting a change in percent correct scores pre-treatment versus 3-months post treatment. (0-100% scale) | Pretreatment to 3 months following treatment termination change |
| Measure | Description | Time Frame |
|---|---|---|
| Response Latency | Change in response latency of confrontation naming pre-treatment versus 3 months post treatment. | Pretreatment to 3 months following treatment termination change |
| Verbs Correctly Named |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane L. Kendall, PhD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phonomotor Therapy | Experimental group Phonomotor Therapy: Experimental therapy. |
| FG001 | Semantic Feature Analysis Therapy | Current standard of care therapy Semantic Feature Analysis therapy: Control therapy; current standard of care therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Race information was not collected in this study
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| ID | Title | Description |
|---|---|---|
| BG000 | Phonomotor Therapy | Experimental group Phonomotor Therapy: Experimental therapy. |
| BG001 | Semantic Feature Analysis Therapy | Current standard of care therapy Semantic Feature Analysis therapy: Control therapy; current standard of care therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spoken Word Production (Confrontation Naming) | Reporting a change in percent correct scores pre-treatment versus 3-months post treatment. (0-100% scale) | Posted | Mean | Standard Deviation | percent correct | Pretreatment to 3 months following treatment termination change |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phonomotor Therapy | Experimental group Phonomotor Therapy: Experimental therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diane Kendall | University of Washington | 2066160537 | dkendall@uw.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2013 | May 14, 2019 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: University of Washington informed consent | Mar 19, 2015 | May 14, 2019 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: VA informed consent | May 5, 2015 | May 14, 2019 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| D000849 | Anomia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Phonomotor Therapy | Behavioral | Experimental therapy. |
|
Change in confrontation naming of verbs were scored for accuracy and percent correct (0% to 100%) was analyzed before versus 3 months post treatment.
| Pretreatment to 3 months following treatment termination change |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Race was not collected from participants. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Response Latency | Change in response latency of confrontation naming pre-treatment versus 3 months post treatment. | Posted | Mean | Standard Deviation | seconds | Pretreatment to 3 months following treatment termination change |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent correct | Pretreatment to 3 months following treatment termination change |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Semantic Feature Analysis Therapy | Current standard of care therapy Semantic Feature Analysis therapy: Control therapy; current standard of care therapy | 0 | 30 | 0 | 30 | 0 | 30 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|