Back to resultsSpeech Therapy for Aphasia: Comparing Two Treatments (PMvSFA)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Semantic Feature Analysis therapy
Phonomotor Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Aphasia, Anomia
Eligibility Criteria
Inclusion Criteria:
- Single, left-hemisphere stroke
- English as primary language prior to stroke
Exclusion Criteria:
- Other neurological disorders
- Untreated depression
Sites / Locations
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Phonomotor therapy
Semantic Feature Analysis therapy
Arm Description
Experimental group
Current standard of care therapy
Outcomes
Primary Outcome Measures
Spoken Word Production (Confrontation Naming)
Reporting a change in percent correct scores pre-treatment versus 3-months post treatment. (0-100% scale)
Secondary Outcome Measures
Response Latency
Change in response latency of confrontation naming pre-treatment versus 3 months post treatment.
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.
Full Information
NCT ID
NCT02153710
First Posted
March 20, 2014
Last Updated
July 26, 2019
Sponsor
VA Office of Research and Development
Collaborators
Portland State University, University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT02153710
Brief Title
Speech Therapy for Aphasia: Comparing Two Treatments
Acronym
PMvSFA
Official Title
A Prospective, Controlled Study of Rehabilitation of Anomia in Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 11, 2014 (Actual)
Primary Completion Date
August 21, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Portland State University, University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Aphasia, Anomia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phonomotor therapy
Arm Type
Experimental
Arm Description
Experimental group
Arm Title
Semantic Feature Analysis therapy
Arm Type
Active Comparator
Arm Description
Current standard of care therapy
Intervention Type
Behavioral
Intervention Name(s)
Semantic Feature Analysis therapy
Intervention Description
Control therapy; current standard of care therapy
Intervention Type
Behavioral
Intervention Name(s)
Phonomotor Therapy
Intervention Description
Experimental therapy.
Primary Outcome Measure Information:
Title
Spoken Word Production (Confrontation Naming)
Description
Reporting a change in percent correct scores pre-treatment versus 3-months post treatment. (0-100% scale)
Time Frame
Pretreatment to 3 months following treatment termination change
Secondary Outcome Measure Information:
Title
Response Latency
Description
Change in response latency of confrontation naming pre-treatment versus 3 months post treatment.
Time Frame
Pretreatment to 3 months following treatment termination change
Title
Verbs Correctly Named
Description
Change in confrontation naming of verbs were scored for accuracy and percent correct (0% to 100%) was analyzed before versus 3 months post treatment.
Time Frame
Pretreatment to 3 months following treatment termination change
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Single, left-hemisphere stroke
English as primary language prior to stroke
Exclusion Criteria:
Other neurological disorders
Untreated depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane L. Kendall, PhD
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Speech Therapy for Aphasia: Comparing Two Treatments
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