Speech Therapy for Aphasia: Comparing Two Treatments (PMvSFA)

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).

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Phonomotor Therapy; Behavioral: Semantic Feature Analysis therapy

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Single, left-hemisphere stroke
• English as primary language prior to stroke

Exclusion Criteria:

• Other neurological disorders
• Untreated depression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phonomotor therapy; Experimental group	Behavioral: Phonomotor Therapy; Experimental therapy.
Active Comparator: Semantic Feature Analysis therapy; Current standard of care therapy	Behavioral: Semantic Feature Analysis therapy; Control therapy; current standard of care therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Washington; Portland State University
• Investigators: Principal Investigator: Diane L. Kendall, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2014
• Primary Completion (Actual): August 21, 2017
• Study Completion (Actual): September 29, 2017

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Aphasia; Anomia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: O1183-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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