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Speech Therapy for Aphasia: Comparing Two Treatments (PMvSFA)

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ClinicalTrials.gov Identifier: NCT02153710
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Portland State University
University of Washington
Information provided by (Responsible Party):
VA Office of Research and Development

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).

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Semantic Feature Analysis therapy Behavioral: Phonomotor Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Controlled Study of Rehabilitation of Anomia in Aphasia
Actual Study Start Date : March 11, 2014
Actual Primary Completion Date : August 21, 2017
Actual Study Completion Date : September 29, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Response Latency [ Time Frame: Pretreatment to 3 months following treatment termination change ]
    Change in response latency of confrontation naming pre-treatment versus 3 months post treatment.

  2. Verbs Correctly Named [ Time Frame: Pretreatment to 3 months following treatment termination change ]
    Change in confrontation naming of verbs were scored for accuracy and percent correct (0% to 100%) was analyzed before versus 3 months post treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Other neurological disorders
  • Untreated depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153710


Locations
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United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Portland State University
University of Washington
Investigators
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Principal Investigator: Diane L. Kendall, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol  [PDF] October 30, 2013
No Statistical Analysis Plan (SAP) exists for this study.


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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02153710     History of Changes
Other Study ID Numbers: O1183-R
First Posted: June 3, 2014    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Aphasia
Anomia
Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms