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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02153710
Other study ID # O1183-R
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2014
Est. completion date September 29, 2017

Study information

Verified date July 2019
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date September 29, 2017
Est. primary completion date August 21, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Single, left-hemisphere stroke

- English as primary language prior to stroke

Exclusion Criteria:

- Other neurological disorders

- Untreated depression

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Semantic Feature Analysis therapy
Control therapy; current standard of care therapy
Phonomotor Therapy
Experimental therapy.

Locations

Country Name City State
United States VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
VA Office of Research and Development Portland State University, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Response Latency Change in response latency of confrontation naming pre-treatment versus 3 months post treatment. 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. Pretreatment to 3 months following treatment termination change
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