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Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163461
First Posted: July 15, 2010
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 who participate in this study will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).

Condition Intervention
Aphasia Behavioral: speech therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Real Word Effects in Phonological Treatment for Word Retrieval

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Speech Production [ Time Frame: Baseline to one week post treatment termination and three months post treatment termination ]
    percent change in the number of untrained words spoken correctly


Enrollment: 28
Actual Study Start Date: September 1, 2010
Study Completion Date: September 30, 2014
Primary Completion Date: June 30, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Treatment
individuals will receive 60 hours of speech therapy
Behavioral: speech therapy
individuals will receive 60 hours of behavioral speech therapy
Experimental: Delayed Treatment
individuals will receive 60 hours of speech therapy after 6 week delay period
Behavioral: speech therapy
individuals will receive 60 hours of behavioral speech therapy

Detailed Description:

The study design was a single group (n=26) with repeated testing (3 times) pre- and post-treatment. All participants received the same treatment protocol (described in detail in Appendix A and in Minkina et al. (under review)). In order to control for improvement in language function related to passage of time, and for the effect of repeated exposure to outcome measures, individuals were randomly assigned to one of two conditions: delayed treatment or immediate treatment (Figure 2). Participants who were randomized to the delayed group received repeated testing three times before and three times after a six-week delay. During the delay phase they were permitted to participate in usual speech-language care (e.g., conversation groups and individual therapy).

Standardized assessments and outcome measures (described in detail below) were administered prior to the start of treatment (for both immediate and delayed groups), at the end of the delay phase (delayed group only), immediately after treatment termination, and at three months post-treatment.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • left hemisphere stroke
  • monolingual English speaking
  • right handed
  • presence of aphasia

Exclusion Criteria:

  • preexisting neurological condition
  Contacts and Locations
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): NCT01163461


Locations
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
Investigators
Principal Investigator: Diane L. Kendall, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01163461     History of Changes
Other Study ID Numbers: C6572-R
First Submitted: July 14, 2010
First Posted: July 15, 2010
Results First Submitted: September 29, 2014
Results First Posted: July 16, 2015
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms