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Apraxia of Speech: Comparison of EPG Treatment (Tx) and Sound Production Treatment (SPT) (EPG&SPT)

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ClinicalTrials.gov Identifier: NCT02554513
Recruitment Status : Recruiting
First Posted : September 18, 2015
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of the proposed research is to examine the effects of two treatment approaches on speech production involving speakers with chronic apraxia of speech (AOS) and aphasia. The planned investigation is designed to examine the acquisition, maintenance and generalization effects of each treatment. One approach, electropalatography (EPG) uses visual biofeedback in conjunction with articulatory-kinematic treatment and the other approach, sound production treatment (SPT) is one of the most systematically studied articulatory-kinematic treatments for AOS.

Condition or disease Intervention/treatment Phase
Apraxias Communication Disorders Speech Disorders Device: EPG Tx Behavioral: SPT Not Applicable

Detailed Description:

EPG has been used to treat apraxia of speech (AOS) as well as other speech production disorders (i.e., articulation disorders & cleft palate). SPT is one of the most systematically studied treatment approaches for AOS. Both treatment approaches are considered clinical treatment approaches/standards of care for AOS. The pseudopalate used in conjunction with EPG treatment is an acceptable device for treating speech production disorders including AOS. The pseudopalate is custom-fit for each patient and is similar to a dental retainer and is considered minimally invasive.

The purpose of this research is to systematically examine the effects of treatment on speech production using EPG treatment vs. an SPT approach. The planned investigation is intended to explicate the acquisition, maintenance, and generalization effects of each treatment approach. The specific experimental questions to be addressed are as follows:

  1. Will treatment using an EPG approach or an SPT approach result in greater accuracy of articulation of trained speech sounds produced in words?
  2. Will treatment using an EPG approach or an SPT approach result in greater accuracy of articulation of untrained exemplars of trained speech sounds produced in words (i.e., response generalization)?
  3. Will treatment using an EPG approach or an SPT approach result in greater long term maintenance effects for trained speech sounds?
  4. Do different treatment approaches result in distinct ratings of functional communication skills via the Aphasia Communication Outcome Measure (ACOM; Doyle et al., 2012) and an outcome measure of speech intelligibility using the Assessment of Intelligibility of Dysarthric Speech (AIDS; Yorkston & Beukelman, 1981)?

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apraxia of Speech: A Comparison of EPG Treatment & Sound Production Treatment
Actual Study Start Date : November 2, 2015
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EPG Tx
An articulatory-kinematic treatment in conjunction with visual biofeedback specifically tongue to palate contact to improve speech production
Device: EPG Tx
behavioral intervention that incorporates a device that provides visual biofeedback
Other Name: Electropalatography Treatment, Palatometer Treatment

Active Comparator: Sound Production Treatment (SPT)
An articulatory-kinematic treatment that uses integral stimulation to improve speech production.
Behavioral: SPT
A treatment hierarchy involving integral stimulation
Other Name: Sound Production Treatment




Primary Outcome Measures :
  1. Change in Speech Production Accuracy for treated stimuli [ Time Frame: up to 32 weeks ]
    Percent accuracy in speech production for treated speech sounds directly receiving treatment


Secondary Outcome Measures :
  1. Change in Speech Production Accuracy for untreated stimuli (related stimuli) [ Time Frame: up to 32 weeks ]
    Percent accuracy in speech production in related stimuli, but untreated stimuli comprised of treated speech sounds

  2. Change in maintenance of speech production accuracy for treated stimuli [ Time Frame: up to 32 weeks ]
    Percent accuracy in speech production for treated speech sounds following treatment

  3. Change in Functional Communication Skills [ Time Frame: up to 32 weeks ]
    Percent change on rating scale for functional communication skills by patient & spouse or family member

  4. Change in Speech Intelligibility [ Time Frame: up to 32 weeks ]
    Percentage of speech intelligibility on the word level by unfamiliar listeners



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans or non Veterans with apraxia of speech who reside in the Salt Lake City region (commutable),
  • 6 months or more post stroke or other focal brain injury, no other neurological conditions
  • native English speakers, hearing adequate for experimental task (e.g., pass puretone screening at 35dB at 500, 1K, 2K Hz or adequate aided hearing)
  • non linguistic cognition within normal limits

Exclusion Criteria:

  • less than 6 months post stroke
  • insufficient hearing, insufficient non linguistic cognitive skills
  • neurological conditions other than stroke
  • unable to attend treatment in the Salt Lake City vicinity

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): NCT02554513


Contacts
Contact: Shannon C Mauszycki, PhD (801) 582-1565 ext 2182 shannon.mauszycki@va.gov

Locations
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Shannon C Mauszycki, PhD    801-582-1565 ext 2182    shannon.mauszycki@va.gov   
Principal Investigator: Shannon C Mauszycki, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Shannon C Mauszycki, PhD VA Salt Lake City Health Care System, Salt Lake City, UT

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02554513     History of Changes
Other Study ID Numbers: C2068-P
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
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

Keywords provided by VA Office of Research and Development:
Apraxia of Speech
Treatment

Additional relevant MeSH terms:
Communication Disorders
Disease
Apraxias
Speech Disorders
Pathologic Processes
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Language Disorders
Neurodevelopmental Disorders
Mental Disorders