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

Primary Purpose

Apraxia of Speech, Aphasia, Acquired, Speech Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EPG Tx
SPT
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apraxia of Speech focused on measuring Apraxia of Speech, Treatment

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Salt Lake City Health Care System, Salt Lake City, UT

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EPG Tx

Sound Production Treatment (SPT)

Arm Description

An articulatory-kinematic treatment in conjunction with visual biofeedback specifically tongue to palate contact to improve speech production

An articulatory-kinematic treatment that uses integral stimulation to improve speech production.

Outcomes

Primary Outcome Measures

Speech Production: Percent Change in Treated Items Immediately Post Treatment
Change in accuracy of articulation of treated items measured by percent increase in accuracy above the highest baseline measurement; production of words designated for treatment was measured repeatedly in non-treatment probes prior to treatment, throughout all study phases and immediately post treatment with percent accuracy calculated for each probe (0% to 100% correct). The highest percentage accuracy achieved in baseline probes was subtracted from the percentage accuracy achieved at the conclusion of treatment to obtain change in accuracy value - this reflects change from maximum correct performance in baseline (baseline). e.g., if in baseline probes, performance ranged from 10% to 30% accuracy and at post treatment performance was 90% accuracy, the change value would be 60% (90% minus 30%). A greater value indicates greater change in articulation/production of words. Change could be positive (improved articulation) or negative (poorer articulation)

Secondary Outcome Measures

Speech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment
Change in articulatory accuracy of untreated items, but related items as measured by percent increase in accuracy above the highest baseline measurement; production of words designated for non-treatment was measured repeatedly in non-treatment probes prior to treatment, throughout all study phases and immediately post treatment with percent accuracy calculated for each probe (0% to 100% correct). The highest percentage accuracy achieved in baseline probes was subtracted from the percentage accuracy achieved at the conclusion of treatment to obtain change in accuracy value - this reflects change from maximum correct performance in baseline. e.g., if in baseline probes, performance ranged from 10% to 30% accuracy and at post treatment performance was 90% accuracy, the change value would be 60% (90% minus 30%). A greater change value indicates greater change in articulation/production of words. Change could be positive (improved articulation) or negative (poorer articulation)
Speech Production: Percent Change for Treated Items After the Completion of Treatment
Change in articulatory accuracy of treated items as measured by percent increase in accuracy above the highest baseline measurement; production of words designated for treatment was measured repeatedly in non-treatment probes prior to treatment, throughout all study phases, and at 7 weeks immediately after each treatment with percent accuracy calculated for each probe (0% to 100% correct). The highest percentage accuracy achieved in baseline probes was subtracted from the percentage accuracy achieved at 7 weeks immediately after the conclusion of each treatment to obtain change in accuracy value - this reflects change from maximum correct performance in baseline (pre-treatment). e.g., if in baseline probes, performance ranged from 10% to 30% accuracy and at post treatment performance was 90% accuracy, the change value would be 60% (90% minus 30%). A greater change value indicates greater change in articulation/production of words.
Functional Communication Skills: T-Score
Measurement of functional every day communication skills using the Aphasia Communication Outcome Measure (ACOM) with a T-score computed at each administration which was at baseline and then 10 weeks after the completion of all treatment. This outcome measure was only completed at baseline and at the completion on all treatment [not measured after the completion of each treatment]. The rating scale for functional communication skills was completed by the patient (or a spouse if patient's auditory comprehension was significantly impaired) (T-Scores range from 0 to 100; Higher T-scores indicate greater functional communication skills)
Speech Intelligibility: Percentage
Measurement of speech intelligibility for a set of fifty words (non-treatment words) from the Assessment of Speech Intelligibility of Dysarthric Speech as judge by an unfamiliar listener that was measured at baseline and then at 10 weeks post all treatment with a percentage of speech intelligibility (0% to 100% intelligible).This measurement was only conducted at pre-treatment and at the conclusion of all treatment [not measured after each treatment].

Full Information

First Posted
August 19, 2015
Last Updated
October 6, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02554513
Brief Title
Apraxia of Speech: Comparison of EPG Treatment (Tx) and Sound Production Treatment (SPT)
Acronym
EPG&SPT
Official Title
Apraxia of Speech: A Comparison of EPG Treatment & Sound Production Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2015 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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: Will treatment using an EPG approach or an SPT approach result in greater accuracy of articulation of trained speech sounds produced in words? 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)? Will treatment using an EPG approach or an SPT approach result in greater long term maintenance effects for trained speech sounds? 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)?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apraxia of Speech, Aphasia, Acquired, Speech Disorders
Keywords
Apraxia of Speech, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant received each arm of treatment
Masking
Outcomes Assessor
Masking Description
Single
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPG Tx
Arm Type
Active Comparator
Arm Description
An articulatory-kinematic treatment in conjunction with visual biofeedback specifically tongue to palate contact to improve speech production
Arm Title
Sound Production Treatment (SPT)
Arm Type
Active Comparator
Arm Description
An articulatory-kinematic treatment that uses integral stimulation to improve speech production.
Intervention Type
Device
Intervention Name(s)
EPG Tx
Other Intervention Name(s)
Electropalatography Treatment, Palatometer Treatment
Intervention Description
behavioral intervention that incorporates a device that provides visual biofeedback
Intervention Type
Behavioral
Intervention Name(s)
SPT
Other Intervention Name(s)
Sound Production Treatment
Intervention Description
A treatment hierarchy involving integral stimulation
Primary Outcome Measure Information:
Title
Speech Production: Percent Change in Treated Items Immediately Post Treatment
Description
Change in accuracy of articulation of treated items measured by percent increase in accuracy above the highest baseline measurement; production of words designated for treatment was measured repeatedly in non-treatment probes prior to treatment, throughout all study phases and immediately post treatment with percent accuracy calculated for each probe (0% to 100% correct). The highest percentage accuracy achieved in baseline probes was subtracted from the percentage accuracy achieved at the conclusion of treatment to obtain change in accuracy value - this reflects change from maximum correct performance in baseline (baseline). e.g., if in baseline probes, performance ranged from 10% to 30% accuracy and at post treatment performance was 90% accuracy, the change value would be 60% (90% minus 30%). A greater value indicates greater change in articulation/production of words. Change could be positive (improved articulation) or negative (poorer articulation)
Time Frame
Baseline vs. Immediately Post Treatment (7 week treatment period)
Secondary Outcome Measure Information:
Title
Speech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment
Description
Change in articulatory accuracy of untreated items, but related items as measured by percent increase in accuracy above the highest baseline measurement; production of words designated for non-treatment was measured repeatedly in non-treatment probes prior to treatment, throughout all study phases and immediately post treatment with percent accuracy calculated for each probe (0% to 100% correct). The highest percentage accuracy achieved in baseline probes was subtracted from the percentage accuracy achieved at the conclusion of treatment to obtain change in accuracy value - this reflects change from maximum correct performance in baseline. e.g., if in baseline probes, performance ranged from 10% to 30% accuracy and at post treatment performance was 90% accuracy, the change value would be 60% (90% minus 30%). A greater change value indicates greater change in articulation/production of words. Change could be positive (improved articulation) or negative (poorer articulation)
Time Frame
Baseline vs. Immediately Post Treatment (7 week treatment period)
Title
Speech Production: Percent Change for Treated Items After the Completion of Treatment
Description
Change in articulatory accuracy of treated items as measured by percent increase in accuracy above the highest baseline measurement; production of words designated for treatment was measured repeatedly in non-treatment probes prior to treatment, throughout all study phases, and at 7 weeks immediately after each treatment with percent accuracy calculated for each probe (0% to 100% correct). The highest percentage accuracy achieved in baseline probes was subtracted from the percentage accuracy achieved at 7 weeks immediately after the conclusion of each treatment to obtain change in accuracy value - this reflects change from maximum correct performance in baseline (pre-treatment). e.g., if in baseline probes, performance ranged from 10% to 30% accuracy and at post treatment performance was 90% accuracy, the change value would be 60% (90% minus 30%). A greater change value indicates greater change in articulation/production of words.
Time Frame
Baseline vs. 7 weeks post treatment [measured immediately after the completion of each treatment]
Title
Functional Communication Skills: T-Score
Description
Measurement of functional every day communication skills using the Aphasia Communication Outcome Measure (ACOM) with a T-score computed at each administration which was at baseline and then 10 weeks after the completion of all treatment. This outcome measure was only completed at baseline and at the completion on all treatment [not measured after the completion of each treatment]. The rating scale for functional communication skills was completed by the patient (or a spouse if patient's auditory comprehension was significantly impaired) (T-Scores range from 0 to 100; Higher T-scores indicate greater functional communication skills)
Time Frame
Baseline vs. 10 weeks after the completion of all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]
Title
Speech Intelligibility: Percentage
Description
Measurement of speech intelligibility for a set of fifty words (non-treatment words) from the Assessment of Speech Intelligibility of Dysarthric Speech as judge by an unfamiliar listener that was measured at baseline and then at 10 weeks post all treatment with a percentage of speech intelligibility (0% to 100% intelligible).This measurement was only conducted at pre-treatment and at the conclusion of all treatment [not measured after each treatment].
Time Frame
Baseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon C Mauszycki, PhD
Organizational Affiliation
VA Salt Lake City Health Care System, Salt Lake City, UT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31693389
Citation
Mauszycki SC, Wambaugh JL. Acquired Apraxia of Speech: Comparison of Electropalatography Treatment and Sound Production Treatment. Am J Speech Lang Pathol. 2020 Feb 21;29(1S):511-529. doi: 10.1044/2019_AJSLP-CAC48-18-0223. Epub 2019 Nov 6.
Results Reference
derived

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

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