- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02554513
Apraxia of Speech: Comparison of EPG Treatment (Tx) and Sound Production Treatment (SPT) (EPG&SPT)
Apraxia of Speech: A Comparison of EPG Treatment & Sound Production Treatment
Study Overview
Status
Conditions
Intervention / Treatment
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)?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84148
- VA Salt Lake City Health Care System, Salt Lake City, UT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
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behavioral intervention that incorporates a device that provides visual biofeedback
Other Names:
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Active Comparator: Sound Production Treatment (SPT)
An articulatory-kinematic treatment that uses integral stimulation to improve speech production.
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A treatment hierarchy involving integral stimulation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech Production: Percent Change in Treated Items Immediately Post Treatment
Time Frame: Baseline vs. Immediately Post Treatment (7 week treatment period)
|
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)
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Baseline vs. Immediately Post Treatment (7 week treatment period)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment
Time Frame: Baseline vs. Immediately Post Treatment (7 week treatment period)
|
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)
|
Baseline vs. Immediately Post Treatment (7 week treatment period)
|
Speech Production: Percent Change for Treated Items After the Completion of Treatment
Time Frame: Baseline vs. 7 weeks post treatment [measured immediately after the completion of each 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.
|
Baseline vs. 7 weeks post treatment [measured immediately after the completion of each treatment]
|
Functional Communication Skills: T-Score
Time Frame: Baseline vs. 10 weeks after the completion of all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]
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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)
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Baseline vs. 10 weeks after the completion of all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]
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Speech Intelligibility: Percentage
Time Frame: Baseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]
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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].
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Baseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]
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Collaborators and Investigators
Investigators
- Principal Investigator: Shannon C Mauszycki, PhD, VA Salt Lake City Health Care System, Salt Lake City, UT
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C2068-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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