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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPG Tx | Active Comparator | An articulatory-kinematic treatment in conjunction with visual biofeedback specifically tongue to palate contact to improve speech production |
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| Sound Production Treatment (SPT) | Active Comparator | An articulatory-kinematic treatment that uses integral stimulation to improve speech production. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPG Tx | Device | behavioral intervention that incorporates a device that provides visual biofeedback |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline vs. Immediately Post Treatment (7 week treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon C Mauszycki, PhD | VA Salt Lake City Health Care System, Salt Lake City, UT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah | 84148 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31693389 | Derived | 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. |
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Each participant received each treatment arm in this crossover design. Order of treatment assignment was random.
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| ID | Title | Description |
|---|---|---|
| FG000 | EPG Tx Then Sound Production Treatment (SPT) | Participants in this arm received EPG Treatment for 20 treatment sessions. Following a 2 week washout period, participants received Sound Production Treatment (SPT) for 20 treatment sessions. EPG Treatment is also a behavioral treatment that includes clinical modeling, integral stimulation ("watch me, listen to me, say it with me"), articulation instruction, repeated practice and verbal feedback, but also incorporates a device that provides visual feedback about tongue placement/movements for articulation. SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation ("watch me, listen to me, say it with me"), articulation instruction, repeated practice and verbal feedback. |
| FG001 | Sound Production Treatment (SPT) Then EPG Tx | Participants in this arm received Sound Production Treatment - Blocked (SPT) for 20 treatment sessions. Following a 2 week washout period, participants received EPG Treatment for 20 treatment sessions. SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation ("watch me, listen to me, say it with me"), articulation instruction, repeated practice and verbal feedback. EPG Treatment is also a behavioral treatment that includes clinical modeling, integral stimulation ("watch me, listen to me, say it with me"), articulation instruction, repeated practice and verbal feedback, but also incorporates a device that provides visual feedback about tongue placement/movements for articulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment Phase (7 Weeks) |
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| Washout (2 Weeks) |
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| Second Treatment Phase (7 Weeks) |
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Participants had moderate to severe acquired apraxia of speech and accompanying aphasia.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants received Electropalatography Treatment (EPG Tx) and Sound Production Treatment (SPT). Half the participants received EPG Tx first for 20 sessions. Following a 2 week washout period, those participants then received SPT for 20 sessions. The other half of the participants received the treatments in the opposite order. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Full Range | % change | Baseline vs. Immediately Post Treatment (7 week treatment period) |
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Entire course of study which was approximately 32 weeks per participant: pretreatment/baseline period = 6 weeks + 7 weeks Treatment 1 + 2 weeks washout + 7 weeks Treatment 2 + follow-up at 10 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EPG Treatment: All Participants | Participants in this arm received EPG Treatment for 20 treatment sessions. Following a 2 week washout period, participants received Sound Production Treatment (SPT) for 20 treatment sessions. EPG Treatment is also a behavioral treatment that includes clinical modeling, integral stimulation ("watch me, listen to me, say it with me"), articulation instruction, repeated practice and verbal feedback, but also incorporates a device that provides visual feedback about tongue placement/movements for articulation. SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation ("watch me, listen to me, say it with me"), articulation instruction, repeated practice and verbal feedback. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shannon Mauszycki | VASLCHCS | 801-582-1565 | shannon.mauszycki@utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2020 | Apr 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001072 | Apraxias |
| D001037 | Aphasia |
| D013064 | Speech Disorders |
| ID | Term |
|---|---|
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Each participant received each arm of treatment
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Single
| SPT | Behavioral | A treatment hierarchy involving integral stimulation |
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| Baseline vs. Immediately Post Treatment (7 week treatment period) |
| 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. | Baseline vs. 7 weeks post treatment [measured immediately after the completion of each treatment] |
| 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) | Baseline vs. 10 weeks after the completion of all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment] |
| 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]. | Baseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment] |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG000 | EPG Treatment | EPG Treatment: Articulatory-Kinematic Treatment in conjunction with visual biofeedback for tongue position |
| OG001 | Sound Production Treatment | Sound Production Treatment: Articulatory-Kinematic Treatment |
|
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| Secondary | 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) | Posted | Mean | Full Range | % change | Baseline vs. Immediately Post Treatment (7 week treatment period) |
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| Secondary | 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. | Posted | Mean | Full Range | % change | Baseline vs. 7 weeks post treatment [measured immediately after the completion of each treatment] |
|
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| Secondary | 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) | Posted | Mean | Standard Deviation | T-Score | 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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| Secondary | 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]. | Posted | Mean | Standard Deviation | Percentage of Words Intelligible | Baseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment] |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Sound Production Treatment: All Participants | Participants in this arm received Sound Production Treatment - Blocked (SPT) for 20 treatment sessions. Following a 2 week washout period, participants received EPG Treatment for 20 treatment sessions. SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation ("watch me, listen to me, say it with me"), articulation instruction, repeated practice and verbal feedback. EPG Treatment is also a behavioral treatment that includes clinical modeling, integral stimulation ("watch me, listen to me, say it with me"), articulation instruction, repeated practice and verbal feedback, but also incorporates a device that provides visual feedback about tongue placement/movements for articulation. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |