An interventional study of EPG Tx and SPT in Apraxia of Speech, Aphasia, Acquired and Speech Disorders, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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:
65 studies on the registry are indexed under Apraxias; 21 are open to participants now.
This study's enrollment of 6 is below the median of 32 across 50 interventional studies indexed under Apraxias.
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Exclusion Criteria:
An articulatory-kinematic treatment in conjunction with visual biofeedback specifically tongue to palate contact to improve speech production
Device: EPG Tx
An articulatory-kinematic treatment that uses integral stimulation to improve speech production.
Behavioral: SPT
behavioral intervention that incorporates a device that provides visual biofeedback
Also known as: Electropalatography Treatment, Palatometer Treatment
A treatment hierarchy involving integral stimulation
Also known as: Sound Production Treatment
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)
Time frame: Baseline vs. Immediately Post Treatment (7 week treatment period)
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)
Time frame: 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.
Time frame: 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)
Time frame: 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 \[not measured after each treatment\].
Time frame: Baseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]
| Milestone | EPG Tx Then Sound Production Treatment (SPT) | Sound Production Treatment (SPT) Then EPG Tx |
|---|---|---|
| Started | 3 | 3 |
| Completed | 3 | 2 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | EPG Tx Then Sound Production Treatment (SPT) | Sound Production Treatment (SPT) Then EPG Tx |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
| Milestone | EPG Tx Then Sound Production Treatment (SPT) | Sound Production Treatment (SPT) Then EPG Tx |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
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)
| % change | EPG Treatment | Sound Production Treatment |
|---|---|---|
| Speech Production: Percent Change in Treated Items Immediately Post Treatment | 59 (40 to 78) | 66 (62 to 70) |
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)
| % change | Treatment With EPG | Sound Production Treatment |
|---|---|---|
| Speech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment | 5 (0 to 10) | 50 (40 to 60) |
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.
| % change | Treatment With EPG | Sound Production Treatment |
|---|---|---|
| Speech Production: Percent Change for Treated Items After the Completion of Treatment | 43 (20 to 66) | 61 (45 to 77) |
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)
| T-Score | All Participants - Pre vs. Post Treatment |
|---|---|
| Pre-Treatment | 43.0 ± 16 |
| Post-Treatment | 46.0 ± 21 |
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 \[not measured after each treatment\].
| Percentage of Words Intelligible | All Participants - Pre vs. Post Treatment |
|---|---|
| Pre-Treatment | 40.0 ± 30 |
| Post-Treatment | 50.0 ± 25 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EPG Treatment: All Participants | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Sound Production Treatment: All Participants | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
Participants had moderate to severe acquired apraxia of speech and accompanying aphasia.
| Age, Continuous(Years) | All Participants |
|---|---|
| Mean | 64.6 ± 15.4 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 3 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 6 |
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