Apraxia of SpeechEPG&SPTNCT02554513
Apraxia of Speech: Comparison of EPG Treatment (Tx) and Sound Production Treatment (SPT)
A study testing EPG Tx and SPT in people with Apraxia of Speech and Aphasia, Acquired, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Apraxia of Speech, Aphasia, Acquired, Speech Disorders
- What is being tested?
- EPG Tx and SPT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2015to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
About this study
Official title: Apraxia of Speech: A Comparison of EPG Treatment & Sound Production 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.
Read the 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)?
- Conditions
- Apraxia of Speech, Aphasia, Acquired, Speech Disorders
- Being tested
- EPG Tx, SPT
- Keywords
- Apraxia of Speech, Treatment
- Medical subject headings
- Apraxias, Aphasia, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPG TxDevice
Also called Electropalatography Treatment, Palatometer Treatment
behavioral intervention that incorporates a device that provides visual biofeedback
SPTBehavioural
Also called Sound Production Treatment
A treatment hierarchy involving integral stimulation
| Study group | Role | What they receive |
|---|---|---|
| EPG Tx | Active comparator | An articulatory-kinematic treatment in conjunction with visual biofeedback specifically tongue to palate contact to improve speech production Receives: Device: EPG Tx |
| Sound Production Treatment (SPT) | Active comparator | An articulatory-kinematic treatment that uses integral stimulation to improve speech production. Receives: Behavioral: SPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline vs. Immediately Post Treatment (7 week treatment period)
Secondary outcomes (4)
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)
Measured: 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.
Measured: 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)
Measured: 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].
Measured: Baseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start2 Nov 2015
- Primary completion1 Feb 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apraxia of SpeechStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Each participant received each arm of treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shannon C Mauszycki, PhD, Principal investigator, VA Salt Lake City Health Care System, Salt Lake City, UT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554513
- Sponsor's protocol ID
- C2068-P
- Acronym
- EPG&SPT
- Status last verified
- Oct 2021
- First submitted
- 19 Aug 2015
- Last updated
- 4 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31693389
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apraxia of Speech: A Comparison of EPG Treatment & Sound Production Treatment
- ClinicalTrials.gov ID
- NCT02554513
- Acronym / sponsor ID
- EPG&SPT / C2068-P
- Conditions
- Apraxia of Speech, Aphasia, Acquired, Speech Disorders
- Keywords
- Apraxia of Speech, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Posted 4 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant received each arm of treatment
| Arm | Type | Receives |
|---|---|---|
| EPG Tx | Active comparator | Device: EPG TxAn articulatory-kinematic treatment in conjunction with visual biofeedback specifically tongue to palate contact to improve speech production |
| Sound Production Treatment (SPT) | Active comparator | Behavioral: SPTAn articulatory-kinematic treatment that uses integral stimulation to improve speech production. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPG TxAlso: Electropalatography Treatment, Palatometer Treatmentbehavioral intervention that incorporates a device that provides visual biofeedback | Device | EPG Tx |
| SPTAlso: Sound Production TreatmentA treatment hierarchy involving integral stimulation | Behavioural | Sound Production Treatment (SPT) |
Primary outcome
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)
4 secondary outcomes
Speech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment
Time frame: 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]
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]
Speech Intelligibility: Percentage
Time frame: Baseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31693389Mauszycki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon C Mauszycki, PhD principal investigator
VA Salt Lake City Health Care System, Salt Lake City, UT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPG Tx and SPT in people with Apraxia of Speech and Aphasia, Acquired, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Production: Percent Change in Treated Items Immediately Post Treatment (time frame: Baseline vs. Immediately Post Treatment (7 week treatment period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02554513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.