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

Apraxia of Speech: A Comparison of EPG Treatment & Sound Production Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02554513
Acronym
EPG&SPT
Enrollment
6
Registered
2015-09-18
Start date
2015-11-02
Completion date
2019-06-28
Last updated
2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Acquired, Apraxia of Speech, Speech Disorders

Keywords

Apraxia of Speech, Treatment

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: 1. Will treatment using an EPG approach or an SPT approach result in greater accuracy of articulation of trained speech sounds produced in words? 2. 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)? 3. Will treatment using an EPG approach or an SPT approach result in greater long term maintenance effects for trained speech sounds? 4. 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)?

Interventions

DEVICEEPG Tx

behavioral intervention that incorporates a device that provides visual biofeedback

BEHAVIORALSPT

A treatment hierarchy involving integral stimulation

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Single

Intervention model description

Each participant received each arm of treatment

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Speech Production: Percent Change in Treated Items Immediately Post TreatmentBaseline 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)

Secondary

MeasureTime frameDescription
Speech Production: Percent Change in Untreated Items (Related Items) Immediately Post TreatmentBaseline 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)
Speech Production: Percent Change for Treated Items After the Completion of TreatmentBaseline 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.
Functional Communication Skills: T-ScoreBaseline vs. 10 weeks after the completion of all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]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: PercentageBaseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]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 \[not measured after each treatment\].

Countries

United States

Participant flow

Pre-assignment details

Each participant received each treatment arm in this crossover design. Order of treatment assignment was random.

Participants by arm

ArmCount
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.
6
Total6

Withdrawals & dropouts

PeriodReasonFG000FG001
First Treatment Phase (7 Weeks)Withdrawal by Subject01

Baseline characteristics

CharacteristicAll Participants
Age, Continuous64.6 Years
STANDARD_DEVIATION 15.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
5 Participants
Region of Enrollment
United States
6 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 5
other
Total, other adverse events
0 / 50 / 5
serious
Total, serious adverse events
0 / 50 / 5

Outcome results

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)

Time frame: Baseline vs. Immediately Post Treatment (7 week treatment period)

ArmMeasureValue (MEAN)
EPG TreatmentSpeech Production: Percent Change in Treated Items Immediately Post Treatment59 % change
Sound Production TreatmentSpeech Production: Percent Change in Treated Items Immediately Post Treatment66 % change
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)

Time frame: Baseline vs. 10 weeks after the completion of all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]

ArmMeasureGroupValue (MEAN)Dispersion
EPG TreatmentFunctional Communication Skills: T-ScorePost-Treatment46.0 T-ScoreStandard Deviation 21
EPG TreatmentFunctional Communication Skills: T-ScorePre-Treatment43.0 T-ScoreStandard Deviation 16
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 \[not measured after each treatment\].

Time frame: Baseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]

ArmMeasureGroupValue (MEAN)Dispersion
EPG TreatmentSpeech Intelligibility: PercentagePre-Treatment40.0 Percentage of Words IntelligibleStandard Deviation 30
EPG TreatmentSpeech Intelligibility: PercentagePost-Treatment50.0 Percentage of Words IntelligibleStandard Deviation 25
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.

Time frame: Baseline vs. 7 weeks post treatment [measured immediately after the completion of each treatment]

ArmMeasureValue (MEAN)
EPG TreatmentSpeech Production: Percent Change for Treated Items After the Completion of Treatment43 % change
Sound Production TreatmentSpeech Production: Percent Change for Treated Items After the Completion of Treatment61 % change
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)

Time frame: Baseline vs. Immediately Post Treatment (7 week treatment period)

ArmMeasureValue (MEAN)
EPG TreatmentSpeech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment5 % change
Sound Production TreatmentSpeech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment50 % change

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026