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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02554513
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Actual Duration (Months): 43.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Apraxia of Speech; Aphasia, Acquired; Speech Disorders	Device: EPG Tx; Behavioral: SPT	N/A

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)?

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Each participant received each arm of treatmentEach participant received each arm of treatment
• Masking: Single (Outcomes Assessor)
• Masking Description: Single
• Primary Purpose: Treatment
• Official Title: Apraxia of Speech: A Comparison of EPG Treatment & Sound Production Treatment
• Actual Study Start Date: Nov 2, 2015
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Jun 28, 2019

Arms and Interventions

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	Device: EPG Tx; behavioral intervention that incorporates a device that provides visual biofeedback; Other Names: Electropalatography Treatment, Palatometer Treatment
Active Comparator: Sound Production Treatment (SPT) An articulatory-kinematic treatment that uses integral stimulation to improve speech production.	Behavioral: SPT; A treatment hierarchy involving integral stimulation; Other Names: Sound Production Treatment

Outcome Measures

Primary Outcome Measures

1. Speech Production: Percent Change in Treated Items Immediately Post Treatment [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)

Secondary Outcome Measures

1. Speech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment [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)

2. Speech Production: Percent Change for Treated Items After the Completion of Treatment [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.

3. Functional Communication Skills: T-Score [Baseline 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)

4. Speech Intelligibility: Percentage [Baseline 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].

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah	United States	84148

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Shannon C Mauszycki, PhD, VA Salt Lake City Health Care System, Salt Lake City, UT

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 12, 2020

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02554513
• Other Study ID Numbers: C2068-P
• First Posted: Sep 18, 2015
• Last Update Posted: Nov 4, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Apraxia of Speech; Treatment
• Additional relevant MeSH terms: Aphasia; Apraxias; Speech Disorders

Study Results

Participant Flow

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

Arm/Group Title	EPG Tx Then Sound Production Treatment (SPT)	Sound Production Treatment (SPT) Then EPG Tx
Arm/Group Description	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.	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.
Period Title: First Treatment Phase (7 Weeks)
STARTED	3	3
COMPLETED	3	2
NOT COMPLETED	0	1
Period Title: First Treatment Phase (7 Weeks)
STARTED	3	2
COMPLETED	3	2
NOT COMPLETED	0	0
Period Title: First Treatment Phase (7 Weeks)
STARTED	3	2
COMPLETED	3	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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.
Overall Participants	6
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	64.6 (15.4)
Sex: Female, Male (Count of Participants)
Female	3 50%
Male	3 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	1 16.7%
Black or African American	0 0%
White	5 83.3%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Speech Production: Percent Change in Treated Items Immediately Post Treatment
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EPG Treatment	Sound Production Treatment
Arm/Group Description	EPG Treatment: Articulatory-Kinematic Treatment in conjunction with visual biofeedback for tongue position	Sound Production Treatment: Articulatory-Kinematic Treatment
Measure Participants	5	5
Mean (Full Range) [% change]	59	66

2. Secondary Outcome

Title	Speech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment With EPG	Sound Production Treatment
Arm/Group Description	Participants received articulatory-kinematic treatment in conjunction with visual-biofeedback via electropalatography (i.e., tongue movement/placement)	Participants received articulatory-kinematic treatment
Measure Participants	5	5
Mean (Full Range) [% change]	5	50

3. Secondary Outcome

Title	Speech Production: Percent Change for Treated Items After the Completion of Treatment
Description	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]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment With EPG	Sound Production Treatment
Arm/Group Description	An articulatory-kinematic treatment in conjunction with visual biofeedback for tongue position	An articulatory-kinematic treatment
Measure Participants	5	5
Mean (Full Range) [% change]	43	61

4. Secondary Outcome

Title	Functional Communication Skills: T-Score
Description	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]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants - Pre vs. Post Treatment
Arm/Group Description	Aphasia Communication Outcome Measure (ACOM)
Measure Participants	5
Pre-Treatment	43.0 (16)
Post-Treatment	46.0 (21)

5. Secondary Outcome

Title	Speech Intelligibility: Percentage
Description	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]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants - Pre vs. Post Treatment
Arm/Group Description	Assessment of Intelligibility of Dysarthric Speech (ASSIDS) - Word Level
Measure Participants	5
Pre-Treatment	40.0 (30)
Post-Treatment	50.0 (25)

Adverse Events

Time Frame	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.
Arm/Group Title	EPG Treatment: All Participants		Sound Production Treatment: All Participants
Arm/Group Description	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.		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.
All Cause Mortality
	EPG Treatment: All Participants		Sound Production Treatment: All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Serious Adverse Events
	EPG Treatment: All Participants		Sound Production Treatment: All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	EPG Treatment: All Participants		Sound Production Treatment: All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.