Trial Outcomes & Findings for Apraxia of Speech: Comparison of EPG Treatment (Tx) and Sound Production Treatment (SPT) (NCT NCT02554513)
NCT ID: NCT02554513
Last Updated: 2021-11-04
Results Overview
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)
COMPLETED
NA
6 participants
Baseline vs. Immediately Post Treatment (7 week treatment period)
2021-11-04
Participant Flow
Each participant received each treatment arm in this crossover design. Order of treatment assignment was random.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Treatment Phase (7 Weeks)
STARTED
|
3
|
3
|
|
First Treatment Phase (7 Weeks)
COMPLETED
|
3
|
2
|
|
First Treatment Phase (7 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Washout (2 Weeks)
STARTED
|
3
|
2
|
|
Washout (2 Weeks)
COMPLETED
|
3
|
2
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Treatment Phase (7 Weeks)
STARTED
|
3
|
2
|
|
Second Treatment Phase (7 Weeks)
COMPLETED
|
3
|
2
|
|
Second Treatment Phase (7 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
First Treatment Phase (7 Weeks)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Apraxia of Speech: Comparison of EPG Treatment (Tx) and Sound Production Treatment (SPT)
Baseline characteristics by cohort
| Measure |
All Participants
n=6 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.
|
|---|---|
|
Age, Continuous
|
64.6 Years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
EPG Treatment
n=5 Participants
EPG Treatment: Articulatory-Kinematic Treatment in conjunction with visual biofeedback for tongue position
|
Sound Production Treatment
n=5 Participants
Sound Production Treatment: Articulatory-Kinematic Treatment
|
|---|---|---|
|
Speech Production: Percent Change in Treated Items Immediately Post Treatment
|
59 % change
Interval 40.0 to 78.0
|
66 % change
Interval 62.0 to 70.0
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
EPG Treatment
n=5 Participants
EPG Treatment: Articulatory-Kinematic Treatment in conjunction with visual biofeedback for tongue position
|
Sound Production Treatment
n=5 Participants
Sound Production Treatment: Articulatory-Kinematic Treatment
|
|---|---|---|
|
Speech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment
|
5 % change
Interval 0.0 to 10.0
|
50 % change
Interval 40.0 to 60.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
EPG Treatment
n=5 Participants
EPG Treatment: Articulatory-Kinematic Treatment in conjunction with visual biofeedback for tongue position
|
Sound Production Treatment
n=5 Participants
Sound Production Treatment: Articulatory-Kinematic Treatment
|
|---|---|---|
|
Speech Production: Percent Change for Treated Items After the Completion of Treatment
|
43 % change
Interval 20.0 to 66.0
|
61 % change
Interval 45.0 to 77.0
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
EPG Treatment
n=5 Participants
EPG Treatment: Articulatory-Kinematic Treatment in conjunction with visual biofeedback for tongue position
|
Sound Production Treatment
Sound Production Treatment: Articulatory-Kinematic Treatment
|
|---|---|---|
|
Functional Communication Skills: T-Score
Pre-Treatment
|
43.0 T-Score
Standard Deviation 16
|
—
|
|
Functional Communication Skills: T-Score
Post-Treatment
|
46.0 T-Score
Standard Deviation 21
|
—
|
SECONDARY outcome
Timeframe: 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 \[not measured after each treatment\].
Outcome measures
| Measure |
EPG Treatment
n=5 Participants
EPG Treatment: Articulatory-Kinematic Treatment in conjunction with visual biofeedback for tongue position
|
Sound Production Treatment
Sound Production Treatment: Articulatory-Kinematic Treatment
|
|---|---|---|
|
Speech Intelligibility: Percentage
Pre-Treatment
|
40.0 Percentage of Words Intelligible
Standard Deviation 30
|
—
|
|
Speech Intelligibility: Percentage
Post-Treatment
|
50.0 Percentage of Words Intelligible
Standard Deviation 25
|
—
|
Adverse Events
EPG Treatment: All Participants
Sound Production Treatment: All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place