Trial Outcomes & Findings for Comparing Traditional and Biofeedback Telepractice Treatment for Residual Speech Errors (NCT NCT04625062)
NCT ID: NCT04625062
Last Updated: 2023-02-13
Results Overview
To assess /r/ production accuracy, participants read probe lists eliciting 25 utterances of /r/ in various phonetic contexts at the start and end of each treatment session. Recorded probe words are presented in randomized order for binary rating (correct/incorrect) by naive listeners who are blind to treatment condition and time point; the accuracy of each token is quantified as the percentage of "correct" ratings across 9 blinded listeners. We then compute the mean percent correct ratings for each probe; the change in this value from pre to post session ("within-session change") is our outcome measure of interest. Summary statistics report the mean and standard deviation of within-session change for each treatment condition, pooled across participants and sessions. This Outcome Measure is assessed using a two-tailed paired-samples t-test comparing mean change in percent correct for each treatment condition across subjects. Outcomes are evaluated relative to a superiority criterion.
COMPLETED
PHASE1
7 participants
Change in word probe accuracy was measured in each treatment session, which were administered over ten weeks.
2023-02-13
Participant Flow
Institutional review board approval was obtained from the Biomedical Research Alliance of New York (BRANY, protocol number 18-10-393). Participants, who could come from anywhere in the US, were recruited through recruitment flyers, listserv announcements, and social media posts.
This study used a within-subjects design. Each participant received both treatment conditions, with sessions randomly assigned to feature one condition or the other (n = 10 sessions in each condition).
Unit of analysis: Sessions
Participant milestones
| Measure |
Visual-acoustic Biofeedback
Visual-acoustic biofeedback: In visual-acoustic biofeedback treatment, the elements of motor-based treatment (i.e., auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3. All treatment will be provided over video calls. All participants completed 10 sessions in the visual-acoustic biofeedback condition.
|
Motor-based Treatment
Motor-based treatment: Motor-based articulation treatment involves providing auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract will be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. All treatment will be provided over video calls. All participants completed 10 sessions in the motor-based treatment condition.
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|---|---|---|
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Overall Study
STARTED
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7 10
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7 10
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Overall Study
COMPLETED
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7 10
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7 10
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Overall Study
NOT COMPLETED
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0 0
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Traditional and Biofeedback Telepractice Treatment for Residual Speech Errors
Baseline characteristics by cohort
| Measure |
Visual-acoustic Biofeedback and Motor-based Treatment
n=7 Participants
This study used a within-subjects randomization design. Each participant received both treatment conditions, with sessions randomly assigned to feature one condition or the other.
Visual-acoustic biofeedback treatment (behavioral) administered via telepractice
Visual-acoustic biofeedback: In visual-acoustic biofeedback treatment, the elements of motor-based treatment (i.e., auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3. All treatment will be provided over video calls.
Motor-based articulation treatment administered via telepractice
Motor-based treatment: Motor-based articulation treatment involves providing auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract will be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. All treatment will be provided over video calls.
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|---|---|
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Age, Continuous
|
132 months
STANDARD_DEVIATION 21.3 • n=5 Participants
|
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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7 participants
n=5 Participants
|
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Percent /r/ sounds correct
|
19.4 Percentage words rated correct
STANDARD_DEVIATION 18.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change in word probe accuracy was measured in each treatment session, which were administered over ten weeks.Population: Note that this study used a within-subjects design. Each participant received both treatment conditions, with individual sessions randomly assigned to feature one condition or the other.
To assess /r/ production accuracy, participants read probe lists eliciting 25 utterances of /r/ in various phonetic contexts at the start and end of each treatment session. Recorded probe words are presented in randomized order for binary rating (correct/incorrect) by naive listeners who are blind to treatment condition and time point; the accuracy of each token is quantified as the percentage of "correct" ratings across 9 blinded listeners. We then compute the mean percent correct ratings for each probe; the change in this value from pre to post session ("within-session change") is our outcome measure of interest. Summary statistics report the mean and standard deviation of within-session change for each treatment condition, pooled across participants and sessions. This Outcome Measure is assessed using a two-tailed paired-samples t-test comparing mean change in percent correct for each treatment condition across subjects. Outcomes are evaluated relative to a superiority criterion.
Outcome measures
| Measure |
Condition 1: Visual-acoustic Biofeedback
n=10 Sessions
Visual-acoustic biofeedback treatment (behavioral) administered via telepractice
Visual-acoustic biofeedback: In visual-acoustic biofeedback treatment, the elements of motor- based treatment (i.e., auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3. All treatment will be provided over video calls.
|
Condition 2: Motor-based Treatment
n=7 Participants
Motor-based articulation treatment administered via telepractice
Motor-based treatment: Motor-based articulation treatment involves providing auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract will be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. All treatment will be provided over video calls.
|
|---|---|---|
|
Within-session Change in Percentage of "Correct" Ratings by Blinded Naive Listeners for /r/ Sounds Produced in Word Probes
|
1.4 Percent correct
Standard Deviation 8.3
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1.9 Percent correct
Standard Deviation 9.6
|
Adverse Events
Condition 1: Visual-acoustic Biofeedback
Condition 2: Motor-based Treatment
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