Trial Outcomes & Findings for Delineation of Sensorimotor Subtypes Underlying Residual Speech Errors (NCT NCT03736213)
NCT ID: NCT03736213
Last Updated: 2023-12-11
Results Overview
During treatment, one trial in each block of 10 was flagged for measurement and the first three formants (F1, F2, F3) were extracted from the center of the /r/ interval. The distance between the second and third formants (F3-F2) was converted to z-scores relative to normative data from age-matched children with typical speech (Lee et al., 1999). A z-score of 0 represents the mean F3-F2 distance for typical children; a z-score of 1 indicates one standard deviation of the normative sample above the sample mean. Because F3-F2 is small in perceptually accurate /r/, larger values indicate lower accuracy; z-scores above 2 are considered clinically atypical. Summary statistics report the mean and standard deviation of normalized F3-F2 distance for each treatment condition, pooled across participants and sessions. A two-tailed paired-samples t-test (superiority criterion) was used to compare mean normalized F3-F2 distance for each treatment condition across subjects.
COMPLETED
PHASE1
7 participants
Acoustic accuracy was measured in all ten sessions of each type of treatment, which were administered over five weeks.
2023-12-11
Participant Flow
Institutional review board approval was obtained from the Biomedical Research Alliance of New York (BRANY, protocol number 18-10-393). Participants were recruited via clinical referrals and public notices in the vicinity of the two treatment sites: Syracuse, NY, and Montclair, NJ. Outreach was conducted using 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.
Unit of analysis: Sessions
Participant milestones
| Measure |
Visual-acoustic Biofeedback
In visual-acoustic biofeedback treatment, the elements of traditional articulatory 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 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.
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Ultrasound Biofeedback
In ultrasound biofeedback, the elements of traditional articulatory treatment are enhanced with a real-time ultrasound display of the shape and movements of the tongue. One or two target tongue shapes will be selected for each participant, and a trace of the selected target will be superimposed over the ultrasound screen. Participants will be cued to reshape the tongue to match this target during /r/ production.
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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
Delineation of Sensorimotor Subtypes Underlying Residual Speech Errors
Baseline characteristics by cohort
| Measure |
Visual-acoustic Biofeedback and Ultrasound Biofeedback
n=7 Participants
This study used a within-subjects design. Each participant received two treatment conditions (visual-acoustic biofeedback and ultrasound biofeedback), with sessions randomly assigned to feature one condition or the other.
Biofeedback--visual-acoustic and ultrasound: In visual-acoustic biofeedback treatment, the elements of traditional articulatory 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 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. In ultrasound biofeedback, the elements of traditional articulatory treatment are enhanced with a real-time ultrasound display of the shape and movements of the tongue. One or two target tongue shapes will be selected for each participant, and a trace of the selected target will be superimposed over the ultrasound screen. Participants will be cued to reshape the tongue to match this target during /r/ production.
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|---|---|
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Age, Continuous
|
147.1 months
STANDARD_DEVIATION 32.7 • n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 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
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PRIMARY outcome
Timeframe: Acoustic accuracy was measured in all ten sessions of each type of treatment, which were administered over five 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. Each participant completed 10 sessions of each type.
During treatment, one trial in each block of 10 was flagged for measurement and the first three formants (F1, F2, F3) were extracted from the center of the /r/ interval. The distance between the second and third formants (F3-F2) was converted to z-scores relative to normative data from age-matched children with typical speech (Lee et al., 1999). A z-score of 0 represents the mean F3-F2 distance for typical children; a z-score of 1 indicates one standard deviation of the normative sample above the sample mean. Because F3-F2 is small in perceptually accurate /r/, larger values indicate lower accuracy; z-scores above 2 are considered clinically atypical. Summary statistics report the mean and standard deviation of normalized F3-F2 distance for each treatment condition, pooled across participants and sessions. A two-tailed paired-samples t-test (superiority criterion) was used to compare mean normalized F3-F2 distance for each treatment condition across subjects.
Outcome measures
| Measure |
Visual-acoustic Biofeedback
n=7 Participants
Visual-acoustic biofeedback: In visual-acoustic biofeedback treatment, the elements of traditional articulatory 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 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.
|
Ultrasound Biofeedback
n=7 Participants
In ultrasound biofeedback, the elements of traditional articulatory treatment are enhanced with a real-time ultrasound display of the shape and movements of the tongue. One or two target tongue shapes will be selected for each participant, and a trace of the selected target will be superimposed over the ultrasound screen. Participants will be cued to reshape the tongue to match this target during /r/ production.
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|---|---|---|
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Normalized F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.
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5.73 Z-score
Standard Deviation 6.33
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6.27 Z-score
Standard Deviation 6.27
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Adverse Events
Visual-acoustic Biofeedback
Ultrasound Biofeedback
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