Trial Outcomes & Findings for staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback (NCT NCT04474691)
NCT ID: NCT04474691
Last Updated: 2023-05-03
Results Overview
From recordings of words containing /r/ produced during treatment sessions, the sound /r/ 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 used as the index of rhoticity. F3-F2 is small in perceptually accurate /r/, larger values indicate lower accuracy. 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 F3-F2 distance for each treatment condition across subjects.
COMPLETED
NA
15 participants
F3-F2 distance was measured in all 16 treatment sessions (eight of each type), which were administered over eight weeks.
2023-05-03
Participant Flow
Social media and mailing lists were used to identify certified speech-language pathologists interested in providing the study treatment to consenting participants on their caseload. Clinical partners completed CITI human subjects training (both basic social/behavioral and Good Clinical Practice). They were also required to complete an Individual Investigator Agreement (if not already covered by an existing IRB) or secure a reliance agreement (if covered by an existing IRB) with the IRB at NYU.
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 and Traditional Articulation Treatment
Visual-acoustic biofeedback: In visual-acoustic biofeedback treatment, the elements of traditional treatment (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 generated by the staRt app. 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. Knowledge of performance feedback will typically involve reference to the location of the third peak or 'bump' on the visual display.
Traditional articulation treatment: Traditional 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 can be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound.
|
|---|---|
|
Overall Study
STARTED
|
15 240
|
|
Overall Study
Visual-acoustic Biofeedback
|
8 56
|
|
Overall Study
Traditional Articulation Treatment
|
8 53
|
|
Overall Study
COMPLETED
|
6 96
|
|
Overall Study
NOT COMPLETED
|
9 144
|
Reasons for withdrawal
| Measure |
Visual-acoustic Biofeedback and Traditional Articulation Treatment
Visual-acoustic biofeedback: In visual-acoustic biofeedback treatment, the elements of traditional treatment (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 generated by the staRt app. 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. Knowledge of performance feedback will typically involve reference to the location of the third peak or 'bump' on the visual display.
Traditional articulation treatment: Traditional 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 can be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
Baseline Characteristics
staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback
Baseline characteristics by cohort
| Measure |
Visual-acoustic Biofeedback and Traditional Articulation Treatment
n=15 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. In traditional articulation treatment, the clinician provides auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract can be used as visual aids; however, no real-time visual display of articulatory or acoustic information is made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound. 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 are cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency.
|
|---|---|
|
Age, Continuous
|
11.3 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 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
|
2 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 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
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: F3-F2 distance was measured in all 16 treatment sessions (eight of each type), which were administered over eight 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.
From recordings of words containing /r/ produced during treatment sessions, the sound /r/ 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 used as the index of rhoticity. F3-F2 is small in perceptually accurate /r/, larger values indicate lower accuracy. 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 F3-F2 distance for each treatment condition across subjects.
Outcome measures
| Measure |
Traditional Articulation Treatment
n=6 Participants
In traditional articulation treatment, the clinician provides auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract can be used as visual aids; however, no real-time visual display of articulatory or acoustic information is made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound.
|
Visual-acoustic Biofeedback
n=6 Participants
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 are cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency.
|
|---|---|---|
|
F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.
|
1793.3 Hz
Standard Deviation 158.3
|
1772.2 Hz
Standard Deviation 99.5
|
Adverse Events
Visual-acoustic Biofeedback
Traditional Articulation 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