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staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback

staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04474691
Acronym
staRt
Enrollment
15
Registered
2020-07-17
Start date
2018-04-04
Completion date
2022-02-28
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Speech Sound Disorder

Keywords

speech, articulation, motor development

Brief summary

Previous research suggests that biofeedback can outperform traditional interventions for RSE, but no controlled studies have tested this hypothesis in the context of app-delivered biofeedback. The objective of this aim is to use the staRt app to test our working hypothesis that speakers will make larger gains in /r/ accuracy when app-based treatment incorporates biofeedback, compared to a non-biofeedback condition. With a network of cooperating SLPs, this project will recruit 15 children with /r/ misarticulation to receive 8 weeks of intervention using staRt. Individual sessions will be randomly assigned to include or exclude the visual biofeedback display. Randomization tests will be used to evaluate, for each individual, whether larger increments of change are associated with biofeedback and non-biofeedback sessions.

Interventions

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.

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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
New York University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Acoustic measures will be obtained by research assistants blinded to the treatment condition assigned for each session.

Intervention model description

Children with /r/ misarticulation will receive 16 sessions/8 weeks of intervention using staRt. Individual sessions will be randomly assigned to include the visual biofeedback display (visual-acoustic biofeedback treatment) or exclude it (traditional treatment). Participants will receive an equal number of sessions (8) of each type.

Eligibility

Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

* Normal performance on a pure-tone hearing screening at 20 dB HL, a screening examination of oral-motor structure and function, and a test of receptive language.

Exclusion criteria

* History of major behavioral, neurological, or hearing impairment, per parent and/or SLP report.

Design outcomes

Primary

MeasureTime frameDescription
F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.F3-F2 distance was measured in all 16 treatment sessions (eight of each type), which were administered over eight weeks.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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

This study used a within-subjects design. Each participant received both treatment conditions, with sessions randomly assigned to feature one condition or the other.

Participants by arm

ArmCount
Visual-acoustic Biofeedback and Traditional Articulation Treatment
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.
15
Total15

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrawal by Subject9

Baseline characteristics

CharacteristicVisual-acoustic Biofeedback and Traditional Articulation Treatment
Age, Continuous11.3 years
STANDARD_DEVIATION 1.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
11 Participants
Region of Enrollment
United States
15 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 15
other
Total, other adverse events
0 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 15

Outcome results

Primary

F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Traditional Articulation TreatmentF3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.1793.3 HzStandard Deviation 158.3
Visual-acoustic BiofeedbackF3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.1772.2 HzStandard Deviation 99.5
p-value: 0.67t-test, 1 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026