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Comparing Traditional and Biofeedback Telepractice Treatment for Residual Speech Errors

Comparing Traditional and Biofeedback Treatment for Residual Speech Errors Via Telepractice

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04625062
Acronym
C-RESULTS TPT
Enrollment
7
Registered
2020-11-12
Start date
2020-09-01
Completion date
2021-03-18
Last updated
2023-02-13

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

This study aims to evaluate the relative efficacy of biofeedback and traditional treatment for residual speech errors when both are delivered via telepractice. In a single-case randomization design, up to eight children with RSE will receive both visual-acoustic biofeedback and traditional treatment via telepractice. Acoustic measures of within-session change will be compared across sessions randomly assigned to each condition. It is hypothesized that participants will exhibit a clinically significant overall treatment response and that short-term measures of change will indicate that biofeedback is associated with larger increments of progress than traditional treatment.

Detailed description

The COVID-19 crisis has forced speech-language pathologists to migrate from in-person delivery of speech treatment services to remote delivery via telepractice. This study will compare the efficacy of visual-acoustic biofeedback treatment versus non-biofeedback treatment in this setting. Specifically, participants will receive both visual-acoustic biofeedback treatment and non-biofeedback treatment via telepractice (Zoom call with screen-sharing) in a single-case randomization design. The hypothesis of interest is that sessions featuring visual-acoustic biofeedback will be associated with larger short-term gains than sessions featuring non-biofeedback treatment. To test this hypothesis, the study team will recruit up to 8 participants who will receive an initial treatment orientation followed by an equal dose of both types of treatment (10 sessions of visual-acoustic biofeedback and 10 sessions of non-biofeedback treatment). Participants will complete approximately two sessions per week via telepractice; each week will feature one session of each type, randomly ordered. They will also complete 4 pre-treatment baseline sessions and 3 post-treatment maintenance sessions to evaluate the overall magnitude of change over the course of treatment.

Interventions

In visual-acoustic biofeedback treatment, participants view a dynamic display of the speech signal in the form of a 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 were cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency.

BEHAVIORALMotor-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 were used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available.

Sponsors

Syracuse University
CollaboratorOTHER
Montclair State University
CollaboratorOTHER
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

All perceptual ratings will be obtained from blinded, naive listeners recruited through online crowdsourcing. Following protocols refined in previous published research, binary rating responses will be aggregated over at least 9 unique listeners per token.

Intervention model description

In this within-subjects single-case randomization design, each participant will receive an equal number of sessions of visual-acoustic biofeedback and traditional treatment (n = 10 each), with randomized allocation of treatment types to individual sessions. Randomization will be blocked, with each week of treatment serving as a block; within each week/block, one session will be randomly assigned to feature visual-acoustic and one to feature traditional treatment.

Eligibility

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

Inclusion criteria

* Must be between 9;0 and 15;11 years of age at the time of enrollment. * Must speak English as the dominant language (i.e., must have begun learning English by age 2, per parent report). * Must speak a rhotic dialect of English. * Must pass a brief examination of oral structure and function. * Must exhibit less than thirty percent accuracy, based on trained listener ratings, on a probe list eliciting /r/ in various phonetic contexts at the word level.

Exclusion criteria

* Must not receive a T score more than 1.3 standard deviations (SD) below the mean on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2) Matrix Reasoning. * Must not receive a scaled score below 6 on the CELF-5 Recalling Sentences or Formulated Sentences subtests. * Must not have history of sensorineural hearing loss or failed infant hearing screening. * Must not have an existing diagnosis of developmental disability, major neurobehavioral syndrome such as cerebral palsy, Down Syndrome, or Autism Spectrum Disorder, or major neural disorder (e.g., epilepsy, agenesis of the corpus callosum) or insult (e.g., traumatic brain injury, stroke, or tumor resection). * Must not show clinically significant signs of apraxia of speech or dysarthria. * Must not have major orthodontia that could interfere with tongue-palate contact.

Design outcomes

Primary

MeasureTime frameDescription
Within-session Change in Percentage of Correct Ratings by Blinded Naive Listeners for /r/ Sounds Produced in Word ProbesChange in word probe accuracy was measured in each treatment session, which were administered over ten weeks.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.

Countries

United States

Participant flow

Recruitment details

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.

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 (n = 10 sessions in each condition).

Participants by arm

ArmCount
Visual-acoustic Biofeedback and Motor-based Treatment
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.
7
Total7

Baseline characteristics

CharacteristicVisual-acoustic Biofeedback and Motor-based Treatment
Age, Continuous132 months
STANDARD_DEVIATION 21.3
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Percent /r/ sounds correct19.4 Percentage words rated correct
STANDARD_DEVIATION 18.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
1 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
5 Participants
Region of Enrollment
United States
7 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 7
other
Total, other adverse events
0 / 70 / 7
serious
Total, serious adverse events
0 / 70 / 7

Outcome results

Primary

Within-session Change in Percentage of Correct Ratings by Blinded Naive Listeners for /r/ Sounds Produced in Word Probes

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Condition 1: Visual-acoustic BiofeedbackWithin-session Change in Percentage of Correct Ratings by Blinded Naive Listeners for /r/ Sounds Produced in Word Probes1.4 Percent correctStandard Deviation 8.3
Condition 2: Motor-based TreatmentWithin-session Change in Percentage of Correct Ratings by Blinded Naive Listeners for /r/ Sounds Produced in Word Probes1.9 Percent correctStandard Deviation 9.6
p-value: 0.72paired t-test, two-tailed

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