Visual-Acoustic Biofeedback for Speech Sound Disorder

(VISIT Trial)

Recruiting at 2 trial locations

Age: < 18

Sex: Female

Trial Phase: Phase 2

Sponsor: New York University

Disqualifiers: Voice disorder, Orthodontia, Hearing loss, Developmental disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help children with speech sound disorders improve their speech clarity. The treatment uses visual-acoustic biofeedback, allowing children to see and hear how to pronounce words correctly. Researchers aim to determine if this treatment is as effective online as it is in person. Children suitable for this trial struggle with pronouncing the /r/ sound and must have a computer and internet access at home for online sessions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to early findings.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that visual-acoustic biofeedback is safe for children with speech sound disorder?

Research has shown that visual-acoustic biofeedback is safe for treating speech sound disorders. This technology often uses ultrasound and remains non-invasive, meaning it doesn't involve surgery or inserting anything into the body. One study reviewed several articles on similar treatments and found no reports of serious side effects. Overall, patients appear to handle the treatment well. These findings suggest that visual-acoustic biofeedback offers a promising and safe method to improve speech in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about visual-acoustic biofeedback for speech sound disorder because it offers a unique, interactive approach that combines visual and auditory cues to help individuals correct their speech. Unlike traditional speech therapy, which often relies solely on auditory feedback, this method provides real-time visual feedback, giving participants a clear picture of how their speech sounds and how it can be adjusted. Additionally, the treatment's flexible delivery options, including both telepractice and in-person sessions, make it more accessible and adaptable to different needs and settings. This innovative approach has the potential to enhance engagement and accelerate progress in speech therapy compared to conventional methods.

What evidence suggests that visual-acoustic biofeedback is effective for speech sound disorder?

Research shows that visual-acoustic biofeedback can greatly improve speech in children with speech sound disorders. Studies have found that children using this therapy improve faster than with traditional methods. This treatment uses real-time visual tools, like ultrasound, to help children see and adjust their tongue movements for better speech. In this trial, participants will receive visual-acoustic biofeedback treatment either through telepractice delivery or in-person delivery. Both in-person and online versions of this treatment have been tested and show promising results, making the therapy accessible without losing effectiveness. Recent evidence suggests that adding visual biofeedback technology to treatment may enhance results, especially for children with ongoing speech difficulties. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children with speech sound disorder, which affects their clarity of speech. The study aims to help these children improve their spoken communication through a special treatment using visual-acoustic biofeedback.

Inclusion Criteria

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

Must have home wifi sufficient to support video calls in the event of randomization to the telepractice condition

I have a laptop or desktop computer for study sessions.

Exclusion Criteria

I have not had an epileptic seizure in the last 6 months.

I do not have non-removable braces that cross my palate.

I do not have noticeable speech difficulties.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive visual-acoustic biofeedback treatment delivered either in-person or via telepractice

10 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Visual-acoustic biofeedback

Trial Overview

The trial is testing if visual-acoustic biofeedback therapy for speech sound disorder can be just as effective when given online (telepractice) as it is in person. Children will use the staRt software and their progress will be measured by how well they speak before and after the treatment.

How Is the Trial Designed?

Group I: Telepractice delivery Experimental Treatment 1 Intervention

Participants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room.

Group II: In-person delivery Active Control 1 Intervention

Participants will receive visual-acoustic biofeedback treatment from a clinician in a private room in research space at one of the two clinical research sites.

Visual-acoustic biofeedback is already approved in United States, European Union for the following indications:

Approved in United States as Visual-acoustic biofeedback therapy for:

• Speech sound disorder
• Residual speech errors
• Childhood apraxia of speech

Approved in European Union as Visual-acoustic biofeedback therapy for:

• Speech sound disorder
• Residual speech errors
• Childhood apraxia of speech

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Montclair State University

Collaborator

Trials

14

Recruited

1,200+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Syracuse University

Collaborator

Trials

54

Recruited

118,000+

Published Research Related to This Trial

Real-time ultrasound scanning was used as a biofeedback therapy to help correct a persistent speech defect by allowing the subject to visualize her tongue movements during speech exercises.

Preliminary results indicate that this ultrasound technique may enhance traditional speech therapy methods, providing a valuable tool for improving articulatory accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound biofeedback for speech training. Instrumentation and preliminary results. Shawker, TH., Sonies, BC.[2019]

In a study involving 62 participants aged around 12 years, the majority reported no concerns about using ultrasound visual feedback in speech therapy, indicating a generally positive reception of the treatment.

The most common undesired effects reported were related to the ultrasound gel (40%) and probe positioning (21%), but these were considered minor and should be balanced against the potential benefits of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Participants Report Any Undesired Effects in Ultrasound Speech Therapy? Preston, JL., Holliman-Lopez, G., Leece, MC.[2023]

This pilot randomized control trial will evaluate the feasibility of using ultrasound visual biofeedback (U-VBF) as a new treatment for improving speech in children with cleft lip and palate, comparing it to standard articulation intervention.

The study aims to enroll up to 40 children aged 4 to 16 and will assess important factors like recruitment rates and family acceptability to inform the design of a larger trial in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate. Cleland, J., Crampin, L., Campbell, L., et al.[2022]

Visual-acoustic biofeedback (VAB) treatment can effectively improve speech outcomes for individuals with speech sound difficulties, particularly in correcting distortions of the /ɹ/ sound.

Successful implementation of VAB relies on key factors such as understanding acoustic representations, selecting appropriate targets and strategies, and providing effective feedback, which together enhance speech sound acquisition and generalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tutorial: Using Visual-Acoustic Biofeedback for Speech Sound Training. Hitchcock, ER., Ochs, LC., Swartz, MT., et al.[2023]

The study evaluated the effectiveness of diagnostic ultrasound as a visual biofeedback tool for treating seven children aged 6-11 with persistent speech sound disorders that did not respond to traditional therapies.

All children showed significant improvement in their speech sound production after the intervention, as indicated by perceptual measures and observable changes in tongue shape, highlighting the potential of ultrasound in speech therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using ultrasound visual biofeedback to treat persistent primary speech sound disorders. Cleland, J., Scobbie, JM., Wrench, AA.[2022]

The study demonstrated that ultrasound visual biofeedback (UVB) training is highly effective in teaching speech-language pathologists (SLPs) how to assess and modify tongue configuration to help correct speech sound errors, based on a proof-of-concept involving two SLPs with no prior experience in UVB.

This research fills a gap in the literature by providing empirical evidence for the effectiveness of UVB training, suggesting it could be a valuable tool for SLPs and academic programs focused on evidence-based teaching strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Ultrasound Visual Biofeedback Training for Tongue Shape Assessment During Speech Sound Production. Campos, AR., Ristau, J.[2022]

Ultrasound visual biofeedback treatment was effective in teaching new speech articulations to children aged 6-15 with various speech sound disorders, with 10 out of 15 participants achieving their target articulation within the first two sessions.

While the treatment showed promise for establishing new articulations, the generalization of these skills to untreated words varied significantly among participants, indicating that while effective, the approach may need further refinement for broader application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enabling New Articulatory Gestures in Children With Persistent Speech Sound Disorders Using Ultrasound Visual Biofeedback. Cleland, J., Scobbie, JM., Roxburgh, Z., et al.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11101137/

Traditional and Visual-Acoustic Biofeedback Treatment via ...

This study aimed to examine the feasibility of telepractice delivery of a treatment package including visual-acoustic biofeedback and motor-based treatment ...

2.

pubs.asha.org

pubs.asha.org/doi/abs/10.1044/2023_PERSP-23-00120

Traditional and Visual–Acoustic Biofeedback Treatment via ...

This study aimed to examine the feasibility of telepractice delivery of a treatment package including visual–acoustic biofeedback (VAB) and motor-based ...

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withpower.com

withpower.com/trial/phase-2-speech-sound-disorder-6-2024-e152c

Visual-Acoustic Biofeedback for Speech Sound Disorder

Visual-acoustic biofeedback treatment is unique because it uses real-time visual tools like ultrasound to help individuals see and correct their tongue ...

4.

frontiersin.org

frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2016.00567/full

Differential Effects of Visual-Acoustic Biofeedback ...

Recent evidence suggests that the incorporation of visual biofeedback technologies may enhance response to treatment in individuals with residual speech errors.

5.

digitalcommons.montclair.edu

digitalcommons.montclair.edu/cgi/viewcontent.cgi?article=1111&context=communcsci-disorders-facpubs

Speech Sound Disorder and Visual Biofeedback Intervention

Twenty-nine articles reporting the use of visual biofeedback intervention for speech sound disorder were identified and coded for treatment ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10023147/

Tutorial: Using Visual–Acoustic Biofeedback for Speech ...

This tutorial summarizes current practices using visual–acoustic biofeedback (VAB) treatment to improve speech outcomes for individuals with speech sound ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10152317/

An initial framework for use of ultrasound by speech and ...

There is growing evidence to support the use of ultrasound as a tool for the assessment and treatment of speech, voice and swallowing disorders across the ...

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researchgate.net

researchgate.net/publication/330917496_Enabling_New_Articulatory_Gestures_in_Children_With_Persistent_Speech_Sound_Disorders_Using_Ultrasound_Visual_Biofeedback

Enabling New Articulatory Gestures in Children With ...

Purpose This study evaluated ultrasound visual biofeedback treatment for teaching new articulations to children with a wide variety of speech sound disorders.