Simplified Ultrasound Feedback for Speech Sound Disorder

(SUFSR Trial)

Overseen By Sarah Dugan, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Hearing impairment

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

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

Compensation: Varies

Number of Visits: 10

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assist children who struggle with the "r" sound, as in "rabbit." Researchers are testing a method called Simplified Ultrasound Feedback, which uses ultrasound (sound waves) to provide feedback through a fun video game, rather than directly showing tongue movements. The study compares this simplified approach to traditional ultrasound speech therapy. Children who speak American English fluently and have difficulty with the "r" sound might be suitable candidates. As an unphased trial, this study offers children a unique opportunity to try an innovative therapy that could enhance their speech in an engaging way.

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 this ultrasound feedback technique is safe for children with speech sound disorders?

Research has shown that using ultrasound feedback in speech therapy is generally safe and well-tolerated. Studies have found that ultrasound can help children learn speech sounds by providing visual feedback. Importantly, this technique has not been associated with significant side effects.

In past studies, ultrasound feedback demonstrated tongue movements, aiding children in improving their speech. This trial explores a new method without showing the tongue, but the safety record of similar therapies remains reassuring. Participants in these studies did not report any major unwanted effects, suggesting that the treatment is safe for children learning new speech sounds.

In summary, based on past research, ultrasound feedback in speech therapy appears safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach using ultrasound biofeedback to help with speech sound disorders. Traditional methods often rely on auditory and visual cues to correct speech, but this trial examines how real-time visual feedback from ultrasound can aid in therapy. By simplifying this method, the trial aims to make therapy more engaging and accessible, potentially speeding up progress and making it easier for participants to understand and correct their speech patterns. The gamified aspect of the simplified ultrasound biofeedback could also make therapy sessions more interactive and enjoyable, which might improve motivation and outcomes for participants.

What evidence suggests that this ultrasound feedback therapy is effective for speech sound disorder?

This trial compares two approaches to ultrasound feedback therapy for speech sound disorders. Research has shown that ultrasound feedback can help children improve their speech. Studies have found that ultrasound biofeedback effectively corrects speech sound errors that traditional methods struggle to address. This technique uses ultrasound images to display tongue movements, which can be particularly beneficial for children who struggle with sounds like "r." Speech-language experts consider this method promising and practical in therapy. Overall, ultrasound feedback has demonstrated positive results in treating persistent speech sound issues. Participants in this trial will experience both traditional and simplified ultrasound biofeedback therapy in different sequences to evaluate their effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Suzanne E Boyce, PhD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for children who have difficulty pronouncing the 'r' sound, as in 'rabbit'. It's designed to help those with speech sound disorders. To participate, children must be able to follow instructions and engage with a computer game that provides feedback on their speech.

Inclusion Criteria

I am between 7 and 17 years old.

I speak American English fluently.

Difficulty producing 'r' (American English rhotic, ex. first sound in 'ray' or last sound in 'or'), scoring less than 20% accuracy on 70 word probe

Exclusion Criteria

Does not pass hearing screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Block 1

Participants receive either traditional or simplified ultrasound biofeedback therapy for the first block

5 weeks

5 visits (in-person) or 1 week intensive

Treatment Block 2

Participants switch to the alternate therapy (simplified or traditional) for the second block

5 weeks

5 visits (in-person) or 1 week intensive

Follow-up

Participants are monitored for changes in speech sound accuracy after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Simplified Ultrasound Feedback

Trial Overview The study compares two types of ultrasound biofeedback therapy for improving speech: traditional therapy focusing on internal tongue movements and a new simplified method using games for external feedback. The effectiveness of these methods in treating 'r' sounds will be evaluated.

How Is the Trial Designed?

Group I: Traditional-then-Simplified Experimental Treatment 2 Interventions

This arm consists of participants who will be engaging in two blocks of therapy. The first block will be traditional ultrasound biofeedback therapy (T-UBT), then after that block of therapy sessions with T-UBT, they will switch to gamified/simplified ultrasound biofeedback therapy (S-UBT). The participants will finish their second block all with S-UBT. Each block will consist of five sessions. Participants will attend speech therapy either 1x/week for five weeks (per block) or 5x/week for one week (per block).

Group II: Simplified-then-Traditional Experimental Treatment 2 Interventions

This arm consists of participants who will be engaging in two blocks of therapy. The first block will be simplified ultrasound biofeedback therapy (S-UBT), then after that block of therapy sessions with S-UBT, they will switch to traditional ultrasound biofeedback therapy (T-UBT). The participants will finish their second block with T-UBT. Each block will consist of five sessions. Participants will attend speech therapy either 1x/week for five weeks (per block) or 5x/week for one week (per block).

Simplified Ultrasound Feedback is already approved in United States, Canada for the following indications:

Approved in United States as Ultrasound Biofeedback Therapy for:

• Childhood Apraxia of Speech (CAS)
• Residual Speech Sound Disorders

Approved in Canada as Ultrasound Biofeedback Therapy for:

• Childhood Apraxia of Speech (CAS)
• Speech Sound Disorders

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Published Research Related to This Trial

The study involved 6 children aged 9-15 years who underwent 18 treatment sessions using ultrasound biofeedback to improve speech sound accuracy related to childhood apraxia of speech (CAS).

All participants achieved at least 80% accuracy on treated sound sequences, with significant improvements maintained for 2 months post-treatment, indicating that ultrasound biofeedback is an effective method for addressing speech sound errors in children with CAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound biofeedback treatment for persisting childhood apraxia of speech. Preston, JL., Brick, N., Landi, N.[2022]

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]

A motor-learning-based treatment using ultrasound visual feedback significantly improved speech sound accuracy in individuals with residual speech sound errors, as shown in a study with 8 participants over 14 sessions.

The addition of prosodic cueing did not significantly enhance the treatment's effectiveness, but participants still demonstrated retention and generalization of learned sounds even two months after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound visual feedback treatment and practice variability for residual speech sound errors. Preston, JL., McCabe, P., Rivera-Campos, A., et al.[2022]

A systematic review of 29 studies involving 28 papers found that ultrasound visual biofeedback (U-VBF) can be an effective adjunct to traditional speech therapy for children with speech sound disorders, particularly in targeting difficult sounds like rhotics.

Despite generally positive outcomes, most studies had small sample sizes and lower quality designs, highlighting the need for more rigorous research to confirm the efficacy of U-VBF in diverse settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of ultrasound visual biofeedback in intervention for speech sound disorders. Sugden, E., Lloyd, S., Lam, J., et al.[2021]

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]

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]

In a study involving 12 children with speech errors, high-frequency ultrasound visual feedback (HF UVF) during speech therapy led to better learning outcomes for the /ɹ/ sound compared to low-frequency feedback (LF UVF).

The results suggest that starting with high-frequency feedback may enhance speech sound learning, as participants who received HF UVF first showed greater improvements than those who started with LF UVF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for Residual Rhotic Errors With High- and Low-Frequency Ultrasound Visual Feedback: A Single-Case Experimental Design. Preston, JL., McAllister, T., Phillips, E., et al.[2019]

Speech-language pathologists (SLPs) view ultrasound biofeedback therapy (UBT) positively for treating speech sound disorders, particularly appreciating its ability to visualize articulatory responses, which enhances treatment effectiveness.

However, SLPs also identified significant barriers to UBT implementation, with limited accessibility being the primary concern, indicating that while UBT shows promise, practical challenges need to be addressed for wider adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Analysis of Clinician Perspectives of Ultrasound Biofeedback for Speech Sound Disorders. Dugan, S., Schwab, SM., Seward, R., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-speech-sound-disorder-9-2023-04c8f

Simplified Ultrasound Feedback for Speech Sound Disorder Research suggests that using ultrasound visual feedback, where patients can see their tongue movements, helps improve speech sound production. Preliminary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10484626/

A Qualitative Analysis of Clinician Perspectives ... In this qualitative study, we explore the perspectives of speech-language pathologists (SLPs) who have used ultrasound biofeedback in programs of speech sound ...

3. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2016.00440/full

Intensive Treatment with Ultrasound Visual Feedback for ... Ultrasound imaging is an adjunct to traditional speech therapy that has shown to be beneficial in the remediation of speech sound errors.

4. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2022_AJSLP-22-00142

Using Visual–Acoustic Biofeedback for Speech Sound ... This tutorial summarizes current practices using visual–acoustic biofeedback (VAB) treatment to improve speech outcomes for individuals with speech sound ...

5. researchgate.net researchgate.net/publication/273323081_Using_ultrasound_visual_biofeedback_to_treat_persistent_primary_speech_sound_disorders

Using ultrasound visual biofeedback to treat persistent ... In this study, we evaluate its effectiveness in treating children with persistent speech sound disorders that have been unresponsive to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4272648/

Ultrasound visual feedback treatment and practice ... A motor-based treatment program that includes ultrasound visual feedback can facilitate learning of speech sounds in individuals with residual speech sound ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03238677?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(%22Childhood%20Apraxia%20of%20Speech%22))&rank=8

NCT03238677 | Treating Childhood Apraxia of Speech The study will compare treatment that includes real-time visual feedback of the tongue during speech using ultrasound vs traditional therapy that does not ...

8. isrctn.com isrctn.com/pdf/17441953

Ultrasound visual biofeedback versus standard treatment ... This project will try a new treatment, ultrasound visual biofeedback (U-VBF), where an ultrasound scanner will be used so that tongue movement ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6105118/

Do Participants Report Any Undesired Effects in ... The purpose is to offer a preliminary summary of the nature of participant-reported undesired effects related to ultrasound visual feedback.