Speech Therapy with Biofeedback for Speech Sound Disorder

(C-RESULTS Trial)

No longer recruiting at 1 trial location
TC
TM
Overseen ByTara McAllister, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: New York University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to improve speech accuracy in children who struggle with pronouncing the /r/ sound, a common issue known as residual speech errors (RSE). Researchers compare traditional speech therapy to therapy enhanced with biofeedback technology, which uses visual or ultrasound feedback to guide speech correction. The goal is to determine if biofeedback is more effective than traditional methods and which type of biofeedback works best for different children. Children who primarily speak English and have noticeable difficulty with the /r/ sound might be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from innovative therapy methods.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both biofeedback methods—visual-acoustic and ultrasound—are generally safe for treating speech sound disorders. Studies indicate that visual-acoustic biofeedback is non-invasive and safe for addressing speech errors, with no significant side effects reported.

Similarly, ultrasound biofeedback is considered safe. A study with 62 participants who had speech sound disorders showed no major negative effects, suggesting it is well-tolerated by those with ongoing speech issues.

Both treatments continue to be studied to fully confirm their effectiveness and safety, but current findings are promising. These methods aim to improve speech accuracy in children with speech sound disorders without causing harm.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Speech Sound Disorder because they offer innovative ways to improve speech through biofeedback. Unlike traditional articulation therapy, which relies on auditory and visual cues, biofeedback-ultrasound allows individuals to actually see their tongue movements during speech, offering a direct visual guide to correct pronunciation. Biofeedback--visual-acoustic, on the other hand, combines visual and auditory feedback to help individuals better understand and adjust their speech sounds. These methods provide a more interactive and engaging approach, potentially leading to quicker and more effective results for those struggling with speech sound disorders.

What evidence suggests that this trial's treatments could be effective for speech sound disorder?

Research has shown that biofeedback in speech therapy can greatly improve speech clarity for individuals with ongoing speech errors. This trial will compare different biofeedback methods with traditional articulation treatment. Participants in one arm will receive ultrasound biofeedback, which allows patients to see their tongue movements, potentially correcting mispronounced sounds. Specifically, one study found that adding ultrasound to therapy led to significant improvements in speech for those with persistent errors. Another arm will involve visual-acoustic biofeedback, providing real-time feedback of speech sounds, which also enhances treatment success. Research suggests these biofeedback methods can be more effective than traditional treatments, which will be tested in a separate arm, offering hope for those who haven't benefited from standard approaches.678910

Are You a Good Fit for This Trial?

This trial is for children aged 9 to almost 16 who speak English as their main language, have a specific speech sound disorder with the /r/ sound, and can pass hearing and oral exams. They shouldn't have severe voice or fluency disorders, significant learning disabilities, major neurological conditions, or score too low on certain intelligence and language tests.

Inclusion Criteria

My mouth and its functions have been checked and are okay.
You need to pass a hearing test at a certain level of sound.
You have difficulty pronouncing the "r" sound in different words.
See 2 more

Exclusion Criteria

Must not exhibit voice or fluency disorder of a severity judged likely to interfere with the ability to participate in study activities
You must score at least 80 on the language test called CELF-5.
I do not have a developmental disability or major brain condition.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either traditional articulation treatment or biofeedback-enhanced treatment for speech sound disorder

10 weeks
3 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Biofeedback-ultrasound
  • Biofeedback--visual-acoustic
  • Traditional articulation treatment
Trial Overview The study compares traditional speech therapy with two biofeedback methods: visual-acoustic and ultrasound. It aims to see which is more effective in correcting persistent mispronunciation of the /r/ sound in children. Participants are randomly assigned to one of these treatments.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment2 Interventions
Group II: Group 2Experimental Treatment2 Interventions
Group III: Group 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials
249
Recruited
229,000+

Syracuse University

Collaborator

Trials
54
Recruited
118,000+

Montclair State University

Collaborator

Trials
14
Recruited
1,200+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Citations

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 ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38282211/
Feasibility of using ultrasound visual biofeedback to treat ...The current study aimed to assess the effectiveness of incorporating ultrasound visual biofeedback (UVB) into a treatment programme addressing persistent ...
Use of Speech-to-Text Biofeedback in Intervention for ...This study was conducted to explore the effectiveness of speech to text as a form of biofeedback intervention for speech sound production in ...
Effectiveness of Ultrasound-Aided Articulation Therapy for ...The study is a prospective randomized controlled procedure to investigate the effect of ultrasound in articulation training and also the effect of treatment ...
Baseline Stimulability Predicts Patterns of Response to ...This study aimed to identify predictors of response to treatment for residual speech sound disorder (RSSD) affecting English rhotics.
Visual Acoustic Biofeedback for RSE Via TelepracticeThis research will meet a public health need by evaluating the efficacy of speech intervention supplemented with real-time visual-acoustic biofeedback when ...
Visual-Acoustic Biofeedback for Speech Sound DisorderThe research suggests that ultrasound visual biofeedback, a type of visual-acoustic biofeedback therapy, is considered non-invasive and safe for use in speech ...
Ultrasound Biofeedback Treatment for Persisting ...A treatment program including ultrasound biofeedback is a viable option for improving speech sound accuracy in children with persisting speech sound errors ...
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 ...
Biofeedback - Medical Clinical Policy BulletinsUnlike migraine and tension headache, there is a lack of published data concerning the safety ... Speech sound disorder and visual biofeedback intervention: A ...
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