Visual-Acoustic Biofeedback for Speech Sound Disorder
(VISIT Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 18
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: New York University
Disqualifiers: Voice disorder, Orthodontia, Hearing loss, Developmental disability, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?Children with speech sound disorder show diminished intelligibility in spoken communication and may thus be perceived as less capable than peers, with negative consequences for both socioemotional and socioeconomic outcomes. New technologies have the potential to transform interventions for speech sound disorder, but there is a lack of rigorous evidence to substantiate this promise. This research will meet a public health need by systematically evaluating the efficacy of visual-acoustic biofeedback intervention delivered in-person versus via telepractice.
The objective of this study is to test the hypothesis that treatment incorporating visual-acoustic biofeedback can be delivered via telepractice without a significant loss of efficacy. Participants will be randomly assigned to receive identical treatment either via online telepractice or in the laboratory setting. The same software for visual-acoustic biofeedback, staRt, will be used in both conditions. Participants' progress in treatment will be evaluated based on blinded listeners' perceptual ratings of probes produced before and after treatment. Pre and post treatment evaluations will be carried out in person for all participants.
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 data supports the effectiveness of the treatment Visual-Acoustic Biofeedback for Speech Sound Disorder?
Research shows that visual-acoustic biofeedback, including ultrasound biofeedback, can help improve speech in individuals with speech sound disorders. Studies have found that children with persistent speech sound disorders made significant progress after using ultrasound visual biofeedback, suggesting it can be a valuable tool in speech therapy.
12345Is visual-acoustic biofeedback therapy safe for humans?
The research suggests that ultrasound visual biofeedback, a type of visual-acoustic biofeedback therapy, is considered non-invasive and safe for use in speech therapy, with no significant undesired effects reported by participants.
12346What makes visual-acoustic biofeedback treatment unique 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 movements during speech, which is especially helpful for those who have difficulty with traditional auditory-based methods. This approach is non-invasive and can be more effective for people who have persistent speech sound disorders that don't respond well to standard treatments.
12347Eligibility Criteria
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.
+7 more
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.
+4 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Telepractice deliveryExperimental Treatment1 Intervention
Participants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room.
Group II: In-person deliveryActive Control1 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:
πΊπΈ Approved in United States as Visual-acoustic biofeedback therapy for:
- Speech sound disorder
- Residual speech errors
- Childhood apraxia of speech
πͺπΊ Approved in European Union as Visual-acoustic biofeedback therapy for:
- Speech sound disorder
- Residual speech errors
- Childhood apraxia of speech
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Syracuse UniversitySyracuse, NY
Montclair State UniversityBloomfield, NJ
New York UniversityNew York, NY
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Who Is Running the Clinical Trial?
New York UniversityLead Sponsor
Montclair State UniversityCollaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
Syracuse UniversityCollaborator
References
Using ultrasound visual biofeedback to treat persistent primary speech sound disorders. [2022]Growing evidence suggests that speech intervention using visual biofeedback may benefit people for whom visual skills are stronger than auditory skills (for example, the hearing-impaired population), especially when the target articulation is hard to describe or see. Diagnostic ultrasound can be used to image the tongue and has recently become more compact and affordable leading to renewed interest in it as a practical, non-invasive visual biofeedback tool. In this study, we evaluate its effectiveness in treating children with persistent speech sound disorders that have been unresponsive to traditional therapy approaches. A case series of seven different children (aged 6-11) with persistent speech sound disorders were evaluated. For each child, high-speed ultrasound (121 fps), audio and lip video recordings were made while probing each child's specific errors at five different time points (before, during and after intervention). After intervention, all the children made significant progress on targeted segments, evidenced by both perceptual measures and changes in tongue-shape.
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. [2022]Children with cleft lip and palate can continue to have problems producing clear speech after surgery. This can lead to social, emotional, and educational challenges. Typical treatment involves teaching children the correct tongue movements to produce speech sounds. This is known as articulation intervention. However, this intervention is challenging because the tongue is hidden from view and movements are difficult to see and describe. This pilot randomized control trial will try a new treatment, ultrasound visual biofeedback (U-VBF) versus standard articulatory intervention for children with cleft lip and palate, as comparison. Feasibility outcomes will be determined.
Tutorial: Using Visual-Acoustic Biofeedback for Speech Sound Training. [2023]This tutorial summarizes current practices using visual-acoustic biofeedback (VAB) treatment to improve speech outcomes for individuals with speech sound difficulties. Clinical strategies will focus on residual distortions of /ΙΉ/.
Ultrasound biofeedback for speech training. Instrumentation and preliminary results. [2019]Real-time ultrasound scanning was employed as biofeedback therapy to correct a persistent articulatory speech defect in a subject. The subject continuously imaged her tongue with a transducer placed submentally. During a speech exercise, the subject could compare her tongue's positioning and movement with an ultrasound image showing the correct tongue placement prerecorded onto video tape by a speech therapist. Preliminary results suggest that this technique could be a valuable addition to speech therapy.
Enabling New Articulatory Gestures in Children With Persistent Speech Sound Disorders Using Ultrasound Visual Biofeedback. [2021]Purpose This study evaluated ultrasound visual biofeedback treatment for teaching new articulations to children with a wide variety of speech sound disorders. It was hypothesized that motor-based intervention incorporating ultrasound would lead to rapid acquisition of a range of target lingual gestures with generalization to untreated words. Method Twenty children aged 6-15 years with a range of mild to severe speech disorders affecting a variety of lingual targets enrolled in a case series with replication. Of these, 15 children completed the intervention. All of the children presented with a variety of errors. We therefore employed a target selection strategy to treat the most frequent lingual error. These individual speech targets were treated using ultrasound visual biofeedback as part of ten to twelve 1-hr intervention sessions. The primary outcome measure was percentage of target segments correct in untreated wordlists. Results Six children were treated for velar fronting; 3 children, for postalveolar fronting; 2 children, for backing alveolars to pharyngeal or glottal place; 1 child, for debuccalization (production of all onsets as [h]); 1 child, for vowel merger; and 2 children, for lateralized sibilants. Ten achieved the new articulation in the 1st or 2nd session of intervention, despite no children being readily stimulable for their target articulation before intervention. In terms of generalization, effect sizes for percentage of target segments correct ranged from no effect (5 children), small effect (1 child), medium effect (4 children), and large effect (5 children). Conclusions Ultrasound visual biofeedback can be used to treat a wide range of lingual errors in children with various speech sound disorders, from mild to severe. Visual feedback may be useful for establishing new articulations; however, generalization is more variable.
Do Participants Report Any Undesired Effects in Ultrasound Speech Therapy? [2023]Ultrasound visual feedback of the tongue is increasingly used as a component of speech therapy in clinical research and practice. The purpose is to offer a preliminary summary of the nature of participant-reported undesired effects related to ultrasound visual feedback.
Effectiveness of an Ultrasound Visual Biofeedback Training for Tongue Shape Assessment During Speech Sound Production. [2022]This proof-of-concept study examined the effectiveness of an ultrasound visual biofeedback (UVB) training within the Participatory Adult Teaching Strategy framework for instructing speech-language pathologists (SLPs) on the assessment of sonographic tongue configuration for remediation of speech sound errors.