Speech Sound DisorderSUFSRNCT06366256
Simplified Ultrasound Feedback for Speech Remediation
A study testing Traditional ultrasound biofeedback and Simplified ultrasound biofeedback in people with Speech Sound Disorder, run by University of Cincinnati at 1 site in United States.
Trial summary
Recent research in motor control shows that people learn new movements best when they receive feedback external to the body. Traditional ultrasound speech therapy works well for many children, but involves teaching children to focus on their internal tongue movements. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Speech Sound Disorder
- What is being tested?
- Traditional ultrasound biofeedback and Simplified ultrasound biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Speaks American English fluently
- Between ages of 7 and 17 years old
Who cannot join
- Does not pass hearing screening
Trial locations and contacts
1 site in 1 country.
Sarah Dugan, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45220
Suzanne E Boyce, PhD, 513-558-8509, boycese@ucmail.uc.edu
Sarah M Dugan, PhD, hamilsm@ucmail.uc.edu
About this study
Recent research in motor control shows that people learn new movements best when they receive feedback external to the body. Traditional ultrasound speech therapy works well for many children, but involves teaching children to focus on their internal tongue movements. The goal of the study is to test whether ultrasound biofeedback delivered without showing children a display of their tongue movements will be effective as a treatment for residual speech sound disorders in children. We focus on children who have trouble producing the sound "r" as in "rabbit". The first aim is to develop a fast reliable system to track movements of different parts of the tongue using ultrasound and to identify which combinations of movements will produce a good "r" and which do not. The second aim is to develop a motivational game in which children receive feedback on the success of their tongue movements by what happens to an animated character on a screen. This developed version of ultrasound feedback therapy will be compared to the traditional version of ultrasound feedback therapy to determine how the two approaches can best be utilized in the clinic.
Read the detailed description
Ultrasound biofeedback therapy (UBT), offering a real-time view of the tongue during speech, has shown promise in treating residual speech sound disorders. However, the clinical utility of UBT is limited by the inherent difficulty of interpreting real-time ultrasound images of rapidly changing tongue deformations during speech. For patients to receive effective feedback from these images, clinicians must provide extensive explanation and orientation over multiple sessions. Especially for younger patients, this rich, complex visual feedback directs attention internally, a direction known to reduce performance and impulse force control during limb and oral movement tasks. Further, since speech sound disorders often coexist with cognitive or behavioral difficulties, many patients never master interpretation of tongue ultrasound images. Thus, the tremendous promise of UBT has not been realized because its feedback is too complex, misdirected, and ambiguous.
Scientific studies on implicit motor learning suggest UBT would be improved if (1) speakers are guided by simpler visual feedback and (2) the simplification engages an external attentional focus. Feedback with these qualities is known to facilitate rapid, robust sensorimotor skill learning. Application of these principles into UBT is expected to provide great benefits to those with speech-sound disorders.
The major goal of this project is to translate these recent advances in UBT and motor learning into a new simplified ultrasound biofeedback system for better clinical treatment of residual speech sound disorders. Our proposed system will transform the complex tongue movements captured by ultrasound into simplified real-time feedback displays, customized for each user to drive tongue movements closer to goal movement patterns. We will concentrate on remediation of /r/ and /l/, the most complex and frustrating sounds in clinical speech therapy. Using a novel method for tongue motion tracking based on processing of real-time ultrasound images, we will automatically characterize differentiated motion of tongue parts during /r/ and /l/ production. We will employ statistical cluster analysis to identify biofeedback targets indicating correct production. These targets will be employed in a prototype simplified UBT system employing simple, engaging visual feedback to guide patients toward correct tongue movement, presented by a highly motivating, gamified interface. Our simplified UBT system will be validated in a pilot clinical trial, testing the hypotheses that simplified UBT is more effective than standard UBT, and that the most effective biofeedback targets will be those promoting greater differentiation of tongue motion. The end result will be translation of recent advances in ultrasound imaging of speech, real-time image processing, and biofeedback-based motor planning into a novel clinical UBT tool that will greatly advance treatment of residual speech sound disorders.
- Conditions
- Speech Sound Disorder
- Being tested
- Traditional ultrasound biofeedback, Simplified ultrasound biofeedback
- Medical subject headings
- Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ultrasound biofeedbackBehavioural
Participants use a B-mode ultrasound device to view their tongue movement on a screen. The participant sees the ultrasound image of their tongue moving in sagittal plane on the screen. The speech-language pathologist working with the participant also views participant's tongue movement and provides verbal instruction on how the participant should move their tongue to produce a perceptually correct "r" sound in simple syllables (CV, VC), as well as evaluative statements about accuracy. Participants practice moving their tongue along with these instructions, practicing the simple syllable (CV, VC) words.
VC=vowel consonant syllables (ex. "or") CV=consonant vowel syllables (ex. "ra")
Simplified ultrasound biofeedbackBehavioural
Participants use a B-mode ultrasound device that captures the movement of their tongue and software that transforms the movement of their tongue into gamified objects on a screen. The participant sees a game object (a character) move on the screen towards goals; the movement of the game object represents the movement of the tongue and the goals are representative of tongue movements that correlate with an acoustic percept of accuracy. The speech-language pathologist working with the participant views the movement of the game object and provides verbal instruction on how the participant should move the game character in order to reach the goals when saying simple syllable words (CV, VC) as well as evaluative statements about accuracy. Participants practice moving their tongue along with these instructions, practicing the simple syllable (CV, VC) words.
VC=vowel consonant syllables (ex. "or") CV=consonant vowel syllables (ex. "ra")
| Study group | Role | What they receive |
|---|---|---|
| Traditional-then-Simplified | Experimental | 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). Receives: Behavioral: Traditional ultrasound biofeedback; Behavioral: Simplified ultrasound biofeedback |
| Simplified-then-Traditional | Experimental | 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). Receives: Behavioral: Traditional ultrasound biofeedback; Behavioral: Simplified ultrasound biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent accurate words in probe list at beginning and midpoint of study
Within-subject measurement of percent accurate words produced in untreated list of word probes from first study visit (initial time point) to midpoint of study (after five treatment sessions)
Measured: First visit and after five treatment sessions (up to 9 weeks)
Change in percent accurate words in probe list at beginning and end of study
Within-subject measurement of percent accurate words produced in untreated list of word probes from first study visit (initial time point) to end of study (after 10 treatment sessions)
Measured: First visit and after 10 treatment sessions (up to 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start24 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech Sound DisorderStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Boyce, University of Cincinnati
- Investigators
- Suzanne E Boyce, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366256
- Sponsor's protocol ID
- 1R01DC017301-01
- Acronym
- SUFSR
- Status last verified
- Apr 2024
- First submitted
- 23 Feb 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Ultrasound Feedback for Speech Remediation
- ClinicalTrials.gov ID
- NCT06366256
- Acronym / sponsor ID
- SUFSR / 1R01DC017301-01
- Conditions
- Speech Sound Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent research in motor control shows that people learn new movements best when they receive feedback external to the body. Traditional ultrasound speech therapy works well for many children, but involves teaching children to focus on their internal tongue movements. The goal of the study is to test whether ultrasound biofeedback delivered without showing children a display of their tongue movements will be effective as a treatment for residual speech sound disorders in children. We focus on children who have trouble producing the sound "r" as in "rabbit". The first aim is to develop a fast reliable system to track movements of different parts of the tongue using ultrasound and to identify which combinations of movements will produce a good "r" and which do not. The second aim is to develop a motivational game in which children receive feedback on the success of their tongue movements by what happens to an animated character on a screen. This developed version of ultrasound feedback therapy will be compared to the traditional version of ultrasound feedback therapy to determine how the two approaches can best be utilized in the clinic.
Detailed description
Ultrasound biofeedback therapy (UBT), offering a real-time view of the tongue during speech, has shown promise in treating residual speech sound disorders. However, the clinical utility of UBT is limited by the inherent difficulty of interpreting real-time ultrasound images of rapidly changing tongue deformations during speech. For patients to receive effective feedback from these images, clinicians must provide extensive explanation and orientation over multiple sessions. Especially for younger patients, this rich, complex visual feedback directs attention internally, a direction known to reduce performance and impulse force control during limb and oral movement tasks. Further, since speech sound disorders often coexist with cognitive or behavioral difficulties, many patients never master interpretation of tongue ultrasound images. Thus, the tremendous promise of UBT has not been realized because its feedback is too complex, misdirected, and ambiguous.
Scientific studies on implicit motor learning suggest UBT would be improved if (1) speakers are guided by simpler visual feedback and (2) the simplification engages an external attentional focus. Feedback with these qualities is known to facilitate rapid, robust sensorimotor skill learning. Application of these principles into UBT is expected to provide great benefits to those with speech-sound disorders.
The major goal of this project is to translate these recent advances in UBT and motor learning into a new simplified ultrasound biofeedback system for better clinical treatment of residual speech sound disorders. Our proposed system will transform the complex tongue movements captured by ultrasound into simplified real-time feedback displays, customized for each user to drive tongue movements closer to goal movement patterns. We will concentrate on remediation of /r/ and /l/, the most complex and frustrating sounds in clinical speech therapy. Using a novel method for tongue motion tracking based on processing of real-time ultrasound images, we will automatically characterize differentiated motion of tongue parts during /r/ and /l/ production. We will employ statistical cluster analysis to identify biofeedback targets indicating correct production. These targets will be employed in a prototype simplified UBT system employing simple, engaging visual feedback to guide patients toward correct tongue movement, presented by a highly motivating, gamified interface. Our simplified UBT system will be validated in a pilot clinical trial, testing the hypotheses that simplified UBT is more effective than standard UBT, and that the most effective biofeedback targets will be those promoting greater differentiation of tongue motion. The end result will be translation of recent advances in ultrasound imaging of speech, real-time image processing, and biofeedback-based motor planning into a novel clinical UBT tool that will greatly advance treatment of residual speech sound disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional-then-Simplified | Experimental | Behavioral: Traditional ultrasound biofeedback, Behavioral: Simplified ultrasound biofeedbackThis 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). |
| Simplified-then-Traditional | Experimental | Behavioral: Traditional ultrasound biofeedback, Behavioral: Simplified ultrasound biofeedbackThis 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). |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
- Speaks American English fluently
- Between ages of 7 and 17 years old
Key exclusion criteria (1 listed)
- Does not pass hearing screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional ultrasound biofeedbackParticipants use a B-mode ultrasound device to view their tongue movement on a screen. The participant sees the ultrasound image of their tongue moving in sagittal plane on the screen. The speech-language pathologist working with the participant also views participant's tongue movement and provides verbal instruction on how the participant should move their tongue to produce a perceptually correct "r" sound in simple syllables (CV, VC), as well as evaluative statements about accuracy. Participants practice moving their tongue along with these instructions, practicing the simple syllable (CV, VC) words. VC=vowel consonant syllables (ex. "or") CV=consonant vowel syllables (ex. "ra") | Behavioural | Simplified-then-Traditional, Traditional-then-Simplified |
| Simplified ultrasound biofeedbackParticipants use a B-mode ultrasound device that captures the movement of their tongue and software that transforms the movement of their tongue into gamified objects on a screen. The participant sees a game object (a character) move on the screen towards goals; the movement of the game object represents the movement of the tongue and the goals are representative of tongue movements that correlate with an acoustic percept of accuracy. The speech-language pathologist working with the participant views the movement of the game object and provides verbal instruction on how the participant should move the game character in order to reach the goals when saying simple syllable words (CV, VC) as well as evaluative statements about accuracy. Participants practice moving their tongue along with these instructions, practicing the simple syllable (CV, VC) words. VC=vowel consonant syllables (ex. "or") CV=consonant vowel syllables (ex. "ra") | Behavioural | Simplified-then-Traditional, Traditional-then-Simplified |
Primary outcome
Change in percent accurate words in probe list at beginning and midpoint of study
Time frame: First visit and after five treatment sessions (up to 9 weeks)
Within-subject measurement of percent accurate words produced in untreated list of word probes from first study visit (initial time point) to midpoint of study (after five treatment sessions)
Change in percent accurate words in probe list at beginning and end of study
Time frame: First visit and after 10 treatment sessions (up to 18 weeks)
Within-subject measurement of percent accurate words produced in untreated list of word probes from first study visit (initial time point) to end of study (after 10 treatment sessions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Dugan, PhD contact
Suzanne E Boyce, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional ultrasound biofeedback and Simplified ultrasound biofeedback in people with Speech Sound Disorder, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Boyce, PhD (513-558-8509, boycese@ucmail.uc.ed-), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent accurate words in probe list at beginning and midpoint of study (time frame: First visit and after five treatment sessions (up to 9 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.