Recruiting

Observational Study

Sponsor:

University of Cincinnati

Code:

NCT06366256

Conditions

Speech Sound Disorder

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Traditional ultrasound biofeedback

Simplified ultrasound biofeedback

Study Details

Brief 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. 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.

Conditions

Speech Sound Disorder

Study ID

NCT06366256

Start date

Oct 24, 2023

Status verified date

Apr, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Does not pass hearing screening

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Traditional-then-Simplified

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).

experimental: Simplified-then-Traditional

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).

Interventions

Traditional ultrasound biofeedback

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 biofeedback

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")

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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Suzanne Boyce, PhD

513-558-8509boycese@ucmail.uc.ed-

Sarah Dugan, PhD

hamilsm@ucmail.uc.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Suzanne E Boyce, PhD

513-558-8509boycese@ucmail.uc.edu

Sarah M Dugan, PhD

hamilsm@ucmail.uc.edu

More Information

Sponsor

University of Cincinnati

Last update posted

Apr 15, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2024-04-15.