Simplified Ultrasound Feedback for Speech Remediation

NCT06366256 | Recruiting

• 1 other identifier: 1R01DC017301-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  First visit and after 10 treatment sessions (up to 18 weeks)

Study Arms (2)

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).

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).

Behavioral: Traditional ultrasound biofeedback; Behavioral: Simplified ultrasound biofeedback

Interventions

Traditional ultrasound biofeedback BEHAVIORAL

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-then-Traditional; Traditional-then-Simplified

Simplified ultrasound biofeedback BEHAVIORAL

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")

Simplified-then-Traditional; Traditional-then-Simplified

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Does not pass hearing screening

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45220, United States

RECRUITING

MeSH Terms

Conditions

Speech Sound Disorder

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Suzanne E Boyce, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Boyce, PhD

CONTACT

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

Sarah Dugan, PhD

CONTACT

hamilsm@ucmail.uc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: April 15, 2024
• Study Start: October 24, 2023
• Primary Completion: December 1, 2024
• Study Completion: August 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

US (1)