Ultrasound Biofeedback for Speech Sound Disorders

April 1, 2020 updated by: Yale University

Biofeedback and Speech Disorders

Children with speech sound disorders will receive speech therapy using real-time images of the tongue from ultrasound. These images will be used to cue the child to change the tongue position when producing speech sounds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Haskins Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must be native English-speaking children with no known hearing or vision deficits. Participants must be within the specified age range and have been identified as having speech production difficulties by a local speech-language therapist.

Exclusion Criteria:

  • Participants will be excluded if there is a history of oral structural impairment (e.g., cleft palate), hearing or vision impairment, history of neurological impairment or injury, developmental disabilities such as Down Syndrome or Autism, or intellectual disability.

During initial testing, participants must score below a standard score of 75 on the Goldman-Fristoe Test of Articulation-2 and also score below 20% accurate on a probe list of words assessing accuracy of the /r/ sound

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound plus prosodic cues
One sound in error is treated with ultrasound visual feedback while also cueing prosodic variation (7 one-hour sessions). Another sound in error is treated with the ultrasound visual feedback with no prosodic variation (7 one-hour sessions). Prosodic variations are cues to coordinate production of the target sound with intonation patterns such as questions (rising intonations), commands (loud/emphatic), or statements (neutral)
Behavioral: Ultrasound visual feedback
Real-time visual displays of the tongue are used to cue participants to modify the tongue position/shape as they articulate speech sounds
Experimental: Ultrasound vs Traditional treatment
One sound in errors is treated with ultrasound visual feedback for approximately half of each session and traditional treatment for half of the session (7 one-hour sessions). Another sound in error is treated with no ultrasound visual feedback, using traditional treatment for the entire session (7 one-hour sessions). These traditional cues include verbal instructions on how to move the tongue to achieve a particular speech sound.
Behavioral: Ultrasound visual feedback
Real-time visual displays of the tongue are used to cue participants to modify the tongue position/shape as they articulate speech sounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent correct for target speech sound
Time Frame: Change in accuracy after 7 one-hour treatment sessions (3.5 weeks), and after 14 one-hour treatment sessions (7 weeks)
Change in accuracy after 7 one-hour treatment sessions (3.5 weeks), and after 14 one-hour treatment sessions (7 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Jonathan Preston, PhD, Haskins Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1303011662

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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