- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01905449
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
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Connecticut
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New Haven, Connecticut, United States, 06511
- Haskins Laboratories
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-
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)
|
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.
|
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)
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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
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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