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Speech Therapy with Biofeedback for Speech Sound Disorder (C-RESULTS Trial)

Phase 2

Recruiting

Research Sponsored by New York University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must pass a brief examination of oral structure and function

Must speak English as the dominant language (i.e., must have begun learning English by age 2, per parent report)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through phase i, which consists of three 90-min treatment sessions delivered over the course of approximately one week

Awards & highlights

C-RESULTS Trial Summary

This trial will compare the efficacy of traditional speech therapy techniques against those that incorporate technologically enhanced sensory feedback, in order to better understand how to treat children with speech sound disorders.

Who is the study for?

This trial is for children aged 9 to almost 16 who speak English as their main language, have a specific speech sound disorder with the /r/ sound, and can pass hearing and oral exams. They shouldn't have severe voice or fluency disorders, significant learning disabilities, major neurological conditions, or score too low on certain intelligence and language tests.Check my eligibility

What is being tested?

The study compares traditional speech therapy with two biofeedback methods: visual-acoustic and ultrasound. It aims to see which is more effective in correcting persistent mispronunciation of the /r/ sound in children. Participants are randomly assigned to one of these treatments.See study design

What are the potential side effects?

There may not be direct side effects from the interventions since they involve non-invasive therapy techniques; however, frustration or fatigue could occur due to intensive practice during treatment sessions.

C-RESULTS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My mouth and its functions have been checked and are okay.

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English is my first language, learned by age 2.

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I am between 9 and 15 years old.

C-RESULTS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through phase i, which consists of three 90-min treatment sessions delivered over the course of approximately one week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through phase i, which consists of three 90-min treatment sessions delivered over the course of approximately one week

This trial's timeline: 3 weeks for screening, Varies for treatment, and through phase i, which consists of three 90-min treatment sessions delivered over the course of approximately one week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

F3-F2 (Hz), an acoustic measure known to correlate with expert listeners' perceptual judgments of accuracy of /r/ sounds, measured from /r/ sounds produced in syllables or words during practice.

Secondary outcome measures

Proportion of "correct" (vs "incorrect") ratings by blinded naive listeners, a measure of perceptually rated accuracy of /r/ production, for /r/ sounds produced in word probes.

Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.

C-RESULTS Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3Experimental Treatment2 Interventions

Biofeedback-ultrasound

Group II: Group 2Experimental Treatment2 Interventions

Biofeedback--visual-acoustic

Group III: Group 1Experimental Treatment1 Intervention

Traditional articulation treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Traditional articulation treatment

2018

N/A

~20

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Syracuse UniversityOTHER

48 Previous Clinical Trials

117,464 Total Patients Enrolled

6 Trials studying Speech Sound Disorder

174 Patients Enrolled for Speech Sound Disorder

New York UniversityLead Sponsor

226 Previous Clinical Trials

314,007 Total Patients Enrolled

5 Trials studying Speech Sound Disorder

79 Patients Enrolled for Speech Sound Disorder

Montclair State UniversityOTHER

9 Previous Clinical Trials

751 Total Patients Enrolled

4 Trials studying Speech Sound Disorder

64 Patients Enrolled for Speech Sound Disorder

Media Library

Biofeedback-ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT03737318 — Phase 2

Speech Sound Disorder Research Study Groups: Group 1, Group 2, Group 3

Speech Sound Disorder Clinical Trial 2023: Biofeedback-ultrasound Highlights & Side Effects. Trial Name: NCT03737318 — Phase 2

Biofeedback-ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT03737318 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Biofeedback--visual-acoustic a potentially hazardous practice for participants?

"There is some evidence to support the safety of Biofeedback--visual-acoustic, hence it was given a score of 2 on our rating system. Furthermore, due to its classification as a Phase 2 trial, there is no data currently available regarding efficacy."

Answered by AI

Are there any vacancies still available for participation in this clinical experiment?

"Affirmative. Records hosted on clinicaltrials.gov reveal that this medical trial, first advertised on March 1st 2019, is actively recruiting volunteers. A total of 110 patients are sought from two distinct sites for the study."

Answered by AI

Could I attain admittance to this experiment?

"This medical experiment is looking for 110 people aged 9 to 15 who suffer from speech sound disorder. Each participant must pass a pure-tone hearing screening of 20 decibels Hearing Level, as well as an assessment on oral structure and function. Additionally, they should present less than 30% accuracy in their pronunciation of the /r/ consonant when rated by trained listeners at the word level."

Answered by AI

What is the aggregate number of individuals currently participating in this experiment?

"Verified. Clinicaltrials.gov is host to information that confirms this study, which was initially published on March 1st 2019, is presently recruiting participants. 110 individuals are sought from two distinct centers."

Answered by AI