Ultrasound Biofeedback for Speech Sound Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
JPreston, Yale University
ClinicalTrials.gov Identifier:
NCT01905449
First received: July 16, 2013
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Speech Sound Disorders
Behavioral: Ultrasound visual feedback
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biofeedback and Speech Disorders

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: May 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905449

Contacts
Contact: Jessica Whittle, MA/CCC-SLP 203-865-6163 ext 245 whittle@haskins.yale.edu
Contact: Jonathan Preston, PhD/CCC-SLP 203-865-6163 ext 247 preston@haskins.yale.edu

Locations
United States, Connecticut
Haskins Laboratories Recruiting
New Haven, Connecticut, United States, 06511
Principal Investigator: Jonathan Preston         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Jonathan Preston, PhD Haskins Laboratories
  More Information

Additional Information:
No publications provided

Responsible Party: JPreston, Research Scientist, Haskins Laboratories, Yale University
ClinicalTrials.gov Identifier: NCT01905449     History of Changes
Other Study ID Numbers: HaskinsA185
Study First Received: July 16, 2013
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease
Language Disorders
Pathologic Processes
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014