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The Effects of Tactile Speech Feedback on Stuttering Frequency

Primary Purpose

Stuttering

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tactile Stimulation
Sponsored by
University of Mississippi, Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stuttering focused on measuring stuttering, haptic, feedback, fluency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults diagnosed with persistent developmental stuttering

Exclusion Criteria:

  • Subjects below 18 years of age

Sites / Locations

  • The University of Mississippi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device: Tactile Stimulation

Arm Description

A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences & Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal.

Outcomes

Primary Outcome Measures

Speech Fluency
Speech fluency was defined by either reading or saying a set syllable sentence in a book which is normally 8th grade reading level or lower. Pauses or stutters are considered positive indicators of dis-fluent speech.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2011
Last Updated
May 9, 2014
Sponsor
University of Mississippi, Oxford
Collaborators
West Virginia University, Auburn University, University of Louisiana at Lafayette
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1. Study Identification

Unique Protocol Identification Number
NCT01315730
Brief Title
The Effects of Tactile Speech Feedback on Stuttering Frequency
Official Title
The Effects of Tactile Speech Feedback on Stuttering Frequency
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Patent being pursued prior to trial initiation
Study Start Date
March 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Mississippi, Oxford
Collaborators
West Virginia University, Auburn University, University of Louisiana at Lafayette

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research project is to test the effects of exposure of different forms of tactile speech feedback on overt stuttering frequency.
Detailed Description
A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences & Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering
Keywords
stuttering, haptic, feedback, fluency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device: Tactile Stimulation
Arm Type
Experimental
Arm Description
A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences & Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal.
Intervention Type
Device
Intervention Name(s)
Tactile Stimulation
Intervention Description
See Arms
Primary Outcome Measure Information:
Title
Speech Fluency
Description
Speech fluency was defined by either reading or saying a set syllable sentence in a book which is normally 8th grade reading level or lower. Pauses or stutters are considered positive indicators of dis-fluent speech.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults diagnosed with persistent developmental stuttering Exclusion Criteria: Subjects below 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwight E Waddell, Ph.D.
Organizational Affiliation
The University of Mississippi
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Mississippi
City
University
State/Province
Mississippi
ZIP/Postal Code
38677
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19425468
Citation
Snyder GJ, Blanchet P, Waddell D, Ivy LJ. Effects of digital vibrotactile speech feedback on overt stuttering frequency. Percept Mot Skills. 2009 Feb;108(1):271-80. doi: 10.2466/PMS.108.1.271-280.
Results Reference
result

Learn more about this trial

The Effects of Tactile Speech Feedback on Stuttering Frequency

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