Protocol summary

Summary
Objective: The aim of present study is to investigate the effects of different altered auditory feedback conditions, including delayed auditory feedback (DAF) and frequency altered feedback (FAF), on stuttering frequency by means of percentage of syllables stuttered in persons who stuttered during monologue speech production. Methods: 22 persons who stuttered aged above 17 years will produce 14 monologue speech samples and 308 samples in total during 2 sessions under 6 different altered auditory feedback conditions and one control condition by Fluency Coach Software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014061618107N1
Registration date: 2014-09-13, 1393/06/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-13, 1393/06/22
Registrant information
Name
Nima Arbabshirani
Name of organization / entity
School of rehabilitation; Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 936 488 7442
Email address
nimaarbab@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research; Isfahan University of medical sciences
Expected recruitment start date
2013-10-27, 1392/08/05
Expected recruitment end date
2014-05-10, 1393/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of altered auditory feedback on stuttering frequency of people who stutter
Public title
Effects of altered auditory feedback on stuttering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Developmental stuttering diagnosis by speech and language pathologist; chronological age at least 17 and above; Hearing threshold levels with in normal limit; No other speech treatments during the research. Exclusion criteria: Lack of tendency to continue and cooperate in research; Using behavioral stuttering reduction strategies.
Age
From 17 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of medical sciences
Street address
Isfahan University of medical sciences, Hezar jerib Ave
City
Isfahan
Postal code
Approval date
2014-01-07, 1392/10/17
Ethics committee reference number
392536

Health conditions studied

1

Description of health condition studied
stuttering[stammering]
ICD-10 code
F98.5
ICD-10 code description
Speech that is characterized by frequent repetition or prolongation of sounds or syllables or words, or by frequent hesitations or pauses that disrupt the rhythmic flow of speech. It should be classified as a disorder only if its severity is such as to ma

Primary outcomes

1

Description
Percentage of syllables stuttered(SS%)
Timepoint
post intervention and control condition
Method of measurement
Stuttering measurment system software

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group: altered auditory feedback in 6 levels: 65 millisecond delay; 75 millisecond delay; 65millisecond delay plus 0.5 otave increment; 65 millisecond delay minus 0.5 octave decrement; 75 millisecond plus 0.5 octave increment; 75 millisecond minus 0.5 octave decrement.
Category
Rehabilitation

2

Description
Control group: Non altered auditory feedback
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Speech therapy section; Al Zahra medical center
Full name of responsible person
Alireza same
Street address
Speech therapy section, Rehabilitation clinic, Al Zahara medical center, Sofeh Ave
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Isfahan University of medical sciences
Full name of responsible person
Peiman Adibi
Street address
Vice chancelor for research of Isfahan University of medical sciences, Hezar jerib Ave
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Isfahan University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of rehabilitation; Isfahan University of medical science
Full name of responsible person
Shafiei Bijan
Position
Master of science in Speech therapy; Academic member
Other areas of specialty/work
Street address
School of rehabilitation, Isfahan University of medical sciences, Hezarjerib Ave
City
Isfahan
Postal code
Phone
+98 31 3792 2021
Fax
Email
shafiei_al@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of rehabilitation; Isfahan University of medical sciences
Full name of responsible person
Nima Arbabshirani
Position
Master of science in speech therapy; Student
Other areas of specialty/work
Street address
School of rehabilitation sciences, Isfahan University of medical sciences, Hezarjerib Ave
City
Isfahan
Postal code
Phone
+98 31 3792 2021
Fax
Email
nimaarb@gmail.com; nimaarb@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of rehabilitation; Isfahan University of medical sciences
Full name of responsible person
Arbabsirani Nima
Position
Master of science in speech therapy; Student
Other areas of specialty/work
Street address
School of rehabilitation, Isfahan University of medical sciences, Hezar jerib Ave
City
Isfahan
Postal code
Phone
+98 31 3792 2021
Fax
Email
nimaarb@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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