The aim of this study is to compare the effectiveness of speech-fluency methods in reducing the severity of stuttering in people with moderate to severe stuttering
Design
The clinical trial has a control group, with parallel groups, double-blind, simple randomized, phase 3 on 36 patients. Randomization will be done simply by drawing even and odd numbers.
Settings and conduct
36 people with stuttering are randomly divided into two groups. Interventions are performed in Ahvaz Rehabilitation School.
In the main intervention group, 12 sessions of prolonged-speech method are presented.
The severity of stuttering is measured by SSI-3 instruments before the intervention, immediately after the end of the treatment sessions, and two weeks after the end of the intervention.
In the control group, conventional speech therapy methods will be used.
Participants, evaluators, and data analysor are blind to the information in this study.
Participants/Inclusion and exclusion criteria
Having stuttering, at least 18 years old, no other speech disorders
Intervention groups
Main intervention group: The Prolonged-speech method includes a set of speech-breathing coordination techniques Which helps the stuttered-person to express the words fluently and inter-connectedly.
Control group: The intervention intended for this group is a common method of speech therapy that include controlling the speed of speech, repeating words by imitating other speakers, and controlling anxiety during speech.
Main outcome variables
Stuttering severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110928007657N4
Registration date:2022-01-03, 1400/10/13
Registration timing:registered_while_recruiting
Last update:2022-01-03, 1400/10/13
Update count:0
Registration date
2022-01-03, 1400/10/13
Registrant information
Name
Peyman Zamani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3322 1002
Email address
zamanip@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of efficacy of Prolonged-speech, Light Contact Consonants, and Bounce methods used at the Pull-out strategy in adults with stuttering
Public title
The comparison of efficacy of Prolonged-speech, Light Contact Consonants, and Bounce methods in adults with stuttering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a developmental stuttering
No history of emotional or mental illness
No history of speech therapy during the last six months
No other speech disorders
Exclusion criteria:
Not being in the age range
Unwillingness of a person to enter and participate in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
The name of each participant is written on a piece of paper. Names are poured into a pot. Then, the names of the people coming out of the pot are placed in the intervention or control group. The odd arrangements will settled in the intervention group and even ranks will settled in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not be aware that the technique they are receiving is the main intervention or the conventional intervention.
The outcome assessor evaluates only the spoken samples and does not meet the participants.
The data analyzer only analyzes the SPSS file and recognizes each participant as a code, and does not meet the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 309, Ordibehesht Ave., Golestan Blvd., University Pardis
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Approval date
2021-06-12, 1400/03/22
Ethics committee reference number
IR.AJUMS.REC.1400.172
Health conditions studied
1
Description of health condition studied
Stuttering
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stuttering Severity
Timepoint
Before of Intervention, After intervention, 2 months for fallow up
Method of measurement
Stuttering Severity Instrument (SSI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The prolonged speech method is considered for this group. It has three levels of treatment: training, consolidation and generalization. The participant acquires skills at each level. Total duration of educational intervention will be 2 months and educational 1-hourly lessens will be administrated 3 times per week.
Category
Behavior
2
Description
Control group: For this group, conventional tasks of speech therapy are used to reduce the severity of stuttering. These exercises include quiet reading, listening training and bio-feedback therapy.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation Sciences at Ahvaz
Full name of responsible person
Peyman Zamani
Street address
No. 309, Ordibehesht Ave., Golestan Blvd., University Pardis
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3322 1002
Email
zamanipdrst@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi moghadam
Street address
No. 309, Ordibehesht Ave., Golestan Blvd., University Pardis
City
Ahvaz
Province
Khouzestan
Postal code
6156335566
Phone
+98 61 3373 8537
Email
dr.peymanslp@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Peyman Zamani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
No. 309, Ordibehesht Ave., Golestan Blvd., University Pardis
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 21 3322 1002
Email
zamanip@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Peyman Zamani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
No. 309, Ordibehesht Ave., Golestan Blvd., University Pardis
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3322 1002
Email
zamanipdrst@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Peyman Zamani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
No. 309, Ordibehesht Ave., Golestan Blvd., University Pardis
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3322 1002
Email
zamanipdrst@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD