The purpose of this study is to investigate the impact of the implementation of the Lidcomb program on reducing stuttering in school-age children
Design
A clinical trial without a control group on a single participant group and evaluation of stuttering before and after intervention
Settings and conduct
Birjand University of Medical Sciences Rehabilitation Clinic in Birjand on a single participant group measuring stuttering before, during and after the implementation of the Lidcomb program
Participants/Inclusion and exclusion criteria
The 15 school-age children who have stuttering and have not used the Lidcomb program to treat them.
Intervention groups
There is a group of participants and the Lidcomb program runs on them
Main outcome variables
Percentage of stuttered syllables
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046018N2
Registration date:2020-03-04, 1398/12/14
Registration timing:retrospective
Last update:2020-03-04, 1398/12/14
Update count:0
Registration date
2020-03-04, 1398/12/14
Registrant information
Name
Elahe Farmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1400
Email address
elahe.farmani@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Lidcomb treatment program on stuttering in school-aged children
Public title
Effectiveness of the Lidcomb Program on Stuttering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stuttering
school age
No history of receiving Ledcomb treatment
Exclusion criteria:
Age
From 7 years old to 11 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghafari St
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-10-14, 1398/07/22
Ethics committee reference number
IR.BUMS.REC.1398.222
Health conditions studied
1
Description of health condition studied
stuttering
ICD-10 code
F80.81
ICD-10 code description
Childhood onset fluency disorder
Primary outcomes
1
Description
Stuttering changes due to the implementation of the Lidcomb program
Timepoint
Before the intervention, the end of the first phase and the end of the second phase of the Lidcomb program
Method of measurement
Measure the percentage of stuttered syllables
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A single group of 15 school-age children with stuttering who is being treated with the Ledcomb program and their stuttering will be assessed before, during and at the end of the Ledcombe program.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation clinic of Birjand University of Medical Sciences
Full name of responsible person
Elahe Farmani
Street address
Shahed St
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 1400
Fax
Email
elahe.farmani@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghafari St
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 1400
Email
elahe.farmani@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Elahe Farmani
Position
instructor of speech therapy
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Ghafari St
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 1400
Email
elahe.farmani@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Elahe Farmani
Position
instructor of speech therapy
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Ghafari St
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 1400
Email
elahe.farmani@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Elahe Farmani
Position
instructor of speech therapy
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Ghafari St
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 1400
Fax
+98 56 3239 1400
Email
elahe.farmani@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available