Back to resultsComparative Study Between Three Different Methods for Stuttering Therapy in Children
Primary Purpose
Stuttering, Childhood
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
speech therapy only
hyperbaric oxygen therapy
medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Stuttering, Childhood
Eligibility Criteria
Inclusion Criteria:
- Children from 5 to 15 years old with IQ above 80
Exclusion Criteria:
- 1 - mental disability. 2- psychiatric problem as autism or attention deficit hyperactive disease. 3. secondary stuttering. 4. Children with sever anxiety. 5. Children with history suggested epileptic fits.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
will be treated by speech therapy only (fluency shaping).
will be treated by speech therapy (fluency shaping) plus Hyperbaric oxygen therapy.
will be treated by speech therapy (fluency shaping) plus medical treatment (brain stimulant).
Outcomes
Primary Outcome Measures
Stuttering severity instrument (SSI-3)
rating scale for stuttering severity
Secondary Outcome Measures
Stuttering severity instrument (SSI-3)
rating scale for stuttering severity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05291572
Brief Title
Comparative Study Between Three Different Methods for Stuttering Therapy in Children
Official Title
Comparative Study Between Three Different Methods for Stuttering Therapy in Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of work is comparing between three different methods for treatment of stuttering in children in order to reach to the best method for treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
will be treated by speech therapy only (fluency shaping).
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
will be treated by speech therapy (fluency shaping) plus Hyperbaric oxygen therapy.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
will be treated by speech therapy (fluency shaping) plus medical treatment (brain stimulant).
Intervention Type
Behavioral
Intervention Name(s)
speech therapy only
Intervention Description
fluency shaping technique
Intervention Type
Device
Intervention Name(s)
hyperbaric oxygen therapy
Intervention Description
chamber system using oxygen with pressure
Intervention Type
Drug
Intervention Name(s)
medical treatment
Intervention Description
brain stimulant
Primary Outcome Measure Information:
Title
Stuttering severity instrument (SSI-3)
Description
rating scale for stuttering severity
Time Frame
before therapy
Secondary Outcome Measure Information:
Title
Stuttering severity instrument (SSI-3)
Description
rating scale for stuttering severity
Time Frame
post therapy by 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children from 5 to 15 years old with IQ above 80
Exclusion Criteria:
1 - mental disability. 2- psychiatric problem as autism or attention deficit hyperactive disease. 3. secondary stuttering. 4. Children with sever anxiety. 5. Children with history suggested epileptic fits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
el-zahraa moemen Abdel Naeem
Phone
01066177366
Email
elzahraa.tawfeek@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ahlam abdel-salam Nabieh
Phone
01001141615
Email
ahlaamaa@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Comparative Study Between Three Different Methods for Stuttering Therapy in Children
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