Comparative Study Between Three Different Methods for Stu... | NCT05291572

Studies
Comparative Study Between Three Different Methods for Stuttering Therapy in Children

NCT05291572

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Mar 22, 2022Actual

Enrollment

30Estimated

Phase

Phase 4

Conditions

Stuttering, Childhood

Interventions

speech therapy only
hyperbaric oxygen therapy
medical treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2022Estimated

Primary Completion Date

Apr 2023Estimated

Completion Date

Oct 2023Estimated

First Submitted Date

Mar 12, 2022

First Submission Date that Met QC Criteria

Mar 12, 2022

First Posted Date

Mar 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2022

Last Update Posted Date

Mar 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	will be treated by speech therapy only (fluency shaping).	Behavioral: speech therapy only
Group B	Active Comparator	will be treated by speech therapy (fluency shaping) plus Hyperbaric oxygen therapy.	Behavioral: speech therapy only Device: hyperbaric oxygen therapy
Group C	Active Comparator	will be treated by speech therapy (fluency shaping) plus medical treatment (brain stimulant).	Behavioral: speech therapy only Drug: medical treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
speech therapy only	Behavioral	fluency shaping technique	Group A Group B Group C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stuttering severity instrument (SSI-3)	rating scale for stuttering severity	before therapy

Secondary Outcomes

Measure	Description	Time Frame
Stuttering severity instrument (SSI-3)	rating scale for stuttering severity	post therapy by 3 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
el-zahraa moemen Abdel Naeem	Contact	01066177366		elzahraa.tawfeek@med.sohag.edu.eg
ahlam abdel-salam Nabieh	Contact	01001141615		ahlaamaa@yahoo.com

Overall Officials

Not provided

Locations

Not provided

Type	Date	Date Unknown
Release	Mar 12, 2025
Reset	Mar 28, 2025

Submission Tracking

Estimated Results First Submitted Date

Mar 12, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 12, 2025			Mar 28, 2025

Condition Browse Module

MeSH Terms

ID	Term
D013342	Stuttering

Ancestor Terms

ID	Term
D013064	Speech Disorders
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006931	Hyperbaric Oxygenation

Ancestor Terms

ID	Term
D010102	Oxygen Inhalation Therapy
D012138	Respiratory Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided