Comparative Study Between Three Different Methods for Stuttering Therapy in Children

March 12, 2022 updated by: Alzahraa Momen Abdelnaeem, Sohag University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
will be treated by speech therapy only (fluency shaping).
Behavioral: speech therapy only
fluency shaping technique
Active Comparator: Group B
will be treated by speech therapy (fluency shaping) plus Hyperbaric oxygen therapy.
Behavioral: speech therapy only
fluency shaping technique
Device: hyperbaric oxygen therapy
chamber system using oxygen with pressure
Active Comparator: Group C
will be treated by speech therapy (fluency shaping) plus medical treatment (brain stimulant).
Behavioral: speech therapy only
fluency shaping technique
Drug: medical treatment
brain stimulant

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

March 12, 2022

First Submitted That Met QC Criteria

March 12, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-03-02

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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