NCT05291572

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 12, 2022

Last Update Submit

March 12, 2022

Conditions

Stuttering, Childhood

Outcome Measures

Primary Outcomes (1)

  • Stuttering severity instrument (SSI-3)

    rating scale for stuttering severity

    before therapy

Secondary Outcomes (1)

  • Stuttering severity instrument (SSI-3)

    post therapy by 3 months

Study Arms (3)

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 onlyDevice: hyperbaric oxygen therapy

Group C

ACTIVE COMPARATOR

will be treated by speech therapy (fluency shaping) plus medical treatment (brain stimulant).

Behavioral: speech therapy onlyDrug: medical treatment

Interventions

speech therapy onlyBEHAVIORAL

fluency shaping technique

Group AGroup BGroup C
hyperbaric oxygen therapyDEVICE

chamber system using oxygen with pressure

Group B
medical treatmentDRUG

brain stimulant

Group C

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children from 5 to 15 years old with IQ above 80

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stuttering

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Central Study Contacts

el-zahraa moemen Abdel Naeem

CONTACT

01066177366elzahraa.tawfeek@med.sohag.edu.eg

ahlam abdel-salam Nabieh

CONTACT

01001141615ahlaamaa@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

March 12, 2022

First Posted

March 22, 2022

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

October 1, 2023

Last Updated

March 22, 2022

Record last verified: 2022-03