- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05640440
Executive Function Performance in Children Who Stutter
December 6, 2022 updated by: Rasha Mohamed Hashem, Sohag University
The study aims to asses the executive function in children who stutter for better management of those children
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
It is a case control study which will be done on 30 child who stutter and 15 normal child as a control group.
Executive function testing will be done using computerized program called PEPL .
Also, total intelligence quation(IQ) , verbal IQ, non verbal IQ will be assessed in both groups.
stuttering severity will be assessed in case group.
Study Type
Observational
Enrollment (Anticipated)
45
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
- Name: Rasha Mo Hashem, Assistant lecture
- Phone Number: 002 01061966022
- Email: rasha.hashem@med.sohag.edu.eg
Study Contact Backup
- Name: Eman M Mostafa, lectural
- Phone Number: 002 01029945463
- Email: rody.saif87@yahoo.com
Study Locations
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-
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Sohag, Egypt, 82511
- Rasha Mohamed Hashem
-
Contact:
- Rasha M Hashem, assistant lectural
- Phone Number: 002 01061966022
- Email: rasha.hashem@med.sohag.edu.eg
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Contact:
- Ahlam A Nabieh, professor
- Phone Number: 02 01029945463
- Email: ahlamaa@yahoo.com
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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
7 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
30 case group, 15 control group age range 7 yrs old and 15 yrs old
Description
Inclusion Criteria:
- Patient and volunteers age between 7 years and 15 years.
- IQ ≥ 85.
Exclusion Criteria:
- History of secondary stuttering.
- Language impairment and other speech problem.
- Concurrent or history of psychiatric, cognitive, neurological disorders or hearing impairment.
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
- Observational Models: Case-Control
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
children who stutter
assessment executive function and stuttering severity in 30 child with stuttering
|
Assessment of executive function subdivision
|
|
children who don't stutter
assessment executive function in 30 child with stuttering
|
Assessment of executive function subdivision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PEPL numerical stroop test
Time Frame: one year
|
Using the Psychological Experimental Building Language (PEBL) current version 2.1 released at 2018 (Muller & Piper, 2014).
The test measuring inhibitory function It asses the reaction time in seconds, the total numbers of errors ranging between 0-200
|
one year
|
|
Cognitive flexibility function (sub-division of executive function testing)
Time Frame: one year
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PEPL Berg's Card Sorting Test 64 version of Berg's (1948) Wisconsin Card Sorting Test.
The child is asked to sort multi-attribute cards into piles according to an unknown and changing rule.
It provides an indication of which rule (shape, color or number) is easiest for the individual.
It aims to asses Number of Correct Responses: ranging between 0-64 Number of Total Errors ranging between 0-64 Percent of Perseverative Responses Percent of Perseverative Errors Percent of Non-Perseverative Errors Number of Unique Errors
|
one year
|
|
Working memory score
Time Frame: one year
|
Sub-test of Stanford-Binet Intelligence Scales, 5th Edition (SB5) The score ranging between 40-130
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one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non word Repetation score(Fawzy et al., 2012)
Time Frame: one year
|
To test the working memory abilities.
the child is asked to repeat a number of non sense words.
The score ranges between 0 to 30
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one year
|
|
Backward digit span score (Aboras et al., 2008)
Time Frame: one year
|
It test the working memory.
The child is asked to retell a number of digit in backward manner.
The score ranges between 0 to 14.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ahlam A Nabieh, professor, ahlaama@yahoo.com
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)
December 1, 2022
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
November 16, 2022
First Submitted That Met QC Criteria
December 6, 2022
First Posted (Estimate)
December 7, 2022
Study Record Updates
Last Update Posted (Estimate)
December 7, 2022
Last Update Submitted That Met QC Criteria
December 6, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-med-22-11-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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