NCT05640440

Brief Summary

The study aims to asses the executive function in children who stutter for better management of those children

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

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

November 16, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

December 7, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 16, 2022

Last Update Submit

December 6, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • PEPL numerical stroop test

    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)

    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

    Sub-test of Stanford-Binet Intelligence Scales, 5th Edition (SB5) The score ranging between 40-130

    one year

Secondary Outcomes (2)

  • Non word Repetation score(Fawzy et al., 2012)

    one year

  • Backward digit span score (Aboras et al., 2008)

    one year

Study Arms (2)

children who stutter

assessment executive function and stuttering severity in 30 child with stuttering

Diagnostic Test: Executive function testing

children who don't stutter

assessment executive function in 30 child with stuttering

Diagnostic Test: Executive function testing

Interventions

Assessment of executive function subdivision

children who don't stutterchildren who stutter

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

30 case group, 15 control group age range 7 yrs old and 15 yrs old

You may qualify if:

  • Patient and volunteers age between 7 years and 15 years.
  • IQ ≥ 85.

You may not qualify if:

  • History of secondary stuttering.
  • Language impairment and other speech problem.
  • Concurrent or history of psychiatric, cognitive, neurological disorders or hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rasha Mohamed Hashem

Sohag, 82511, Egypt

Location

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ahlam A Nabieh, professor

    ahlaama@yahoo.com

    STUDY DIRECTOR

Central Study Contacts

Rasha Mo Hashem, Assistant lecture

CONTACT

Eman M Mostafa, lectural

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

November 16, 2022

First Posted

December 7, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

July 1, 2024

Last Updated

December 7, 2022

Record last verified: 2022-11

Locations