NCT05444075

Brief Summary

Aim of the work The aim of this study is to test an Arabic alphabet communication system designed to train physicians to communicate with Arabic-speaking patients with LIS. Subjects and methods

  • Place of study: Department of Neurology at Sohag university hospital
  • Type of study: clinical trial.
  • Subjects: Thirty healthy subjects from three different educational levels. Ten subjects have a preparatory education level, ten subjects with a high school education or its equivalent, and ten subjects who have a university education or are still in a university education stage. They will be collected from among patients' relatives and employees of Sohag University Hospital. Methods of the study: The method shown in the figure No. 1 is the Arabic alphabet (arranged in the traditional order) printed on double-sided cardboard, with one copy facing the person and one facing the doctor. The code will be in the case of a positive selection (the desired line or letter) by looking up or one blink, but in the case of a negative selection (not the desired line or letter), it will be by looking down or two blinks. The person will choose the letters of each word and then choose the end of the word and after selecting all the words of the sentence choose the end of the sentence. After the strategy has been taught to the subject, he or she will be asked to communicate with the physician using this way.

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 all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

May 16, 2022

Last Update Submit

June 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alphabetic communication

    The participant's ability to communicate in the Arabic alphabet using vertical eye movement

    up to 24 weeks

Study Arms (3)

subjects with preparatory education level

Ten subjects have a preparatory education level

Other: a method for communication

subjects with high school education

ten subjects with a high school education or its equivalent

Other: a method for communication

subjects with university education

ten subjects who have a university education, or are still in a university education stage

Other: a method for communication

Interventions

the Arabic alphabet (arranged in the traditional order) printed on double-sided cardboard, with one copy facing the person and one facing the doctor. The code will be in the case of a positive selection (the desired line or letter) by looking up or one blink, but in the case of a negative selection (not the desired line or letter), it will be by looking down or two blinks. The person will choose the letters of each word and then choose the end of the word and after selecting all the words of the sentence choose the end of the sentence. After the strategy has been taught to the subject, he or she will be asked to communicate with the physician using this way.

subjects with high school educationsubjects with preparatory education levelsubjects with university education

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Thirty healthy subjects from three different educational levels. Ten subjects have a preparatory education level, ten subjects with a high school education or its equivalent, and ten subjects who have a university education or are still in a university education stage. They will be collected from among patients' relatives and employees of Sohag University Hospital.

You may qualify if:

  • educated healthy subjects

You may not qualify if:

  • non-educated, healthy subjects
  • subjects with any sensory deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coma

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

May 16, 2022

First Posted

July 5, 2022

Study Start

August 1, 2022

Primary Completion

December 30, 2022

Study Completion

April 15, 2023

Last Updated

July 5, 2022

Record last verified: 2022-06