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Completed

NCT Number: NCT04392817

Efficacy of an Arabic Articulatory Error Remediation Software Program in Patients With Velopharyngeal Valve Dysfunction:

To develop a remediation software program that is specific for correcting speech errors in patients with velopharyngeal dysfunction in the Arabic language and test its efficacy, on one group comparing pre and post results

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Key information

Conditions

Velopharyngeal Insufficiency Articulation Disorders Communication Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypernasality Syndrome Due to Velopharyngeal Weakness Language Disorders Mouth Abnormalities Mouth Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms Speech Disorders Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Alexandria universtiy

Alexandria, 21500, Egypt

About this study

The study was carried on 40 patients having articulation errors in cases of velopharyngeal valve dysfunction attending the unit of phoniatrics, otorhinolaryngology department, Alexandria University.

The patients met the specified inclusion and exclusion criteria. The patient underwent pre intervention evaluation and 3 parameters were chosen to compare efficacy of the program before and after therapy.

these include auditory perceptual assessment of speech, nasometer test and articulation test.

The patient underwent the remediation software program as individual sessions. then after finishing the therapy, the patients underwent post therapeutic evaluation with the 3 specified criteria

Statistical analysis Was carried out using SPSS statistics software version 23. Quantitative data were tested for normality using the Kolmogorov-Smirnov test. The variables which were normally distributed were described by Mean± SD. The variables which were not normally distributed, were described by median (Min-Max). Qualitative data were expressed by numbers and percentages. The results were calculated at a level of significance of 5% or less.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinically presented by articulation errors due to velopharyngeal dysfunction
  • Age of 5 years and above with
  • must have normal hearing and vision.

Exclusion criteria

  • Unrepaired cleft palate.
  • Large palatal fistula.
  • Brain damage and intellectual disability.

Treatment and study plan

Arabic Articulatory Error Remediation software program

Behavioral

A speech therapy computerized intervention

Primary outcomes

  1. change in Arabic articulation test

    Time frame: base line( pre -intervention)

    a qualitative test that define presence or absence of articulation errors

  2. change in Arabic articulation test

    Time frame: immediately after intervention

    a qualitative test that define presence or absence of articulation errors

  3. change in naso meter values

    Time frame: pre intervention

    a device that measure nasalance score as a ratio expressed in percentage between nasal sound energy to nasal plus oral sound in patients pre and post intervention for quantitaive assesment of nasal air emission and nasal tone where the lower values mean beteer results

  4. change in naso meter values

    Time frame: immediately after intervention

    a device that measure nasalance score as a ratio expressed in percentage between nasal sound energy to nasal plus oral sound in patients pre and post intervention for quantitaive assesment of nasal air emission and nasal tone where the lower values mean beteer results

  5. change in Auditory perceptual assessment of speech

    Time frame: pre intervention

    A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)

  6. change in Auditory perceptual assessment of speech

    Time frame: immediately after intervention

    A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)

Secondary outcomes

  1. effect of the age factor on nasometer values after intervention

    Time frame: immediately after intervention

    statistical tests for correlation

  2. effect of the age factor on auditory perceptual assessment after intervention

    Time frame: immediately after intervention

    statistical tests for correlation

  3. effect of the surgical repair on the nasometer values after intervention

    Time frame: immediately after intervention

    comparison between two groups

Sponsors and collaborators

Lead sponsor

Alaa Mamdouh

Other

Registry information

Official study title

Formulatin and Application of a Remediation Software Porgram for Correction of Articulatory Errors in Patients With Velopfaryngeal Dysfunction

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 19, 2020
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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