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

Not Applicable

Completed

• Conditions: Velopharyngeal Insufficiency; Hypernasality Syndrome Due to Velopharyngeal Weakness; Articulation Disorders
• Interventions: Behavioral: Arabic Articulatory Error Remediation software program

• Registration Number: NCT04392817
• Lead Sponsor: Alaa Mamdouh

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-01-02
• Primary Completion: 2019-01-23
• Study Completion: 2019-02-09
• Status Verified: 2020-05
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-13
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
the participating group in the intervention	Arabic Articulatory Error Remediation software program	patient complaining of seppch rerrors due t ovelopharyngeal insufficiency and underwent the intervention

Primary Outcome Measures

Name	Time	Method
change in naso meter values	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
change in Auditory perceptual assessment of speech	immediately after intervention	A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)
change in Arabic articulation test	immediately after intervention	a qualitative test that define presence or absence of articulation errors

Secondary Outcome Measures

Name	Time	Method
effect of the age factor on auditory perceptual assessment after intervention	immediately after intervention	statistical tests for correlation
effect of the surgical repair on the nasometer values after intervention	immediately after intervention	comparison between two groups
effect of the age factor on nasometer values after intervention	immediately after intervention	statistical tests for correlation

Trial Locations

Locations (1)

Faculty of Medicine, Alexandria universtiy; 🇪🇬 Alexandria, Egypt