Clinical trial NCT04392817: Efficacy of an Arabic Articulatory Error Remediation Software Program in Patients With Velopharyngeal Valve Dysfunction:
Official title: Formulatin and Application of a Remediation Software Porgram for Correction of Articulatory Errors in Patients With Velopfaryngeal Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Velopharyngeal Insufficiency
Articulation Disorders
Hypernasality Syndrome Due to Velopharyngeal Weakness
Keywords: Velopharyngeal dysfunction Hypernasality
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a quasi experimental study comparing pre to post therapy intervention in one group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in Arabic articulation test
timeFrame: base line( pre -intervention)
measure: change in Arabic articulation test
timeFrame: immediately after intervention
measure: change in naso meter values
timeFrame: pre intervention
measure: change in naso meter values
timeFrame: immediately after intervention
measure: change in Auditory perceptual assessment of speech
timeFrame: pre intervention
measure: change in Auditory perceptual assessment of speech
timeFrame: immediately after intervention
Secondary outcomes:
measure: effect of the age factor on nasometer values after intervention
timeFrame: immediately after intervention
measure: effect of the age factor on auditory perceptual assessment after intervention
timeFrame: immediately after intervention
measure: effect of the surgical repair on the nasometer values after intervention
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria universtiy
Study officials:
affiliation: Otorhinolaryngology department,Faculty of Medicine, Alexandria University
name: Engy S Elhakeem, PhD
role: STUDY_DIRECTOR
affiliation: Otorhinolaryngology department,Faculty of Medicine, Alexandria University
name: Reham M Elmaghraby, PhD
role: STUDY_CHAIR
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