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Clinical Trials/NCT04392817
NCT04392817CompletedNot Applicable

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

Alaa Mamdouh2 sites in 1 country40 target enrollmentStarted: January 2, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
change in naso meter values

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
5 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

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)

change in Arabic articulation test

Time Frame: immediately after intervention

a qualitative test that define presence or absence of articulation errors

Secondary Outcomes

  • effect of the age factor on auditory perceptual assessment after intervention(immediately after intervention)
  • effect of the surgical repair on the nasometer values after intervention(immediately after intervention)
  • effect of the age factor on nasometer values after intervention(immediately after intervention)

Investigators

Sponsor
Alaa Mamdouh
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Alaa Mamdouh

Assistant lecturer of phoniatrics

Alexandria University

Study Sites (2)

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