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

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

Study Overview

• Status: Completed
• Conditions: Articulation Disorders; Velopharyngeal Insufficiency; Hypernasality Syndrome Due to Velopharyngeal Weakness
• Intervention / Treatment: Behavioral: Arabic Articulatory Error Remediation software program

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21500
    • Faculty of Medicine, Alexandria universtiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the participating group in the intervention; patient complaining of seppch rerrors due t ovelopharyngeal insufficiency and underwent the intervention	Behavioral: Arabic Articulatory Error Remediation software program; A speech therapy computerized intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alaa Mamdouh
• Investigators: Study Chair: Reham M Elmaghraby, PhD, Otorhinolaryngology department,Faculty of Medicine, Alexandria University

Publications and helpful links

General Publications

• Siegel-Sadewitz VL, Shprintzen RJ. Changes in velopharyngeal valving with age. Int J Pediatr Otorhinolaryngol. 1986 Apr;11(2):171-82. doi: 10.1016/s0165-5876(86)80011-8.
• Ha S, Cho SH. Nasalance scores for normal Korean-speaking adults and children: Effects of age, vowel context, and stimulus length. Int J Pediatr Otorhinolaryngol. 2015 Aug;79(8):1235-9. doi: 10.1016/j.ijporl.2015.05.019. Epub 2015 Jun 4.
• Phua YS, de Chalain T. Incidence of oronasal fistulae and velopharyngeal insufficiency after cleft palate repair: an audit of 211 children born between 1990 and 2004. Cleft Palate Craniofac J. 2008 Mar;45(2):172-8. doi: 10.1597/06-205.1.
• Sell D. Issues in perceptual speech analysis in cleft palate and related disorders: a review. Int J Lang Commun Disord. 2005 Apr-Jun;40(2):103-21. doi: 10.1080/13682820400016522.
• Brunnegard K, Lohmander A, van Doorn J. Comparison between perceptual assessments of nasality and nasalance scores. Int J Lang Commun Disord. 2012 Sep-Oct;47(5):556-66. doi: 10.1111/j.1460-6984.2012.00165.x. Epub 2012 Jul 25.
• Kummer AW( 2104) Cleft Palat and Craniofacial Anomalies: Effect on speech and resonance, 3rd edition ed. Delmar Cengage, NY. 23-31 p. .
• Dudas JR, Deleyiannis FW, Ford MD, Jiang S, Losee JE. Diagnosis and treatment of velopharyngeal insufficiency: clinical utility of speech evaluation and videofluoroscopy. Ann Plast Surg. 2006 May;56(5):511-7; discussion 517. doi: 10.1097/01.sap.0000210628.18395.de.
• 3. Kirschner RE, Baylis AL(2013) Velopharyngeal dysfunction. In: Neligan PC, Gurtner GC, editors. Plastic Surgery: Principles and practice, 3rd ed. Elsevier Inc, St. Louis. p. 614-30.
• Kotby MN, Bassiouny S, El-Zomor M, E M, editors.(1986) Standardization of an Articulation Test (In Arabic). Proceeding of the 9th Annual Ain Shams Medical Congress, Cairo, Egypt.
• Abou-Elsaad T, Baz H, Afsah O, Mansy A. The nature of articulation errors in Egyptian Arabic-speaking children with velopharyngeal insufficiency due to cleft palate. Int J Pediatr Otorhinolaryngol. 2015 Sep;79(9):1527-32. doi: 10.1016/j.ijporl.2015.07.003. Epub 2015 Jul 14.
• 18. Kotby MN E-SA, Alloush T, Gamal N(1992) 3. Dysarthria Annual Bulletin of Yufuin Kosenenkin Hospital. Hiese. 373-80.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): January 23, 2019
• Study Completion (Actual): February 9, 2019

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Velopharyngeal dysfunction Hypernasality
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Language Disorders; Communication Disorders; Speech Disorders; Articulation Disorders; Velopharyngeal Insufficiency
• Other Study ID Numbers: 0105440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: It is not yet known if there will be a palne to make IPD available
• IPD Sharing Time Frame: for 6 months after puplishing
• IPD Sharing Access Criteria: Through the Email Address A_abdelhamed14@alexmed,edu,eg
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No