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

Velopharyngeal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392817
• Other study ID #: 0105440
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: February 9, 2019

Study information

• Verified date: May 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 9, 2019
• Est. primary completion date: January 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Articulation Disorders
• Hypernasality Syndrome Due to Velopharyngeal Weakness
• Velopharyngeal Insufficiency

Intervention

Behavioral:
• Arabic Articulatory Error Remediation software program
A speech therapy computerized intervention

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Alexandria universtiy	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alaa Mamdouh

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

18. Kotby MN E-SA, Alloush T, Gamal N(1992) 3. Dysarthria Annual Bulletin of Yufuin Kosenenkin Hospital. Hiese. 373-80.

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.

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. — View Citation

Brunnegård 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. — View Citation

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. — View Citation

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. — View Citation

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.

Kummer AW( 2104) Cleft Palat and Craniofacial Anomalies: Effect on speech and resonance, 3rd edition ed. Delmar Cengage, NY. 23-31 p. .

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. — View Citation

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. Review. — View Citation

Siegel-Sadewitz VL, Shprintzen RJ. Changes in velopharyngeal valving with age. Int J Pediatr Otorhinolaryngol. 1986 Apr;11(2):171-82. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Arabic articulation test	a qualitative test that define presence or absence of articulation errors	base line( pre -intervention)
Primary	change in Arabic articulation test	a qualitative test that define presence or absence of articulation errors	immediately after intervention
Primary	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
Primary	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
Primary	change in Auditory perceptual assessment of speech	A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)	pre intervention
Primary	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	effect of the age factor on nasometer values after intervention	statistical tests for correlation	immediately after intervention
Secondary	effect of the age factor on auditory perceptual assessment after intervention	statistical tests for correlation	immediately after intervention
Secondary	effect of the surgical repair on the nasometer values after intervention	comparison between two groups	immediately after intervention