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

NCT04392817 | Completed DMC

• 1 other identifier: 0105440
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Velopharyngeal dysfunction Hypernasality

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• effect of the age factor on nasometer values after intervention

  immediately after intervention

• 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

Study Arms (1)

the participating group in the intervention

EXPERIMENTAL

patient complaining of seppch rerrors due t ovelopharyngeal insufficiency and underwent the intervention

Behavioral: Arabic Articulatory Error Remediation software program

Interventions

Arabic Articulatory Error Remediation software program BEHAVIORAL

A speech therapy computerized intervention

the participating group in the intervention

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• clinically presented by articulation errors due to velopharyngeal dysfunction
• Age of 5 years and above with
• must have normal hearing and vision.

You may not qualify if:

• Unrepaired cleft palate.
• Large palatal fistula.
• Brain damage and intellectual disability.

Sponsors & Collaborators

• Alaa Mamdouh: lead

Study Sites (1)

Faculty of Medicine, Alexandria universtiy

Alexandria, 21500, Egypt

Location

Related Publications (11)

• 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.

  PMID: 3744698 BACKGROUND

• 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.

  PMID: 26089139 BACKGROUND

• 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.

  PMID: 18333650 BACKGROUND

• 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.

  PMID: 16101269 BACKGROUND

• 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.

  PMID: 22938066 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 16641626 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26209352 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Velopharyngeal Insufficiency; Articulation Disorders

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Diseases; Stomatognathic System Abnormalities; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Engy S Elhakeem, PhD

  Otorhinolaryngology department,Faculty of Medicine, Alexandria University

  STUDY DIRECTOR

• Reham M Elmaghraby, PhD

  Otorhinolaryngology department,Faculty of Medicine, Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of phoniatrics

Model Details: a quasi experimental study comparing pre to post therapy intervention in one group

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 19, 2020
• Study Start: January 2, 2018
• Primary Completion: January 23, 2019
• Study Completion: February 9, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: for 6 months after puplishing
• Access Criteria: Through the Email Address A\ abdelhamed14@alexmed,edu,eg

Locations

EG (1)