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

NCT ID: NCT04392817

Last Updated: 2020-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2019-02-09

Brief Summary

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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

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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.

Conditions

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Velopharyngeal Insufficiency Articulation Disorders Hypernasality Syndrome Due to Velopharyngeal Weakness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

a quasi experimental study comparing pre to post therapy intervention in one group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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the participating group in the intervention

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

Group Type EXPERIMENTAL

Arabic Articulatory Error Remediation software program

Intervention Type BEHAVIORAL

A speech therapy computerized intervention

Interventions

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Arabic Articulatory Error Remediation software program

A speech therapy computerized intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alaa Mamdouh

OTHER

Sponsor Role lead

Responsible Party

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Alaa Mamdouh

Assistant lecturer of phoniatrics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Engy S Elhakeem, PhD

Role: STUDY_DIRECTOR

Otorhinolaryngology department,Faculty of Medicine, Alexandria University

Reham M Elmaghraby, PhD

Role: STUDY_CHAIR

Otorhinolaryngology department,Faculty of Medicine, Alexandria University

Locations

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Faculty of Medicine, Alexandria universtiy

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 3744698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26089139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18333650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16101269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22938066 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 16641626 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 26209352 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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0105440

Identifier Type: -

Identifier Source: org_study_id

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