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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Arabic Articulatory Error Remediation software program
Sponsored by
Alaa Mamdouh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Velopharyngeal Insufficiency focused on measuring Velopharyngeal dysfunction Hypernasality

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine, Alexandria universtiy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

the participating group in the intervention

Arm Description

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

Outcomes

Primary Outcome Measures

change in Arabic articulation test
a qualitative test that define presence or absence of articulation errors
change in Arabic articulation test
a qualitative test that define presence or absence of articulation errors
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
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
change in Auditory perceptual assessment of speech
A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)
change in Auditory perceptual assessment of speech
A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)

Secondary Outcome Measures

effect of the age factor on nasometer values after intervention
statistical tests for correlation
effect of the age factor on auditory perceptual assessment after intervention
statistical tests for correlation
effect of the surgical repair on the nasometer values after intervention
comparison between two groups

Full Information

First Posted
May 11, 2020
Last Updated
May 18, 2020
Sponsor
Alaa Mamdouh
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1. Study Identification

Unique Protocol Identification Number
NCT04392817
Brief Title
Efficacy of an Arabic Articulatory Error Remediation Software Program in Patients With Velopharyngeal Valve Dysfunction:
Official Title
Formulatin and Application of a Remediation Software Porgram for Correction of Articulatory Errors in Patients With Velopfaryngeal Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
January 23, 2019 (Actual)
Study Completion Date
February 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alaa Mamdouh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Velopharyngeal Insufficiency, Articulation Disorders, Hypernasality Syndrome Due to Velopharyngeal Weakness
Keywords
Velopharyngeal dysfunction Hypernasality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a quasi experimental study comparing pre to post therapy intervention in one group
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the participating group in the intervention
Arm Type
Experimental
Arm Description
patient complaining of seppch rerrors due t ovelopharyngeal insufficiency and underwent the intervention
Intervention Type
Behavioral
Intervention Name(s)
Arabic Articulatory Error Remediation software program
Intervention Description
A speech therapy computerized intervention
Primary Outcome Measure Information:
Title
change in Arabic articulation test
Description
a qualitative test that define presence or absence of articulation errors
Time Frame
base line( pre -intervention)
Title
change in Arabic articulation test
Description
a qualitative test that define presence or absence of articulation errors
Time Frame
immediately after intervention
Title
change in naso meter values
Description
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
Time Frame
pre intervention
Title
change in naso meter values
Description
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
Time Frame
immediately after intervention
Title
change in Auditory perceptual assessment of speech
Description
A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)
Time Frame
pre intervention
Title
change in Auditory perceptual assessment of speech
Description
A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)
Time Frame
immediately after intervention
Secondary Outcome Measure Information:
Title
effect of the age factor on nasometer values after intervention
Description
statistical tests for correlation
Time Frame
immediately after intervention
Title
effect of the age factor on auditory perceptual assessment after intervention
Description
statistical tests for correlation
Time Frame
immediately after intervention
Title
effect of the surgical repair on the nasometer values after intervention
Description
comparison between two groups
Time Frame
immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Engy S Elhakeem, PhD
Organizational Affiliation
Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Reham M Elmaghraby, PhD
Organizational Affiliation
Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, Alexandria universtiy
City
Alexandria
ZIP/Postal Code
21500
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
3744698
Citation
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.
Results Reference
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PubMed Identifier
26089139
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.
Results Reference
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PubMed Identifier
18333650
Citation
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.
Results Reference
background
PubMed Identifier
16101269
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. doi: 10.1080/13682820400016522.
Results Reference
background
PubMed Identifier
22938066
Citation
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.
Results Reference
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Citation
Kummer AW( 2104) Cleft Palat and Craniofacial Anomalies: Effect on speech and resonance, 3rd edition ed. Delmar Cengage, NY. 23-31 p. .
Results Reference
background
PubMed Identifier
16641626
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. doi: 10.1097/01.sap.0000210628.18395.de.
Results Reference
background
Citation
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
26209352
Citation
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.
Results Reference
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Citation
18. Kotby MN E-SA, Alloush T, Gamal N(1992) 3. Dysarthria Annual Bulletin of Yufuin Kosenenkin Hospital. Hiese. 373-80.
Results Reference
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Efficacy of an Arabic Articulatory Error Remediation Software Program in Patients With Velopharyngeal Valve Dysfunction:

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