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AzTrials

Velopharyngeal InsufficiencyNCT04392817

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

A study testing Arabic Articulatory Error Remediation software program in people with Velopharyngeal Insufficiency and Articulation Disorders, run by Alaa Mamdouh at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 5 years and older
What is being tested?
Arabic Articulatory Error Remediation software program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
2 Jan 2018to 9 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Medicine, Alexandria universtiy

    Alexandria, 21500

Other trials in Egypt

About this study

Official title: 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

Read the 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.

Being tested
Arabic Articulatory Error Remediation software program
Keywords
Velopharyngeal dysfunction Hypernasality
Medical subject headings
Velopharyngeal Insufficiency, Articulation Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arabic Articulatory Error Remediation software programBehavioural

    A speech therapy computerized intervention

Study groups in NCT04392817
Study groupRoleWhat they receive
the participating group in the interventionExperimentalpatient complaining of seppch rerrors due t ovelopharyngeal insufficiency and underwent the intervention
Receives: Behavioral: Arabic Articulatory Error Remediation software program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in Arabic articulation test

    a qualitative test that define presence or absence of articulation errors

    Measured: base line( pre -intervention)

  2. change in Arabic articulation test

    a qualitative test that define presence or absence of articulation errors

    Measured: immediately after intervention

  3. 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

    Measured: pre intervention

  4. 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

    Measured: immediately after intervention

  5. change in Auditory perceptual assessment of speech

    A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)

    Measured: pre intervention

  6. change in Auditory perceptual assessment of speech

    A qualitative scale of patient speech : 5 grade from 0( not present) to 4 (sever)

    Measured: immediately after intervention

Secondary outcomes (3)

  1. effect of the age factor on nasometer values after intervention

    statistical tests for correlation

    Measured: immediately after intervention

  2. effect of the age factor on auditory perceptual assessment after intervention

    statistical tests for correlation

    Measured: immediately after intervention

  3. effect of the surgical repair on the nasometer values after intervention

    comparison between two groups

    Measured: immediately after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start2 Jan 2018
  3. Primary completion23 Jan 2019
  4. Study completion9 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
a quasi experimental study comparing pre to post therapy intervention in one group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04392817
Sponsor's protocol ID
0105440
Status last verified
May 2020
First submitted
11 May 2020
Last updated
20 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: It is not yet known if there will be a palne to make IPD available

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.

    PubMed 3744698

  • 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.

    PubMed 26089139

  • 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.

    PubMed 18333650

  • 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.

    PubMed 16101269

  • 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.

    PubMed 22938066

  • 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.

    PubMed 16641626

  • 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.

    PubMed 26209352

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

Questions about this trial

What is this clinical trial studying?

A study testing Arabic Articulatory Error Remediation software program in people with Velopharyngeal Insufficiency and Articulation Disorders, run by Alaa Mamdouh at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in Arabic articulation test (time frame: base line( pre -intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04392817, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.

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