Semi-occluded Vocal Tract Exercise in Velopharyngeal Dysfunction in Patients With Cleft Palate

Study Overview
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Brief Summary
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Analyze the effect of SOVTE (Semi-occluded Vocal Tract Exercise), with high resistance tube, on the velopharyngeal mechanism, for speech rehabilitation of twelve patients with cleft palate with vocal alterations, after four weeks. The study was developed in the city of Porto Alegre, southern Brazil. The hypothesis of the study is that after four weeks of exclusive therapy with exercise it will be improvement in the voice of patients with cleft palate.

Detailed Description
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The study is an uncompared before-after clinical trial. All patients were submitted to videonasoendoscopy and had their vocal emissions recorded before and after the four weeks of speech therapy. These individuals were submitted to multidimensional evaluation comprised of analysis of images generated by specialized videonasoendoscopy software, analysis of speech emissions by perceptual-auditory evaluation and acoustic analysis, and vocal self-assessment.

Official Title
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Exercise Of Semi-Occluded Vocal Tract In Velopharyngeal Dysfunction In Patients With Cleft Palate : Effects Of Short-Term

Conditions
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Cleft Palate

Intervention / Treatment
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* Behavioral: Group before-after


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with surgically repaired CLP (Cleft lip and palate), regardless of gender and regardless of the type of clef palate. The sample only included patients aged 6+ because this is the ideal age to be submitted to videonasoendoscopy. These patients attended four speech therapy sessions. All individuals agreed to participate in this research voluntarily. Exclusion Criteria: Individuals with cleft lip and palate associated with genetic syndromes or other congenital malformation Individuals who proved unable to do SOVTE (Semi-occluded Vocal Tract Exercise), No condition to be submitted to videonasoendoscopy examination, Patients who did not attend the four sessions of therapy or who did not do exercise at home were excluded from the sample.

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Uncompared before-after clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group before-after<br>Speech therapy with Semiocluded vocal tract exercise. | Behavioral: Group before-after<br>* The group was submitted to four weeks of speech therapy intervention with Semiocluded vocal tract exercise. The 12 participants were evaluated before and after the intervention with a multidimensional evaluation comprised of analysis of images generated by specialized videonasoendoscopy software, analysis of speech emissions by perceptual-auditory evaluation and acoustic analysis, and vocal self-assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the effect of semi-occluded vocal tract exercise, with high resistance tube, on the velopharyngeal mechanism | Patients were submitted to evaluation of the VPS (velopharyngeal sphincter) region before and after the speech therapy. Patients were sitting in the examination chair, facing the examiner, throughout the entire procedure. The otorhinolaryngologist framed the image of the VPS and tried to maintain the optic fiber positioned at this site while those being evaluated performed selected sentences. | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on speech after semi-occluded vocal tract exercise in cleft palate. | To measure this outcome, samples of the participant's speech were recorded before and after the exercise with semi-occluded vocal tract (SOVTE). The vocal samples were randomly presented to three experients judges, voice specialists. They analyzed the samples and consensually completed the protocol of perceptual-auditory evaluation. | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cleft palate, velopharyngeal sphincter, velopharyngeal insufficiency, speech therapy, rehabilitation