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

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.

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Key information

Conditions

Cleft Palate Communication Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mental Disorders Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities Velopharyngeal Insufficiency

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group before-after

Behavioral

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.

Primary outcomes

Analyze the effect of semi-occluded vocal tract exercise, with high resistance tube, on the velopharyngeal mechanism

Time frame: one month

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.

Secondary outcomes

Changes on speech after semi-occluded vocal tract exercise in cleft palate.

Time frame: one month

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.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: May 29, 2019
Registry last updated: May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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