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

Not Applicable

Completed

• Conditions: Cleft Palate
• Interventions: Behavioral: Group before-after

• Registration Number: NCT03966482
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-05-01
• Primary Completion: 2017-10-26
• Study Completion: 2017-11-28
• Status Verified: 2019-04
• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-05-28
• Last Update Submitted: 2019-05-28
• Study First Posted: 2019-05-29
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group before-after	Group before-after	Speech therapy with Semiocluded vocal tract exercise.

Primary Outcome Measures

Name	Time	Method
Analyze the effect of semi-occluded vocal tract exercise, with high resistance tube, on the velopharyngeal mechanism	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 Outcome Measures

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