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

Cleft Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966482
• Other study ID #: 49953815.4.0000.5327
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: November 28, 2017

Study information

• Verified date: April 2019
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 28, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Behavioral:
• Group before-after
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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