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

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Completed

CT.gov ID

NCT03966482

Collaborator

(none)

Enrollment

Arm

18.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cleft Palate	Behavioral: Group before-after	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Uncompared before-after clinical trialUncompared before-after clinical trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Oct 26, 2017

Actual Study Completion Date :

Nov 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group before-after Speech therapy with Semiocluded vocal tract exercise.	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.

Arm

Intervention/Treatment

Experimental: Group before-after

Speech therapy with Semiocluded vocal tract exercise.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.