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Clinical Trials/NCT03966482
NCT03966482CompletedNot Applicable

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

Hospital de Clinicas de Porto Alegre0 sites12 target enrollmentStarted: May 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Primary Endpoint
Analyze the effect of semi-occluded vocal tract exercise, with high resistance tube, on the velopharyngeal mechanism

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

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.(one month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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