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

NCT03966482 | Completed

• 1 other identifier: 49953815.4.0000.5327
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cleft Palate

Keywords

cleft palate; velopharyngeal sphincter; velopharyngeal insufficiency; speech therapy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  one month

Study Arms (1)

Group before-after

EXPERIMENTAL

Speech therapy with Semiocluded vocal tract exercise.

Behavioral: Group before-after

Interventions

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.

Group before-after

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Cleft Palate; Velopharyngeal Insufficiency; Communication Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Marcus Vinicius M Collares, MD, PhD

  Chief of plastic surgery of Clinicas Hospital of Porto Alegre's

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Uncompared before-after clinical trial

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 29, 2019
• Study Start: May 1, 2016
• Primary Completion: October 26, 2017
• Study Completion: November 28, 2017
• Last Updated: May 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share