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

NCT ID: NCT03966482

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2017-11-28

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.

Conditions

Cleft Palate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group before-after

Speech therapy with Semiocluded vocal tract exercise.

Group Type: EXPERIMENTAL

Group before-after

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcus Vinicius M Collares, MD, PhD

Role: STUDY_DIRECTOR

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

Other Identifiers

49953815.4.0000.5327

Identifier Type: -

Identifier Source: org_study_id