Back to resultsSemi-occluded Vocal Tract Exercise in Velopharyngeal Dysfunction in Patients With Cleft Palate
Primary Purpose
Cleft Palate
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group before-after
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Palate focused on measuring cleft palate, velopharyngeal sphincter, velopharyngeal insufficiency, speech therapy, rehabilitation
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group before-after
Arm Description
Speech therapy with Semiocluded vocal tract exercise.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03966482
First Posted
April 26, 2019
Last Updated
May 28, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03966482
Brief Title
Semi-occluded Vocal Tract Exercise in Velopharyngeal Dysfunction in Patients With Cleft Palate
Official Title
Exercise Of Semi-Occluded Vocal Tract In Velopharyngeal Dysfunction In Patients With Cleft Palate : Effects Of Short-Term
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
November 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate
Keywords
cleft palate, velopharyngeal sphincter, velopharyngeal insufficiency, speech therapy, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Uncompared before-after clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group before-after
Arm Type
Experimental
Arm Description
Speech therapy with Semiocluded vocal tract exercise.
Intervention Type
Behavioral
Intervention Name(s)
Group before-after
Intervention Description
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.
Primary Outcome Measure Information:
Title
Analyze the effect of semi-occluded vocal tract exercise, with high resistance tube, on the velopharyngeal mechanism
Description
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.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Changes on speech after semi-occluded vocal tract exercise in cleft palate.
Description
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.
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Vinicius M Collares, MD, PhD
Organizational Affiliation
Chief of plastic surgery of Clinicas Hospital of Porto Alegre's
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The IPD was analysed and will be published in conjunction.
Learn more about this trial
Semi-occluded Vocal Tract Exercise in Velopharyngeal Dysfunction in Patients With Cleft Palate
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