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Use of vocal exercises in subjects with cleft lip and palate: randomized clinical trial

Speech therapy intervention program with semi-occluded vocal tract exercise in subjects with cleft lip and palate: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3xvgcsz
Enrollment
Unknown
Registered
2022-04-01
Start date
2022-03-24
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft palate with cleft lip

Interventions

The total sample will have 66 participants, randomly divided into two groups. The Intervention Group will have 33 participants and the Control Group will have 33 participants. Patients in the Interven
between the second and fifth sessions there will be the production of vowels, voiced labiodental fricative phone ([v]) and the song ‘parabéns a você’. From the sixth to the tenth session, the same pro

Sponsors

Hospital da Criança Santo Antônio - Irmandade Santa Casa de Misericórdia de Porto Alegre/ Rio Grande do Sul
Lead Sponsor
Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA
Collaborator

Eligibility

Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: Present cleft lip and palate corrected by labiaplasty, palatoplasty or both; Be between four and twelve years old; Attend the research sites during speech therapy sessions and present 75% of attendance at the sessions.

Exclusion criteria

Exclusion criteria: Present diagnosed genetic syndromes related or not to the presence of cleft; Present facial malformations, in addition to cleft lip and palate, that compromise the functioning of the velopharyngeal sphincter; Presence of cognitive impairment that impairs the performance of the assessment and/or therapeutic intervention; Present inability to carry out the exercise with semi-occluded vocal tract (SOVTE); Present posterior oro-nasal fistula; Inability to produce the voiced labiodental fricative phoneme; Have undergone palatoplasty less than three months ago; Have been discharged due to completion of speech and/or voice speech therapy.

Design outcomes

Primary

MeasureTime frame
It is expected to find an improvement in vocal resonance (nasality degree), assessed using the CAPE-V scale (voice auditory-perceptual assessment) and the 'Orofacial myofunctional assessment protocol for individuals with cleft lip and palate', of one or more levels in the scales, in pre and post intervention measurements

Secondary

MeasureTime frame
6) It is expected to find an improvement in the movement of the soft palate and pharyngeal walls, evaluated through the 'Protocol of orofacial myofunctional assessment for individuals with cleft lip and palate', of one or more levels in the item grading, in pre- and post-intervention measurements. ;1) It is expected to find a decrease in nasal air leakage, evaluated through the 'Altmann mirror test', of 1 mm in the circumference of the recorded area, in pre and post intervention measurements. ;2) It is expected to find an improvement in vocal characteristics, evaluated through the CAPE-V scale and the 'Protocol of orofacial myofunctional assessment for individuals with cleft lip and palate', of one or more levels on the scale, in pre and post intervention measurements. ;3) It is expected to find an improvement in speech intelligibility, evaluated through the 'Protocol of orofacial myofunctional assessment for individuals with cleft lip and palate', of one or more levels in the item grading, in pre- and post-intervention measurements. ;4) It is expected to find an improvement in orofacial anatomic and myofunctional aspects, evaluated through the 'Orofacial myofunctional assessment protocol for individuals with cleft lip and palate', of one or more levels in the graduation, in pre and post intervention measurements.;5) It is expected to find an improvement in speech (phonetic and phonological characteristics), evaluated through the 'Protocol of orofacial myofunctional assessment for individuals with cleft lip and palate', of one or more levels in the items, in the pre and post intervention measurements.

Countries

Brazil

Contacts

Public ContactGabriela Schilling

Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA

gabrielar.schilling@gmail.com51 36008817

Outcome results

None listed

Source: REBEC (via WHO ICTRP)