SciELO - Scientific Electronic Library Online

vol.27 issue2Comparison between clinical and videofluoroscopic evaluation of swallowing in children with suspected dysphagiaRespiratory mode, nasal patency and palatine dimensions author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand




Related links



On-line version ISSN 2317-1782

CoDAS vol.27 no.2 São Paulo Mar./Apr. 2015 

Original Articles

Proposal and content validation of an orofacial myofunctional assessment protocol for individuals with cleft lip and palate

Andréia Fernandes Graziani 1  

Ana Paula Fukushiro 1  

Katia Flores Genaro 1  

(1)Graduate Program in Rehabilitation Sciences, Hospital for Rehabilitation of Craniofacial Anomalies, São Paulo University - USP - Bauru (SP), Brazil



To create and validate the content of an orofacial myofunctional assessment protocol for individuals with cleft lip and palate.


The first version of an orofacial myofunctional assessment protocol for individuals with cleft lip and palate was created by two speech-language pathologists, who contemplated the structural and functional aspects of the stomatognathic system. This version was analyzed by other two speech-language pathologists experienced in cleft lip and palate assessment, who suggested changes that led to the second version of the protocol. Dynamic and static images necessary for performing the orofacial myofunctional examination were recorded from three individuals with cleft lip and palate, who represented three life stages: childhood, adolescence, and adulthood. Five examiners evaluated the images, applied the proposed protocol, and judged each item regarding its clarity to validate the content, from Content Validity Index.


The assessment protocol was finalized with 13 items, ten related to structural aspects and three related to functional aspects, with their corresponding sub-items. The general agreement in the validation of its content was 100%, so that only one stage was required.


A protocol to evaluate the orofacial myofunctional aspects of individuals with cleft lip and palate was created with 13 items, as well as their corresponding sub-items, and its content was validated.

Key words: Cleft Palate; Stomatognathic; System; Validation; Studies Speech, Language and Hearing Sciences Evaluation


Cleft lip and palate can affect the lip, the palate, or both, and can be associated with other more complex malformations( 1 ). In such cases, a number of stomatognathic system structures are affected, which requires us to understand the alterations presented. Thus, the use of a protocol to perform the orofacial myofunctional assessment facilitates establishing the diagnosis, defining the conduct and treatment planning, and carrying out all relevant referrals.

It is recommended(2) that the evaluation be performed at least twice in the first year and once in a year until adolescence, the period when the pharyngeal tonsil undergoes the process of involution; and after this phase, it should be conducted every 2 years until the completion of dental-skeletal development. Furthermore, it should also be performed before and after the interventions. This assessment shall include aspects such as anatomy and physiology, language, speech, and voice, as well as investigate the velopharyngeal function by instrumental methods( 3 ).

The use of a standardized assessment tool facilitates the comparison of pre- and post-treatment results and leads to the discussion among professionals from different study fields( 4 - 6 ). In several areas of health, the validation of assessment tools has been performed to obtain more accurate and reliable results( 7 - 9 ). In Speech-Language Pathology and Audiology, some studies validated assessment protocols for diverse populations( 10 - 14 ).

Specifically for individuals with cleft lip and palate, the literature presents some validated instruments( 14 , 15 ), which cover aspects related to speech. In Brazil, professionals who assist individuals with cleft lip and palate use their own forms of evaluation, which require standardization and validation to facilitate the comparison of results and the development of research. This paper aims to contribute to the development and validation of the contents of a specific orofacial myofunctional assessment tool for individuals with cleft lip and palate, which favors the scientific improvement( 16 ) in this field and supports the proposal of the Orofacial Motricity Committee of the Brazilian Society of Speech-Language Pathology and Audiology.


The study was approved by the Research Ethics Committee of the Hospital for Rehabilitation of Craniofacial Anomalies of University of São Paulo (USP), under protocol no. 200.397, and all participants signed an informed consent.

For the development of the first version of the orofacial myofunctional assessment protocol, literature was consulted and, based on the clinical experience of two experts in orofacial motricity, particularly in cleft lip and palate patients, items and subitems were proposed on aspects related to the stomatognathic system and the performance of orofacial functions, in addition to possible answers for each item.

This version was presented to two other guest speechlanguage pathologists, with broad experience in the assessment of individuals with cleft lip and palate, who analyzed the protocol with respect to the items, subitems, and possible responses, and thus the second version was obtained after adjustments.

Static and dynamic images of three operated unilateral cleft lip and palate individuals at ages 7, 14, and 20 years, representing three stages of life: childhood, adolescence, and adulthood, were selected. Such individuals, randomly selected, were taken from a sample of 75 individuals from another study, and individuals with neurological or motor problems, hearing loss, syndrome or other associated malformations were not included.

For image capturing, subjects sat on a chair with a back support and feet flat on the floor. The images obtained with a digital camera (Sony DSC-HX1 model) helped in the assessment of each item and subitem of the proposed protocol, and an endoscopic camera (CCC Waterproof USB Endoscope, 10 mm), specifically for capturing oropharyngeal images, was used as well. The camera was attached to a tripod and positioned in front of the participants. The lenses were 1 m away from them, to frame the shoulders, neck and face. To have a better visualization of lips, tongue, hard palate, and soft palate, the camera was approximated. A single professional was responsible for capturing the images, which were stored in a computer and transferred to a mobile device (flash drive) to be subsequently analyzed.

Five new examiners with clinical experience ranging from 6 to 20 years in the care of individuals with cleft lip and palate analyzed the images from the proposed protocol. They received previous verbal and written guidance as to the completion of the protocol. After assessment, the examiners rated each item on its clarity in a four-point scale: 1 = no clarity; 2 = unclear; 3 = clear and 4 = very clear, to perform content validation by applying the equation of the Content Validation Index (CVI)( 17 ). If the examiners marked options 1 or 2, the items had to be reformulated( 18 ).


The orofacial myofunctional assessment protocol specific for individuals with cleft lip and palate was elaborated after analysis by four speech-language pathologists. It contains 13 items, 10 related to structural aspects and 3 related to functional aspects, with their corresponding subitems (Appendix 1). The items included referenes to the lips, tongue, cheeks, teeth and occlusion, palatine tonsils, hard palate, soft palate, and uvula and pharyngeal walls, as well as breathing, speech, and velopharyngeal functions.

In content validation, the investigators examined the items on the basis of their clarity for the calculation of the CVI (Tables 1 and 3); 75% of the examiners classified the items as "very clear" and 25% as "clear", with 100% agreement.

Table 1. Distribution of the frequency of the content validity index regarding the assessment of aspects of the lips, tongue, cheeks, palatine tonsils, teeth, occlusion, and hard palate 

Aspects and Description Very clear (%) Clear (%)
Habitual position 60 40
Upper lip appearance 60 40
Lower lip appearance 20 80
External mucosa 80 20
Internal mucosa 20 80
Upper mouth vestibule 60 40
Length of the upper lip 60 40
Habitual position 40 60
Width 60 40
Height 40 60
Mucosa 80 20
Extension of the frenulum 80 20
Fixation of the frenulum on the tongue 40 60
Fixation of the frenulum on floor 80 20
Function limitation 100 0
Mucosa 100 0
Palatine tonsils
Presence 80 20
Size 60 40
Dentition 100 0
Number of teeth 100 0
Missing teeth 80 20
Teeth health 80 20
Gum health 80 20
Use of orthodontic appliances 100 0
Dental prosthesis 80 20
Horizontal relationship 80 20
Vertical relationship 80 20
Transverse relationship 80 20
Hard palate
Aspect 80 20
Depth 60 40
Width 60 40
Fistula 80 20

Table 2. Distribution of the frequency of the content validity index regarding the assessment of aspects of the soft palate, uvula, pharynx, and mirror test 

Aspects and Description Very clear (%) Clear (%)
Soft palate
Aspect 80 20
Diastasis 60 40
Symmetry 60 40
Extension 100 0
Fistula 60 40
Insertion of the levator muscle 100 0
Mobility 60 40
Aspect 100 0
Lateral walls 60 40
Posterior wall 100 0
Mirror test
Blowing 100 0
“/a/” 100 0
“/u/” 100 0
“/i/” 100 0
/f/ 100 0
/s/ 100 0
/∫/ 100 0
Phrases /p/ 100 0
Phrases /b/ 100 0
Phrases /t/ 100 0
Phrases /d/ 100 0
Phrases /k/ 100 0
Phrases /g/ 100 0
Phrases /f/ 100 0
Phrases /v/ 100 0
Phrases /s/ 100 0
Phrases /z/ 100 0
Phrases /∫/ 100 0
Phrases /ȝ/ 100 0

Table 3. Distribution of the frequency of the content validity index regarding the assessment of aspects of speech, voice, and breathing 

Aspects and Description Very clear (%) Clear (%)
Hypernasality 100 0
Hyponasality 100 0
Phonological disorder 60 40
Compensatory articulation 60 40
Obligatory errors 60 40
Functional adjustment 60 40
Acoustic distortion 60 40
Speed 80 20
Mouth opening 80 20
Lip movement 80 20
Mandibler movement 100 0
Saliva 100 0
Coordination between breathing and speech 100 0
Intelligibility 100 0
Articulatory precision 60 40
Pitch 100 0
Loudness 100 0
Voice quality 80 20
Mode 80 20


The purpose of this study was to develop and validate the content of a specific instrument for orofacial myofunctional assessment for individuals with cleft lip and palate. Some spects concerning the general orofacial myofunctional assessment, such as mobility, muscular tonus, chewing and swallowing, were not anticipated, as it is believed that such assessments do not differ from those applied in other cases and thus other available assessment tools( 5 , 6 ) can be used.

The elaboration of the items contemplated in the proposal was based on professional experience and in the literature on the field of orofacial motricity and related to cleft lip and palate( 4 , 5 , 19 - 29 ).

Loudness 100 0 In the first version proposed, the examiners who ana-Voice quality 80 20 lyzed it suggested some adjustments related to possible Breathing answers, which helped clarify the proposal. According to Mode 80 20 some authors, the assessment of the instrument by experienced and competent examiners in the specific area to be tested is essential and should be considered in the content validation process( 8 , 13 , 29 ).

The content validation refers to the judgment from different examiners of an instrument, who must consider the items regarding content and the relevance of objectives to be measured, as well as make suggestions on how to remove, add, or modify items( 7 ).On the basis of evaluation conducte by a group of experts, some authors performed content validation only by means of qualitative analysis( 18 , 29 ), whereas other authors considered it highly relevant to perform a quantitative analysis( 8 , 13 ).

In this study, for the content validation, performed through analysis from the examiners, images from individuals with complete unilateral cleft lip and palate were selected, due to its incidence and also because this type of cleft affects many aspects of the stomatognathic system. Thus, all items proposed in the protocol could be included. In addition, one individual at every stage of life (childhood, adolescence, and adulthood) was selected so that the instrument could be applied to different age groups.

In the content validation, the CVI was used to measure the percentage of agreement between the five examiners who assessed the second version. The 100% agreement was obtained, in which 75% examiners classified the items as "very clear" and 25% as "clear." According to some authors, as the examiners did not mark the "no clarity" and "unclear" options, there was no need to exclude or reformulate any item( 18 ).

The proposal was adequate and the content of the instrument was validated in a single step, with a percentage of agreement above that established in the literature to be considered valid( 13 , 17 , 18 , 29 ). Thus, the content of the instrument proposed in this study was considered to be a valid and accurate measure for the 13 items evaluated, as well as their subitems.

This study did not aim to establish assessment criteria for the judgment of certain items, which will be conducted in a new study, as well as the continuity of the validation process of the instrument. In the course of this study, it was verified that the quality of images requires suitable equipment and techniques to facilitate the visualization of detailed structures for assessment.


A proposed protocol for the orofacial myofunctional assessment of individuals with cleft lip and palate, consisting of 13 items covering both structural and functional aspects, was developed and its content was validated.


Dixon MJ, Marazita ML, Beaty TH, Murray JC. Cleft lip and palate: understanding genetic and environmental. Nat Rev Genetic. 2011;12(3):167-78. [ Links ]

American Cleft Palate-Craniofacial Association [Internet ]. Parameters for evaluation and treatment of patients with cleft lip/palate or other craniofacial anomalies: revised edition. November 2009 [cited 2014 May 25 ]. Available from: Rev_2009.pdfLinks ]

Kuehn DP, Moller KT. Speech and language issues in the cleft palate population: the state of the art. Cleft Palate Craniofac J. 2000;37(4):348-35. [ Links ]

Felício CM, Ferreira CLP. Protocol of orofacial myofunctional evaluation with scores. Int J Pediatr Otorhinolaryngol. 2008;72:367-75. [ Links ]

Genaro KF, Berretin-Félix G, Rehder MIBC, Marchesan IQ. Avaliação miofuncional orofacial - Protocolo MBGR. Rev CEFAC. 2009;11(2):237-55. [ Links ]

Felício CM, Folha GA, Ferreira CLP, Medeiros APM. Expanded protocol of orofacial myofunctional evaluation with scores: validity and reliability. Int J Pediatr Otorhinolaryngol. 2010;74:1230-9. [ Links ]

Raymundo, VP. Construção e validação de instrumentos: um desafio para a psicolinguística. Letras de Hoje. 2009;44(3):86-93. [ Links ]

Fujinaga CI, Scochi CGS, Santos CB, Zamberlan NE, Leite AM. Validação do conteúdo de um instrumento para a avaliação da prontidão do prematuro para início da alimentação oral. Rev Bras Saúde Matern Infant. 2008;8(4):391-9. [ Links ]

Cunha VLO, Capellini AS. Construção e validação de instrumento de avaliação da compreensão de leitura para escolares do terceiro ao quinto ano do ensino fundamental. CoDAS. 2014;26(1):28-37. [ Links ]

Brancalioni AR, Magnago KF, Keske-Soares M. Validação de um modelo linguístico Fuzzy para classificar a gravidade do desvio fonológico. Rev CEFAC. 2012;14(3):448-58. [ Links ]

Paulinelli BR, Gama ACC, Behlau M. Validação do questionário de performance vocal no Brasil. Rev Soc Bras Fonoaudiol. 2012;17(1):85-91. [ Links ]

Marchesan IQ, Andrade IS, Farias MS, Uliano IAM, Zullo VD, Nemr K. Validação do Protocolo MBGR em adultos sem queixas miofuncionais. In: 19º Congresso Brasileiro e 8º Internacional de Fonoaudiologia; 2011 out-nov; São Paulo. Anais. São Paulo: SBFA; 2011;1520. [ Links ]

Siqueira MMM. Construção e validação da escala de percepção de suporte social. Psicol Estud. 2008;13(2):381-8. [ Links ]

John A, Sell D, Sweeney T, Harding-Bell A, Williams A. The cleft audit protocol for speech-augmented: a validated and reliable measure for auditing cleft speech. Cleft Palate Craniofac J. 2006;43(3):272-88. [ Links ]

Wermker K, Jung S, Joos U, Kleinheinz J. Objective assessment of hypernasality in patients with cleft lip and palate with the nasalview system: a clinical validation study. Int J Otolaryngol. 2012; 1-6. [ Links ]

Henningsson G, Kuehn DP, Sell D, Sweeney T, Trost-Cardamone JE, Whitehill TL. Universal parameters for reporting speech outcomes in individuals with cleft palate. Cleft Palate Craniofac J. 2008;45(1):1-15. [ Links ]

Alexandre NMC, Coluci MZO. Validade de conteúdo nos processos de construção e adaptação de instrumentos de medidas. Ciênc Saúde Colet. 2011;16(7):3061-8. [ Links ]

Wynd CA, Schmidt B, Schaefer MA. Two quantitative approaches for estimating content validity. West J Nurs Res. 2003;25(5):508-18. [ Links ]

Genaro KF, Yamashita RP, Trindade IEK. Avaliação clínica e instrumental na fissura labiopalatina. In: Ferreira LP, Befi-Lopes DM, Limongi SCO, organizadoras. Tratado de Fonoaudiologia. São Paulo: Roca; 2004. p. 456-77. [ Links ]

Marchesan IQ. Avaliação miofuncional. In: Marchesan IQ. Fundamentos em Fonoaudiologia: aspectos clínicos da motricidade orofacial (ou oral). 2ª edição. revista e ampliada. Rio de Janeiro: Guanabara Koogan; 2005. p. 19-27. [ Links ]

Konst EM, Rietveld T, Peters HFM, Weersink-Braks H. Use of a perceptual evaluation instrument to assess the effects of infant orthopedics on the speech of toddlers with cleft lip and palate. Cleft Palate Craniofac J. 2003;40(6):597-605. [ Links ]

Kummer AW. Velopharyngeal dysfunction (VPD) and resonance disorders. In: Kummer AW, editor. Cleft palate and craniofacial anomalies. San Diego: Singular; 2001. p. 145-76. [ Links ]

Peterson-Falzone SJ, Trost-Cardamone JE, Karnell MP, Hardin-Jones MA. The clinician's guide to treating cleft palate speech. St. Louis: Mosby; 2006. [ Links ]

Sell D. Issues in perceptual speech analysis in cleft palate and related disorders: a review. Int J Lang Comm Dis. 2005;40(2):103-21. [ Links ]

Trindade IEK, Genaro KF, Yamashita RP, Miguel HC, Fukushiro AP. Proposta de classificação da função velofaríngea na avaliação perceptivoauditiva da fala. Pró-Fono R Atual Cient. 26. 2005;17(2):259-62. [ Links ]

Bakke M, Bergendal B, Macaliester A, Sjögreen L, Astem P. Development and evaluation of comprehensive screening for orofacial dysfunction. Swed Dent J. 2007;31:75-84. [ Links ]

Sell D, John A, Harding-Bell A, Sweeney T, Hegarty F, Freeman J. Cleft Audit Protocol for Speech (CAPS-A): a comprehensive training package for speech. Analysis. Int J Lang Comm Dis. 2009;44(4):529-48. [ Links ]

Marchesan IQ, Berretin-Felix G, Genaro KF. MBGR Protocol of orofacial myofunctional evaluation with scores. Int J Orofacial Myology. 2012;38:38-77. [ Links ]

Hermida PMV, Araújo IEM. Elaboração e validação do instrumento de entrevista de enfermagem. Rev Bras Enferm. 2006;59(3):314-20. [ Links ]

Study carried out at the Physiology Laboratory, Hospital for Rehabilitation of Craniofacial Anomalies, São Paulo University - USP -Bauru (SP), Brazil.

Financial support: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES.

*AFG participated in the study idealization, data collection, analysis and interpretation, and drafting of the article; APF participated in the idealization of the study, data analysis, and interpretation; KFG participated in the idealization of the study, data analysis and interpretation, and drafting of the article.


Myofunctional Assessment Protocol Developed

Received: May 24, 2014; Accepted: September 21, 2014

Correspondence address: Katia Flores Genaro Alameda Doutor Octávio Pinheiro Brisola, 9-75, Vila Universitária, Bauru (SP), Brasil, CEP: 17012-901. E-mail:

Conflict of interests: nothing to declare.

Creative Commons License This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.