Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate

Cleland, Joanne; Crampin, Lisa; Campbell, Linsay; Dokovova, Marie

doi:10.1186/s40814-022-01051-x

Cited by 5 publications

(7 citation statements)

References 24 publications

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“…This study reported on the acceptability of UVBF versus standard treatment as part of a pilot feasibility trial (Cleland et al, 2022). Results met our objectives: in both intervention arms more than 75% of families rated randomization as acceptable in a questionnaire.…”

Section: Discussionmentioning

confidence: 88%

“…This study was approved by the West Midlands -South Birmingham Research Ethics Committee (21/WM/0104). The trial was registered on the 22nd of March, 2021 ISRCTN17441953 and the protocol was published prior to data collection (Cleland et al, 2022).…”

Section: Methodsmentioning

confidence: 99%

“…Acceptability is important because patients are more likely to adhere to interventions which are acceptable and UVBF is a novel intervention which involves the use of instrumentation that children are unfamiliar with, thus we cannot assume it is acceptable to children and their carers. The current study reports on the participant and carers' views on UVBF intervention compared with articulatory treatment as part of a pilot feasibility randomised control trial comparing these two interventions (Cleland et al, 2022).…”

Section: Ultrasound Visual Biofeedbackmentioning

confidence: 99%

“…The overall study has a number of feasibility objectives and criteria which will be used to determine whether progression to a full trial is warranted (Cleland et al, 2022). Those relevant to the current report of parents' and children's perspectives were:…”

Section: Ultrasound Visual Biofeedbackmentioning

confidence: 99%

“…All families were invited to take part in online focus groups about their experiences of the intervention and of taking part in the trial. (Cleland et al, 2022). In short, we aimed to make the interventions as similar to each other as possible in terms of dosage and agent of intervention.…”

Section: Participantsmentioning

confidence: 99%

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A Mixed-Methods Pilot Randomised Control Trial of Ultrasound Visual Biofeedback versus Standard Intervention for Children with Cleft Palate +/- Cleft Lip: Parents’ and Children’s Perspectives.

Cleland,

McCluskey,

Dokovova

et al. 2024

Preprint

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Background: Ultrasound visual biofeedback has the potential to be useful for the treatment of compensatory errors in speakers with Cleft Palate +/- Lip, but there is little research on its effectiveness, nor on how acceptable families find the technique. This study reports on parents’ and children’s perspectives on taking part in a pilot randomised control trial of ultrasound visual biofeedback compared to articulation intervention. Aims: To determine the acceptability of randomisation, ultrasound visual biofeedback, and articulation intervention to families. We set feasibility criteria of at least 75% of responses rated as acceptable or positive in order to determine progression from a pilot to full randomised control trial. Methods & Procedures: 19 families who received ultrasound visual biofeedback therapy (11 families) and articulation intervention (8 families) were invited to participate. Mixed methods were employed: two questionnaires to determine the acceptability of ultrasound visual biofeedback and articulation intervention respectively; and semi-structured focus groups/interviews. Questionnaires were analysed for frequency of positive versus negative acceptability, and the focus groups/interviews were analysed using thematic analysis and coded using the theoretical framework of acceptability.Outcomes & Results: More than 75% of families rated randomisation as acceptable and more than 75% of families rated both interventions as acceptable, with the caveat that half of participants did not wish to continue articulation intervention after the study. Six families (3 in each intervention) volunteered to take part in the focus groups/interviews. Results showed more positive than negative themes regarding acceptability, particularly affective attitude where high levels of enjoyment were expressed, although some participants found the articulation intervention “boring”. In both groups there was a considerable burden involved in travelling to the hospital location. Conclusions & Implications: Randomisation in a clinical trial is acceptable to families; ultrasound visual biofeedback and articulation intervention are acceptable and indeed enjoyable. The burden of the additional outcome measures required for a clinical trial are manageable, although there is a travel burden for participants. Future studies should seek to mitigate travel burden by considering additional locations for intervention.

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Section: Discussionmentioning

confidence: 88%

Section: Methodsmentioning

confidence: 99%

Section: Ultrasound Visual Biofeedbackmentioning

confidence: 99%

Section: Ultrasound Visual Biofeedbackmentioning

confidence: 99%

Section: Participantsmentioning

confidence: 99%

See 3 more Smart Citations

A Mixed-Methods Pilot Randomised Control Trial of Ultrasound Visual Biofeedback versus Standard Intervention for Children with Cleft Palate +/- Cleft Lip: Parents’ and Children’s Perspectives.

Cleland,

McCluskey,

Dokovova

et al. 2024

Preprint

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How differences in anatomy and physiology and other aetiology affect the way we label and describe speech in individuals with cleft lip and palate

Pereira,

Sell

2023

Intl J Lang & Comm Disor

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BackgroundSpeech in individuals with cleft lip and/or palate (CLP) is a complex myriad of presenting symptoms. It is uniquely associated with the structural difference of velopharyngeal insufficiency (VPI), together with a wide and heterogeneous range of other aetiologies which often co‐occur. The nature of the speech sound disorder (SSD) including VPI may also change over the course of an individual's care pathway. Differences in terminology and approaches to analysis are currently used, resulting in confusion internationally. Additionally, current diagnostic labels and classification systems in SSD do not capture the complexity and full nature of speech characteristics in CLP.AimsThis paper aims to explore the different aetiologies of cleft palate/VPI speech and to relate aetiology with speech characteristic(s). In so doing, it attempts to unravel the different terminology used in the field, describing commonalities and differences, and identifying overlaps with the speech summary patterns used in the United Kingdom and elsewhere. The paper also aims to explore the applicability of current diagnostic labels and classification systems in the non‐cleft SSD literature and illustrate certain implications for speech intervention in CLP.Methods and ProceduresThe different aetiologies were identified from the literature and mapped onto cleft palate/VPI speech characteristics. Different terminology and approaches to analysis are defined and overlaps described. The applicability of current classification systems in SSD is discussed including additional diagnostic labels proposed in the field.Outcomes and ResultsAetiologies of cleft palate/VPI speech identified include developmental (cognitive‐linguistic), middle ear disease and fluctuating hearing loss, altered oral structure, abnormal facial growth, VPI‐structural (abnormal palate muscle) and VPI‐iatrogenic (maxillary advancement surgery). There are four main terminologies used to describe cleft palate/VPI speech: active/passive and compensatory/obligatory, which overlap with the four categories used in the UK speech summary patterns: anterior oral cleft speech characteristics (CSCs), posterior oral CSCs, non‐oral CSCs and passive CSCs, although not directly comparable. Current classification systems in non‐cleft SSD do not sufficiently capture the full nature and complexity of cleft palate/VPI speech.Conclusions and ImplicationsOur attempt at identifying the heterogeneous range of aetiologies provides clinicians with a better understanding of cleft palate/VPI speech to inform the management pathway and the nature and type of speech intervention required. We hope that the unravelling of the different terminology in relation to the UK speech summary patterns, and those used elsewhere, reduces confusion and provides more clarity for clinicians in the field. Diagnostic labels and classification require international agreement.WHAT THIS PAPER ADDSWhat is already known on the subject Speech associated with cleft palate/velopharyngeal insufficiency (VPI) is a complex myriad of speech characteristics with a wide and heterogeneous range of aetiologies. Different terminology and speech summary patterns are used to describe the speech characteristics. The traditional classification of cleft palate/VPI speech is Articulation Disorder, although evidence is building for Phonological Disorder and contrastive approaches in cleft speech intervention.What this paper adds to existing knowledge This paper explores the range of aetiologies of cleft palate/VPI speech (e.g., altered oral structure, abnormal facial growth, abnormal palate muscle and iatrogenic aetiologies) and attempts to relate aetiology with speech characteristic(s). An attempt is made at unravelling the different terminology used in relation to a well‐known and validated approach to analysis, used in the United Kingdom and elsewhere. Complexities of current diagnostic labels and classifications in Speech Sound Disorder to describe cleft palate/VPI speech are discussed.What are the potential or actual clinical implications of this work? There needs to be a common language for describing and summarising cleft palate/VPI speech. Speech summary patterns based on narrow phonetic transcription and correct identification of aetiology are essential for the accurate classification of the speech disorder and identification of speech intervention approaches. There is an urgent need for research to identify the most appropriate type of contrastive (phonological) approach in cleft lip and/or palate.

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Ultrasound Tongue Imaging in Research and Practice with People with Cleft Palate ± Cleft Lip

Cleland

2023

The Cleft Palate Craniofacial Journal

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Ultrasound tongue imaging is becoming popular as a tool for both phonetic research and biofeedback for treating speech sound disorders. Despite this, it has not yet been adopted into cleft palate ± cleft lip care. This paper explores why this might be the case by highlighting recent research in this area and exploring the advantages and disadvantages of using ultrasound in cleft palate ± cleft lip care. Research suggests that technological advances have largely overcome some of the difficulties of employing ultrasound with this population and we predict a future increase in the clinical application of the tool.

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Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate

Cited by 5 publications

References 24 publications

A Mixed-Methods Pilot Randomised Control Trial of Ultrasound Visual Biofeedback versus Standard Intervention for Children with Cleft Palate +/- Cleft Lip: Parents’ and Children’s Perspectives.

A Mixed-Methods Pilot Randomised Control Trial of Ultrasound Visual Biofeedback versus Standard Intervention for Children with Cleft Palate +/- Cleft Lip: Parents’ and Children’s Perspectives.

How differences in anatomy and physiology and other aetiology affect the way we label and describe speech in individuals with cleft lip and palate

Ultrasound Tongue Imaging in Research and Practice with People with Cleft Palate ± Cleft Lip

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