Quantitative results of SonoSpeech Cleft Pilot : a mixed-methods pilot randomised control trial of ultrasound visual biofeedback versus standard intervention for children with cleft palate ± cleft lip

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Cairney, Maria and Crampin, Lisa and Campbell, Linsay and Cleland, Joanne (2025) Quantitative results of SonoSpeech Cleft Pilot : a mixed-methods pilot randomised control trial of ultrasound visual biofeedback versus standard intervention for children with cleft palate ± cleft lip. Pilot and Feasibility Studies, 11 (1). 61. ISSN 2055-5784 (https://doi.org/10.1186/s40814-025-01640-6)

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Abstract

Background: Despite its growing popularity, there is limited evidence of the effectiveness of ultrasound visual biofeedback speech therapy for children with cleft palate ± cleft lip (CP ± L). This study reports on the findings of a pilot feasibility study of ultrasound visual biofeedback versus standard care. Results will be used to determine if a full-scale randomised controlled trial (RCT) is feasible. Methods: We used a mixed-methods pilot RCT. Participants were children aged 5–16 with repaired CP ± L and at least one compensatory articulation. Participants were randomised, stratified for age, to receive six sessions of either articulation therapy (standard care) or ultrasound visual biofeedback (U-VBF) therapy. Outcome indicators for progression to full trial were measured as percentage targets achieved including the following: participants recruited and retained; outcome measure completion; and therapy protocol adherence. Due to the nature of treatment, the treating Speech and Language Therapists (SLTs) and families were not blinded; however, the assessing SLTs were blinded to treatment allocation until the end of the trial. Results: Eight participants were randomised to articulation therapy and eleven to ultrasound. All participants’ data was included for analysis. All but one of the pre-determined criteria for moving to full trial were fully met and the remaining indicator was partially met. At least 75% of the following were achieved: outcome measure completion; therapy protocol adherence; participant retention in each arm of the study. The target number of participants, 20 per treatment arm, was not reached. Conclusion: Most feasibility measures were successful. This study suggests that a full RCT comparing articulation therapy to U-VBF therapy would be possible if the current recruitment strategy is addressed.

ORCID iDs

Cairney, Maria ORCID logoORCID: https://orcid.org/0000-0002-4350-6082, Crampin, Lisa, Campbell, Linsay and Cleland, Joanne ORCID logoORCID: https://orcid.org/0000-0002-0660-1646;
CORE (COnnecting REpositories)