Work

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

Year: 2025

Type: article

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. TRIAL REGISTRATION: ISRCTN, ISRCTN17441953. Registered 22 March 2021.

Source: Pilot and Feasibility Studies

DOI: 10.1186/s40814-025-01640-6

Authors: Maria Cairney, Lisa Crampin, Linsay Campbell, Joanne Cleland

Institutions: University of Strathclyde, NHS Greater Glasgow and Clyde, Royal Hospital for Children

Language: English

Topic: Cleft Lip and Palate Research

Subfield: Genetics

Field: Biochemistry, Genetics and Molecular Biology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,490