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

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/design: 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: 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.