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

Maria Cairney, Lisa Crampin, Linsay Campbell, Joanne Cleland

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
Article number61
Number of pages17
JournalPilot and Feasibility Studies
Volume11
Issue number1
DOIs
Publication statusPublished - 6 May 2025

Funding

Source of monetary or material support is Chief Scientist Office of Scotland. Chief Scientist Office, Scottish Government Health and Social Care Directorate, TCS/20/02, Joanne Cleland

Keywords

  • cleft palate +/- cleft lip
  • articulation intervention
  • ultrasound visual biofeedback
  • speech therapy

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