Skip to content

Ultrasound visual biofeedback versus standard treatment for children with cleft lip and palate

SonoSpeech Cleft Pilot: A pilot randomised control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17441953
Enrollment
40
Registered
2021-03-22
Start date
2021-08-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Speech disorders associated with cleft lip and palate Neonatal Diseases Cleft lip and cleft palate

Interventions

Children will be randomised in a 1:1 ratio stratified for age by the Glasgow Clinical Trial Unit. The research has five main time points, each described in more detail below: 1. Assessment 2. Six sess

Sponsors

University of Strathclyde
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 4 to 16 years 2. Diagnosis of cleft lip and palate (repaired)

Exclusion criteria

Exclusion criteria: 1. No spoken English 2. Severe hearing loss 3. Severe learning disability

Design outcomes

Primary

MeasureTime frame
Percentage targeted consonants correct measured using speech assessment as the percentage of treated speech sounds produced correctly in words at baseline, 6 weeks, and 3 months

Secondary

MeasureTime frame
1. Patient- and carer-reported speech function and intelligibility for children aged =8 years measured using the Intelligibility in Context Scale and the CLEFT-Q speech function scale at baseline, 6 weeks, and 3 months 2. Patient- and carer-reported quality of life for children aged =8 years measured using the CLEFT-Q quality of life scale at baseline, 6 weeks, and 3 months 3. Patient and carer satisfaction with both interventions measured using the Experience of Service Questionnaire at baseline, 6 weeks, and 3 months

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026