Data category | Information |
---|---|
Primary registry and trial identifying number | ISRCTN 17441953 |
Date of registration in primary registry | 22 March 2021 |
Secondary identifying numbers | Â |
Source(s) of monetary or material support | Chief Scientist Office of Scotland |
Primary sponsor | University of Strathclyde |
Secondary sponsor(s) | N/A |
Contact for public queries | |
Contact for scientific queries | |
Public title | Ultrasound visual biofeedback versus standard treatment for children with cleft lip and palate |
Scientific title | SonoSpeech Cleft Pilot: a pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate |
Countries of recruitment | Scotland |
Health condition(s) or problem(s) studied | Cleft lip and palate |
Intervention(s) | Active comparator: ultrasound visual biofeedback |
Treatment as usual: articulation intervention | |
Key inclusion and exclusion criteria | Ages eligible for study: 4 to 16 years |
Sexes eligible for study: all | |
Accepts healthy volunteers: no | |
Inclusion criteria: speech disorders associated with cleft lip and palate | |
Exclusion criteria: no spoken English; severe hearing loss; severe learning disability | |
Study type | Interventional |
Allocation: randomized intervention model. Parallel assignment masking: single blind (investigator, outcomes assessor) | |
Primary purpose: treatment | |
Phase II | |
Date of first enrolment | October 2021 |
Target sample size | 40 |
Recruitment status | Recruiting |
Primary outcome(s) | 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 |
Key secondary outcomes | 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 6 weeks, and 3 months |