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Table 2 WHO trial items

From: Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate

Data category Information
Primary registry and trial identifying number ISRCTN 17441953
Date of registration in primary registry 22 March 2021
Secondary identifying numbers  
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 joanne.cleland@strath.ac.uk
Contact for scientific queries joanne.cleland@strath.ac.uk
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