About this trial
This prospective randomized controlled trial investigates the effect of ultrasound visual biofeedback as an adjunct to articulation therapy in children with speech sound disorders involving lingual targets. The intervention aims to facilitate acquisition of misarticulated sounds by providing real-time visualization of tongue movements. Participants are randomized 1:1 to immediate treatment or wait-list control, with stratification by disorder type, age, and gender where feasible. The wait-list control group continues usual care for 4 weeks before crossing over to receive the same intervention (ethical crossover design).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary diagnosis of speech sound disorder with errors on lingual target sounds
Probe accuracy <70% on the primary target sound at baseline
Cantonese as the first language
Hearing thresholds ≤25 dB in at least one ear, with no hearing loss exceeding 50 dB in the other ear
Disqualifiers
Presence of syndromes or dysmorphic features
Language disorder associated with biomedical conditions (e.g., cerebral palsy, autism spectrum disorder)
Hearing thresholds >25 dB in one ear and >50 dB in the other ear Planned surgical intervention during the study period
Trial design
Crossover
Treatments tested in this trial
Ultrasound-aided articulation therapy
BehavioralThe intervention under investigation is a motor-phonetic approach to articulation therapy, enhanced with ultrasound visual biofeedback (UVBF). The treatment group will receive the intervention immediately, while the waitlist control group will receive treatment after the initial group completes the study. This design allows for comparative outcome assessments between both groups, ensuring that all participants ultimately receive treatment.
Treatment groups
Trial outcomes
Primary outcomes
20-item probe list accuracy
Perceptual accuracy on an individualized 20-item target sound probe spanning varying linguistic levels (single words to narrative), reported in percentage.
Secondary outcomes
Intelligibility in Context Scale (ICS): Traditional Chinese
A 7-item parent-report measure of functional intelligibility across communication partners (parents, immediate family, extended family, friends, acquaintances, teachers, strangers), rated on a 5-point scale for each item (total averaged score 1-5); higher scores indicate better intelligibility.
Percentage Consonants Correct (PCC)
Derived from standardized perceptual speech assessment (HKCAT), a standardized word-level articulation test. PCC was calculated as the number of consonants produced correctly divided by total consonants, expressed as a percentage.
PedsQL TM (Pediatric Quality of Life Inventory TM)
A 23-item child self-report and parent-proxy measure of health-related quality of life across physical, emotional, social, and school functioning domains (score range 0-100); higher scores indicate better health-related quality of life.
Strengths and Difficulties Questionnaire (SDQ)
A 25-item parent-report behavioral screening tool assessing emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior (total difficulties score range 0-40); higher scores indicate more behavioral difficulties.
Sponsors and contacts
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