Communication in Children With or Without Biomedical Conditions: Speech and Language Profile, Related Outcomes and Articulation Treatment With Ultrasound
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 20-item probe list accuracy
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •No syndromes or obvious dysmorphic features
- •No language disorders associated with biomedical conditions (e.g., cerebral palsy, autism spectrum disorder)
- •No oronasal fistula identified on oral examination or diagnosed velopharyngeal insufficiency
Exclusion Criteria
- •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
Arms & Interventions
Immediate treatment group
Ultrasound-aided articulation therapy
Intervention: Ultrasound-aided articulation therapy (Behavioral)
Wait-list Control Group
No treatment for 4 weeks, and later having the same ultrasound-aided articulation therapy as immediate treatment group
Outcomes
Primary Outcomes
20-item probe list accuracy
Time Frame: Week0, Week4, Week8, Week16
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(Week1, Week 8, Week 16)
- Percentage Consonants Correct (PCC)(Week0, Week 16)
- PedsQL TM (Pediatric Quality of Life Inventory TM)(Week 0, Week 8,Week 16)
- Strengths and Difficulties Questionnaire (SDQ)(Week 0, Week 8, Week16)
- Parental Stress Scale (PSS)(Week0, Week 8, Week 16)
Investigators
Yiu Oi Yan
Principal Investigator
The University of Hong Kong